August 20, 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
Microbiology Devices; Reclassification of Influenza Virus Antigen Detection Test Systems
Intended for Use Directly With Clinical Specimens
[Docket No. FDA-2014-N-0440]

Members of the Patient, Consumer, and Public Health Coalition strongly support the up-classification of influenza detection devices. We support moving the devices from class I to class II with special controls and into a new device classification regulation (from 21 CFR 866.3330 to 21 CFR 866.3328).  We agree with the FDA that “the accuracy of these devices has serious public health implications,” since influenza can cause serious illness and death.1

Many of the rapid influenza antigen detection tests or RIDTs (also referred to as antigen tests) that were cleared since 1998 have had performance problems (good specificity but low sensitivity).2 The 2009 flu pandemic underscored that RIDTs “performed poorly resulting in misdiagnosed cases.”3

On June 13, 2013, the Microbiology Advisory Panel met to discuss performance problems with RIDT systems. The panel noted that “poor sensitivity of RIDTs has always been a concern,”4 and they raised concerns that influenza viruses mutate quickly.  Fast changing viruses “may cause the functional components of influenza diagnostic devices not to recognize current influenza strains,” which will lead the devices to provide inaccurate results.5

Panel members indicated that putting RIDTs into Class II with special controls was needed to mitigate the risks of false positive and false negative results.  We strongly agree.

In the past, FDA has cleared these less-than-effective RIDT devices as class I 510(k) devices. This allowed the devices to be used as predicates for new 510(k) submissions, which “promotes further clearance of devices that do not meet the needed performance for detection and management of infection by novel strains of influenza.”6  Reclassifying RIDTs as class II will better ensure that ineffective devices are no longer cleared on an ineffective class I RIDT predicate. Devices that were cleared as class I RIDTs will have to meet the class II special controls to remain on the market, which will better protect patients and public health.

We agree with FDA’s proposed order that RIDTs regulated under 21 CFR 866.3330 be reclassified into Class II with special controls under the new device name “influenza virus antigen detection tests system”(21 CFR 866.3328).  Section 866.3328 specifically states, “Because influenza is highly contagious and may lead to an acute respiratory tract infection causing severe illness and even death, the accuracy of these devices has serious public health implications.”7 The regulation also lists precise special controls for these devices including sensitivity and specificity performance characteristics.

The early diagnosis of influenza can reduce the inappropriate use of antibiotics.  In contrast, the failure of the device to perform accurately could harm patients. For example, a false negative could result in a dangerous delay in treatment, or could result in spreading the flu in families and communities as well as vulnerable settings such as hospitals, retirement communities, and nursing homes. A false positive could lead to unnecessarily isolating a patient or a delay in treating respiratory infections caused by something else besides the flu.

Conclusions

Due to the widespread use of RIDTs—and their current lack of accuracy—we strongly support the FDA’s proposed order to up-classify the devices from class I to class II with special controls.  More stringent requirements for influenza diagnostic devices would assist health care professionals in accurately diagnosing patients, and help public health officials better respond to influenza outbreaks. Because flu viruses can make people severely ill or lead to death, RIDTs must be as accurate as possible, and up-classification with specific special controls is urgently needed to protect patients and the public health.

American Medical Women’s Association
Annie Appleseed Project
Center for Medical Consumers
Connecticut Center for Patient Safety
National Center for Health Research
National Consumers League
National Organization for Women
National Women’s Health Network
POGO
Public Citizen
WARS
WoodyMatters

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

By Diana Zuckerman, Ph.D.

The media frenzy surrounding the Ebola crisis in West Africa shows that many journalists don’t understand that an experimental drug is just that – a scientific experiment. It is not a “breakthrough” drug or a “cutting-edge treatment” or a prize to be envied, unless or until it is proven to be safer and more effective than nothing.

Ebola is a deadly disease, but it doesn’t kill 100% of those who are diagnosed. Experts estimate that this Ebola strain kills 60% of patients. That’s horrific, but not high enough to say with certainty that a person who took the experimental drug and survives has been saved by the drug – as Sanjay Gupta announced on CNN.

The CDC points out that some Ebola patients recover with no treatment other than “supportive care.” We don’t yet know if the experimental drug for Ebola, ZMapp, helps patients more than supportive care. Nevertheless, the hype keeps growing and pressure on the FDA is mounting to make the treatment more available. The FDA already responded to that pressure by making another Ebola drug, TKM-Ebola, more available, even though it is also not proven safe or effective.

