January 23 Update

After this blog was written, Sen. Orrin Hatch (R-UT) introduced S. 160, which would repeal the tax described below.  No need to look at the facts – just bow to special interests while trying to kill Obamacare!  To see which 5 Democrats and 23 other Republicans who support a bill that would help destroy Obamacare, scroll below this blog.  And make sure they hear from you!

Congress is Up to Something. The Huffington Post.

by guest blogger Diana Zuckerman, PhD, National Center for Health Research

If you think health insurance should be affordable and you didn’t get a 65 percent raise over the last two years, keep reading!

Congress is up to something, and only you can prevent it from happening. Even though the upcoming Supreme Court decision about the Affordable Care Act could drastically curtail it, that may not be the greatest threat to the millions of Americans who don’t want to lose their health insurance.

A greater threat comes from certain U.S. companies and from hundreds of members of Congress, and the culprits might surprise you.

The senators and representatives you need to worry about include some of the most conservative Republicans, but also some Democrats that are usually strong supporters of patients and consumers–including Elizabeth Warren, Chuck Schumer, and Barbara Mikulski.

And they’re bowing to pressure from companies that advertise on NPR, your favorite TV shows, and other media, touting how they save lives every day. In truth, these companies do save lives. But they also make billions of dollars and don’t feel like giving any of it to help pay for the Affordable Care Act, as the legislation requires. And that could be fatal to countless Americans.

This is what happened: The three industries that would benefit from millions more insured Americans were asked to make small financial compromises to help pay the cost of subsidies that would make health insurance affordable to millions more Americans. The compromises included lowering certain prices, limiting profits, or paying a small excise tax on products sold.

Two of the industries kept their agreements, but the third immediately tried to repeal the part of the law that affected it.

No, it’s not Big Pharma that is the problem. Those companies understand how the Affordable Care Act helps their bottom line and their patients.

It’s not the insurance companies, either. They fought the Affordable Care Act but eventually agreed to the terms that have helped keep prices under control. They haven’t reneged, and they even lined up in greater numbers to sell policies at lower costs through the state exchanges this year.

The problem includes companies that make lifesaving heart valves and stents, hip and knee replacements, PT scanners and mammography machines, and the contact lenses that millions of us rely on.

The medical device companies selling these and other products spent more than $150 million to try to repeal a 2.3 percent tax on the devices they sell in the U.S. These include implants that cost $20 to make but that sell for $500, as well as devices that sell for half a million dollars but are as obsolete as your iPhone 2 after a few years.

They’re complaining to Congress that the tax is killing jobs and cutting funds for the research and development needed to create the innovative products that patients deserve. If they get their way and the tax is repealed, there will be $29 billion less to pay for health insurance over the next decade, and we can expect Pharma and the insurance companies to try to get out of their contributions, as well.

I’m a scientist, so I decided to examine the evidence for the “job killing” and other claims made by the device companies.

First we looked at stock prices–all publicly available online. Not all device companies have publicly traded stock, but the ones complaining the loudest about the device tax do. We looked at the 12 largest U.S.-based companies that sell nothing but devices (not ones that also sell pharmaceuticals or appliances). In the two years since the tax started, their stock went up a whopping 65 percent on average–much more than the NY Stock Exchange (25 percent) or the largest U.S.-based pharmaceutical companies (54 percent).

Then we looked at sales. Sales steadily increased over the last decade, including after the device tax was implemented. So, there would seem to be no reason to cut jobs and every reason to hire more workers.

What about R & D costs to develop new products and possibly hire new workers? Again, a steady increase over the decade, and after the tax went into effect.

What about profit margins? These were stable over the decade for most companies, despite the 2008 economic meltdown and despite the device tax. Again, no reason to cut jobs or raise a ruckus about the tax.

And yet, the House of Representatives has passed several bills that include repealing the tax, and the Senate passed a bipartisan resolution declaring its opposition to the tax. Fortunately, the resolution specified support for repeal only if another source is designated to make up for the $29 billion in revenues that the tax would provide.

Finding another $29 billion seems unlikely, yet congressional leaders keep saying there is overwhelming support to repeal the tax, and journalists repeatedly report that “widespread bipartisan opposition” to the tax will inevitably result in a repeal.

If that happens, the dominoes start to fall and the Affordable Care Act would become unaffordable.

Don’t let that happen. Here’s more information and the Senate voting record on repealing the tax. Let your voice be heard.

Diana Zuckerman is the president of the National Center for Health Research. She received her PhD from Ohio State University and was a post-doctoral fellow in epidemiology and public health at Yale Medical School. After serving on the faculty of Vassar and Yale and as a researcher at Harvard, Dr. Zuckerman spent a dozen years as a health policy expert in the U.S. Congress and a senior policy adviser in the Clinton White House. She is the author of five books, several book chapters, and dozens of articles in medical and academic journals, newspapers, and websites.

Around the same time this blog went online, 29 Senators co-sponsored a new bill to repeal the medical device excise tax: 5 Democrats and 23 Republicans.  Contact the senators who haven’t co-sponsored S. 149, to urge them to reject this bill. 

And if any of your senators have signed on, let them know how you feel: 

S.149: Medical Device Access and Innovation Protection Act
Sponsor: Sen Hatch, Orrin G. [UT] (introduced 1/13/2015)      Cosponsors (28)
Related Bills: H.R.160
Latest Major Action: 1/13/2015 Referred to Senate committee. Status: Read twice and referred to the Committee on Finance.

COSPONSORS(28), ALPHABETICAL:

Sen Alexander, Lamar [TN] – 1/13/2015
Sen Ayotte, Kelly [NH] – 1/13/2015
Sen Barrasso, John [WY] – 1/20/2015
Sen Blunt, Roy [MO] – 1/21/2015
Sen Burr, Richard [NC] – 1/13/2015
Sen Capito, Shelley Moore [WV] – 1/21/2015
Sen Casey, Robert P., Jr. [PA] – 1/13/2015
Sen Cassidy, Bill [LA] – 1/13/2015
Sen Coats, Daniel [IN] – 1/13/2015
Sen Collins, Susan M. [ME] – 1/20/2015
Sen Crapo, Mike [ID] – 1/20/2015
Sen Donnelly, Joe [IN] – 1/13/2015
Sen Flake, Jeff [AZ] – 1/22/2015
Sen Franken, Al [MN] – 1/13/2015
Sen Gardner, Cory [CO] – 1/20/2015
Sen Inhofe, James M. [OK] – 1/20/2015
Sen Isakson, Johnny [GA] – 1/13/2015
Sen Kirk, Mark Steven [IL] – 1/20/2015
Sen Klobuchar, Amy [MN] – 1/13/2015
Sen Lankford, James [OK] – 1/21/2015
Sen Moran, Jerry [KS] – 1/20/2015
Sen Murkowski, Lisa [AK] – 1/13/2015
Sen Portman, Rob [OH] – 1/13/2015
Sen Roberts, Pat [KS] – 1/20/2015
Sen Scott, Tim [SC] – 1/13/2015
Sen Shaheen, Jeanne [NH] – 1/13/2015
Sen Toomey, Pat [PA] – 1/13/2015
Sen Wicker, Roger F. [MS] – 1/13/2015

 

By Anna E. Mazzucco, PH.D.

