Hatch Closing Act: OTC Monograph Reform Legislation?
The Utah Republican has been instrumental during his more than 40 years in office in passing legislation central to the growth of the OTC drug and dietary supplement industries. But the expansion of the OTC market is stifled by FDA's monograph system for making more ingredients available, a process agency officials say no longer works.
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Federal agencies have “put brakes on new regulations” during the Trump administration and made efforts toward deregulation across the board, bringing about a “good and friendly environment for most businesses and industries,” says lobbyist Pete Evich. “We need to be careful about complacency that has a tendency to creep back in at a time like this when direct attacks and threats are down,” he said in a recent webinar.
The Utah Republican and Rhode Island Democrat sponsor legislation to make selective androgen receptor modulators subject to the same authority the Drug Enforcement Administration has to regulate anabolic steroids. Hatch said the SARMs Control Act of 2018 would "ensure that the DEA has the authority it needs to prevent abuse and diversion of these dangerous substances.”
The House Health subcommittee asks whether allowing manufacturers' periods of US market exclusivity for some approved OTC monograph proposals is needed, or would be fair to consumers.