In addition to the “we need new drugs faster” mantra in the U.S. — which is almost as strong for every other new drug as it is for Ebola drugs — one of the messages coming from overseas is that the U.S. is hogging this miracle drug for its own citizens. USA Today reports that, “Two Americans with Ebola received at least half of the world’s supply of a drug that might be able to change the course of the deadly virus. Some people are asking how to allocate additional doses of this drug and whether it was ethical to give those drugs to American missionaries when they weren’t available to West Africans suffering from or fighting the outbreak…. Anthony Kamara, a 27-year-old man riding a bicycle in Freetown, Sierra Leone, said ‘Americans are very selfish. They only care about the lives of themselves and no one else.’”

Medical ethicists point out that it is appropriate to give limited drug supplies to medical missionaries such as Nancy Writebol and Kent Brantly, because as first responders they got sick caring for Ebola patients. And, the FDA already has a humanitarian exemption that allows patients’ access to experimental drugs when necessary, if the drug company agrees to it. So, rushing FDA approval for ZMapp or other Ebola drugs is not necessary and we can all feel good that the two patients seem to be doing well so far.

It is discouraging to see so many journalists and “talking heads” missing the point: we don’t know yet if ZMapp, or any other Ebola drugs in development, will save lives or cost lives. We don’t know if some of these drugs might work on patients at an early stage of the disease but harm them at a later stage. Science can eventually tell us, and this epidemic may be a good time to test experimental drugs, but science takes time. It makes sense to give patients an informed choice to face the risks of an experimental drug, if that is possible, but that doesn’t mean that it is ethical to distribute an unproven drug to everyone.

Urgent situations show us how important good science is, but good science takes time. AIDS activists have learned those lessons and are now recommending FDA be cautious before approving unproven new drugs: “AIDS Activist Takes Up New Fight: Defending FDA,” AP, August 11, 2014.

Meanwhile, let’s celebrate the efforts of scientists to cure Ebola and use the teachable moment to explain why research is necessary and why it is important to do it well.

——

Read the article on AAAS’s “Sci on the Fly” blog here.

Anna E. Mazzucco, Ph.D.

August 13, 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. in Cell Biology at Harvard Medical School, I conducted research at the National Institutes of Health.  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 pharmaceutical companies, and therefore I have no conflicts of interest.

Antibiotic resistance and the inability to treat common infections is an increasingly urgent public health crisis which affects everyone, but especially some of the most vulnerable in our society- the very young, the old, and the ill.  A CDC report from last year estimated that there at least 2 million illnesses and 23,000 deaths annually in the United States due to antibiotic resistance.8

The NARMS effort is the primary source of information on antibiotic resistance in foodborne pathogens in the United States.  We thank the FDA, CDC, and USDA for all their joint efforts in this critical endeavor.  However, we feel that additional steps would strengthen these ongoing efforts.  Specifically:

  • Mounting evidence supports the link between antibiotics in animal production and the increase in resistant infections in humans.  FDA efforts to reduce antibiotic use in animal production need to be broadened to halt use of antibiotics for disease prevention purposes, not just those used for growth promotion. Identical drugs and treatment durations are often used in both scenarios.  And voluntary agreements are not enough: we need requirements that are enforced, including phase-outs and bans.9
  • NARMS sample testing should be expanded to include more on-farm sites, breeding facilities and slaughterhouses in more geographic areas in addition to animal feed.  Such information is critical to accurately pinpoint sources of contamination, as these are important entry points into the food supply chain.  Quantitative data on antibiotic use in animal feed, especially antibiotics important for human medicine, is urgently needed, and should be added to NARMS monitoring.
  • To better understand human infections, NARMS should expand its testing to also include human extraintestinal clinical samples to monitor pathogenic E. coli and Enterococcus.
  • Retail product testing should be expanded to include a sufficient number of samples to generate meaningful results. Testing should also be expanded to include dairy products, and ground pork and turkey products, as these products have been a significant source of antibiotic resistant outbreaks.
  • More comprehensive microbial testing for other strains such S. aureus and MRSA should also be done.  A 2012 report found that 65% percent of 395 pork samples were contaminated with S. aureus and that 7% were contaminated with MRSA.10
  • More sensitive microbial techniques should be used to detect antibiotic resistance, such as using selective broth culturing rather than single colony testing.
  • There is still a significant delay in releasing data from NARM surveillance efforts.  Faster turnover times are needed for this critical data to be actionable by public health and medical workers in order to respond to emerging situations in a timely manner.

