As Prescribed

Taking a step toward fulfilling its requirements under Section 506K of the Federal Food, Drug, and Cosmetic Act (Section 506K), FDA has issued Draft Guidance describing how the agency intends to implement the Platform Technology Designation Program. Section 506K was established by Section 2503 of the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act of 2022 and enacted as part of the 2023 Consolidated Appropriations Act.

Pharmaceutical drug pricing and reimbursement continues to make headlines nationwide. In a recent development, Maryland’s Prescription Drug Affordability Board (PDAB) finalized its list of selected drugs for affordability review. The board will engage in what it contends will be a comprehensive “cost review” where it will seek public comments, additional information, and data over a 60-day period to determine if the selected drugs will be subject to state-prescribed upper payment limits.

In what is being touted as a significant win for pharmaceutical drug manufacturers, the DC Circuit affirmed on May 21, 2024 that Section 340B of the Public Health Service Act does not categorically prohibit manufacturers from imposing distribution restrictions on covered drugs to covered entities. By rejecting the US government’s position that the 340B Drug Pricing Program categorically prohibits manufacturers from imposing any contractual conditions on the distribution of covered outpatient drugs, the court opened the door for new contract relationships between program manufacturers and covered entities.

At a time when pharmaceutical drug prices are at the height of political scrutiny, manufacturers can breathe a small sigh of relief as the Centers for Medicare and Medicaid Services (CMS) announced on May 15, 2024 that it will not, at this time, finalize its best price stacking provision in its May 23, 2023 Medicaid Drug Rebate Program (MDRP) proposed rule.

On May 21, 2024, the Drug Enforcement Administration (DEA) issued a notice of proposed rulemaking in the Federal Register (FR) to reschedule marijuana from Schedule I to Schedule III of the Controlled Substances Act (CSA). This announcement comes nearly a year after the US Department of Health and Human Services (HHS) August 29, 2023 letter to the DEA recommending that marijuana be rescheduled. It also follows an April 11, 2024 opinion letter from the DOJ Office of Legal Counsel that the United States' international treaty obligations do not prevent rescheduling marijuana. The proposed rule represents the most significant policy shift for marijuana since the passage of the CSA in 1970, which categorized marijuana as a Schedule I controlled substance.

Pharmaceutical drug pricing and reimbursement remains a bipartisan focus as we draw closer to the November presidential elections, with politicians remaining steadfast in their efforts to turn up the heat on pharmaceutical manufacturers. Politicians and other groups from across the political spectrum have coalesced around a 40-year-old statute known as the Bayh-Dole Act—intended to facilitate the public’s beneficial use of patented inventions by securing intellectual property (IP) rights for inventors—and are seeking to transform the statute’s never-before-used “march-in” rights to influence the price of drug products.

FDA recently issued a revised draft guidance titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products. This guidance provides specific recommendations for all three classes of products—biologics approved under 351(a) of the Public Health Service Act (PHS Act), and biosimilar products and interchangeable biosimilar products approved under 351(k) of the PHS Act—with respect to meeting FDA’s general accuracy and truthful and non-misleading standards that are applied to advertising and promotion of prescription drug products generally.

The development of psychedelic drugs for medicinal uses has substantially expanded since 2020, as evidenced by an exponential growth in Drug Enforcement Administration (DEA) production quotas for both psilocybin and psilocin. In 2024, these quotas grew to 20,000 g and 24,000 g, respectively, from just 30 g and 50 g in 2020.

Earlier this year, the US Food and Drug Administration (FDA) published new draft guidance substantially revising the agency’s previous guidance on the Establishment and Operation of Clinical Trial Data Monitoring Committees (DMCs). Since the original guidance was published in 2006, the agency has noticed an uptick in not only DMC usage but also broader DMC functions. As DMC use has changed, the guidance provides detailed considerations for sponsors regarding a variety of areas, including when a DMC may be appropriate, the scope of DMC responsibilities, and how to properly set up a DMC.

2024 is shaping up to be a big year for prescription drug affordability boards (PDABs). Like state price transparency reporting laws, state legislation establishing PDABs continues expansion. In response to rising prescription costs and overall state-level health care spending, numerous states have established PDABs to review certain high-cost prescription drugs and determine if states should take action to reduce those prices.