Wednesday, December 12, 2007

DC Council takes first step to clipping the wings of the pharmaceutical industry

Today's Washington Post reports a bold move by the D.C. Council to regulate pharma reps who peddle drugs to District physicians and hospitals. The SafeRx Act of 2007 breaks new ground in the effort to reel in the multibillion-dollar prescription drug trade. Below are highlights from the must-read article.

The D.C. Council voted 7 to 6 yesterday to give initial approval to legislation that would make the District the first jurisdiction in the country to license pharmaceutical sales representatives, a major blow to the prescription drug industry and one that could have national implications if states follow the District's lead.

"For too long, we have allowed profit and paternalism to be our guide for patient safety," said Council member David A. Catania (I-At Large), who has become known in national health circles as an industry watchdog. "The truth is, no one is minding the store."

After the vote, Ken Johnson, senior vice president of Pharmaceutical Research and Manufacturers of America, issued a statement through spokesman Jeff Trewhitt.

"We regret that the council voted in favor of legislation that creates unnecessary financial burdens for the District of Columbia at a time when the money would be better spent addressing a wide array of health care challenges confronting the city including HIV/AIDS, diabetes and heart disease," the
statement said. "The bill passed by the council puts the city into a regulatory arena that has been effectively addressed by federal laws and federal government agencies for years."

Under the bill, salespeople would have to be licensed and sign a code of ethics and would be regulated by a pharmacy board. To qualify for a license, the representatives, dubbed "detailers" in industry lingo, would have to be college graduates. They would also have to refrain from using titles that would give the impression that they are licensed to practice pharmacy, nursing or medicine.

The bill, which has several parts, also would ban pharmaceutical manufacturers from engaging in a practice called "data mining," when doctors' prescription data are used for marketing purposes without their knowledge and consent.

Critics say the information trickles down to detailers who can then target a doctor for a particular drug by looking at his or her prescribing habits. District doctors could opt in to the program to allow firms to get their prescription data from pharmacies.

New Hampshire, Maine and Vermont, which have passed similar legislation, are in court with data collection companies and manufacturers fighting the new laws. New Hampshire is appealing the decision of a U.S. District Court judge to block the state from enforcing its new data mining law on the grounds that it restricts commercial free speech.

The District could face the same fight, council members said.

Catania said that is to be expected. "They are taking their playbook from the tobacco industry," he said. "Sue, sue, sue."

Yesterday's vote, however, will not end the debate. The council must vote again Jan. 8 on final approval of the legislation.

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