Last but definitely not least, we urge the participating agencies to ensure that NARMS receives the funding that it needs to maintain and build upon these vital efforts.  Antibiotic resistant infections are estimated to cost the U.S. healthcare system between $21 and $34 billion dollars every year.11 The above recommended changes would be cost effective, saving millions if not billions of dollars for federal programs and individual taxpayers.  Our Center will help educate Congress about the need for these efforts, but the agencies need to clearly make the case that this is an urgent priority.

 

 

 

 

 

 

 

By Dr. Diana Zuckerman. August 14, 2014.

A new study shows that the contaminated drinking water at USMC Base Camp Lejeune from the 1950s to 1985 was deadly to civilians working there12 as well as the active military and their family members living there.

The study found more deaths from cancers of the kidney, rectum, oral cavity, leukemias, multiple myeloma, and Parkinson’s disease among those workers compared to workers at Camp Pendleton.  It usually takes decades for cancer to develop after exposure, so it is necessary to continue this research to learn more and to appropriately compensate the individuals and families who were harmed.  Most important it is essential that this kind of outrageous disregard for human health of our military families and the workers that serve them never happens again.

By Anna E. Mazzucco, Ph.D. Updated February 2014.

 

fracking

Fracking is in the news, but what is it exactly? Hydraulic fracturing or “fracking” has boomed in the last few years and is now producing most of the natural gas in the U.S. It is praised as helping the U.S. be more “energy independent” and has lowered the cost of natural gas. But, the controversy is whether it can harm our health, especially for people who live near the drilling sites, which are most common in Colorado, Texas, North Dakota, and Pennsylvania.

Fracking uses more than 750 chemicals, some of which are known to harm human health.13 14 15 But since fracking is a relatively new technology in the U.S., scientists are still trying to understand how fracking chemicals get into the air and drinking water in nearby areas.

Of the more than 750 chemicals used in fracking, more than 100 can affect our hormones. These chemicals are called endocrine-disrupting chemicals, and research published in 2011 shows that these chemicals can get into the water near fracking sites, where they could potentially cause infertility, diabetes, and cancer.16 This study in Colorado found higher levels of endocrine disrupting chemicals in water samples from areas with more drilling sites compared to areas with fewer sites. Many of the water samples were found to contain chemicals that either mimicked or blocked estrogen (a hormone that is high in females) or androgen (a hormone that is high in males). In fact, 89% of the samples taken near fracking sites had chemicals which increased estrogen, 41% had chemicals that blocked estrogen, 12% had chemicals that increased androgen, and 46% had chemicals that blocked androgens. In contrast, water from areas far from fracking rarely had chemicals that affect hormones. The researchers also found small increases in these chemicals in the Colorado River, probably from the fracking sites. This could spread the chemicals into a larger area.

What kind of impact could these chemicals have on human health? When children are exposed to high levels of hormones, this could cause early puberty in children, or abnormal sexual development in a fetus. Chemicals that block hormones could also affect sexual development or fertility. In adults, this exposure could increase the risk of infertility, obesity, diabetes, or certain types of cancer, such as breast cancer, testicular cancer, and vaginal cancer. Serious diseases, and especially cancer, can take years to develop, so it is important to study families in fracking areas carefully for many years to see what happens. Of course, meanwhile the families could be harmed if they are not protected from these chemicals in their water.

Two other reports have raised concern about fracking and the health of newborn babies. These reports provide evidence that mothers living near fracking sites are more likely to give birth to newborns who are underweight. One study found that babies were 25% more likely to have low birth weight if they were born to mothers living near fracking sites compared to babies born of mothers who didn’t live near one.17 A second study found that the chance of a low birth weight baby was more than 50% higher for babies born near fracking sites, compared to babies born to the same mothers in a location far from fracking.18This study was presented at the annual meeting of the American Economic Association in January 2014. Neither of these two studies has been published yet.

To be more conclusive about the health risks of living near fracking sites, we need large public health studies that include information from medical records and residence history. Currently, most of the information we have is based on evidence of surface and ground water contamination from fracking sites.19 20

Meanwhile, several families and communities have already sued because of their concerns about health problems related to fracking, and the Environmental Protection Agency (EPA) and state agencies have investigated drinking water contamination in West Virginia, Pennsylvania, Wyoming and Texas. The EPA is currently working on a report on the potential impact of fracking on the U.S. water supply, with a draft expected late in 2014. Legislation to lower health risks due to fracking has been proposed in many states, including California and Illinois. In 2012, Vermont became the first and only state to ban fracking.

