House and Senate Advance FDA User Fee Reauthorization Bills

By Pete Evich

In the month of June, both the House and Senate advanced separate pieces of legislation that reauthorize FDA’s prescription drug, medical device, biosimilars, and generic drug user fee programs for a five-year period. If Congress does not enact legislation by Sept. 30, 2022, all four user fee programs will expire. Because of the billions of dollars these user fee programs bring into FDA’s coffers, the user fee reauthorization measure is considered by Congress to be “must-pass” legislation. The bill’s importance has also turned it into a magnet for federal lawmakers to add extraneous FDA legislative policy provisions. In this regard, both the House and Senate versions of the legislation, which are currently moving through Congress, have attracted several FDA policy rider provisions.

AAHP has been watching this legislation closely to examine if any provisions are included in either the House or Senate versions that may impact the regulation of homeopathic drug products, or even the category of OTCs more broadly. This vigilance is borne out of past experience when AAHP identified provisions in prior Congressional user fee authorization legislation that would have inadvertently impacted the regulation of homeopathic drug products.

Fortunately, thus far, the House and Senate user fee reauthorizations bills moving through Congress contain only a few limited provisions that impact the broader OTC community. Those include the following:

• The House bill directs FDA to establish a pilot program for conducting unannounced foreign inspections of drug manufacturers. It also calls for FDA to evaluate the differences between domestic and foreign facilities and report back to Congress on its findings and recommendations.
• The House bill directs FDA to establish a pilot program for conducting unannounced foreign inspections of drug manufacturers. It also calls for FDA to evaluate the differences between domestic and foreign facilities and report back to Congress on its findings and recommendations.
• The House and Senate bills both clarify that all OTC monograph drug products are drugs and not medical devices. *FDA had been considering deeming certain ophthalmic products as medical devices.
• Both the House and Senate bill require FDA to move forward with policies to authorize over-the-counter hearing aids.

The House measure, which is called “The Food and Drug Amendments of 2022” (H.R. 7667), passed out of the full House on June 8. In addition to the user fee reauthorization language, this bill contains a number of provisions related to drug development, including a focus on clinical trial diversity, decentralized clinical trials, real-world evidence, pediatric drug development, and provisions to encourage new ways to develop and manufacture drugs.

On June 14, the Senate Health, Education, Labor and Pensions (HELP) Committee advanced The Food and Drug Administration Safety and Landmark Advancements, or FDASLA Act (S. 4348) by a vote of 14 to 9. Some of the key provisions of S. 4348 include:

• Clarifying the pathway for importation of drugs from Canada as well as expanding the range of eligible products.
• Strengthening FDA oversight over cosmetics and dietary supplements by establishing a broad range of new requirements and regulatory processes for these products.
• Updating FDA policies for authorizing in vitro diagnostics, with an eye to enhancing the agency’s ability to evaluate effective lab tests in public health crises. This particular part of the legislation is called the Verifying Accurate Leading-edge IVCT Development or VALID Act.
• Addressing the infant formula crisis by establishing a premarket review process for manufacturers of infant formula.

The Senate has decided not to bring the HELP Committee passed user fee bill (S. 4348) to the full Senate floor for a vote. Instead, the HELP Committee passed legislation will be considered the Senate version of measure for negotiations purposes with the House. At this stage, the leaders of the House Energy & Commerce and Senate HELP Committees will begin to meet to iron out differences between the two bills. The goal is to have a reconciled, final House-Senate measure enacted before Congress adjourns for its August recess. However, if that deadline slips, Congress will need to complete the negotiation process and send final legislation to the President’s desk by Sept. 30.