For any of our readers seeking recommendations on which drinks pair well with turkey this Thanksgiving, certain fruit-flavored beverages may be off the table. Earlier this month, FDA issued a proposed rule that would revoke 21 C.F.R. § 180.30, its interim authorization of the use of …
On October 31, 2023, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would amend its prior notice regulations to add new information requirements and deadlines. More specifically, the proposed rule, if finalized, would: Amend 21 C.F.R. § 1.281(b)(10) to require that prior …
The U.S. District Court for the District of Columbia has vacated the Notice of Benefits and Payment Parameters (NBPP) rule issued in May 2020 (2020 NBPP Rule) which allowed health insurers and pharmacy benefit managers to use copay accumulators to exclude drug manufacturers’ copay assistance when …
On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 (SF 2744), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers. The drug pricing provisions of SF 2744 establish …
On May 16, the U.S. Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. The draft CPG reflects the three major laws and regulations that …
Chocolate-lovers and hopeless romantics rejoice: FDA has announced that it does not intend to object to the use of certain qualified health claims regarding the relationship between the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease. Though not …
Last week, the U.S. Food and Drug Administration (FDA) issued two guidance documents, one draft and one final, on food allergen labeling requirements. The draft guidance, “Questions and Answers Regarding Food Allergen Labeling (Edition 5),” replaces the 16-year-old Edition 4 of the final guidance with new …
At the risk of ruining our readers’ appetite for America’s most food-focused holiday, foodborne illnesses have been a feature of Thanksgiving for some time now. Some of us might still recall the 2017 salmonella outbreak linked to raw turkey products that caused over 279 infections, …
We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay assistance program would violate the AKS. Now, after an unfavorable HHS Office of the Inspector …
Three patient advocate groups have sued the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS), challenging HHS’s 2020 Notice of Benefits and Payment Parameters (NBPP) rule. As it stands, the rule allows insurers and pharmacy benefit managers …
In a recent decision, the Second Circuit upheld the HHS Office of the Inspector General (OIG)’s position that Pfizer’s proposed copay assistance program for its high-cost heart treatment would violate the Federal Anti-Kickback Statute (AKS). Pfizer, Inc. v. U.S. Department of Health and Human Services …
On December 6, 2021, FDA published a proposed rule to reorganize and amend the highly criticized agricultural water provisions of the Produce Safety Rule (PSR). This marks the Agency’s latest effort to balance public health protections with covered farms’ persistent concerns that the current provisions …