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

August 11, 2014

Comments of members of the Patient, Consumer, and Public Health Coalition
on the Draft Guidance
“Appropriate Use of Voluntary Consensus Standards
in Premarket Submissions for Medical Devices”
Docket No. FDA-2014-D-0456

Members of the Patient, Consumer, and Public Health Coalition appreciate the opportunity to comment on the draft guidance for the Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.

The draft guidance states that the use of consensus standards will “streamline premarket review” and “facilitate market entry for safe and effective medical products.”  We support a more efficient process, but are concerned about the potential for lowering the standards for safety and effectiveness since the draft guidance states that one of the purposes of declaring conformance with a consensus standard is to “reduce the amount of supporting data and information that are submitted to FDA.” We would strongly oppose any reduction in the already limited information regarding safety, effectiveness, or substantial equivalence.

Below are our detailed comments on the draft guidance:

Use of Consensus Standards

We agree with the FDA that consensus standards should only be one part of a premarket submission and that by themselves they provide insufficient data for the FDA to make regulatory decisions.   We support the draft guidance’s clear language that states, “Even when a premarket submission appropriately demonstrates conformity with one or more consensus standards, such conformity may not satisfy all requirements under the FD&C Act.”

We are concerned that FDA has found that submitters (device makers) “do not always use consensus standards appropriately,” such as using a version of the consensus standard that the FDA does not recognize or standards that do not apply to their device.  We strongly urge that the draft guidance explicitly state that when a consensus standard is used inappropriately, that FDA will not approve or clear the device.

Promissory Statements

We strongly support this section of the draft guidance, which states, “The use of a promissory statement indicating future conformance with a consensus standard is not appropriate to support a premarket submission.”

Declarations of Conformity for FDA-Recognized Consensus Standards

We support the clear language in this section that requires testing be done before the premarket submission.   The draft guidance states, “FDA expects that all necessary testing required by the consensus standard will be performed and conformance to the consensus standard will be met prior to the premarket submission.”

We support language in the draft guidance that states that when an FDA-recognized consensus standard describes a test method but does not provide specific details, “the submitter should provide the test results in its premarket submission to FDA.”

We also support language in the draft guidance that states, “Not all FDA-recognized consensus standards are appropriate for declarations of conformity without the submission of underlying data” because they are too general or broad. We agree that consensus standards do not list all of the detailed acceptance criteria for performance tests and that FDA has the authority and responsibility of requesting additional information based on science, “including test results.”

The National Center for Health Research recently studied summaries for more than 1,000 Premarket Notification applications (510(k)s) for implantable devices, and found a dearth of information on substantial equivalence or on safety and effectiveness for these devices. Few of the summaries included test results, although some made vague references such as “clinical experience in several hundred patients in Europe.” In addition, recent research indicates that most PMA applications are supplemental applications, which, like 510(k) submissions, also lack clinical trial data.

Limitations of Consensus Standards

We support the draft guidance’s language on limitations of consensus standards, which states that consensus standards do not take “precedence over existing FDA laws and regulations” and if there is a conflict between the two, FDA regulations would prevail.  This will protect patients and consumers by ensuring that FDA regulations that address safety and effectiveness of medical devices are not undermined by weaker consensus standards.

Managing Product Development When Standards Change: Transition Periods

This section of the guidance document notes that consensus standards may become obsolete or need updating, which could delay a device’s development.  The draft guidance states, “Generally, if a submission is under active review when a new consensus standard or updated version of an existing consensus standard is recognized, FDA will continue to review that submission based on the previously recognized consensus standard,” unless “a known safety issue is addressed by a new or updated consensus standard.”  This seems reasonable as long as patient safety is the key factor that the FDA uses to decide whether or not an updated consensus standard must be used.

We strongly support the draft guidance’s language that states that falsifying a declaration of conformity is a prohibited act under the FD&C Act, which would mean the device is an adulterated product.

Summary

Although we strongly support sections of the draft guidance that clarify the limitations of consensus standards, we are concerned that the use of consensus standards could lead to less stringent requirements for evidence of safety and effectiveness or substantial equivalence for medical devices.  The standards for approval and clearance are already dangerously weak and subjective, and efforts to be more “flexible” or accommodating to consensus standards would put patients at serious risk.

American Medical Women’s Association
Annie Appleseed Project
Breast Cancer Action
Center for Medical Consumers
Connecticut Center for Patient Safety
National Center for Health Research
National Consumers League
National Physicians Alliance
National Women’s Health Network
The TMJ Association
Center for Science and Democracy at the Union of Concerned Scientists
WARS
WoodyMatters

To reach the Patient, Consumer, and Public Health Coalition, contact Paul Brown at (202)223-4000 orpb@center4research.org

This Associated Press article quotes Gregg Gonsalves’ testimony at the Senate briefing hosted by the National Center for Health Research on June 12, 2014.

