As Prescribed

President Joseph Biden issued an “Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy” (EO) on September 12. Under this EO, the president aims to “advance biotechnology and biomanufacturing towards innovative solutions in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security” through a multipronged and collaborative approach.

While the Biden administration and US Congress continue to debate ways to address perceived prescription drug pricing concerns, the Food and Drug Administration (FDA) is taking action. Under its Drug Competition Action Plan (DCAP), administered by the Office of Generic Drugs (OGD), FDA has published approximately 24 guidance documents since 2017, directing industry stakeholders on how to develop, prepare, and submit abbreviated new drug applications (ANDAs), so that generic drugs can obtain timely FDA approval and more quickly reach the market. In January 2022, FDA published three more guidance documents in the DCAP series.

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.

China’s long-awaited Personal Information Protection Law (PIPL) has potentially significant implications for pharmaceutical and medical device companies doing business in China or with the market in China. Personal health information is considered sensitive personal information and is now subject to enhanced data compliance requirements for collection, processing, and cross-border transfer. After two rounds of draft versions, the PIPL was finally passed by the Standing Committee of the National People's Congress on August 20, 2021 and will become effective November 1, 2021.

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).

Last year was a record-breaking one for capital raising in life sciences, and 2021’s first quarter was robust for special purpose acquisition company (SPAC) transactions. Now, after a second-quarter SPAC and initial public offering (IPO) slowdown, the outlook for summer SPACs has rebounded just in time for the Morgan Lewis Global Public Academy program, Going Public Through a SPAC: Current Issues for SPAC Sponsors and Private Companies 2021. Our panelists will discuss some of the most important legal issues for companies considering going public through a SPAC and for SPACs seeking an acquisition target. Topics covered will include the use of private investments in public equity (PIPEs), obtaining shareholder approval for a merger, and the required SEC filings and review process.

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.

The US Food and Drug Administration (FDA) has issued new guidance describing its current recommendations with respect to master protocols for the evaluation of drugs and biologics to treat or prevent COVID-19. While somewhat belated, this guidance may shed light on FDA’s approach to master protocols for other disease states/products.