Letter to Congresswoman Rosa DeLauro Supporting “Helping Effective Antibiotics to Last” (HEAL) Act

The Centers for Disease Control and Prevention (CDC) points out that two major actions are urgently needed to address the threat posed by antibiotic resistance are: 1) stop the misuse of existing antibiotics, and 2) develop effective new antibiotics. HEAL is the first bill to focus on both these necessary actions. Continue reading

Chantix Citizen Petition

Five leading nonprofit consumer, research and medical organizations identified below petition the Food and Drug Administration (FDA) pursuant to the Food, Drug, and Cosmetic Act 21 USC 352, 505(o)(4), and 21 CFR 10.30 to take action to improve the safety information included in the label for CHANTIX® (varenicline) tablets , a smoking cessation aid approved under NDA 021-928. Continue reading

Letter to Senator Waxman Expressing Concerns About Speeding Up the Development of New Antibiotic Drugs (ADAPT Act)

September 18, 2014. We are writing to express our strong concerns about proposed legislation to speed the development of new antibiotic drugs, H.R. 3742, the Antibiotic Development to Advance Patient Treatment (ADAPT) Act of 2013. Antibiotic resistance is of grave concern, but this legislation will create more problems than it will solve. Continue reading

Letter to Senator Booker Supporting the Securing Assistance for Victim Empowerment (SAVE) Act

September 23, 2014. We strongly support this legislation to end the tax-exempt status of major professional sports leagues and use the money saved for domestic abuse programs. We strongly agree with your statement that “stopping domestic violence is a national priority that requires long-term, meaningful investment.” Continue reading

Letter to Congressman Cooper strongly supporting the Research for All Act of 2014

June 5, 2014. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the Research for All Act. It would require the FDA to develop policies to ensure that clinical trials for medical products granted expedited approval are sufficient in design and size to determine the safety and effectiveness for men and women, using subgroup analysis. Continue reading

Letter to FDA Commissioner Hamburg About Approving Cobas HPV Test Alone (Without Pap Smear) and FDA Response, April 2014

April 11, 2014. We are writing as members of the Patient, Consumer, and Public Health Coalition and other interested experts to express our grave concerns about the March 12, 2014 FDA meeting of the Microbiology Medical Devices Panel of the Medical Devices Advisory Committee. Under consideration was the premarket approval of a new indication for the Cobas HPV test, as a first-line primary screening tool for cervical cancer in women aged 25 and older.
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Coalition Concerns about H.R. 3742, the Antibiotic Development to Advance Patient Treatment (ADAPT) Act of 2013

As members of the Patient, Consumer, and Public Health Coalition, which includes groups representing physicians, scientists, consumers, and patients, we are writing to express our concerns about H.R. 3742, the Antibiotic Development to Advance Patient Treatment (ADAPT) Act of 2013 Continue reading

Letter to FDA Regarding Advisory Committee Panel on Reclassification of CPR Devices

November 5, 2013. We are writing to express our strong concerns about the September 11, 2013 FDA meeting of the Advisory Committee for Circulatory System Devices. This Advisory Committee meeting discussed and made recommendations regarding the proposed down-classification of External Cardiac Compressor (ECC) devices. The panel members were asked to consider the FDA recommendation that ECC devices be reclassified from Class III (high risk) to Class II (moderate risk) with special controls. Continue reading

Coalition Letter to House Leaders in Opposition to Piecemeal Funding of FDA

October 4, 2013. We are writing as public health, patient, consumer, and scientific nonprofit organizations to oppose H.J. Res 77 and any other efforts to single out the Food and Drug Administration for funding.  Our organizations represent millions of patients, consumers, health professionals, and scientists who strongly support the work of the FDA and urge Congress to provide the level of appropriations the agency needs throughout FY 2014. Continue reading

Coalition Letter to Senator Harry Reid supporting Affordable Care Act and opposing repeal of excise tax on medical devices

September 26, 2013. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the Patient Protection and Affordable Care Act (ACA) and oppose efforts to undermine this essential program that will benefit millions of Americans. In the upcoming negotiations over the budget and debt ceiling, we urge you to reject the repeal of the 2.3% excise tax on medical devices. Continue reading

Letter to Senator Gillibrand in Support of the Military Justice Improvement Act

September 17, 2013. On behalf of the following nonprofit organizations from the Patient, Consumer, and Public Health coalition, we urge you to support Senator Kirsten Gillibrand’s (D-NY) Military Justice Improvement Act (S. 967) when it is offered as an amendment to the 2014 National Defense Authorization Act. Continue reading

