Health Legislation

It is vitally important that the treatments approved by the FDA are proven to be both safe and effective for all patients. The only way this can be accomplished is through increased diversity and improved equity. There also is a need to improve overall accessibility to information related to medical device development and approval.

At the recent E&C Subcommittee on Health markup of the 21st Century Cures Act, Committee Ranking Member Frank Pallone stated that the Act was “far from a finished product,” and the Health Subcommittee Ranking Member Gene Green said there is “still work to do.”  We agree. Several sections of the Act would lower standards for the approval of antibiotics, medical devices, and most prescription drugs – putting patients at unnecessary risk of injury or death. 

We are very concerned about the controversial Trickett Wendler Right To Try Act of 2017, which purports to help dying patients gain access to experimental treatments that can save their lives. However, patients already have access to the FDA’s Expanded Access Program, which gives patients compassionate access to experimental drugs if their doctor believes it is appropriate and the company which makes the drug agrees to provide it for that use.

The RAA would do more harm than good by undermining life-saving safeguards that protect the public. We strongly urge you to consider the impact on your constituent and oppose the Regulatory Accountability Act of 2017.

We urge you to strongly oppose S. 204 because it would undermine the successful program already in place to enable patients to have access to experimental drugs for free or at cost. The proposed law would potentially harm many patients and family members, including seriously ill patients who could be harmed by scam artists in a treatment environment with no checks and balances. This legislation could open the floodgates to undermine the scientific requirements that made FDA approval the gold standard for the world.

We are writing to urgently express our strong opposition to the newly revised 21st Century Cures Act, both in terms of the process of trying to pass a bill without adequate time for public debate, and for specific provisions in the bill that would harm patient safety. Passing a 996-page bill that was negotiated behind closed doors and includes provisions that were never voted on before represents the kind of legislative sausage that Congress should reject.

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).