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Last week, on December 29, 2020, the Food and Drug Administration (“FDA”) published a notice setting the amount of new annual facility fees for both for over-the-counter (“OTC”) monograph drug product manufacturers and for OTC monograph drug product contract manufacturing organizations (“CMOs”). The annual facility fee for OTC monograph drug manufacturers – the so-called Monograph Drug Facility (“MDF”) fee – was set at $14,060,[i] and the annual facility fee for CMOs was set at $9,373.[ii] According to the notice, for FY 2021, facility fees would have come due February 12, 2021.[iii]
However, just two days later, on December 31, 2020, the Department of Health and Human Services (“HHS”) withdrew the FDA notice and directed FDA to cease enforcement of the OTC user fees[iv] at least for the time being. HHS’ action responded to criticism that fees would apply to OTC hand sanitizer manufacturers ope
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With only a few days left in 2020, a year that has been mostly focused on the Food and Drug Administration’s (FDA) Coronavirus pandemic response, the agency has taken another step to further implement the provisions of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) that modernized the Over-the-Counter (OTC) Drug Review. On December 29, 2020, the FDA published a long-awaited
Federal
Register notice announcing the fee rates under the OTC Monograph user fee program for fiscal year 2021.
[1]
As discussed in previous bulletins (here, here, and here), the CARES Act, among other things, amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow FDA to assess and collect user fees from manufacturers of OTC monograph drugs and submitters of OTC monograph order requests (OMORs).