Health Legislation

The purpose of federal regulations is to protect the U.S. public from harm by implementing reasonable safeguards.  The purpose of U.S. public health agencies is to support scientifically sound research and protect the integrity of the scientific enterprise.  Even our current regulatory oversight has failed to protect hundreds of thousands of patients from unsafe drugs and defective devices, as evidenced by the needless deaths linked to Vioxx and serious injuries from metal on metal hips. Voluntary safeguards are not sufficient, nor is reliance on public/private negotiations to develop research agendas or scientific research safeguards.

As Members of the Patient, Consumer, and Public Health Coalition we appreciate the opportunity to provide comments on the Food and Drug Administration Safety and Innovation Act (FDASIA) Action Plan. We strongly support separate analyses of safety and effectiveness for demographic subgroups in clinical trials for drugs and devices. All patients deserve to be assured that the FDA has required that drugs and devices be proven safe and effective on people like them.  The data must be methodologically sound and publicly available.

As members of the Patient, Consumer, and Public Health Coalition, which includes organizations representing patients, consumers, physicians, and scientists, 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.

We do not support the FDA’s Safety and Innovation act as we believe it will undermine the FDA’s mission to protect the public health. The framework “primarily relies” on the ONC and private sector capabilities to coordinate activities with FDA and FCC, which leaves the FDA in a secondary role. The FDA has overseen medical devices, including medical device software, for nearly four decades. The Agency has been regulating software on mobile platforms for more than a decade and has cleared approximately 100 mobile medical apps such as ECG machines and smartphone based ultrasounds.

The Patient, Consumer, and Public Health Coalition, many of whom have worked with your staff for years, writes to express our concerns with in the 21st Century Cures project. We request that future discussions include representatives from our Coalition.  We believe that we bring an essential perspective and valuable expertise.

The Patient, Consumer, and Public Health Coalition, writes to support the agency’s evidence-based evaluation and decision regarding flibanserin.  We agree with the FDA that there is no evidence that the very modest benefit would outweigh the risks.

The House of Representatives sends a thank you notes to the Patient, Consumer, and Public Health Coalition.

The Patient, Consumer, and Public Health Coalition, which includes groups representing physicians, scientists, consumers, and patients, writes to express our strong support for updated standards that will enable the capture and transmission of the new unique device identifier(UDI) system in the claims transaction.

As members of the Patient, Consumer, and Public Health Coalition, we strongly support S. 1256, the Preventing Antibiotic Resistance Act.  The Act would help to preserve the effectiveness of antimicrobials used to treat diseases in both animals and humans.