Groups Urge Acting FDA Commissioner to Push for OTC Monograph Reform
A group of eight healthcare, advocacy and industry organizations are calling on Acting US Food and Drug Administration (FDA) Commissioner Ned Sharpless to continue efforts to reform the agency’s over-the-counter (OTC) monograph system.In a letter addressed to Sharpless, the Pew Charitable Trusts, American Academy of Allergy, Asthma & Immunology, American Academy of Pediatrics, American Public Health Association, Consumer Healthcare Products Association, March of Dimes, National Association of County and City Health Officials, and the Society for Maternal-Fetal Medicine urge the newly instated Acting Commissioner to work with Congress to pass and implement an OTC monograph reform package that stalled in the Senate last year.
“Reform of the monograph system is long overdue, and this legislation would streamline regulation for these drugs, transitioning away from the current rulemaking process and authorizing the use of administrative orders,” the group writes.
While efforts to overhaul the OTC monograph system have been underway for years, last year those efforts edged closer to actuality with the passage of H.R. 5333, the Over-the-Counter Monograph Safety, Innovation and Reform Act of 2018.
Under the bill, FDA would collect fees from companies that own facilities identified as OTC monograph drug facilities. Contract manufacturers also be required to pay two-thirds of the facility fee. These fees would allow FDA to work through its backlog of tentative monographs.
Despite passage in the House, the Senate did not vote on its version of the bill, S. 2315.
Pew, Letter