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September 30, 2022.  That’s the date the Food and Drug Administration’s (FDA) user fee programs for drug products and medical devices are set to expire.  Given the “must-pass” nature of user fee reauthorization, lawmakers and FDA stakeholders are using this moment to advance other FDA-related reforms pertaining to the accelerated approval process, promoting clinical trial diversity, competition in drug markets, and other areas.  While the House and Senate user fee packages are fundamentally similar, there are some differences between the two.  For instance, the Senate package includes policies related to dietary supplements, diagnostic labs, and cosmetics; the House does not.  Given the differences between the packages and the pressure to get a signed bill before the August recess, stakeholders would be keen to watch the legislative process unfold.

A Brief History of the FDA User Fee Process

Enacted in 1992, the Prescription Drug User Fee Act (PDUFA) authorized the FDA to collect user fees from companies that submit applications for drug products.  Since then, Congress has added additional user fee programs for other products like medical devices, generic drugs, and biosimilars.  Congress reauthorizes user fee bills every five years, and the reauthorization process marks an important opportunity for lawmakers to consider FDA-related policies as well as overall FDA performance.

Since FDA depends on user fees to operate, failure to reauthorize user fee programs would catastrophically disrupt FDA operations by triggering massive layoffs of career staff who review new drugs and devices and monitor drug safety.   As a result, the timelines for new drug products to reach patients and providers would increase exponentially.

Although current authority for the user fee programs expires at the end of Fiscal Year (FY) 2022, Congress typically passes reauthorization bills in the summer preceding the September deadline to avoid disrupting FDA operations. With that in mind, the House and Senate are on the clock to pass a legislative package over the next couple of months before the FDA starts handing out pink slips.

What’s in the House and Senate Bills?

The House Energy and Commerce Committee and the Senate Health, Education, Labor, and Pensions (HELP) Committee have already released their own respective user fee reauthorization bills that would reauthorize fees that drugs, biosimilars, and medical device companies must pay the agency for review of their products.  Both bills appear to move forward with fee levels that were negotiated between FDA and industry groups prior to their release.

Additionally, both bills set out to reform the FDA’s accelerated approval program, which allow the agency to approve drugs more quickly for serious conditions that fill an unmet medical need.  In exchange, drug manufacturers must complete post-approval trials to confirm those clinical benefits – something the FDA has not consistently ensured.

Both the House and Senate bills would allow the FDA to require manufacturers to start post-approval studies prior to accelerated approvals, give the FDA more control over study design and deadlines, and create a mechanism for the agency to pull drugs off the market.  The bills also would clarify that post-approval studies could rely on real-world evidence (RWE) to confirm that drugs are effective.  Notably, the Senate bill differs from the House bill in that it would create an interagency coordinating council that would periodically review accelerated approvals.

Additionally, both bills set out to promote drug competition through better access to generic and biosimilar drugs, albeit through different paths.  For instance, the House bill contains provisions that would streamline the generic approval process in certain types of cases, while the Senate bill addresses exclusivity for interchangeable biosimilar products.

Outside of fee proposals, changes to the accelerated approval process, and access to generic and biosimilar drugs, both bills contain several notable differences.  For example, the House bill includes provisions aimed at improving diversity in clinical trials by requiring trial sponsors to submit diversity action plans with details on how the sponsors intend to enroll a diverse group of trial participants.  Other provisions would require the FDA to submit reports on diversity action plans and to hold public workshops on improving trial diversity. While the Senate bill does not contain such a provision, another Senate HELP Committee-approved bipartisan bill, the PREVENT Pandemics Act, does include policy intended to promote clinical trial diversity.

Among the Senate’s user fee package proposals are provisions that would enhance the regulation of laboratory-developed tests (LDTs) by allowing the FDA to regulate LDTs based on the level of risk associated with them, similar to how the agency regulates medical devices.  The Senate bill would also expand the FDA’s ability to regulate dietary products by requiring dietary supplement companies to list their products with the agency, which would theoretically improve the FDA’s ability to enforce consumer protections.  Furthermore, the Senate bill contains a slew of provisions aimed at boosting regulation of cosmetics.  These include requirements for cosmetics manufacturers to register their products with the FDA, new labeling requirements, and the establishment of good manufacturing practice regulations.

What Comes Next?

The House Energy and Commerce Committee voted in favor of its user fee package in the Health Subcommittee on May 11 and the full committee on May 18 with a vote on the House floor scheduled for June 7.   Over in the Senate, the HELP Committee is scheduled to mark up its user fee package on June 14, along with legislation to improve access to mobile health clinics.

Congress has always addressed the user fee reauthorization legislation ahead of the expiration deadline (September 30), and leaders from both House and Senate committees with jurisdiction over the FDA have publicly stated that they don’t want to hold up the reauthorization process.  However, substantive differences between the House and Senate versions of the reauthorization bill combined with a highly partisan climate have the potential make passing user fee legislation more difficult than in previous years.

Additionally, the Senate HELP Committee has also voted in favor of its PREVENT Pandemics Act, another top priority of Chair Patty Murray (D-WA) and Ranking Member Richard Burr (R-NC), who is retiring at the end of this year, for enactment.  Likewise, a priority of House Energy and Commerce Health Subcommittee Chair Anna Eshoo (D-CA) will be enactment of her bipartisan House legislation creating the Advanced Research Project Agency for Health (ARPA-H).  It remains unclear if/how these policy priorities and user fee reauthorization packages will come together and form one bill to be signed by the President before the expiration of the current user fee programs. As the summer unfolds, stakeholders would keen to monitor the reconciliation process to see which provisions and changes make it into the final reauthorization bill.