August 11, 2025
Re: Reauthorization of GDUFA Amendments Public Comment from National Center for Health Research [Docket No. FDA-2025-N-0873]
The National Center for Health Research is a nonprofit think tank that scrutinizes the safety and effectiveness of medical products, and we do not accept funding from companies that make those products or have any financial interest in our work. Since our founding in 1999, we have focused on FDA policies and issues pertaining to the quality of medical care and are pleased to have the opportunity to share our views on improvements needed for GDUFA IV.
Our U.S. healthcare system relies on generic drugs and would be unaffordable without them. We wish Congressional appropriations would be sufficient to support all of the FDA’s essential work, but we know that the FDA needs user fees to ensure getting safe and effective medical products to market in a timely manner. However, speed is not the most important part of that equation.
In its summary of its request for public comments, the FDA stated that GDUFA is designed to facilitate timely access to safe and effective generic drugs for the public, by requiring that generic drug manufacturers and other relevant entities pay user fees to “finance critical and measurable generic drug program enhancements.” As described in the GDUFA III Commitment Letter, FDA committed to achieve certain performance goals, and to provide enhancements “designed to foster the development, assessment, and approval of complex generic products.”
Transparency
We appreciate the accomplishments of GDUFA III, but to achieve its stated goals GDUFA needs to be improved in ways that matter to patients and the U.S. healthcare system. We support recent HHS and FDA statements about transparency and about the need for the FDA to regulate industry, rather than to be influenced by unduly cozy relationships with industry. An important first step would be for user fee negotiations to include patient, consumer, and public health advocates, instead of only representatives of industry and the FDA negotiating behind closed doors. Unfortunately, all user fee negotiations have focused on what industry wants and needs and what they are willing to pay for, and not on what patients and consumers want and need. That needs to be improved, and no user fee programs are more important to patients, consumers, and healthcare in the U.S. than GDUFA.
All of us depend on generic drugs, whether taken for headaches or potentially deadly cancer or heart disease. Patients have been told to trust that generic medications work, but if our experience with a specific generic drug is inferior to what we previously experienced with the brand name version of the drug, our trust in all generic drugs can be harmed. In some cases, problems with specific generic drugs have been well-documented. That has happened too often in recent years, and that is why patients’ and health professionals’ trust in generic drugs has eroded. GDUFA needs to explicitly show that user fees will focus on ensuring that generic drugs are truly equivalent to brand name treatments in all the ways that matter to patients. Speed should be secondary, because when patients and health professionals realize that some generic drugs are ineffective or unsafe, it harms patients but also harms companies whose products are safe and effective.
Performance Goals
Performance goals need to be improved. Too few have been focused on safety or effectiveness. We are glad that metrics have included the number of inspections and timeliness of inspections and follow-up warning letters, import alerts, and regulatory meetings, and those metrics should be continued. However, they are not sufficient.
Last summer, the FDA determined that Synapse (a company in India) “faked and forged” data submitted to the FDA. FDA withdrew the bio-equivalency rating of 400 of their drugs, but they are apparently still on the market. Neither patients nor pharmacists have access to the names of those drugs. Why is that? That decision is terribly unfair to patients, but it is also unfair to companies whose safe and effective generic medications are competing with those 400 drugs.
More important, it is unfair to all generic companies that make excellent medications when patients don’t know which generic drugs they can trust, and which they can’t trust.
Valisure has also conducted research showing a sizable number of generic drugs are substandard, with doses that are too high, too low, or drugs that are contaminated or have other problems. That’s important information for consumers to know, so the FDA should follow-up on Valisure’s findings to get those drugs off the market. However, it is equally important that the agency should be on the forefront of conducting that type of research, requiring recalls of those inferior drugs, and warning patients that those medications need to be replaced with those made by a different generic or brand name company. If the FDA does not have sufficient staff to do that, they should hire additional staff, and GDUFA should help to make that possible.
These are just a few examples of why post-market surveillance, pre-market and post-market inspections, and re-inspections are so important and why GDUFA should include funding for staff who will accomplish those quality performance goals. GDUFA should include relevant metrics in the Commitment Letter that show that these problems are being addressed and that FDA can therefore ensure that generic drugs are truly safe and equivalent to brand name drugs. That’s the promise that GDUFA and the FDA have made to patients, and it needs to be kept.
Here is an important list of the kinds of metrics that are missing from previous GDUFA Commitment Letters and should be included in FDA monitoring under GDUFA IV. They are not new ideas; this is the exact same list that the FDA states are criteria for all generic drugs. The FDA says they must be:
- Pharmaceutically equivalent
- Capable of making the drug correctly
- Capable of making the drug consistently
- The active ingredient is the same as the name brand and the same amount gets in the body
- Inactive ingredients are safe
- Drug does not break down over time
We appreciate the progress that has resulted in reducing the backlog of generic drug applications. However, many patients and knowledgeable health professionals currently lack confidence in generic drugs, and in some cases their concerns are well-founded. To regain public trust, we respectfully urge the FDA to improve GDUFA by adding performance goals metrics that are focused on ensuring safety and equivalence in GDUFA IV in the ways recommended above.
We would welcome the opportunity to discuss these issues and answer any questions. We can be contacted at info@center4research.org.