As Prescribed

The accelerated approval pathway (i.e., the pathway that permits FDA to rely on surrogate or intermediate endpoints for the approval of a drug for serious conditions with unmet medical needs) has proven to be an important tool to provide patients with access to promising products. By example, as of June 2021, the Center for Drug Evaluation and Research approved 269 drug and biologic products via accelerated approval. This does not include Center for Biologics Evaluation and Research approvals, which, as reported in the New England Journal of Medicine, has granted more than 155 accelerated approvals for oncology products alone.

Earlier in the summer, the FDA issued a quartet of guidance documents setting forth the Agency’s plan for implementing requirements under the Drug Supply Chain Security Act (DSCSA). The DSCSA directs FDA to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. It also requires that FDA establish national licensure standards for wholesale distributors and third-party logistics providers and establishes requirements for these entities to issue annual reports to FDA. Taken as a whole, these new guidances clarify FDA’s expectations for stakeholders to comply with the law to achieve a safer, more secure, and more trusted drug supply chain.

A bipartisan group of lawmakers in the US House of Representatives’ Judiciary Antitrust Subcommittee recently voted three bills out of committee that target the pharmaceutical industry practices of so-called “reverse payments,” “product hopping,” and “sham” citizen petitioning. Versions of some of these bills had been under consideration by this subcommittee for years, but had not been voted out of committee until now.

FDA’s Office of Pharmaceutical Quality (OPQ) issued a new Manual of Policies and Procedures (MAPP) in June explaining the agency’s internal procedures for evaluating color additives and flavors in an oral drug product submitted as part of an investigational new drug application (IND), new drug application (NDA), and Type IV drug master file (DMF).

In a May 27 Federal Register notice, the US Department of Health and Human Services (HHS) announced the reinstatement of the Unapproved Drugs Initiative, the FDA’s compliance policy governing marketed unapproved drugs. The announcement is an abrupt—but not unexpected—reversal from a previously issued controversial decision by the Trump administration’s HHS to end the Unapproved Drugs Initiative in November 2020. The reinstatement means that companies that market unapproved drugs should reassess their risk under FDA’s preexisting enforcement priorities.