- The Washington Times - Wednesday, January 9, 2008

The D.C. Council yesterday approved legislation placing new requirements on physicians and pharmaceutical sales representatives operating in the District, but the bill’s sponsor pulled back a contentious provision that would have ultimately landed the city in a legal battle.

The American Medical Association and IMS Health, a medical-data company in Norwalk, Conn., adamantly opposed the provision that called for new restrictions on the groups’ access to doctors’ drug-prescribing practices. IMS Health won legal challenges to similar laws in New Hampshire and Maine and vowed a legal fight in the District.

During the final round of voting, the bill to regulate pharmaceutical salespeople passed the council 7-6 vote. The bill had the same supporters and opponents as in its first reading on Dec. 11 and has the support of Mayor Adrian M. Fenty.

The legislation makes the District the first in the country to license pharmaceutical company sales representatives and will put in place a regulatory framework that will be capable of revoking that license if a salesperson’s activities are deemed fraudulent.

“Today is a great day for patients and seniors,” said council member David A. Catania, at-large independent, the bill’s sponsor. “The District will lead the nation in the regulation of false and misleading advertising of prescription drugs.”

The bill, dubbed SafeRx, mandates that drug representatives have a bachelor’s degree, adhere to a code of ethics and refrain from giving doctors gifts. Further, it requires physicians to tell their patients when they’re prescribing medication for a treatment not specifically authorized by the Food and Drug Administration. Finally, it sets the framework for a new city-funded system of educating area physicians about new drugs on the market.

But because the so-called “data-mining” portion of the bill was removed, IMS Health will not bring legal action against the District, as it did in New Hampshire and Maine.

“We have no reason to go to court. We have no interest to go to court,” said Randy Frankel, vice president for external affairs at IMS Health. “We believed all along these data would have value to the District in addressing their health issues, and we are glad that we”ll be able to access it.”

However, a spokesman for Mr. Catania said neither the AMA nor IMS Health have seen the last of the prescribing-data provision.

“We’re watching the two court cases and believe the state of New Hampshire will be successful in appeals,” the spokesman said. “And when they are, we will reintroduce the provision as stand-alone legislation.”

The bill approved yesterday also adds a requirement for physicians to include new pharmaceutical product and trend information in their continuing-education mandates to learn more about the drug industry.

Ed Shanbacker, vice president of the Medical Society for the District of Columbia, said the continuing-education mandate is the most troubling requirement in the bill for doctors.

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