We have been hearing, for some time, rumors that powerful medical device manufacturers’ trade organizations were going to push Congress to tack onto the FDA User Fee Legislation new definitions of remanufacturing, which would redefine “remanufacturing” in a way likely to impact medical device servicing in a substantial way. All early signs pointed to this as more than a possibility. Indeed, H.R. 7253, titled “Clarifying Remanufacturing To Protect Patient Safety Act of 2022” was filed in March by Representative Scott Peters and two co-sponsors seeking to redefine remanufacturing as “any act that could significantly change the performance or safety specifications, or intended use.”
IAMERS together with U.S. Public Interest Research Group (“PIRG”), the Alliance and leaders from health networks across the country opposed key provisions in the bill. That the FDA had listed finalization and release of its Remanufacturing Guidance as among its “A-list” of priorities for 2022, seemed to be of no concern to some in the press to approve this legislation. From disclosures filed with the U.S. Congress Clerk’s Office, it appears that considerable resources were devoted to pushing forward the remanufacturing legislative agenda. However, the remanufacturing legislation was not included in the House User Fee legislation, which was approved several weeks ago.
Yesterday the U.S. Senate Health, Energy, Labor and Pensions (“HELP”) Committee held a daylong hearing on the FDA User Fee Legislation and various amendments. The Senate legislation, co-sponsored by HELP chair Senator Patti Murray and ranking member Senator Richard Burr, (and titled the “FDA Safety and Landmark Advancement Act’, S. 4348) was approved without reference to the Remanufacturing legislative proposal. Among the amendments considered were riders designed to address the infant formula shortage, foreign drug importations, cybersecurity, FDA consultant conflict of interest disclosures and much more. No riders were offered seeking to include remanufacturing legislation.
The FDA User Fee legislation reportedly funds significant portions of FDA operations. Though the Senate bill (if approved, as expected) and the House User Fee Bill contain differences to be resolved in riders and amendments, these will likely be sorted via a Senate/House conference. Both the Senate and the House leaders have publicly expressed commitments to proceed with a final bill well before the expiration of the current bill in September.
Leaders on both sides of the aisle understand that time is of the essence and that the situation calls for consensus and pragmatism. As House Energy & Commerce Chair Pallone bluntly stated a few weeks ago during a hearing on the mark-up of the House User Fee bill: “t]he problem we face and the reason we want to move so quickly is we don’t want a situation where the FDA has to send out these pink slips [to FDA employees] which they have done before.”
Yesterday, Senator Burr, ranking member on HELP expressed the need to support a bill which has bipartisan backing in an exchange with Senator Bernie Sanders on his proposed amendment addressing re-importation. “I want to tell my colleagues, if you want to kill this bill, do reimportations … Bernie, you’re entitled to your own opinion, but you’re not entitled to your own set of facts, and just because you speak loudly does not mean what you say is in fact true.” Senator Sanders’ amendment was eventually tabled. The HELP Committee Chair, Senator Murray pointed out that Senator Sanders’ amendment did not have bipartisan support and an earlier amendment to the User Fee bill required the FDA to issue regulations allowing the importation of drugs from Canada.
What was clear: not everyone is getting everything they want in the User Fee bill. Indeed, Senator Burr ultimately voted in committee against the User Fee package. The reasons mentioned in his post-hearing statement pertain to some of the amendments, which in his view, may stifle innovation.
About the author: Robert J. Kerwin is general counsel for IAMERS, the International Association of Medical Equipment Remarketers and Servicers.
This article is reprinted with permission of DOTmed HealthCare Business News and can be read online in its original format at: https://www.dotmed.com/news/story/58171