By Mark Land, AAHP President
This year marks the 30th anniversary of the enactment of the Prescription Drug User Fee Act (PDUFA). Enacted in 1992, PDUFA authorized FDA to collect user fees from companies that submit applications for human drug products. Congress has since passed additional legislation allowing FDA to collect user fees from makers of medical devices (MDUFA), generic drugs (GDUFA), and biosimilars (BsUFA). The FDA user fee model for these products has addressed the issue of funding gaps at the agency to hire staff, perform timely reviews, and develop procedures and standards for a predictable premarket review process.
All four user fee programs outlined above expire on Sept. 30 of this year and will need to be re-authorized by Congress through a singular user fee reauthorization measure (UFA). Congress will aim to pass this important legislation this summer to avoid disruptions to agency operations with respect to user fee funded activities.
By law, the reauthorization process is kicked off with FDA holding public meetings on the user fee programs. These meetings are followed by negotiations with industry stakeholders to develop recommendations and performance goals. The proposed agreements with industry are finalized in written commitment letters, which FDA releases for public comment before the ratified agreements between the agency and industry negotiators are submitted to Congress for further action.
With three of the four commitment letters having been ratified by the negotiators and transmitted by the Department of Health and Human Services to Congress, the Committees with jurisdiction over FDA — Senate HELP and House Energy and Commerce Committees — are ready to hold hearings to discuss the user fee agreements and draft legislation to reauthorize the programs.
On Feb. 3, the first Congressional UFA hearing took place before the House Energy and Commerce’s Health Subcommittee. Lawmakers focused on several policy areas of interest for the drug programs (PDUFA, GDUFA and BsUFA), including an accelerated approval pathway, the potential return to in-person work at FDA, and diversity in clinical research. Some members also lamented a lack of progress on the medical device user fee (MDUFA) negotiations.
As with prior reauthorizations, Congress is likely to use this must-pass vehicle to advance a number of other priorities related to FDA regulation of medical products. For example, Congress may attempt to add language to:
- Rewrite the nation’s pandemic preparedness policies;
- Adopt a “Cures 2.0,” which would build upon prior legislation to speed up medical innovations;
- Create an “ARPA-H”, which is President Biden’s proposed new medical research agency;
- Include provision to continue to address the opioid epidemic;
- Create a mandatory product registration system for dietary supplements; or
- Update the regulatory framework for cosmetics.
While AAHP does not anticipate Congressional consideration of provisions that are specifically aimed at homeopathic drug products, or even the category of OTCs more broadly, we are watching the legislative process closely. This vigilance is borne out of past experience where we identified provisions in draft UFA legislation that would have inadvertently impacted the regulation of homeopathic drug products. On those occasions, AAHP was able to act quickly to address those provisions with federal lawmakers and satisfactorily resolve the concerns we raised.
With UFA legislation activity on the horizon, AAHP has been meeting with key Congressional offices to inform, educate, and offer the association as a resource should homeopathic issues come to the surface. These engagements also afford us the opportunity to readily follow up should we identify UFA legislative language under consideration which would alter the manner that homeopathic drug products are manufactured or marketed.