Rep. Andy Biggs, R-AZ, proposed before withdrawing an amendment not to target FDA spending for a specific use but to preclude any funding for the agency to enforce its draft guidance for homeopathic drugs.

The House Appropriations Committee stated that Biggs amendment would "prevent funds from being used to finalize, implement, or enforce the draft guidance issuedby the [FDA] in December of 2017 titled Drug Products Labeled as Homeopathic: Guidance for FDA Staff and Industry." But, on 20 June, "by unanimous consent, the Biggs amendment was withdrawn," the committee stated.

The FDA's draft guidance identified problems in the homeopathic drug industry it will target for enforcement while allowing products to remain available without pre-market approval. The draft did not specify testing of homeopathic ingredients for certain indications but stated that the FDA will use an enforcement approach similar to its oversight of conventional OTC and Rx drugs that are marketed following agency evaluation of applications or nonprescription products available under monographs. (Also see "US FDA Moves Homeopathic Drug Enforcement To Risk-Based Approach" - Pink Sheet, 19 December, 2017.)

Homeopathic manufacturers have questioned whether the agency needs to change its oversight policy for the industry, saying the category of drugs has a history of safety under a 1988 compliance policy guide. The draft states that upon finalization of the guidance, the guide will be withdrawn.

The American Association of Homeopathic Pharmacists industry group is conducting its first Quality & Safety in Homeopathic Manufacturing Summit 27-28 June in Baltimore to help manufacturers develop strategies for complying with the FDA's enforcement priorities.

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