OMB Reviewing FDA Rules on Drug Importation, ACE Filing for Veterinary Devices
A proposed rule that would allow importation of drugs intended for foreign markets is now under review by the Office of Management and Budget, according to the OMB website. Though OMB doesn’t say what exactly the rule would do, the Food and Drug Administration has said it would soon publish a proposal to allow pilot (or demonstration) projects developed by states, wholesalers or pharmacists to import certain drugs from Canada that are versions of FDA-approved drugs that are manufactured consistent with the FDA approval (see 1907310018).
Sign up for a free preview to unlock the rest of this article
Communications Daily is required reading for senior executives at top telecom corporations, law firms, lobbying organizations, associations and government agencies (including the FCC). Join them today!
The proposal is part of a broader effort to allow imports of cheaper foreign prescription drugs. FDA has also said that it would, through a guidance document, “provide recommendations to manufacturers of FDA-approved drugs who seek to import into the U.S. versions of those drugs they sell in foreign countries.”
OMB is also now reviewing a separate FDA proposal to require electronic filing in ACE for veterinary devices. Specifically, the proposal would require that certain data elements be submitted to CBP and FDA “to ensure that FDA has adequate information to determine admissibility” for veterinary devices. “This rule ensures that the regulations on import submissions for veterinary devices are the same as for all other FDA regulated products.” OMB reviews of regulations are limited to 90 days, extendable by another 30, and may end with approval of the rule for publication.