Letter to the CA Bureau of Electronic and Appliance Repair in Support of Improved Flammability Standards for Furniture

September 3, 2013. As a nonprofit organization dedicated to improving public health, the National Research Center for Women & Families strongly supports the proposed revisions of California’s flammability standards for upholstered furniture and other products. Continue reading

Letter to Congressman Markey in Support of VALID Act About Compounding Pharmacies

May 22, 2103. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the Verifying Authority and Legality in Drug (VALID) Compounding Act of 2013. This bill would significantly strengthen FDA oversight of compounding pharmacies and help ensure patients get safe and effective life-saving medical products. Continue reading

Comments from Members of the Patient, Consumer, and Public Health Coalition Re: HELP Committee’s Draft Proposal on Pharmaceutical Compounding

The Patient, Consumer, and Public Health Coalition expressed concern that the draft does not adequately address the public health threats posed by compounding pharmacies and will not do enough to prevent future health care crises. The Coalition provided comments on how to improve the draft to better protect the American public. Continue reading

Letter to Key U.S. Senators in Support of Funding for the Affordable Care Act

Like you, members of the Patient, Consumer, and Public Health Coalition are very supportive of the Patient Protection and Affordable Care Act (ACA). We were extremely disappointed that the Hatch-Klobuchar amendment (S. Amdt. 297 to S. Con. Res. 8) to repeal the 2.3% excise tax on medical devices was overwhelmingly supported. Thank you very much for your important vote against the amendment. Continue reading

Letter supporting Delivering Antimicrobial Transparency in Animals Act

Letter to Representatives Henry Waxman and Louise Slaughter supporting the DATA act, which would require better reporting of how antibiotics are used in animals raised for food. This information is critical to understanding how antibiotic resistant bacteria in food animals affects human health. Continue reading

Letter to Congressman Edward J. Markey on the VALID Compounding Act of 2012

As members of the Patient, Consumer, and Public Health Coalition, we thank you for your commitment to the health of patients and consumers by introducing the Verifying Authority and Legality in Drug (VALID) Compounding Act of 2012. This bill would strengthen FDA oversight of compounding pharmacies in several essential ways, and is clearly needed to prevent tragedies such as the contaminated steroid injections that have already resulted in 356 cases of fungal meningitis and 28 deaths. Continue reading

Comments from Members of the Patient, Consumer, and Public Health Coalition Re: FDA’s Recent HELP Committee testimony on pharmacy compounding

As members of the Patient, Consumer, and Public Health Coalition, we welcome the opportunity to provide our views regarding FDA Commissioner Margaret Hamburg’s November 15, 2012 testimony at the HELP Committee hearing, “Pharmacy Compounding: Implications of 2012 Meningitis Outbreak.” Continue reading

Comments from Members of the Patient, Consumer, and Public Health Coalition Re: “Questions for Stakeholders Regarding Appropriate Regulation of Pharmacy Compounding”

Members of the Patient, Consumer, and Public Health Coalition welcome the opportunity to provide our views regarding pharmacy compounding.  Stronger regulations are clearly needed to prevent tragedies such as the contaminated steroid injections that have already resulted in 356 cases of fungal meningitis and 28 deaths.  Current laws and regulations regarding compounding pharmacies have resulted in giant loopholes that allow medical products that are neither safe nor effective to be sold throughout the country, putting patients’ lives at risk. Continue reading

Letter to Dr. Joshua Sharfstein, Maryland’s Secretary of Health, in support of banning the sale of baby bumper pads in Maryland, September 28, 2012

The ASTM standard that claims some bumper pads are less risky will muddle the safety issue even more and give parents a false sense of security. Maryland’s proposed ban on crib bumper pads will help to protect more than 70,000 babies born in the state each year, and that is a bottom line upon which we should all agree. Continue reading

FDA Needs to Provide Breast Implant Patients and Physicians with Unreported Industry Data about Quality of Life, Connective Tissue Symptoms, Rupture Rates per Patient, and Other Complications

January 5, 2012 Dr. Jeffrey Shuren, Director Center for Devices and Radiological Health Food and Drug Administration Silver Spring, MD 20993 RE: FDA Needs to Provide Breast Implant Patients and Physicians with Unreported Industry Data about Quality of Life, Connective … Continue reading