New federal guidelines could shift Rx marketing - News - Health and Human Services guidelines - prescription drugs

WASHINGTON -- Health and Human Services inspector general Janet Rehnquist is warning pharmaceutical makers they must drop an array of widely used marketing techniques and rebate programs designed to promote the prescribing and dispensing of their medications. The changes could significantly alter relationships among drug manufacturers, prescription benefits managers, physicians and pharmacists.

Rehnquist issued a draft set of guidelines aimed at bringing the industry into full compliance with what the National Association of Chain Drug Stores called a "vast array of laws governing business practices." Although the guidelines are based on laws and regulations already on the books and don't carry the force of law, they're likely to lead to sweeping changes in the way drugs are marketed and prescribed in the United States.

In effect, the government is warning manufacturers they must abandon or modify a whole series of incentive programs designed to encourage the use of their products. They include payments or rebates for drug "switch" programs for PBMs and pharmacies, as well as other formulary incentive programs aimed at shifting market share from one drug to another. Also covered: entertainment and travel freebies for doctors, financial incentives to big drug purchasing groups, research grants and educational programs that promote certain medications.

Such programs, noted the OIG, may be fueling higher prescription drug costs for Medicaid and Medicare and are in violation of existing laws. Drug makers that continue the practices do so at their own peril, the agency indicated.

The OIG opened a 60-day public comment period for final revisions.