As you will recall, the Senate HELP Committee included mandatory product listing and several other dietary supplement policy changes to its version of legislation reauthorizing FDA collection of user fees from prescription drug, device and other manufacturers. The House passed its version of this bill without any dietary supplement provisions. The user fee legislation must be passed before September 30, 2022, or the resulting loss of revenues will force FDA to lay-off staff working on drug and device approvals.
Traditionally, this bill is seen as a “vehicle” for FDA program amendments on a broader basis. The Senate Committee bill included the dietary supplement mandatory listing authority as well as several other provisions related to supplements, including one that would establish a new “prohibited act” that would allow FDA to use the threat of criminal prosecution to remove products that don’t meet the definition of dietary supplements from the market. UNPA has been actively supporting a new mandatory product listing (with a focus on limiting what is reported to FDA to information on the supplement label), but we have expressed serious concerns about the “prohibited act” provision.
Because of the September 30 deadline, House and Senate staff have been working to add the user fee language to a “continuing resolution” (CR) that would extend all government funding to mid-December, after the elections. This legislation is needed to avoid a government shutdown on October 1. It was thought that the CR would be introduced as early as today and voted on in the House as early as tomorrow. But we have received word that House leadership has released members to leave D.C. tonight, with no votes scheduled tomorrow. This is a recognition that there are still some major issues of disagreement that need to be resolved.
Hill sources advise us that the CR is still expected to be passed by September 30. The FDA user fee reauthorization language IS expected to be included in the CR as a five-year extension of FDA programs, with a few non-contentious provisions (such as new requirements for accelerated approval of prescription drugs). Knowledgeable Hill staff tell us it is extremely unlikely either the MPL or other supplement provisions will be included because they lack sufficient support as passed by the Senate HELP Committee.
We will continue to keep you posted, but our assessment now is that action on MPL will happen no earlier than late this year or will be pushed off until the new Congress convenes in 2023. There is some chance that the MPL provision and other policy changes that were included in the Senate and/or House FDA user fees but dropped in the version to be passed in the CR later this month could be taken up and passed later this year after the November elections. We will continue to urge Congress to use this additional time to craft a narrow MPL provision without extraneous additions.
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