December 27, 2013

 

Quitting  smoking is hard to do, and new studies suggest that what works for men may not always work for women, and vice versa.  Scientists believe that nicotine is more important for men, while other aspects of smoking seem to be more important for women.  If you are trying to quit, there’s new research that may help you choose the strategy that is most likely to work for you.

Many counselors, quit lines, and other experts recommend talking with your doctor about your interest in quitting or cutting back on the number of cigarettes you smoke. Your doctor will discuss different tools and medications, some of which require a prescription.  Nicotine patches and gum, for instance, can be purchased without a prescription.  These are often used to “step down” nicotine levels (see this article for more information),  but studies have suggested that these medications may work better for men than women, especially when it comes to quitting for good. 1  Other types of medication to help you quit smoking, such as prescription drugs Chantix and Zyban, do not replace nicotine, but instead try to reduce the craving for it.  But these drugs are riskier and have more side effects than nicotine replacements (see this article for more information).

So, what are the other options, especially for women who may not be helped as much by nicotine patches or gum, and who don’t want to use prescription medicines with serious side effects?  Most experts suggest the following:

  1. Plan for success.  Start by picking a good time to quit.  Experts recommend choosing a time of year that is not particularly stressful, since quitting can take a lot of energy.  You might try setting a goal like a “smoke-free” date that is personally meaningful to you—maybe your or a loved one’s birthday, or a holiday.  Some people decide to save the money they would have spent on cigarettes for something special.  If watching your savings accumulate is helpful, consider putting a glass jar somewhere where you can easily see it and get re-inspired daily!  Interestingly, one study showed that women who try to quit during the first half of their monthly cycle (right after menstruation) are more likely to succeed.2
  2. Know yourself.  Quitting can be more successful if you try to identify the situations where you tend to smoke.  Do you have a particular time of day, or group of people that you enjoy smoking with? Anticipate these situations and come up with plans for how to handle them ahead of time.
  3. Find healthier replacements.   Some people find mint gum, lozenges, sunflower seeds or shelled nuts can help reduce their craving for a cigarette.   This may be especially important for women, who often need to replace the hand-to-mouth aspects of smoking as much or more than the nicotine itself.  Research suggests that certain foods might make cigarettes less appealing, such as healthy fruits and vegetables and spicy foods, which might curb the craving for a strong taste.3  Even brushing your teeth can help keep cravings at bay!
  4. Be good to your body.  Regular exercise, such as brisk walking, jogging, yoga or tai chi, can help reduce stress and increase a sense of well-being.  Research suggests that these feel-good replacements may be especially useful for those who smoke to cope with stress. 4  Lungs can quickly begin to heal once you quit smoking.  So breathe deeply and enjoy!
  5. Call in reinforcements.  Next time you feel a craving, try calling a friend, or consider joining a support group.  There are also online quitting tools such as TheExPlan, SmokeFree Women Quit Plan, QuitNet, and Freedom From Smoking Online.  And, you guessed it, there are now many “quitting apps” such as Smoke Out, tweetsmoking, Butt Out, Livestrong MyQuit Coach, and Smoke Break.   Apps can help you count the days since your last cigarette, calculate money saved, show your decreasing risks for diseases, and share your progress with others– and many of them are free. (For a detailed review, see this site). There are also many websites with useful information and links, compiled here by the Center for Disease Control.

 

December 19, 2014

Margaret A. Hamburg, M.D.
Commissioner
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002

Re: Anti-Infective Drugs Advisory Committee (AIDAC) Meeting on December 5, 2014

Dear Commissioner Hamburg,

We are writing as members of the Patient, Consumer, and Public Health Coalition to express our strong concerns about the approval standards considered and the conflicts of interest apparent at the December 5, 2014 FDA meeting of the Anti-Infective Drugs Advisory Committee (AIDAC) regarding a new combination antibiotic product, ceftazidime-avibactam (CAZ-AVI). This antibiotic was being considered for three indications: complicated intra-abdombinal infections (cIAI), complicated urinary tract infections (cUTI), and aerobic gram-negative infections, including HABP/VABP (hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia).

All of us understand the dangers posed by antibiotic resistance and our diminishing ability to treat serious infections. However, as you know, ineffective antibiotics worsen antibiotic resistance and simultaneously expose patients to unnecessary risks while delaying administration of effective treatment. From this perspective, we were deeply troubled by the minimal evidence presented by the sponsor in support of this application, and the overall regulatory approach being taken by the FDA, including use of the section 505(b)(2) pathway for this new entity and its indication for use among a poorly defined patient group. Specifically,

– Limited clinical experience with CAZ-AVI did not meet the FDA standard of substantial evidence for any indication

    • There was Phase III level data only for one indication (cIAI), and those data were preliminary data from one trial, which was not reviewed by the FDA prior to the Advisory Committee meeting. It is not clear why the Advisory Committee meeting was not rescheduled to be held after the FDA had time to review and it is shocking that FDA scientists made it clear in the briefing material that FDA review of the data was not essential prior to approval.
    • The evidence for cUTI and remaining evidence for cIAI included preliminary interim results from one ongoing pooled open-label trial, two small phase II trials and a meta-analysis, all of which had substantial inadequacies, described in detail in this letter. This is completely inadequate and should not have been considered sufficient to be considered for recommending approval by an Advisory Committee.
    • There was absolutely no human data to support the last indication, for aerobic gram-negative infections, including HABP/VABP (hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia). We strongly believe that including this untested indication for review by an Advisory Committee sets a terrible precedent for companies seeking approval for their drugs.

