Drug companies are responsible for PBM actions

The FDA alerted pharmaceutical companies that it will hold them accountable for the advertising and marketing activities of their subsidiaries, including pharmacy benefit management companies.

Under the guidelines, PBMs must submit copies of all advertisements, brochures and other promotional materials for FDA review.

In its proposed guidance for industry, the FDA stated: "Generally, a medical product sponsor will be held responsible for promotional activities performed by its health care organization or PBM subsidiary that violate the act or regulations (e.g., the dissemination of false or misleading labeling or advertising). Promotional labeling and advertising disseminated by the subsidiary are subject to the existing post-marketing reporting requirements."

In the past, the FDA has not regulated the promotional practices of PBMs because their traditional role was to manage health care costs. However, recent marriages between several PBMs and large pharmaceutical manufacturers have raised concerns at the FDA.

One major concern is that pharmaceutical manufacturers could use their clout to influence which prescription products their affiliated PBMs select and market to health care-purchasing customers.

Pharmaceutical companies that lack similar relationships have complained that the pairings create an unfair marketing and promotional loophole.

In its guidance, the FDA acknowledged that it "generally does not exercise jurisdiction over materials disseminated by individuals or entities that are not in any way affiliated with a medical product sponsor." However, the agency continued, "the sponsor should not be permitted to avoid regulations by changing the form through which their communication is accomplished."

The FDA said it would allow for a 90-day comment period before issuing a final guidance. PR