American pharmaceuticals marketers – renowned for their aggressive sales techniques and largesse toward doctors and other prescribing healthcare professionals – could be in breach of federal fraud and abuse laws.

The iron-fist warning was issued by Janet Rehnquist, inspector general of the Department of Health and Human Services, within the velvet glove of new guidelines to the pharmaceutical industry published this week.

Said Rehnquist: “In today's environment of increased scrutiny of corporate conduct and increasingly large expenditures for prescription drugs, it is imperative for pharmaceutical manufacturers to establish and maintain effective compliance programs.”

Outlawed from now on are incentive payments or other “tangible benefits” to encourage or reward the prescribing or purchase of particular drugs by doctors, health plans or companies that manage drug benefits for employers and insurers.

Although the new rules are not enshrined in law, transgressor companies are liable to investigation and prosecution if they are found to be in violation of extant federal fraud and corruption statutes.

As the new regulations bite there will be some surprising losers: Broadway theatres, five star hotels, expensive restaurants will all feel the pinch. Pharma marketers have traditionally lavished these and other freebie luxuries on willing medics and others able to influence drug choice.

Companies have also ‘rewarded’ middlemen, or pharmacy benefit managers, for including their brands on formularies – in plain English, lists of recommended drugs. Some marketers have even bribed doctors and drugstores for switching patients’ medication to another brand.

The public and the pharma industry now have sixty days to comment on the new regulations which may be revised according to the responses received.

Sourced from: New York Times; additional content by WARC staff