In a previous blog post (here), we discussed the results of an April 16, 2021 decision by the U.S. Court of Appeals for the District of Columbia Circuit in Genus Med. Techs., LLC v. FDA, 2021 (U.S. App. Lexis 10928 [April 16, 2021]) which the FDA decided not to appeal.  This court decision dealt with the FDA’s long-held position that radiologic contrast agents met the definition of drugs and classified them as such.  However, as explained in the decision, the FDA could not unilaterally require the products to be submitted as drugs if the products met both the definition of a drug or a device.

Well, apparently Congress felt the pain and concern that FDA and industry had expressed due to the confusion and potential disruption caused by the Court’s decision (as explained in the above- referenced blog post), and included provisions (hopefully to be in the must-pass User Fee Reauthorization legislation) that would codify the contrast agents as drugs. The language, if passed. would be very simple:

Sec. 803. Regulation of certain products as drugs

Deem all contrast agents, radioactive drugs, and over-the-counter monograph drugs to be drugs and not medical devices.

This is among a number of issues that the new reauthorization legislation would, if passed as is, strengthen or clarify the requirements for, including generic drug approvals, and providing new drugs and generic drugs, medical devices, and biosimilars with strengthened, clear, and more transparent legislative footing.

One other important section of the proposed legislation would authorize FDA to make the Q1/Q2 differences of a proposed generic more transparent.

Sec. 601. Increasing transparency in generic drug applications.

Requires FDA to provide generic drug sponsors, upon request, information regarding any differences in ingredients between their generic drug and the reference listed drug to which they are compared, to facilitate generic drug development and review. Requires FDA to issue guidance explaining how it determines whether a generic drug is qualitatively and quantitatively the same as the listed drug.

The proposed legislative text for the reauthorization Act can be found here  and a section-by-section summary of all of the provisions can be found here.

According to the Association of Accessible Medicines, “the subcommittee markup is expected to be noticed for Wednesday (May 11), with full committee markup on Wednesday (May 18)”. Hold onto your hats until then!