As Prescribed

While many provisions of the FY 2023 Consolidated Appropriations Act (Omnibus) have received much attention, one has flown under the radar. In its explanatory statement on the Omnibus, the US Congress indicated that it is keeping an eye on how FDA approves orphan drug products.

The Civil Division of the US Department of Justice (DOJ) released its annual fraud statistics for fiscal year 2022 on February 7. Of the $2.2 billion recovered under False Claims Act (FCA) settlements and judgments, more than $1.7 billion related to matters that involved the healthcare industry, including medical device and pharmaceutical manufacturers.

The Centers for Medicaid and Medicare Services (CMS) announced a model on February 14, 2023 that would allow CMS to pay less for drugs approved via FDA’s accelerated approval pathway before a clinical benefit has been confirmed by the required confirmatory studies.

The US Food and Drug Administration (FDA) recently issued a notice clarifying the agency’s approach to determining the scope of orphan drug exclusivity. According to the FDA, it intends to continue applying its orphan drug regulations such that the scope of orphan drug exclusivity is tied to the specific orphan indication for which a drug is approved, not the indication for which it was designated. This approach, however, is in contrast with the 2021 Catalyst Pharmaceuticals Inc. v. Becerra ruling, and will likely position the agency for future challenges. The FDA’s approach also lends uncertainty to the ultimate scope of current and future periods of orphan drug exclusivity.

Big changes may be on the way for the life sciences industry, especially in the pharma segment, resulting from the Federal Trade Commission’s (FTC’s) proposed rule to ban employers from entering into and using noncompete provisions in employment contracts.

On October 17, 2022, the US Food and Drug Administration (FDA) implemented revisions to two of its compliance policy guides (CPGs). CPGs are intended to advise FDA staff as to the agency's strategy when assessing and enforcing industry compliance. They typically establish FDA policy and interpretation where there is a need for clarification or to address other issues not covered by existing FDA laws, regulations, or guidance.

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.

The US Food and Drug Administration (FDA) has issued a proposed rule—“National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers” (Proposed Rule)—pursuant to FDA’s obligations under the Drug Supply Chain Security Act (DSCSA or the Act) that, when finalized, would require all US wholesale drug distributors (WDDs) and third-party logistic providers (3PLs) to be licensed according to a national standard.

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 US Senate voted on February 15 to confirm Dr. Robert M. Califf as the next commissioner of the US Food and Drug Administration (FDA), a position that has been filled since April 2021 by acting commissioner Dr. Janet Woodcock.