 Submitted studies all had significant limitations identified by the FDA

    • We agree with the FDA scientists regarding the interim results of the open-label trial for cIAI and cUTI, who stated “there are concerns about exchangeability of subjects due to potential differences in doses and infusion time, baseline patient and disease characteristics, prognostic factors and the supportive care they had received.”
    • The FDA briefing material described the phase II trials for cIAI and cUTI as having “no pre-specification of any formal hypotheses for inferential testing, and statistical analysis is limited to descriptive data summaries.” The FDA briefing material described the sponsor’s meta-analysis as having “considerable uncertainties in these studies…they are not similar with respect to design, dose, and duration of treatment, baseline disease characteristics, timing of assessment and other factors.” We agree.

Taken together, these studies do not constitute the substantial evidence of safety and efficacy required by the FDA. Scheduling an Advisory Committee meeting to even consider three indications with so little scientific evidence to support them sends a message that the FDA has drastically lowered its bar for the evidence needed for approval. It is disturbing that most Advisory Committee members did not seem to understand the low quality of these data and how risky it would be to use these unproven drugs, and recommended approval for two out of the three indications being sought (for both cIAI and cUTI). This raises questions regarding the limited scientific expertise of these Committee members, most of whom are primarily clinicians. It may be that the data on the first 2 indications were perceived as adequate only because they were better than the data for the 3rd indication, which received a unanimous rejection from Committee members.

– Safety and efficacy concerns were identified in the preliminary analysis of the phase III study; the study has not yet been reviewed by the FDA

    • The preliminary results of the phase III trial for cIAI had 8 deaths (26%) in the CAZ-AVI + MTZ group versus only 3 deaths (9%) in the comparator group, among patients with moderately impaired renal function. These patients, who are a significant clinical demographic, also had a lower clinical cure rate (45% in the CAZ-AVI group versus 74% in the comparator group). The sponsor stated that the mortality imbalance was unlikely to be due to the study drug and that the observed lack of efficacy is likely due to drug underexposure. That is a biased interpretation of scientific data, given that the briefing material from both the FDA and the sponsor indicated that the small size of this subgroup made these findings difficult to interpret. Follow-up studies are needed to address these concerns before patients with compromised renal function are exposed to the drug. Otherwise, these patients may be put needlessly at risk when more effective treatment options already exist. It was very disappointing that the committee voted 11 to 1 in favor of recommending approval for this indication despite the paucity of evidence. While this was the only indication with Phase III data, the results were very worrisome and the FDA should reject the Advisory Committee’s ill-considered recommendation.

 Questionable use of the section 505(b)(2) pathway

    • The FDA background document stated that “The Agency’s regulatory approach to this NDA is to rely on the Agency’s prior finding of safety and effectiveness of ceftazidime. The contribution of avibactam will be demonstrated by in vitro studies, animal models of infection and with limited clinical data. Safety of avibactam will be determined from Phase 1 studies of avibactam alone and phase 1 and 2 studies of CAZ-AVI.”

This combination still represents a novel drug entity with unique properties; therefore, we find application of the section 505(b)(2) pathway here inappropriate. The FDA background document asserts that “the avibactam component is a new chemical entity that is not currently marketed in any country, either alone or in combination.” In the 1970 Upjohn versus Finch court case, it was determined that for “…combination drugs purported to have advantages exceeding those of the components, there must be adequate, well-controlled data documenting the claimed advantages.”5 As the mechanism-of-action of avibactam is to restore activity of ceftazidime among certain ceftazidime-resistant pathogens, CAZ-AVI meets the definition described in Upjohn versus Finch, and renders invocation of the 505(b)(2) pathway here dubious at best.

– Poorly defined indication for use among those with “limited or no alternative treatment options” could easily result in dangerous overuse

The last indication being sought by the sponsor was described in the FDA briefing materials as for “aerobic gram-negative infections with limited or no alternative treatment options including HABP/VABP.” However, in the sponsor’s presentation at the meeting, their wording of this indication was exclusively “no alternative treatment options.” This discrepancy was noted by the advisory committee and prompted the use of an additional voting question to separately address each of these possible wordings. This action by the Advisory Committee highlights the importance of clearly defining the intended patient population. The term “limited options” is vague and is likely to be used to justify exposure of patients to treatments that have increased risks when safer and more effective treatments are available.

 Potential conflict of interest not disclosed during the open public hearing

Open public hearing speakers are encouraged to share any conflicts of interest with the committee at the beginning of their testimony. At the December 5 meeting and other meetings of this committee, we have observed speakers who state that they have no conflicts of interest, but they don’t mention that they represent organizations that have substantial financial ties to companies with conflicts of interest. In addition, IDSA is treated by FDA as an independent voice, when in fact their membership has significant ties to the companies that make antibiotics. In the interest of a transparent meeting process, the FDA should encourage speakers to disclose not only individual conflicts of interest, but also potential conflicts of interest for organizations that they represent.

In summary:

  1. All studies submitted by the sponsor had serious limitations and do not meet the evidential standard of the FDA.
  2. The regulatory approach taken by the FDA is based on improper use of the 505(b)(2) pathway and poorly defined patient populations. Because they have not clearly defined the target population, this is likely to result in needless risk for patients.
  3. There were NO studies in humans to support the indication for aerobic gram-negative infections, including HABP/VABP (hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia). This indication was rejected by the Advisory Committee but should not have even been included for consideration.
  4. Presenters at open public hearings should be encouraged to disclose both individual and organization-level conflicts of interest.

We strongly urge the FDA to require the sponsor to complete all ongoing phase III studies, as well as its own review, before considering CAZ-AVI for approval for any indication. Indications which are intended for patients with few existing treatment options should be more clearly defined in order to prevent use of the drug by patients who are more likely to be harmed than helped by a drug approved only for a narrow targeted population.

Sincerely,
American Medical Student Association
Annie Appleseed Project
Breast Cancer Action
Center for Medical Consumers
Connecticut Center for Patient Safety
Jacobs Institute of Women’s Health
MISSD
National Center for Health Research
National Women’s Health Network
Our Bodies Ourselves
The TMJ Association
WoodyMatters

Contact Information: Anna Mazzucco, PhD at (202) 223-4000 or am@center4research.org

By Dr. Anna Mazzucco, Ph.D

Thank you for the opportunity to speak today at this very important meeting.  My name is Dr. Anna Mazzucco, and I am speaking on behalf of the National Center for Health Research.   I received my Ph.D. in cell biology from Harvard Medical School, and I conducted post-doctoral research here at NIH. Our nonprofit organization conducts research, scrutinizes data in the research literature, and then explains the evidence of risks and benefits to patients and providers.  [Our organization does not accept funding from companies that sell medical products, and therefore I have no conflicts of interest.]

