Comments of the National Center for Health Research on
GDUFA II Commitment Letter
[Docket No. FDA-2012-N-0882]
Thank you for the opportunity to speak today. I am Paul Brown, Government Relations Manager for the National Center for Health Research. Our Center is a think tank that conducts and scrutinizes research on the safety and effectiveness of medical products.
Our Center does not accept funding from pharmaceutical companies, so we have no financial interests in the medical products and policies we examine.
We respect the FDA and we’re committed to ensuring that it has the resources it needs to make sure that our medical products safe and effective. Given the inadequate appropriations provided to the FDA, we strongly support increasing GDUFA and other user fees to improve FDA’s resources in order to enable the agency to fulfill its public health mission.
Our Center has attended in-person or by phone all of the GDUFA II stakeholder meetings. We agree with GDUFA’s intent, which is to provide additional revenues so that FDA can hire more staff and improve the generic drug review process that will lead to increased access to generic drugs.
We also support the commitment letter’s streamlining of the user fee structure, which will provide a more stable source of funding, and give small companies a financial break on the user fees.
We support the GDUFA II Commitment Letter. It increases user fees by nearly $1 billion over 5 fiscal years from 2018 to 2022. GDUFA I users fees totaled $299 million a year; the fees go up to $493.6 million a year for GDUFA II. The increased fees are needed because the number of Abbreviated New Drug Applications (ANDAs) was under-estimated in GDUFA I. FDA has hired additional staff to meet the increased demand and estimates that it will spend $430 million in the final year of GDUFA I. However, we are concerned that if applications go up to more than estimated in GDUFA II, then even the increased user fee amounts will not be enough to cover the needed FDA staff.
We are also concerned that the fees may not have increased enough to offset the increased workload that the performance goals required FDA to meet. The performance goals are resource- intensive and include tight timelines for the review of original ANDAs and ANDA amendments (both standard and priority submissions), PASs (Prior Approval Supplements) and PAS amendments. They also include short timelines regarding the review of Drug Master Files, controlled correspondence, pre-submission meetings, safety determination letters, teleconferences, and many other deadlines.[1]
Some of the performance goals in the commitment letter seem unrealistic. For example, the commitment letter states that FDA will meet 90% of most of the performance goals by certain dates, including 6 months for priority major ANDA amendments. That sounds like a New Year’s resolution: “I will lose 90% of my body fat by the end of June.” It’s a nice goal but is it doable? As public health advocates, we need more information on how much time and staff it currently takes the FDA to review and act on these applications. Then we can better estimate how much additional staff and funding it will take to reach these goals. [2]
Safety
FDA monitors adverse events reports for generic drugs. It is one way that FDA evaluates the safety of drugs after approval. This is important. It is not unusual for side effects from drugs to show up years after the drug has been on the market—when the generic drug is dominating the market or the only drug on the market. That is why GDUFA fees should be used for enhanced safety reviews.
Conflicts of interest
FDA’s primary mission is to protect the public health. GDUFA and other user fees should fund an independent review of how the program has affected overall public health. Have user fees changed FDA’s priorities? Is FDA now treating industry as a customer that it needs to please, instead of acting as a regulator to ensure the public health? Some ethics researchers suggest that user fees are harming, not helping, the FDA’s public health mission.[3],[4]
Process Issues
Let’s start with the positive. We greatly appreciated the GDUFA II Fee Structure Summary. It was concise and easy to read.
But the commitment letter itself needs improvement. The current letter uses too much jargon. Too many abbreviations are not defined, making the commitment letter a chore to read.
Regarding the meetings themselves, FDA needs to improve its outreach efforts. It was disappointing that few consumer, patient, and public health advocates attended the GDUFA stakeholder update meetings. For GDUFA III, we recommend that you hold some of the meetings in Washington, DC at the Hubert H. Humphrey Building. It is difficult for some advocates to attend meetings at FDA’s White Oak campus, which is not easily accessible by Metro.
Conclusions
We strongly support increasing GDUFA and other user fees to improve FDA’s resources in order to enable the agency to fulfill its public health mission. We strongly support the increased resources for hiring review staff. However, we have not seen enough data in the commitment letter to convince us that the GDUFA user fees are adequate to cover the increased workload, especially since the proposed performance goals call for tight deadlines and numerous time-consuming meetings between FDA and industry.
Patients and consumers and the groups and public health advocates should have a greater role in the discussion of how user fees are spent. We do not pay the fees, but we do pay for the medications. We pay directly when we use our own money to buy the products, pay for insurance and federal health programs, or pay for the health problems that may result when the medicines don’t work well. And, as taxpayers we pay for the appropriations that are still supporting a major proportion of FDA resources, including the salaries of FDA staff and officials. We should be at the table or at least in the room when negotiations take place for user fees.
Once again, thank you for the opportunity to speak.
- Food and Drug Administration (2016). GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018- 2022.
- http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2282014##
- Light DW, (July 17, 2013). Risky Drugs: Why The FDA Cannot Be Trusted, Harvard University, Edmond J. Safra Center for Ethics; http://ethics.harvard.edu/blog/risky-drugs-why-fda-cannot-be-trusted
- Light DW, Lexchin J, Darrow JJ (June 1, 2013). Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs; http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2282014##