By Matthew Perrone

WASHINGTON (AP) — As an AIDS activist in the early 1990s, Gregg Gonsalves traveled to Washington to challenge the Food and Drug Administration.

Photo from Associated Press. In this July 22, 2014 photo, AIDS activist Gregg Gonsalves walks outside Grand Central Terminal during a photo session, in New York. In the early 1990s, Gonsalves traveled to Washington to confront, provoke and challenge officials at the Food and Drug Administration. A quarter century later, he still travels to Washington, but with a very different agenda: to defend the FDA. (AP Photo/Richard Drew)

Photo from Associated Press.
In this July 22, 2014 photo, AIDS activist Gregg Gonsalves walks outside Grand Central Terminal during a photo session, in New York. In the early 1990s, Gonsalves traveled to Washington to confront, provoke and challenge officials at the Food and Drug Administration. A quarter century later, he still travels to Washington, but with a very different agenda: to defend the FDA. (AP Photo/Richard Drew)

Gonsalves was part of the confrontational group AIDS Coalition to Unleash Power, which staged protests outside the FDA’s headquarters, disrupted its public meetings and pressured its leaders into speeding up the approval of experimental drugs for patients dying of AIDS.

A quarter century later, Gonsalves still travels to Washington, but with a different agenda: to defend the FDA.

At a recent forum on FDA issues, Gonsalves implored congressional staffers to protect the agency from growing anti-regulatory sentiment that he worries will roll back safety and effectiveness standards for all types of drugs. The efforts include new state laws designed to undercut the FDA’s authority by giving patients early access to unapproved drugs and a lobbying push by industry groups to speed up the time it takes the FDA to review new treatments.

Both initiatives come at a time when researchers who study the FDA say the caricature of a slow, outdated bureaucracy is inaccurate. The FDA reviews most drugs in 10 months and high-priority drugs in six months or less. And a 2012 review in the New England Journal of Medicine showed that FDA regulators approve new drugs faster than their counterparts in Europe and Canada.

“The rhetoric we hear today is that FDA stifles innovation, that FDA keeps drugs out of patients’ hands. And you know, that was our rhetoric in 1989,” says 50-year-old Gonsalves, now a program director at Yale University. “But there’s no countervailing narrative that we need a strong FDA.”

The story of how Gonsalves went from FDA critic to supporter is intertwined with the AIDS movement’s impact — and its unintended consequences — on the agency.

Groups like ACT UP showed that FDA’s bureaucracy could be influenced by outside pressure. Following protests by ACT UP, the FDA went from taking over two years to approve most drugs to clearing HIV drugs in a few months. In the early 1990s, those shorter review times were written into laws that have governed FDA procedures ever since. But while the push for ever-faster reviews was kicked off by AIDS activists, it is now primarily driven by pharmaceutical lobbying groups and libertarian think tanks.

Since May, three states — Colorado, Louisiana and Missouri — have passed laws designed to allow terminally ill patients to receive experimental drugs that have not been cleared by the FDA. Arizona will vote on its own so-called “right to try” initiative in November and lawmakers in Florida, Oklahoma and Utah are set to introduce similar bills. All of these efforts are driven by lobbyists from the Goldwater Institute, a libertarian think tank.

Supporters have dubbed the measures “Dallas Buyers Club” laws, after the Oscar-winning movie about an AIDS patient who thwarts FDA regulators by smuggling in HIV drugs from overseas. And lawyers for the Goldwater Institute acknowledge that groups like ACT UP helped pave the way for their strategy, though they say more deregulation is needed.

“Many, many groups have been trying to get FDA reform for decades and the only real successful movement was the AIDS movement,” says Christina Sandefur, an attorney with the Arizona-based Goldwater Institute.

Mark Harrington, executive director of the Treatment Action Group, which spun off from ACT UP in the 1990s, says AIDS activists have long tried to distance themselves from such anti-Washington efforts. By the mid-1990s, Harrington and Gonsalves were actually pushing for longer, larger studies of HIV drugs. That’s because the first drugs approved by the FDA were linked to dangerous side effects, including anemia and nerve damage.

Harrington says the Goldwater-backed state laws are political theater that will not help desperate patients. “They’re providing false hope and really pushing quack cures and medicines that could be unsafe and ineffective,” he says.

