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 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.
Coalition Letter to FDA regarding transparency of the MDUFA V reauthorization process Read More »
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.
Coalition Letter to FDA and CDRH regarding MDUFA Reauthorization Read More »
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.
Public Comments on FDA’s Generic Drugs Commitment Letter Read More »
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.
Public Comments on the Reauthorization of the Prescription Drug User Fee Act Read More »
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.
Patient and Consumer Stakeholder Consultation Meeting, MDUFA V Reauthorization Read More »
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.
Letter to Congresswoman DeGette Expressing Concerns About 21st Century Cures Read More »
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.
Coalition Letter Opposing the “Right to Try” Law Read More »
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.
Coalition Letter to Member of Congress Regarding Regulatory Accountability Act of 2017 Read More »
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.
Letter of Opposition to Trickett Wendler Right to Try Act of 2017 (S. 204) Read More »
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.
Coalition Letter Protesting 21st Century Cures Read More »
