Representative_____ Energy and Commerce U.S. House of Representatives Washington, DC Dear Representative______, As members of the Patient, Consumer, and Public Health Coalition, we are writing to express our strong support for several provisions in The Food and Drug Amendments Act (H.R. 7667), and our concerns about other provisions that could be improved. The coalition was founded …
On the State and Federal level, legislation is passed every year that affects our access to healthcare as well as the quality and affordability of our health care. We fight for legislation that will improve the health of all adults and children across the country.
We would like to express our substantial concerns with the overall process as well as the shortcomings of the Commitment letter. The negotiations between the Food and Drug Administration (FDA) and medical device industry were not transparent and excluded patients, consumers, and other stakeholders.
We write today to follow up on your response to several requests for information at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Medical Device User Fee Amendments (MDUFA V) stakeholders meeting on February 28, 2022.
As key stakeholders, we strongly urge the FDA to hold firm in the demands to strengthen pre- and post-market safety performance measures and surveillance as part of the MDUFA Commitment Letter as you enter into final negotiations with industry. MDUFA performance goals should include metrics regarding safety, and not just speed of review, in order to achieve the FDA’s mission to protect patients from unsafe products and enhance public health.
We believe that the proposed recommendations must do more to ensure that generic drugs are providing an equally beneficial treatment for patients and consumers. We appreciate the efforts of the agency to work toward those ends, but as long as patients and consumers are excluded from the GDUFA negotiations, the concerns and priorities of these principal stakeholders will also be excluded.
We appreciate the opportunity to review the Commitment Letter for PDUFA VII upon conclusion of these negotiations. After reviewing the Commitment Letter, we offer our comments on the agreement as it stands at this stage of the reauthorization process.
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.