Federal law makes clear that patients do not have a right to experimental drugs and the Supreme Court has refused to hear challenges to FDA’s authority over the matter. For its part, the FDA already gives dying patients access to unapproved medicines if drugmakers are willing to provide them.

“The agency stands ready to work with companies that are interested in providing access to experimental drugs,” said FDA spokesman Stephanie Yao, in a statement.

But there’s nothing in the state laws that require companies to grant early access.

While the FDA faces pushback from conservative activists at the state level, it is also faces industry pressure at the federal level.

House lawmakers have held half a dozen hearings this year on “accelerating the pace of cures in America.” The push is part of a pharmaceutical industry-backed initiative dubbed “21st Century Cures,” designed to streamline the drug approval process.

“There is no doubt that our antiquated, patch-work clinical trial system makes developing new treatments a cumbersome, expensive and protracted process,” said the Friends of Cancer Research group in recent congressional testimony. The group receives funding from Pfizer Inc., GlaxoSmithKline and many other drugmakers.

Some FDA watchers say it’s too early to worry about a major overhaul of the agency. Congress is gridlocked and no major health legislation is expected to pass until after the next presidential election.

But Gonsalves isn’t wasting time. In closing his talk on Capitol Hill earlier this summer, Gonsalves warned Senate staffers that a political shift to the right in coming elections could “change the game” for drug safety and effectiveness.

“We will have a different FDA than we have had for the last 30 years.”

Photo credit to the Associated Press, click here for the original story online.

 

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

August 8, 2014

Comments of members of the Patient, Consumer, and Public Health Coalition
On proposed Deeming Rule
Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products; Extension of Comment Period
Docket No. FDA-2014-N-0189

As members of the Patient, Consumer, and Public Health Coalition we are writing to comment on various aspects of the proposed rule to extend FDA’s jurisdiction to tobacco (including made or derived from tobacco) products other than cigarettes, including e-cigarettes. It is essential that the proposed rule be strengthened, since nicotine is highly addictive.

1.      We strongly oppose exempting any cigars from the rule, including those designated as “premium.”  According to the FDA’s deeming rule, “a large cigar may contain as much tobacco as a whole pack of cigarettes” and “nicotine levels in cigar smoke can be up to 8 times higher than levels in cigarette smoke.”  We concur with the FDA that “all cigars are harmful and potentially addictive,” and this is true regardless of their price, the size of the manufacturer, and whether or not they are handmade. In addition, providing cigars special treatment encourages cigarette and other tobacco-related product manufacturers to continue to misclassify products that are actually cigarettes as cigars, in order to take advantage of this regulatory loophole.

2.      We also strongly oppose exempting or weakening the rules for smaller manufacturers or manufacturer of “premium” tobacco products, regardless of their so-called “unique challenges.” As noted above, cigars can be more dangerous than cigarettes.  Regardless of the cost or whether they are manufactured on a small scale, cigars have large-scale, long-term health consequences.

3.      The FDA’s proposed rule does not go far enough to safeguard the health of young people. It proposes a national minimum age of 18 for the purchase of the newly deemed products, which we wholeheartedly endorse, but it permits sale through the internet where age verification is difficult if not impossible to enforce. For this reason, we urge the FDA to prohibit internet sales of the deemed products (and eventually all tobacco products), or  require sellers to adopt the same age verification procedures established under the 2009 Prevent All Cigarette Trafficking Act for internet sales of cigarettes and smokeless tobacco.

4.       The proposed rule does not go far enough to restrict the marketing and advertising of e-cigarettes and cigars to minors. The number of middle and high school students who reported ever using e-cigarettes doubled between 2011 and 2012; and high school boys are just as likely to smoke cigars as they are cigarettes (16.4% vs. 16.5%). E-cigarettes, cigars and other newly deemed tobacco products should be kept behind store counters just like cigarettes.  They should not be displayed in the open, like the candy that many of these newer tobacco products try to emulate, with flavors like “Cinnamon Apple Crunch,” “Tahitian Punch,” and “Iced Berry.

The proposed rule permits self-service displays, does not prohibit low-cost, mini packs of cigars (that are obviously more affordable to children) and also allows brand sponsorship of concerts or sporting events popular with teenagers. These should all be strictly prohibited. Moreover, the FDA has not proposed limiting the advertising of the deemed products the way cigarettes and smokeless tobacco advertising has been limited. By allowing unfettered advertisement of e-cigarettes and cigars, the FDA is ensuring that youth will continue to be exposed to ad campaigns as effective as the ones in years past, which equated cigarette use with glamour, sex appeal, and cartoon characters like Joe Camel.

