As Congress returned from the July Fourth recess, the path forward on reauthorizing the Food and Drug Administration (FDA) agreements to collect user fees from prescription drug, generic drug, biosimilar, and medical device developers as well as other related FDA policies remained unclear following diverging statements from House and Senate negotiators on July 14. One of the related policies under consideration is a new regulation of laboratory-developed tests (LDTs) through the FDA. The AAMC has repeatedly expressed serious concerns about the impact of the legislation on the practice of medicine and innovation in diagnostics and patient care at academic medical centers [refer to Washington Highlights, June 3]
One of the leading negotiators of the FDA user fee package and proponent of including policies governing FDA regulation of LDTs, Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Richard Burr (R-N.C.), introduced the Food and Drug Administration Simple Reauthorization Act of 2022 (S. 4535, FDASRA) on July 14 out of concern that the necessary reauthorizations would not be approved by the Sept. 30 expiration of the current authorities. He also expressed concern about additional proposals added on as amendments to the Senate’s negotiated package during the HELP Committee markup.
“Unfortunately, the user fee package reported out of [the HELP] Committee would, if enacted, undermine the very purpose of the user fee program. The policies added to this bill endanger the development of drugs for rare diseases, imperil intellectual property rights, threaten Americans’ access to breakthrough treatments and cures, and deter private sector innovation,” Burr said in a press statement.
“Instead, the legislation I’ve introduced today preserves the user fee agreements as they’ve already been negotiated — without harmful additions. … As the authorizing deadline approaches, this clean reauthorization represents the clearest path forward,” he concluded. FDASRA does not include language regarding FDA oversight of LDTs.
In response to this proposal, HELP Committee Chair Patty Murray (D-Wash.) issued a press statement urging Burr to continue negotiation on the committee-passed Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act [refer to Washington Highlights, June 17]. FDASLA does include language to create a framework for the FDA to regulate LDTs under a new category of in vitro diagnostic called in vitro clinical tests.
“Senator Burr and I have spent months negotiating bipartisan policies that will keep families safe, support innovation, bring down drug prices, and much, much more. People want us to get this done — all of it,” Murray said.
“Pink slips are unacceptable to me, and they should be unacceptable to all of us … The fastest way to get this done is to move forward with the comprehensive bipartisan bill we have already advanced out of committee, and which includes so many desperately needed, long overdue, and bipartisan policies. I urge Senator Burr to return to the table, and finish what he started,” Murray concluded.
The House of Representatives already passed its bipartisan user fee reauthorization, the Food and Drug Amendments of 2022 (FDA22, H.R. 7667), which does not include language related to FDA regulation of LDTs [refer to Washington Highlights, June 10]. The lead negotiators of the House bill, Energy and Commerce Committee Chair Frank Pallone (D-N.J.) and Ranking Member Cathy McMorris Rodgers (R-Wash.) also issued a July 14 press statement urging the Senate to take up and pass the House-passed bill in advance of the Sept. 30 deadline.
“Any delay is unacceptable, especially after the House passed the bipartisan Food and Drug Amendments of 2022 more than five weeks ago by an overwhelming vote of 392-28. We urge Senate leaders to bring our strong bipartisan package to the floor for a vote before August,” they stated.
Committee staff are expected to continue negotiations on a user fee package that can be agreed to in both chambers as Congress looks ahead to several weeks of recess in August.