As we previously reported, in March, as part of the CARES Act, OTC monograph reform was signed into law. This law amended the FDC Act to include, among other things, an OTC monograph drug user fee program, under which FDA is authorized to assess and collect facility fees from manufacturers of OTC monograph drugs.
On Monday the 28th of December, FDA announced its scheduled Federal Register notice setting the user fees for manufacturers and contract manufacturers of OTC monograph drugs. Based on information about manufacturing facilities registered by Dec. 31, 2019, FDA has set the user fees as follows:
- Manufacturer facility fee: $14,060
- Contract manufacturer facility fee $9,373
The fees are effective as of October 1, 2020, when the Continuing Appropriations Act, 2021, Division A of Pub. L. 116-159 was enacted. (Section 123 of this Act provided an appropriation for the user fees).
The facility fee applies to manufacturers of finished monograph products, not to those manufacturers who produce only an active pharmaceutical ingredient. In addition, a facility fee will not be assessed for an OTC monograph drug facility which, prior to December 31, 2019, had ceased all activities related to OTC monograph drugs and updated its registration to reflect this. Other exemptions include facilities that are involved in the production of clinical research supplies; testing; or the placement of outer packaging on packages containing multiple products, for such purposes as creating multipacks, when all monograph drug products included are already in a final packaged form before placement in the outer overpackaging.
As we reported previously, the new law also provides for fees for OTC monograph order requests (OMORs). Fees for OMORs are set at $500,000 for a Tier 1 and at $100,000 for a Tier 2 OMOR. No fee will be assessed if the OMOR seeks to make certain safety changes with respect to an OTC monograph drug. As FDA notes, OMOR fees are not included in the OMUFA target revenue calculation.
Parties subject to the fees must complete an OTC Monograph User Fee Cover Sheet cover sheet. The facility fees are due 45 days after the date of publication of the Federal Register notice, which is scheduled to be published on Dec. 29, 2020.