5.      We strongly support the FDA’s proposal to include health warnings about nicotine addiction on all nicotine-containing tobacco products, including e-cigarettes and cigars. We also support the FDA proposal to require that all cigars, including premium cigars, carry additional rotating health warnings on the risk of mouth and throat cancer; the risk of lung cancer and heart disease; the risk of lung cancer and heart disease from secondhand smoke; and stating that cigars are not a safe alternative to cigarettes. However, we strongly urge the FDA to include a fifth warning on the increased risk of infertility, stillbirth and low birth weight. This is particularly important, given the growing popularity of cigars among teenagers and the fact that teenage girls and young women have the highest rates of smoking during pregnancy (16.6% for girls 15-19 and 18.6% for women 20-24 in 2005). We also urge the FDA to revert to the 12-month compliance period (from the date of the final rule) which was changed after OMB review to an unacceptably long 24 months.

According to the CDC’s June 2014 report, nearly one-quarter of all male high school seniors smoke cigars (23%). To save lives, the FDA should mandate its proposed warning about nicotine addiction for all tobacco products; require all cigar manufacturers to rotate all five of the warnings that the FTC imposed on seven cigar manufacturers in 2000; and stipulate that all warnings must be in effect no later than 12 months from the final rule.

6.      We also urge the FDA to strengthen the proposed rule regarding characterizing flavors in cigars or e-cigarettes.  Cigarettes, for instance, can only be sold with tobacco-flavor or menthol flavor; the newly deemed products should be held to the same standard as they are similarly addictive, nicotine-containing products. More than 80% of adult cigarette smokers began smoking before the age of 18; flavors like “bubble gum” and “banana split” are specifically designed to appeal to children and teens and attract people who otherwise would not use a tobacco product.

The bottom line regarding flavored nicotine products: any flavor that makes the use of tobacco products more palatable should be banned. If a major benefit of e-cigarettes is to cut back on regular cigarette use, then those buying e-cigarettes will not be seeking candy or fruit flavors.  These flavored options clearly promote the use of tobacco products by new customers.

7.      The proposed rule does not mention requiring child-resistant packaging of liquid nicotine for use in e-cigarettes. Given the alarming rise in nicotine poisonings resulting from children coming into contact with “e-juice,” FDA should issue a proposed rule to prevent this public health problem.

8.      The FDA is proposing a premarket review requirement for all newly deemed products, while recommending that manufacturers have 24 months from the final rule to file substantial equivalence and new product applications. This would allow manufacturers to keep existing products on the market and introduce new deemed products for two full years following the promulgation of the final rule. It would also allow products for which an application has been submitted to stay on the market unless or until FDA denies it. These loopholes are unacceptable, given that there has already been a 3-year delay in issuing the deeming rule, giving companies more than enough time to prepare for regulatory requirements. To reduce any further delay, the FDA  should: a) issue a final rule within a year of the proposed rule’s issuance, and no later than April 25, 2015, and b) shorten the period for submitting new application or proving substantial equivalence to one year from the final rule.

The Tobacco Control Act (TCA) was enacted in 2009 to give FDA the authority to prevent and control tobacco use. The deeming rule is meant to extend that authority so as to protect children and adults from the harms of cigars and e-cigarettes. We recommend further strengthening the deeming rule in the ways described above and/or concurrently issuing additional proposed rules. The FDA’s mission is to protect and advance public health, and unfortunately the proposed rule falls short.

American Medical Women’s Association
Annie Appleseed Project
Breast Cancer Action
Cancer Prevention and Treatment Fund
Connecticut Center for Patient Safety
National Alliance for Hispanic Health
National Consumers League
National Organization for Women
Our Bodies Ourselves
Women Advocating Reproductive Safety
WomenHeart

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

August 1, 2014

Good afternoon. My name is Dr. Laurén Doamekpor, and I am a senior fellow at the National Center for Health Research. Our non-profit research center scrutinizes scientific and medical data and provides objective health information to patients, providers and policy makers. Our organization does not accept funding from device companies, and therefore I have no conflicts of interest.

We can all agree that a safe and complication-free recovery from any type of surgery are major concerns for patients and their physicians. We believe in the innovative potential of this product to aid in the healing process for patients after abdominoplasty. Unfortunately, the larger study does not support this, and both studies raise questions that need to be answered before this product meets the standards of FDA approval.

The sponsor’s data from the 1st pivotal trial did not meet the key primary or secondary effectiveness end-points. Using TissuGlu with drains did not effectively decrease the number of days patients needed drains or the amount of total wound drainage output.  One can only conclude that it did not work.