I am speaking as a scientist who appreciates the power of data and who also wants patients and physicians to have the best information possible before they make potentially life and death decisions.  The FDA released new guidance on laboratory-developed tests because of evidence that patients are harmed by faulty tests.

We applaud the FDA for their plan to improve oversight of lab tests and the NIH for their commitment to medical care. We have a few key points:

  • Many of these tests are used to diagnose a disease or determine a course of treatment.  If the test doesn’t work correctly, the patient may be exposed to risks from a treatment they didn’t need, OR not receive treatment that would help them.
  • When the FDA started regulating devices almost 40 years ago, these tests were very different.  They are now widespread and are the basis of high-risk decisions.
  • Under CLIA, test makers do not have to demonstrate “clinical validity”.  At FDA, approval standards include safety and effectiveness.  FDA review will improve transparency and data quality.
  • Current policies do not require adverse event reporting or manufacturing safeguards.  FDA approval does.  Patients using high-risk diagnostics deserve those protections.

Our Center has frequently urged the FDA to improve their oversight of medical devices. Despite past criticisms, we believe it is essential that FDA have the authority to regulate laboratory-developed tests in order to stimulate even better science, and help ensure that patients receive the full benefit of our growing scientific knowledge.

To paraphrase Dr. Josh Sharfstein’s JAMA article:

Patients travels in ambulances that are regulated, to hospitals that are regulated, for care using medicines that are regulated, administered by nurses and physicians, who are regulated. That same patient’s life or death should NOT depend on whether an unregulated diagnostic test result is accurate.

Thank you for the opportunity to speak today.

 

This is a sample of the letters that were sent to key Democrats and Republicans in the House and Senate in January 2015. To view this sample letter as a PDF, click here.  To view a sample of an earlier version of our letter to key Congressional leaders on this topic, click here.

January 9, 2015

The Honorable Mitch McConnell
Majority Leader
United States Senate
Washington, DC 20510

Dear Majority Leader McConnell,

We are writing to challenge the claim that the 2.3% excise tax on medical devices should be repealed because it is harming medical device companies.  As scientists, we decided to scrutinize the evidence, and found that medical device companies have continued to prosper since the tax went into effect in January 2013.

We examined the stock prices, profit margins, sales, and R & D spending of the 12 largest companies[1] based in the United States that exclusively make medical devices.

We compared stock prices on the day the law went into effect and on its two year anniversary.  As you can see in our chart below, stock prices for the 12 companies increased by 6% to 126% with an average increase of 66%. Medical device makers strongly outperformed the New York Stock Exchange Composite Index, which increased by 25% during that same period, and NASDAQ, which increased 52%. The device company stocks increased even more than stocks in the top US-based pharmaceutical companies, which increased 54% during the same two years. And, over the last decade, profit margins for the 12 largest device companies averaged between 9-17% (except for 1% in 2009), and the most recently reported  12-month profit margins averaged above 15%.

Device Company Close on 1/2/2013 Close on 1/2/2015 % change in last 2 years Net Profit Margin for the last 12 months*
Boston Scientific (NYSE:BSX) $5.89 $13.22 124% 3.9%
St. Jude Medical (NYSE:STJ) $36.61 $64.94 77% 14.8%
Allergan (NYSE:AGN) $94.04 $212.75 126% 18.6%
Zimmer Holdings (NYSE:ZMH) $67.70 $112.59 66% 17.0%
CareFusion (NYSE:CFN) $29.28 $59.43 103% 10.6%
CR Bard (NYSE:BCR) $101.83 $167.48 64% 25.5%
Medtronic (NYSE:MDT) $41.88 $71.88 72% 16.8%
Stryker (NYSE:SYK) $55.88 $93.99 68% 6.7%
Hologic (NasdaqGS:HOLX) $20.47 $26.38 29% 0.7%
Varian Medical Systems (NYSE:VAR) $72.47 $87.02 20% 13.2%
Edwards Lifesciences (NYSE:EW) $92.14 $127.72 39% 34.7%
Intuitive Surgical (NasdaqGS:ISRG) $497.52 $525.57 6% 20.8%
AVERAGE 66.2% 15.3%
N.Y. Stock Exchange Composite Index $8,632.01 10,830.92 25%
NASDAQ $3,112.26 $4,726.81 52%

*Data from nytimes.com on 1/7/15 representing trailing 12 months of data posted by the companies.

More detailed information about the top device companies is included in the attached chart, which provides data from 2005 or earlier, depending on the indicator.  As you can see, sales have steadily increased since 2005, R & D spending has steadily increased, and profit margins are remarkably stable from year to year.  There is absolutely no evidence that the device tax had a negative impact. Please note, we have R & D statistics and sales for 2013, but 2014 data won’t be posted until February.

Of course, stock prices and other economic indicators are influenced by many factors, including acquisitions and mergers, new blockbuster products, and frightening recalls.  However, the trends are absolutely clear: the device companies are doing well (despite some expensive, well-publicized recalls of medical devices in recent years) and there is no indication of problems resulting from the device tax when 2013 and 2014 indicators are compared to any of the last 10+ years.

As the Washington Post Fact Checker reported yesterday, there is no objective evidence that small device companies were harmed by the device tax.  In fact, a January 2014 survey of 1,203 senior managers at U.S. medical device companies by Emergo Group, a medical device industry consulting firm, found that 50% did not make any significant changes in response to the tax.[2] Fewer than 9% said they reduced staff or employee headcounts in 2013 to lower costs.  We agree with the Fact Checker article that these data are more meaningful than the more subjective predictions made by only 38 device companies that responded to the AdvaMed survey; moreover, with its response rate of less than 13%, the AdvaMed survey is not considered scientifically valid.

Device companies are thriving because about 10 million Americans have obtained health insurance through the Affordable Care Act and millions more through Medicaid expansion.[3]  The ACA is greatly benefiting medical device manufacturers because baby boomers and others no longer have to wait for Medicare coverage in order to have diagnostic tests, joint replacements, cardiac surgery, and other surgeries and treatments that involve devices. Like the other levies in the ACA, the device tax was designed to ensure that the companies that are benefiting from the ACA will do their part to help support it.

