Westbank Louisiana News

U.S. Senator Bill Cassidy has called on the Food and Drug Administration (FDA) to explain its lack of guidance on how drug manufacturers should list patents in the FDA's Orange Book. Cassidy, the ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, highlighted ongoing confusion over patent listings for drug-device combination products like auto-injectors and inhalers.

The Hatch-Waxman framework, established by Congress in 1984, aims to facilitate the timely introduction of generic drugs by requiring brand drug manufacturers to list relevant patents in the Orange Book. This listing provides notice to generic manufacturers about patents they must navigate to produce copies of brand drugs.

For years, both brand and generic manufacturers have struggled with whether patents for device components of drug-device combinations should be listed in the Orange Book. Despite numerous requests for clarity from Congress and industry stakeholders, FDA has not provided definitive guidance on this issue. Consequently, the Federal Trade Commission (FTC) has stepped in to enforce patent listings under antitrust law, leading to further confusion.

"Despite Congress’ clear charge to FDA to set the rules for listing patents in the Orange Book, FDA has been absent...Letting FTC enforce terms of the FDCA is an extraordinary abdication of authority by FDA," wrote Dr. Cassidy. "It is well within FDA’s authority to identify the types of patents that manufacturers should, or should not, list in the Orange Book."

Cassidy continued: "FTC’s actions have sown confusion amongst manufacturers about how they should list patents for drug-device combinations, exacerbated by FDA’s inaction...FDA’s continued silence on this issue is untenable, and patients ultimately stand to benefit through clarity on these requirements."

Cassidy's letter underscores that proper patent listings are crucial for compliance with legal requirements and avoiding accusations of either blocking competitors or deceiving them. He noted that accurate listings help facilitate litigation that allows lower-cost generics to reach patients more quickly.

The senator also referenced a January 2022 report from FDA which did not take a definitive stance but mentioned creating a multidisciplinary working group to examine patent listing issues further. However, nearly two years later, there is still no clear outcome from this effort.

Cassidy posed several questions for FDA Commissioner Robert Califf regarding the status of any work product from their multidisciplinary group and whether additional rulemaking or guidance will be provided on this matter. The deadline for responses is October 25, 2024.