GDUFA III Commitment Letter – Public Comment
Patients, Consumers, and Public Health Coalition
As members of the Patient, Consumer, and Public Health Coalition, which includes nonprofit organizations that represent patients, consumers, scientists, and researchers, we appreciate the opportunity to provide our comments regarding the Commitment Letter that resulted from the Generic Drug User Fee Act (GDUFA III) negotiations between the Food and Drug Administration (FDA) and generic drug industry.
Our primary concern is that most of the performance goals reflect the priorities of industry, and do not adequately include safeguards regarding the safety and efficacy of generic drugs that are being reviewed and approved by the FDA. We support the efforts to ensure generic drugs are approved as quickly as possible, but these drugs must first demonstrate that they are equivalent to brand name drugs, which should include evidence that they are safe and effective.
We were pleased to see a few performance goals pertaining to inspections in the Commitment Letter. These include the number of inspections conducted by domestic or foreign establishment location and inspection type; median time throughout the process of beginning inspection of facilities to issuance of warning letters and official action designation for failing to comply; and the number of applications accepted for standard and priority assessment. Information should also be provided on the number and percentage of applications rejected to give an adequate view of FDA’s performance as safety gatekeeper for patients and consumers.
Moreover, the FDA should take steps to prioritize these and other goals relevant to safety and efficacy throughout the GDUFA III authorization. The FDA website states that generic drugs meet the following requirements:
• Be pharmaceutically equivalent” to the brand name drug.
• The manufacturer is capable of making the drug correctly.
• The manufacturer is capable of making the drug consistently.
• The “active ingredient” is the same as that of the brand name drug and the same amount gets into the body.
• Inactive ingredients are shown to be safe.
• The drug does not break down over time.
Other than the performance goals that pertain to inspections of manufacturing plants, none of the GDUFA performance goals provide any metrics relevant to these major requirements. The GDUFA III Commitment Letter fails to include monitoring to ensure that these requirements are met. This is a major shortcoming of the Commitment Letter and for that reason the Commitment Letter should be revised.
Finally, there is a need for improved transparency and accessibility throughout the GDUFA negotiations for all groups who are potentially receiving the drugs; this includes older adults, children, and people with disabilities. The FDA should work to ensure information is presented in multiple formats to meet the needs of diverse populations. This includes multiple languages, website content that can be accessed by a screen reader, and the use of plain language. Videos and virtual meetings should have the option for closed-captioning and American Sign Language translation. These changes will help to create a more inclusive process of GDUFA negotiations and will give a voice to a broader group of people affected by these decisions.
In conclusion, 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 ask the Biden Administration to stand up for these excluded interests and improve the GDUFA III proposals by supporting the topics discussed in this letter.
Patient, Consumer and Public Health Coalition member organizations