- The Washington Times - Monday, January 7, 2008

The District’s push to impose new regulations on drug companies is steamrolling toward a court battle, industry representatives warn.

The SafeRx Act, which is scheduled for a final vote tomorrow, would prohibit drug companies from accessing physicians’ prescription records without their knowledge. The practice, known as data mining, allows health care organizations to collect doctors’ prescribing data to sell to drug companies and academic researchers.

Prescription data collection companies IMS Health Inc. of Norwalk, Conn., and another prescription data collection company, Verispan LLC of Yardley, Pa., challenged similar laws in Maine and New Hampshire and would likely do the same in the District.

“We have said we will oppose restrictions on the flow of information,” said Randy Frankel, vice president of external affairs at IMS Health. “We’ll make a determination when we see the law but that has been our approach in the past.”

D.C. Council member David A. Catania, the bill’s sponsor, said the legislation is necessary to slow the rising cost of prescription drugs by increasing supervision of pharmaceutical sales representatives.

The bill also requires physicians to tell their patients when they prescribe medication for a treatment that is not specifically authorized by the Food and Drug Administration and sets the framework for a new city-funded system of educating physicians about new drugs.

About 4,000 pharmaceutical sales representatives work in the District and the surrounding region. If the bill becomes law, sales representatives could decide to take their business outside the city, D.C. medical professionals warn.

The American Medical Association, the nation’s most powerful doctors lobby, said the D.C. Council’s effort to block access to data about what drugs doctors prescribe is a misguided move that could undermine the council’s goal of helping city residents.

“The commercial collection and use of prescribing data generates revenue that makes possible the development of databases used by government agencies, medical researchers and businesses for a wide range of health care purposes,” said Dr. Michael Maves, executive vice president of the AMA.

“The result of this bill would be a major setback for the medical research community and the health outcomes that they are trying to improve.”

Mr. Catania was unmoved by the AMA’s position, saying doctors are more concerned about their own financial position than lowering health care costs.

“The AMA has a financial interest in seeing the bill defeated,” said Mr. Catania, at-large independent. “It’s a sad commentary on the AMA that they choose their financial well-being over the well-being of patients and the financial well-being of jurisdictions across the country. The practice of data mining is to sell people drugs they don’t need and can’t afford.”

Mayor Adrian M. Fenty declined to comment on the legislation through a spokeswoman. But his office supplied a copy of a letter that the mayor sent to D.C. Council Chairman Vincent C. Gray, at-large Democrat, urging passage of the bill last month. Mr. Fenty, also a Democrat, called the bill an “innovative measure” that would “ensure prescription drug safety for District residents.”

Mr. Catania was recently elected chairman of the National Legislative Association on Prescription Drug Prices, a nonprofit organization of state lawmakers whose goal is to reduce drug prices, according to the group’s Web site at www.reducedrugprices.org.

His original bill would have required that pharmaceutical sales representatives hold advanced degrees in biology or chemistry and that they enter all information from clinical drug trials into a city-managed database for patients and health care providers. The initial bill also called for doctors to get a patient’s written consent before prescribing any off-label uses of drugs.

Those requirements were dropped from the bill, which the council approved in a 7-6 vote Dec. 13. The council will consider the bill again on Tuesday.

Ed Shanbacker, executive vice president of the Medical Society of the District of Columbia, said the group remains opposed to the overall bill and is concerned that it could prompt pharmaceutical companies to take their business elsewhere.

“This bill is a case of the government in search of a problem,” Mr. Shanbacker said. “If the District is a hard place to do business, the drug companies will downplay their presence here.”

The medical society’s concerns were partly mollified when the council amended the bill’s provision on regulating off-label use of drugs. The bill now requires doctors only to explain a drug’s potential side effects to patients, rather than requiring doctors to obtain written informed consent from them.

The bill’s intent to curb pharmaceutical companies from reviewing doctors’ prescriptions without their knowledge and targeting them with aggressive marketing is a national issue.

Two recent federal court decisions on similar laws in New Hampshire and Maine suggest that the legislation, if passed, will end up in court. In April, a federal judge in New Hampshire overturned a state law that restricted access by medical data companies to a doctor’s prescribing information. Last month, a federal judge in Maine prevented a similar law from taking effect, saying it would violate the free speech guarantee of the First Amendment.

Mr. Catania said he is not sure how the bill will be constructed in light of the recent court decisions, but added, “I’m not afraid of litigation. The fact that this mighty industry can tie up government in court does not mean governments stop working.”

Mr. Frankel insisted that health care information should be transparent in order to improve quality and keep costs down. He pointed to the District’s high rate of HIV/AIDS patients as a specific reason to allow the exchange of prescribing information between doctors and drug companies.

“The bill is the wrong prescription for public health, especially for a city dealing with public health crises like the HIV/AIDS epidemic. Now that the city has a clearer picture of the affected population, why would they draw the blinds on how that population is being treated? That is one of the many points we are making to City Council members,” he said.

Jim McElhatton contributed to this article.

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