21 U.S.C. § 826a — Attorney General report on drug shortages

The Attorney General must send a report on drug shortages to two congressional committees. They are the House Committee on Energy and Commerce, and the Senate Committee on the Judiciary. The first report was due within six months of July 9, 2012. After that, the Attorney General must send this report every year. The report must cover three things. First, it must count the requests received under section 826(h) and state their average review time. It must also count how many were granted and denied, giving the reason for each denial. Second, it must describe how the Drug Enforcement Administration and the Food and Drug Administration work together to prevent or fix drug shortages. Third, it must name drugs containing a controlled substance covered by section 826 that the Secretary has determined are currently in shortage.

The record. According to the source credit, this section was enacted by Public Law 112-144, title X, § 1006, approved July 9, 2012, and published at 126 Stat. 1105. The credit reflects a single enactment with no subsequent amendment history noted beyond the original codification. Historical context. Public Law 112-144 is the Food and Drug Administration Safety and Innovation Act of 2012, a broad statute reauthorizing FDA user-fee programs and addressing related drug-regulation matters. Title X of that Act, sometimes referenced in connection with efforts to address drug shortages, is generally understood to have responded to a period in the early 2010s when shortages of certain prescription drugs—including some containing controlled substances—drew significant public and congressional attention. The reporting requirement in this section, directing the Attorney General to inform relevant congressional committees about requests processed under section 826(h) and about coordination between the Drug Enforcement Administration and the Food and Drug Administration, is consistent with a broader legislative interest in improving transparency and interagency cooperation to prevent or alleviate such shortages. Beyond this general understanding of the Act's era and subject matter, the record does not establish the specific legislative intent behind this particular reporting mandate, including why Congress selected the particular reporting elements or timeline set out in the text. Any more detailed account of committee deliberations or specific policy rationale would go beyond what is documented here.