Healthy Skepticism Library item: 11509

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Publication type: news

Neibauer M.
Measure would put drug sales reps under microscope
The Examiner 2007 Sep 19
http://www.examiner.com/a-943107~Measure_would_put_drug_sales_reps_under_microscope.html

Full text:

The pharmaceutical sales representatives who regularly peddle their merchandise to D.C. physicians would have to be licensed under a bill to be considered by the D.C. Council. “The person who cuts your hair is subject to more government regulation than the person pitching drugs to your doctor,” said Council Member David Catania, chair of the health committee.

Catania on Tuesday introduced the Safe Rx Act of 2007, which he claims will “lead to a safer environment, a more informed environment” for consumers of prescription medications.

The bill also tackles off-label prescription use – uses not explicitly approved by the Food and Drug Administration – as well as gifts to regulators and disclosure of clinical drug trial data.

The legislation requires that all new pharmaceutical reps hold a license issued by the D.C. Board of Pharmacy, earn at least a bachelor’s degree in pharmacy or science, and follow a new code of ethics for the profession.

There is a grandfather clause for salespeople with at least one year on the job. The average D.C. doctor meets with 28 representatives a week, Catania claimed, and most are chosen for their looks, not their medical knowledge. It is believed the bill’s licensing provision is the first of its kind in the country.

The measure drew the immediate condemnation of the drug lobby.

In a statement, the Pharmaceutical Research and Manufacturers of America said comprehensively trained drug sales representatives are carefully monitored through “adequate safeguards” established by the Food and Drug Administration and the U.S. Department of Justice, and follow voluntary guidelines issue by PhRMA.

In addition to the sales rep provisions, the bill also requires that D.C. physicians obtain patients’ informed consent before they are prescribed a medication for off-label use.

From Celebrex to Lyrica, thousands of drugs have been developed for one purpose but found to be helpful for something else, said Dr. Peter Lavine, chairman of the Medical Society of D.C.

“These are onerous, unnecessary burdens placed on physicians, and it’s going to have a chilling effect on the appropriate off-label use of medication,” Lavine said.