Health Legislation

We respectfully urge you to not advance the Senate’s Innovation for Healthier Americans bills or the House’s 21st Century Cures Act during the lame duck session of Congress.  While the House version of the legislation provides additional funding for the National Institutes of Health (NIH), both the House and the Senate versions contain more controversial measures which would lower safety and approval standards for drugs and medical devices at the Food and Drug Administration (FDA).

As members of the Patient, Consumer, and Public Health Coalition, we strongly urge against co-sponsorship bill S. 2912. This bill gives terminally ill patients access to experimental drugs that have passed phase I testing – testing that is often done on healthy volunteers, not people with serious illnesses. While this type of legislation promises cures, it offers false hope.

We want all Americans to have the best possible medical treatments but we are concerned that the primary focus of 21st Century Cures is on getting medical products to market more quickly, instead of making sure they are safe and effective. Whether creating a new expedited pathway for devices (which already are approved based on much lower standards than drugs) or deregulating health IT software.

We are writing to express our views as consumers, physicians, scientists, and public health experts regarding the health care legislation scheduled to be marked up on March 9, 2016. We want all Americans to have the best possible medical treatments, and that includes making sure that the safety and effectiveness of medical products are not compromised in the process.

The Patient, Consumer, and Public Health Coalition held a Senate briefing titled “Innovation for Healthier Americans: The Impact of Proposed Health Bills on Patients & Consumers”. This article covers the details of the briefing.

The Patient, Consumer, and Public Health Coalition strongly supports efforts to improve the safety and effectiveness of drugs and medical devices. We urge Senator Alexander and Senator Murray to prioritize patient safety in the health legislation that the committee will mark up on February 9, 2016 and in March.

We strongly  support  the Senate Committee on Health, Education, Labor, and Pensions (HELP) Committee’s efforts to improve patients’ access to safe and effective medical products in a timely manner  through the Innovations for Healthier Americans initiative. We urge the Committee to consider the inclusion of components of the Research for All Act of 2015 within the legislative text of the Innovations initiative.

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.  The Act also increases the study of female animals, tissues, and cells in basic research conducted or supported by NIH.

We would like to express our strong and enthusiastic support for the “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.

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.