FDA to regulate drug company-owned PBMs
FDA to regulate drug company-owned PBMs
Do drug company-owned pharmacy benefit managers (PBMs) push for drug switching through misleading or false claims about their drugs? Do they pressure physicians and manipulate formularies to the point of causing adverse reactions among the 115 million Americans under their plans? The U.S. Food and Drug Administra-tion is moving to find out and has drafted a five-page guidance proposal intended to become regulation.
At issue is the promotional and marketing claims made by drug company-owned PBMs to the physicians and insurance plans whose formularies they can influence. The FDA proposal would require the firms to submit these claims for an accuracy review, just as other drug makers do when bringing a drug to market. Violations of the regulation would fall under the federal Food, Drug, and Cosmetic Act. Throughout the past year, public watchdog groups have stepped up the accusations that pressure to switch drugs have caused patients harm, and the FDA’s Laurie Burke says the agency’s main motivation is to eliminate health risks.
Big PBMs are scrutinized
Specifically under the spotlight are PCS Health Systems Inc., owned by Eli Lilly & Co.; Diversified Pharmaceutical Services, owned by SmithKline Beecham; and Merck & Co.’s Merck-Medco. Also, drug makers who don’t own PBMs but contract with them will be included in the proposed oversight.
The FDA is taking comments on the proposal through April and will then decide whether to extend that period or begin drafting a final policy. But it may not be that easy: The newly passed FDA overhaul bill allows drug companies to communicate certain cost-effectiveness data without FDA approval, but the FDA says there is still room in the new law’s language for the type of oversight it is proposing.
(For more on drug-company owned PBMs, see Drug Utilization Review’s November 1997 cover story, "PBMs at a Crossroad.")
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.