According to the Joint Committee on Taxation, repealing the excise tax on medical devices would cost more than $29 billion over 10 years,[4] which our economy cannot afford.  It is also worth noting that U.S. Taxpayers are paying a disproportionate share of the cost of medical devices, since the prices of devices in the U.S. far exceed the prices for the same devices sold in other comparable countries, and these costs contribute to the higher costs of health care in the U.S. compared to other countries with longer life expectancies.[5], [6]

As our charts (above and attached) show, the medical device industry is highly profitable and is thriving since they started paying the excise tax.  Whether or not the manufacturers increase the cost of their devices by 2.3% as a result of the tax, it has had or would have almost no impact on the cost of consumers’ health care or insurance, given the many other factors contributing to the high cost of health care.[7]  In fact, the cost of health care increased less from 2013 to 2014 than it has in the past 10 years.[8]

It is important to note that Congress designed the excise tax so that it applies equally to imported and domestically produced devices, and does not apply to devices produced in the U.S. for export, so there would be no benefit for manufacturers to shift production overseas.

Thank you for your commitment to the fiscal integrity of our economy.  The medical device industry has spent nearly $150 million in lobbying to repeal the medical device excise tax,[9] but lobbying clout should not be the deciding factor regarding a tax that is estimated to provide $29 billion to the U.S. budget over the next 10 years and is being used to expand Medicaid and provide affordable health insurance for your constituents and millions of other Americans.

Sincerely,

Diana Zuckerman, PhD, President

 

 

[1] We selected the 12 largest US-based companies that primarily or exclusively sell devices from the top company listed on Medical Device and Diagnostic Industry (December 14, 2013). Top 40 Medical Device Companies. http://www.mddionline.com/article/top-40-medical-device-companies

[2] Lee, M (January 7, 2015). Fact Checker: Has the medical device tax eliminated ‘thousands’ of jobs? The Washington Post.  http://www.emergogroup.com/resources/research/annual-medical-device-industry-survey

[3] New York Times (November 11, 2014). The Upshot: Affordable Care Act Enrollment FAQs.http://www.nytimes.com/interactive/2014/11/11/upshot/obamacare-facts-affordable-care-act-enrollment.html?module=Search&mabReward=relbias%3Aw%2C%7B%221%22%3A%22RI%3A11%22%7D&abt=0002&abg=0

[4] Joint Committee on Taxation (May 29, 2012). Description of H.R. 436, the Protect Medical Innovation Act of 2011. https://www.jct.gov/publications.html?func=startdown&id=4431

[5] Angrisano C, Farrell D, Kocher B, Laboissiere M, Parker S. (January 2007). Accounting for the Cost of Health Care in the United States.  McKinsey Global Institute. http://www.mckinsey.com/insights/health_systems_and_services/accounting_for_the_cost_of_health_care_in_the_united_states

[6] Farrell D, Jensen E, Kocher B, MD, Lovegrove N, Melhem F, Mendonca L, Parish B (December 2008). Accounting for the cost of US health care: A new look at why Americans spend more. McKinsey Global Institute. http://www.mckinsey.com/insights/health_systems_and_services/accounting_for_the_cost_of_us_health_care

[7] Center on Budget and Policy Priorities (October 2, 2013).  Excise Tax on Medical Devices Should Not Be Repealed, Industry Lobbyists Distort Tax’s Impact   http://www.cbpp.org/cms/?fa=view&id=3684

[8] U.S. Bureau of Labor Statistics. Medical Care. http://data.bls.gov/timeseries/CUUR0000SAM?output_view=pct_12mthsNew York Times (November 11, 2014). The Upshot: Affordable Care Act Enrollment FAQs.

[9] USA Today editorial (January 4, 2015). Keep medical device tax: Our view.  http://www.usatoday.com/story/opinion/2015/01/04/obamacare-medical-device-tax-repeal-congress-editorials-debates/21261737/

 

 

December 22, 2014
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061

Rockville, MD 20852

Comments of members of the Patient, Consumer, and Public Health Coalition on
the proposed order on Reclassification of Iontophoresis Devices Intended for Any Other Purposes

 Docket No. FDA-2000-N-0158

As members of the Patient, Consumer, and Public Health Coalition, we strongly oppose the down classification of iontophoresis devices intended for any other purposes from Class III to Class II (special controls).  This down classification could needlessly expose patients to harm, and would eliminate essential safeguards.

On February 21 of this year, a member of our coalition, the National Research Center for Women & Families (which subsequently changed its name to the National Center for Health Research (NCHR)), testified at the advisory committee meeting of the Orthopedic and Rehabilitation Devices Panel in opposition to down classification of these devices.  While this federal register notice states that “FDA is proposing this reclassification on its own initiative based on new information,”[1]  we challenge that statement.  The FDA has not provided evidence that there is sufficient new information to justify this down classification since the date of the advisory committee meeting, or since the original Class III designation of these devices in 1979.

At the time of the February meeting, several safety issues had previously been reported to the FDA through the Manufacturer and User Facility Device Experience (MAUDE) database for iontophoresis devices intended for other uses. As stated at the February FDA meeting, NCHR researchers found 40 adverse event reports in MAUDE in the previous five years; it is widely recognized that MAUDE reports represent a small fraction of adverse events.  Even so, the 40 reports include 12 burns, including 6 patients with third degree burns.  In the Federal Register notice, the FDA identified several other risks to health, including electric shock, insufficient or excessive delivery, interference with other medical devices, adverse tissue reactions, infection, and ear trauma. Device malfunction is a potential cause cited by the FDA for several of these serious risks.

The Federal Register notice states that the FDA seeks to down-classify these devices because “general controls and special controls are sufficient to provide a reasonable assurance of safety and effectiveness.”1 We strongly disagree.  Device malfunction has been implicated in several of the identified risks to health, and that won’t necessarily be prevented with special controls such as performance testing.  Manufacturing inspections prior to marketing would help ensure that these devices are constructed properly and therefore be less likely to cause third degree burns and other injuries. Unfortunately, down classification to Class II will eliminate such inspections, which are only conducted for Class III devices approved through the PMA process.

Another risk mitigation strategy proposed by the FDA is a labeling warning about adverse systemic effects.  As clinicians and patients may not see or read the label, this safeguard is not sufficient to protect patients from dangerous doses due to misuse or malfunction of these devices.  We do feel a label warning of potential systemic side effects should be directly affixed to these devices, rather than being placed on either a loose informational sheet or on the packaging, as both these can easily be misplaced.

