FDA Issues Draft Guidance Staying Enforcement of Sample Reporting

On April 3, 2012, the Food and Drug Administration (FDA) issued a muchawaited announcement that the agency would exercise its enforcement discretion regarding the drug sample reporting requirements mandated under Section 6004 of the Affordable Care Act (ACA). The draft guidance for industry, entitled “Compliance Policy on Reporting Drug Sample Distribution Information,” states that the FDA will not object until at least October 1, 2012, if manufacturers and authorized distributors delay submitting information on drug sample distribution as required by statute.1 In addition, the FDA confirmed that it would provide notice before revising the policy to exercise enforcement discretion in this area.

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