New plan would require D.C. drug detailers to be licensed

The Washington, D.C., city council last month became the first legislative body in the nation to approve the licensing of drug reps. At press time, the bill was awaiting the signature of Mayor Adrian M. Fenty, who supports the legislation.

The measure, dubbed SafeRx, would require detailers to pay a licensure fee, adhere to an ethics code, receive continuing education and refrain from misleading doctors about drugs. Sales reps could be fined up to $10,000 for operating without a license.

The last five years have seen several state bills aimed at licensing drug reps, said Sharon Anglin Treat, a state representative in Maine. She is executive director of the National Legislative Assn. on Prescription Drug Prices, or NLARx, a group of legislators in 17 states pushing for laws to restrict many forms of pharmaceutical marketing in an effort to slow prescription drug spending.

Now that one proposal is on the verge of becoming law, the idea could gain steam nationally, she said.

"Success often does breed other efforts," Treat said. "There is a tendency of legislatures to look and see what has passed somewhere else, instead of what hasn't passed."

The bill was spearheaded by D.C. Council Member-at-Large David A. Catania, who chairs NLARx. Ben Young, Catania's chief of staff, said the District of Columbia aims "to be the first place in the country where somebody's minding the store. ... We wanted to have a mechanism so that if there's false or misleading advertising we can revoke the license or impose a penalty and at least oversee the safety aspect."

He added that "if enough states follow -- which we believe they will -- then we can change the whole system that is now geared toward prescribing the newest and most expensive medicines at the expense of the most efficacious drugs."

Jerome L. Avorn, MD, agreed.

"In light of the fact that the [U.S. Food and Drug Administration] has not been as aggressive as one would like in containing problematic marketing in the last seven years, it can only help to have local authority to deal with the problem," said Dr. Avorn, professor of medicine at Harvard Medical School and author of the 2004 book, Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs.

Dr. Avorn advised Catania on a provision in the bill establishing an academic detailing program aimed at helping physicians prescribe based on the best available medical evidence. He leads a team that runs an academic detailing program in Pennsylvania known as the Independent Drug Information Service. Several other states offer similar "counter-detailing" programs.

Licensing reps a waste, PhRMA says

But not everyone supports the plan.

The Pharmaceutical Research and Manufacturers of America opposed the SafeRx Act. In a statement, PhRMA Senior Vice President Ken Johnson said the measure is unnecessary and would do "absolutely nothing to benefit patients" because drug reps already are monitored by the FDA and the U.S. Dept. of Justice.

"The money required to implement the bill would be better spent on other more pressing District of Columbia health care priorities," he said.

The Medical Society of the District of Columbia opposed the bill, which also would require physicians to tell patients when they are prescribing a drug off-label.

"Our view is that this was a purported governmental solution in search of a problem," said K. Edward Shanbacker, executive director of the society. "This was not driven by any reported problems on the ground in the District of Columbia, but it is essentially a national agenda driven by NLARx."

Physicians especially objected to the SafeRx provision requiring them to "provide the patient with information regarding the potential risks and side effects associated with using the medication for off-label use" as unnecessary, intrusive and time-consuming. Shanbacker said at least one member physician told him that he planned to prescribe a newer, more expensive on-label drug rather than a cheaper off-label alternative to avoid having to comply with the disclosure.

The AMA opposed an earlier version of the bill, which would have banned the sale of physician prescribing data for commercial marketing purposes. The AMA has policy supporting physician use of off-label medications or devices "when such use is based upon sound scientific evidence and sound medical opinion."