A critical difference between Class III and Class II devices is that for companies making new models of Class II devices will never have to demonstrate safety or effectiveness.  They will only have to show that their devices are substantially equivalent to other devices currently or previously on the market.   In this situation, it would be possible for a new iontophoresis device to be cleared even if it is substantially equivalent to the worst iontophoresis device previously on the market.  Without the more thorough safety data required for Class III devices through the PMA process, we will never have comparative safety research to determine which of these devices are most likely to harm patients. By not requiring proof that a new device is itself safe and effective, FDA is asking patients to take unnecessary risk.

Conclusion

After examining the adverse event reporting, risks associated with these devices, and proposed mitigation strategies, we strongly oppose the down-classification of iontophoresis devices “intended for any other purposes” to Class II.  Patients deserve such devices to be tested for safety and effectiveness, as well as inspected to make sure they were manufactured correctly.   Retaining Class III status and approving the device through the more rigorous PMA process is the best way to protect patients from preventable injuries from these devices.  In addition, we feel that a labeling warning from the FDA about adverse systemic effects should be included by direct attachment to such devices.

Annie Appleseed Project

Center for Medical Consumers

Jacobs Institute of Women’s Health

National Center for Health Research

National Physicians Alliance

Center for Science and Democracy, Union of Concerned Scientists

WoodyMatters

The Patient, Consumer, and Public Health Coalition can be reached through Paul Brown at (202) 223-4000 orpb@center4research.org

[1] Federal Register Volume 79, Number 183 (Monday, September 22, 2014).  Proposed order on Reclassification of Iontophoresis Devices Intended for Any Other Purposes [Docket No. FDA-2000-N-0158].

December 15, 2014

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Comments of members of the Patient, Consumer, and Public Health Coalition on
the proposed order to reclassify External Pacemaker Pulse Generator devices and Pacing System Analyzers
Docket No. FDA-2011-N-0650

As members of the Patient, Consumer, and Public Health Coalition, we strongly oppose the down-classification of External Pacemaker Pulse Generator (EPPG) devices and Pacing System Analyzers (PSAs) from Class III to Class II. EPPGs are clearly life-sustaining devices and they should remain in Class III and be reviewed by the more rigorous Premarket Approval (PMA) process, which will better ensure that the devices are safe and effective.

The Cardiovascular Devices Panel stated on March 9, 1979 that these devices should be classified into Class III because the device “provided temporary life-support and that certain kinds of failures could cause this device to emit inappropriate electrical signals, which could cause cardiac irregularities and death.”6] This statement is as accurate today as it was then, as one of the uses for these devices listed in the 2014 FDA Federal Register notice is as “a temporary substitute for the heart’s intrinsic pacing system until a permanent pacemaker can be implanted.”7.]

One of the predictable tragedies if this life-saving device malfunctions would be death.  A review of the Manufacturer and User Facility Device Experience (MAUDE) database for the last five years (1/01/2010 through 11/30/2014) shows reports of 25 deaths associated with EPPG devices (product code DTE), 264 reports of injuries, and more than 3,500 malfunctions.8 The FDA proposed order states that “The low frequency of serious adverse events” reported in the MAUDE database supports “the reclassification of these devices to class II.”2  We don’t consider 25 deaths, 264 injuries, and more than 3,500 malfunctions a “low frequency” and point out that other devices have been restricted or recalled for much lower rates of reported serious adverse reactions.  The FDA’s Total Product Life Cycle (TPLC) database is consistent with the high MAUDE numbers we found. TPLC data shows 3,235 problems reported for EPPG devices in the last five years.9 Unfortunately, as the FDA knows well, adverse events are almost always greatly under-reported, especially when problems have not been widely reported in the media.

While the FDA states in the 2014 Federal Register notice that they believe new information since the 1979 designation warrants reclassification of these devices into Class II with special controls, the recent data from the MAUDE and TPLC databases irrefutably contradicts that proposal.

The 2011 Federal Register notice stated that these devices pose “risks to health,” including a failure of the electronic circuitry, which can cause failure to pace the patient’s heart; improper pacing leading to high rate-electric failure, which can lead to arrhythmias or unwanted stimulation; and micro/macro shocks resulting in an arrhythmia or cardiac tissue damage.1  The 2014 Federal Register notice adds an additional risk of “misdiagnosis,” which can result in the physician prescribing “a course of treatment that places the patient at risk unnecessarily.”2 The above-mentioned adverse events reported and these newly identified risks to health suggest that EPPG devices should stay in Class III.

Several risks associated with these devices cannot be adequately mitigated by Class II with special controls.  For example, “Failure to pace” is listed as one of the risks associated with these devices, which can be caused by “failure of mechanical/electrical components of the device.”2 Non-clinical performance testing cannot prevent malfunctions of individual devices.  Instead, manufacturing inspections, a key feature of the PMA process, are absolutely essential to ensure that these devices are properly manufactured.  For these reasons, Class II with special controls for EPPG devices do not provide reasonable assurance of their safety and effectiveness.

Regarding Pacing System Analyzers (PSA), we oppose the down-classification of the device from Class III device to Class II because for the six identified risks of the device (including “Micro/Macro Shock”2), the FDA relies on labeling to mitigate the risks.  We strongly doubt that labeling will adequately reduce risks since the preponderance of evidence indicates that health care providers often do not read or follow labeling instructions.

 

Conclusion

In January 2012, members of the Patient, Consumer, and Public Health Coalition submitted comments opposing the down-classification of EPPG devices. The FDA stated that in 2012 it received the following comments on the proposed reclassification: EPPG devices should stay in Class III, that the reclassification was “not adequately supported by new publicly valid scientific evidence” and that the performance standards (special controls) “are insufficient.”2 Those comments are still valid today.  The FDA has not provided any scientific evidence to contradict them.

At a September 11, 2013 Advisory Committee meeting, one of our coalition partners, the National Research Center for Women & Families (which has since changed its name to the National Center for Health Research) spoke against the down-classification.

In conclusion, after reviewing the regulatory history, adverse event reporting, and risks associated with these devices, we strongly oppose down-classifying EPPG device to Class II with special controls. The devices should remain in Class III.  This designation is needed to assure physicians and their patients that patients will not be harmed by these devices when their lives may depend on them.    We also strongly oppose the down-classification of PSAs, in that case because the special controls rely heavily on labeling to mitigate risks, and there is no evidence that would be sufficient to protect the health of patients.

