On March 27, 2020, the President signed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to aid response efforts and ease the economic impact of COVID-19. Division A of the CARES Act includes an important legislative initiative, detailed in subtitle F of title III, that reforms and modernizes the way certain nonprescription, over-the-counter (or OTC) drugs are regulated in the United States.
The new user fee program, which we refer to as the Over-the-Counter Monograph User Fee Act (or "OMUFA"), is modeled after the successful Prescription Drug User Fee Act (PDUFA). For OMUFA purposes, industry-paid fees will help fund a portion of FDA’s regulatory activities for OTC monograph drugs and FDA agreed to adhere to performance goals, including to review submissions within specific time frames. As with PDUFA, FDA anticipates that this user fee program will provide additional resources to help the agency conduct these important regulatory activities in a timely manner and ultimately help provide the public with access to innovative OTC monograph drugs.
OTC Monograph User Fees
FDA establishes a new OTC User Fee Program (OMUFA) through which it will collect fees from the manufacturers. FDA will collect 2 types of fees:
1. Facility User Fee
-For qualifying persons who own an OTC monograph drug facility, including contract manufacturing organization facilities.
When is the facility fee due?
-The facility fee is due annually.
Are Contract manufacturing organization (CMO) facilities required to pay a facility fee?
-Yes, a qualifying CMO facility pays a fee equal to two-thirds of the amount of the fee for a qualifying OTC monograph drug facility that is not a CMO facility.
2. OTC Monograph Order Request (OMOR) Fees
Who pays an OMOR fee?
-As described in section 744M(a) of the FD&C Act, beginning with fiscal year 2021, each person that submits an OMOR is subject to an OMOR fee upon submission of the OMOR. However, a person that submits an OMOR shall not be subject to an OMOR fee if FDA finds that the OMOR seeks to change the drug facts labeling of an OTC monograph drug in a way that would add to or strengthen,
(i) a contraindication, warning, or precaution;
(ii) a statement about risk associated with misuse or abuse; or
(iii) an instruction about dosage and administration that is intended to increase the safe
use of the OTC monograph drug.
As OTC Monograph Reform progresses, FDA will release additional information about specific reforms and the implementation process.
To learn more, please contact us at firstname.lastname@example.org