As Prescribed

Substantial evidence, the evidentiary standard for effectiveness established in 1962 by the US Federal Food, Drug, and Cosmetic Act (FD&C Act), is the measure against which all drugs and biologics are approved in the United States. This standard is, in large part, what makes the FDA’s approval standard often considered the worldwide “gold standard” for drug approvals. Now, recent draft guidance issued by FDA looks to refine this standard even further.

The Federal Trade Commission (FTC), supported by the Food and Drug Administration (FDA), issued a policy statement on September 14 indicating that the FTC intends to “scrutinize improper Orange Book listings” to identify potential violations of Section 5 of the FTC Act, which prohibits, among other things, unfair methods of competition.

After almost a decade, the Food and Drug Administration (FDA or Agency) finalized the Informed Consent guidance document (Final Guidance). The Final Guidance finalizes the 2014 draft Informed Consent Information Sheet guidance document (Draft Guidance) and supersedes the 1998 FDA guidance document, “A Guide to Informed Consent.” FDA issued the Final Guidance as part of an ongoing effort to modernize and harmonize its human subject protection policies and regulations.

FDA recently issued draft guidance with updated recommendations for implementing the International Council for Harmonisation’s (ICH’s) guidelines on good clinical practice (GCP). The goal of the draft guidance is to modernize the design and conduct of clinical trials, making them more agile while maintaining data integrity and participant protections. FDA has initiated a public consultation period, seeking feedback on the guidance and how its recommendations should be applied to increasingly diverse trial types and data sources.

In a continuing effort to improve the quality system effectiveness of human drug manufacturing sites, FDA revised MAPP 5014.1, Understanding CDER’s Risk-Based Site Selection Model (Site Selection MAPP or the Policy).

As drug shortages are once again front-page crises news, demanding drastic action by FDA—currently with a particular focus on sterile, injectable platinum-based chemotherapy drugs—a refresher on the scope of FDA’s tools to address a drug shortage is useful.

FDA recently published a Federal Register notice announcing a public listening session on good manufacturing practices (GMPs) for cosmetic products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which added Section 606 of the Federal Food, Drug, and Cosmetic Act requiring FDA to establish GMP regulations for cosmetics.

The US Food and Drug Administration (FDA) recently published a final guidance pertaining to quality considerations for clinical research involving cannabis and cannabis-derived compounds,” which adds minor updates to a 2020 draft guidance. The final guidance follows the passage of the Medical Marijuana and Cannabidiol Research Expansion Act and provides key clarifications on quality requirements for cannabis and cannabis-derived compounds used in clinical research.

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 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.