 

Annie Appleseed Project
Center for Medical Consumers
Connecticut Center for Patient Safety
Jacobs Institute of Women’s Health
MAME
MISSD
National Center for Health Research
National Consumers League
National Organization for Women
National Physicians Alliance
Our Bodies Ourselves
Center for Science and Democracy at the Union of Concerned Scientists
Women Advocating Reproductive Safety
WomenHeart: The National Coalition for Women with Heart Disease.

 

The Patient, Consumer, and Public Health Coalition can be reached through Paul Brown at (202) 223-4000 or at pb@center4research.org

By Margaret Dayhoff-Brannigan, PhD

December 2014

Dementia is a term that is used to describe a wide range of brain diseases that cause long-term problems with memory and the ability to think and reason clearly. Alzheimer’s disease is a common form of dementia, and is usually diagnosed in people over 65 years old. Although memory loss and confusion are often called Alzheimer’s by doctors, patients, and family members, the only way to confirm diagnosis is by an autopsy after the patient has died. Most of the time when a doctor says a patient has Alzheimer’s, what they really mean is that the patient has dementia that might be caused by Alzheimer’s.

There are a few types of dementia that can be cured because they are caused by specific diseases such as hypothyroidism or Lyme disease.  There are no cures for the other forms of dementia, including Alzheimer’s disease. There are drugs to slow the progression of dementia and Alzheimer’s, but these have very limited efficacy.

 

Signs of Alzheimer’s/dementia

Many of the common signs of early Alzheimer’s and dementia are similar. Many of these symptoms can also be typical age-related changes. For example, having difficulty finding something like a recipe can be typical age-related change, however difficulty following a recipe could be a symptom of dementia.   More dramatically, forgetting where you put your car keys can be a sign of aging, whereas forgetting what the key is for is a sign of dementia.  If you or a loved one has one or more of the following symptoms you may want to talk about them with a doctor.

  1. Memory loss that disrupts daily life
  2. Challenges in planning or solving problems
  3. Difficulty completing familiar tasks at home, at work or at leisure
  4. Confusion with time or place
  5. Trouble understanding visual images and spatial relationships
  6. New problems with words or in speaking or writing
  7. Misplacing things and losing the ability to retrace steps
  8. Decreased or poor judgment
  9. Withdrawal from work or social activities
  10. Changes in mood and personality

 

Ways to prevent or delay dementia or Alzheimer’s

A family history of Alzheimer’s or other types of dementia increases the chances of developing the condition, but there are strategies that help prevent these conditions.  Exercise and a healthy lifestyle can be effective ways to reduce your risk of Alzheimer’s disease and other forms of dementia. These include:

  1. Regular physical exercise
  2. Eating healthy
  3. Maintaining a healthy weight
  4. Not smoking and moderating alcohol intake (to one drink a day)
  5. Mental stimulation and maintaining an active social life
  6. Stress management and quality sleep

Exercise has been shown to have the largest impact on preserving memory and thinking skills. Exercise was shown to protect against the brain shrinking even if people with a family history of Alzheimer’s disease. Mutations in a specific gene (the APOE-e4 gene), found in 30% of the population, can make it 10 times more likely that you will develop Alzheimer’s. Brisk walking, jogging, swimming or cycling at least three times a week makes brain shrinkage less likely in people with and without the gene mutation. Although the amount or type of exercise that is best is not known, in general, physical exercise that is physically healthy will also be mentally healthy 10,11

Long-term exposure to pesticides and other toxins that affect the neurological system, such as DEET and organophosphates, may increase the risk of Alzheimer’s and other types of dementia.12  Common exposures include mothballs (and other “bug killers”), insect repellants used inside the home (such as RAID), on the lawn or farms (Round Up and DTT) and on the body (OFF and other bug repellants).

 

Possible Causes

There are several theories about why Alzheimer’s disease develops, but none are proven. The leading theory is that the disease is caused by a buildup of proteins in the brain called “plaques.” One type of plaque is caused by misshapen proteins that accumulate as the person ages. When shaped normally, these proteins are important for developing and maintaining a healthy brain. These plaques are often found during autopsies of Alzheimer’s patients. One theory is that the plaques cause brain cells to weaken and die, which can cause the brain to shrink.

More research is needed to fully understand Alzheimer’s and other types of dementia. If it develops early, which happens rarely, it is probably influenced by one’s genes. The disease can take many years to start showing symptoms, and once symptoms appear, it can take many more years for the symptoms to obviously worsen.

 

Recent study linking Dementia to Anti-Anxiety Medications

A recent article published online in the prestigious British Medical Journal found a link between dementia and the use of anti-anxiety medications such as Valium, Xanax and other benzodiazepines (often referred to as “benzos”). The researchers examined almost 9,000 older adults for 6 years after the use of the medication for insomnia or anxiety.  People in their study were 51% more likely to develop dementia if they had ever taken benzodiazepines, and the longer they took the drugs the more likely they were to develop it.13  However, anxiety and sleep disorders could be early symptoms of dementia, rather than caused by dementia. This study didn’t examine whether using the drugs occurred before or after dementia started.  Since dementia usually takes years to develop, and this study only followed patients for 6 years, it is very likely that many of these patients were already developing the disease before taking benzodiazepines. The study was also missing information about other risk factors that the patients may have had for Alzheimer’s, such as smoking and alcohol use.

There are many reasons to be cautious about taking benzodiazepines, particularly if other treatments are available. However further research is needed before concluding that benzodiazepines cause dementia.

 

More information about pesticide use and Alzheimer’s can be found here.

More information about these signs and symptoms can be found here.

December 9, 2014

My name is Dr. Anna Mazzucco.  Thank you for the opportunity to speak today on behalf of the National Center for Health Research.   After completing my Ph.D. at Harvard Medical School, I conducted research at the National Cancer Institute.  Those are the perspectives I bring today.

Our research center conducts research, analyzes data in the research literature, and then explains the evidence of risks and benefits to policymakers and consumers.  Our president is on the Board of Directors of the Alliance for a Stronger FDA, which is a nonprofit dedicated to increasing the resources that the FDA needs to do its job.  Our organization does not accept funding from chemical or consumer product companies, and therefore I have no conflicts of interest.