The sponsor tried a different design for their 2nd pivotal trial, comparing TissuGlu to drains.  The TissueGlu group had significantly fewer post-operative invasive treatments compared to the control group.

The problem with the 2nd pivotal trial is that it is too small and too short-term.  That makes it impossible to just ignore the results from the 1st trial, which the company has asked you to do.  Almost 100 patients received the product in trial 1 and only 64 in the 2nd trial.  The FDA should not approve a product for millions of patients on the basis of such a small study.

The size of the study is of particular concern because there are no men in the 2nd trial (and only 2 in the first), and only 7 Hispanics and 12 Blacks using TissuGlu.  At the very least, the sponsor should show subgroup analyses of the various measures of effectiveness and separately for Blacks and Whites, to see if the results are favorable for each group separately, not just when combined. The FDA doesn’t need to use tests of statistical significance, they just need to see those two racial groups separately to be able to draw conclusions about whether TissueGlu is likely to be safe and effective for women. Given the lack of men, it should not be approved for men.

FDA guidelines urge sponsors to include people of color in their clinical trials and analyze them separately. The sponsor included a reasonable percentage of people of color, but since the total number of patients was too small, the number of Blacks and Hispanics was also too small.  If the FDA were to approve this device, it would need to be approved for white women only.  Is that an acceptable decision in 2014? I think you will agree with our Center that it is not.

The product was NOT studied on cancer patients and definitely should not be approved for them.  In fact, the label should specify that it has not been studied on cancer patients.

By Katie Thomas, The New York Times

July 31, 2014

 

morcellator

Johnson & Johnson, which has come under withering criticism for its response to problems with some of its medical devices, won cautious praise from critics on Thursday for its decision to withdraw three products used in uterine surgery because of a risk of spreading cancerous tissue, only months after the safety issue became widely known.

Some experts continued to debate the medical value of the devices. A handful of other, smaller companies sell similar products.

The Ethicon unit of Johnson & Johnson said Wednesday that it was asking hospitals to return three types of power morcellators, devices that are commonly used in uterine surgery to remove fibroids by cutting the tissue into tiny pieces and extracting them through small incisions. In April, the Food and Drug Administration recommended that doctors stop using the procedure after the agency concluded that the risk of spreading cancer was higher than previously thought. That led Johnson & Johnson to announce that it would suspend sales and marketing of its products while it studied the issue, but it stopped short of withdrawing them from the market.

In a letter sent to health care providers, Ethicon asked that hospitals return three models of power morcellators made by the company: the Gynecare Morcellex and Gynecare X-Tract tissue morcellators, as well as the Morcellex Sigma tissue morcellator system.

About 50,000 operations a year involve power morcellation of tissue containing fibroid tumors, according to the F.D.A.

Some critics said they were pleasantly surprised that Johnson & Johnson acted as quickly as it did. “The company has had a rather abysmal track record on the public health front of ethical breaches in the last few years, so this is good that they’re doing this,” said Diana Zuckerman, president of the National Center for Health Research, a public health advocacy group that has criticized the company in the past over its safety record, especially concerning pelvic mesh implants. Dr. Zuckerman owns stock in Johnson & Johnson and her father, now retired, worked for many years in quality control at the company. Speaking of the decision on the power morcellators, she said, “At least it goes back to an earlier time when the company was seen as doing the right thing.”

The move comes as some in the gynecology field continue to disagree about the usefulness of power morcellators. Although the risk of spreading cancer through this procedure has been previously known, it was long believed that the chances for spreading cancer were lower, ranging from 1 in 10,000 to 1 in 500. In April, the F.D.A. concluded that the risk was closer to 1 in 350.

Still, some doctors cautioned against vilifying the procedure, saying that power morcellation allows minimally invasive surgery that, if carefully done, can be a better choice for some women. Without morcellation, more women will have to undergo serious abdominal surgery, which carries the risk of infection, bleeding, pain and blood clots. “These are things that people also die of,” said Dr. Barbara Goff, director of gynecological oncology at University of Washington. “So my concern is that we aren’t looking at this in balance.”

That medical debate is the reason Prof. Erik Gordon, who teaches business at the University of Michigan and has previously criticized the company for its safety record, said he was surprised that it acted as quickly as it did. “This is one of those things where it’s enough up in the air that you might have expected Johnson & Johnson to say, well, we’re going to keep it on the market because the evidence is inconclusive,” he said. “But that’s not what they did.”