As Prescribed

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 The Final Guidance finalizes the 2014 draft Informed Consent Information Sheet guidance document (Draft Guidance) and supersedes the 1998 FDA guidance document, “A Guide to Informed Consent.”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FDA recently issued draft guidance with updated recommendations for implementing the International Council for Harmonisation’s (ICH’s) guidelines on good clinical practice (GCP). The goal of the draft guidance is to modernize the design and conduct of clinical trials, making them more agile while maintaining data integrity and participant protections.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 Boston Bar Association held its annual White Collar Crime Conference on May 4, 2023, featuring lawyers from the defense and plaintiffs’ bar and current and former prosecutors from the US Attorney’s Office for the District of Massachusetts (Office) and the Office of the Massachusetts Attorney General.

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for clinical research involving cannabis and cannabis-derived compounds,” which adds minor updates to a 2020 draft guidance.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 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.