We applaud the agency for holding this meeting, and for its interest in expanding the Redbook to enhance the safety of the food and products we eat and use every day.  We enthusiastically welcome further action from the FDA on all substances over which the Center for Food Safety and Applied Nutrition has authority.  While the FDA has taken steps to address safety concerns regarding some substances, we strongly urge the agency to use its full authority to ensure the safety of all food-related and consumer products.  Specifically,

  • The FDA has banned bisphenol A from baby bottles and children’s cups.  Yet it is still present in the canned and bottled food consumed by everyone else, including pregnant women, nursing mothers, and young children.  The greatest risk of BPA is probably prenatal exposure, and yet pregnant women are constantly exposed to BPA in food containers.  In addition, BPA exposure can reduce the effectiveness of chemotherapy for breast cancer patients.14   The very limited ban on BPA must be expanded to include all food containers.  As the FDA has now acknowledged the harms of BPA, everyone should be afforded the same protections from it.
  • Current evaluation of food additives for carcinogenic activity is narrowly focused on genotoxic mechanisms of action.  The FDA should add tests for endocrine disruption to its toxicological evaluation of food contact substances and additives to ensure that all food contact substances, both old and new, are safe.  As studies show that BPA substitutes may have similar harmful endocrine-disrupting properties, such a step is critical to achieve meaningful change.15
  • Studies have raised health concerns about numerous ingredients in cosmetics, such as phthalates, linking them to cancer, infertility, brain development and other health problems.  The Consumer Product Safety Commission bans the most dangerous phthalates from toys and other products for children under 3, but there is enormous exposure for pregnant and nursing women as well as children over 3 and all adults. The FDA should implement stronger chemical safety requirements for these products which Americans use regularly and long-term.16  One study found that teenage girls use up to 17 personal care products a day.17
  • A 2010 Government Accountability Office report asserted that the FDA needs to strengthen its regulation of food safety and, in particular, its application of the GRAS designation.  We enthusiastically support the recommendations of this report, which included requiring companies to file GRAS studies with the FDA and to make them public.18  When will that be implemented?

Lastly, we ask that sufficient resources be dedicating to these safety programs in order for the FDA to be able to do its important work which we all rely on.

Thank you for the opportunity to address the panel today.

 

 

 

December 5, 2014

My name is Dr. Anna Mazzucco.  Thank you for the opportunity to speak today on behalf of the National Center for Health Research.   After completing my Ph.D. at Harvard Medical School, I conducted research at the National Institutes of Health before joining the Center’s staff.  Those are the perspectives I bring today.

Our research center conducts research, analyzes data in the research literature, and then explains the evidence of risks and benefits to health professionals, patients, and policymakers.  Our president is on the Board of Directors of the Alliance for a Stronger FDA, which is a nonprofit dedicated to increasing the FDA’s budget, so that it can do its job well. Our organization does not accept funding from pharmaceutical companies, and therefore I have no conflicts of interest.

We are all concerned about the growing problem of antibiotic resistance.  We want to ensure effective treatment options for those with serious infections.  However, ineffective antibiotics actually worsen our situation by increasing antibiotic resistance.  They also expose patients to unnecessary risks, with no chance for benefit, and delay effective treatment.  For these reasons, we must be sure that antibiotics are adequately studied and demonstrate clear safety and efficacy before being used.

With these considerations in mind, we are gravely concerned about the minimal evidence being presented here today.  You are asked to consider a new drug based on preliminary data from a recently unblinded phase III trial for only one of the three indications being sought.  The remaining phase III trials are either ongoing or still being analyzed. We urge the committee to clearly recommend that the FDA wait until these trials have been completed and further analysis has been done before making any recommendations regarding approval.

Although preliminary, the phase III trial data on complex intra-abdominal infections (cIAI) showed that patients who had moderate renal impairment at baseline (MRIB) had a lower clinical cure rate when treated with CAZ-AVI + MTZ compared to  meropenem.  Of even greater concern, 8 deaths were observed in the CAZ-AVI + MTZ group versus only 3 deaths in the comparator.  Not surprisingly, the sponsor believes that this safety signal and the lack of efficacy are unlikely to be related to the study drug.  However, that claim is not based on conclusive evidence.  The size of this subgroup is too small to make a conclusion, which the sponsor has acknowledged.  Furthermore, the agency has not yet reviewed this data, making any conclusions inappropriate.

But even after the FDA reviews the data, the samples are too small to draw the conclusion that this new drug is safe or effective.

The FDA has stated that the sponsor’s pooled meta-analysis from the literature has several uncertainties and should only be used as additional supportive evidence.  We strongly agree.  The only other evidence we have is from two small phase II trials, which the FDA has stated were not analyzed in a formal statistical manner and had no pre-specified hypotheses.  Instead, the results of these trials were summarized descriptively.

The totality of this evidence is not sufficient for informed decision-making.  While I personally would not seek an antibiotic with a higher death rate, it would make sense for the panel to strongly urge the FDA to wait until all the phase III trials have been completed and the agency has fully reviewed the data before making a decision.

We have carefully reviewed the agency’s regulatory approach regarding this drug combination and the section 505(b)(2) pathway as described in the background material.  The FDA background document states that “the contribution of avibactam will be demonstrated by in vitro studies, animal models of infection and with limited clinical data. Safety of avibactam will be determined from Phase 1 studies of avibactam alone and phase 1 and 2 studies of CAZ-AVI.” We are alarmed that the agency would consider this new combination entity on such limited data.  In fact, in the 1970 Upjohn versus Finch court case it was determined that for “…combination drugs purported to have advantages exceeding those of the components, there must be adequate, well-controlled data documenting the claimed advantages.”19  That type of evidence is NOT presented here.

Although I am a scientist, I also want to speak on behalf of patients today.  Patients care about antibiotics that make them feel better sooner and save their lives.  Animal and in vitro studies cannot ensure either.  Furthermore, as stated before, antibiotics are unique among drugs in that ineffective antibiotics can worsen a patient’s condition and also create new problems.  There are numerous unfortunate examples of antibiotics that were approved and subsequently withdrawn from the market due to safety concerns.  In fact, the withdrawal rate of antibiotics over the last three decades was triple that of other drug classes, with 26 out of 61 antibiotics approved during that time being subsequently withdrawn.20

We strongly urge the committee to ask for completion of the remaining phase III trials and the agency’s review before making any recommendations about approval.

Thank you for the opportunity to address the panel today.