A bill to regulate pharmaceutical sales representatives was approved 7-6 on first reading by the District of Columbia Council on Dec. 11.
The bill, said to be the first of its kind, would require the licensing of those sales reps, prohibit using physicians' private prescription data for marketing purposes without their consent, and create a program for educating doctors on the latest drug research as a way of countering biased marketing-driven information they receive from sales representatives.
The second reading is scheduled with a binding vote Jan. 8.
Proposed by council member David Catania, the SafeRx Act of 2007 has undergone substantial revision from its original version and would include provisions banning the members of the D.C. medical advisory committees from receiving pharmaceutical company gifts. It would also require drug company detailers to meet educational standards and maintain a code of professional conduct or face fines and loss of their license.
In an editorial, the Washington Post urged the council "to reject this well-intentioned but badly thought-out bill," while the Pharmaceutical Research and Manufacturers of America trade group released a statement in which it warned of creating a patchwork of local laws regulating drug marketing. Instead, PhRMA recommended leaving "the task in the capable and experienced hands of the Food and Drug Administration and U.S. Justice Department officials."
American Medical Association Executive Vice President and Chief Executive Officer Michael Maves wrote a letter to D.C. Council Chairman Vincent Gray warning that the bill’s data collection restrictions could have unintended consequences for medical research, public health databases and the analysis of drug safety and effectiveness.
"It is the AMA's sincere hope that the council will recognize the vital and beneficial uses of prescriber data and oppose the enactment of the SafeRx Act of 2007," the letter concluded. "As advocates for physicians, and ultimately our patients, we believe that the collection of data is so important to medical research and public health that it should continue to benefit the patients and physicians of the District of Columbia."
The bill would specifically make it illegal to use, sell, transfer, license or exchange for value any prescription information that identifies a patient or prescriber without the prescriber's consent. But the bill also notes that this prohibition would not apply to information used in clinical trials or for de-identified data aggregated by medical specialty or by ZIP code or other geographic region for commercial purposes.
In his letter, however, Maves stated that prescribing data are extensively used by the FDA and the Centers for Disease Control and Prevention for long-term studies and the analysis of new drugs.
"Aggregate data is not a substitute for prescriber-specific data for some research efforts," Maves added, and he cited examples of how such data are useful in studying overuse of antibiotics and for developing guidelines for antibiotic use. He also noted how doctors who participate in an AMA program called AMA Therapeutic Insights use similar information to compare their prescribing patterns with the anonymously aggregated data of their peers on state and national levels.
"The SafeRX Act of 2007, which inhibits the collection of prescriber data in commercial databases, would make the AMA Therapeutic Insights program nonviable," the letter stated.
Deborah Peel, a psychiatrist and founder of the Austin, Texas-based Patient Privacy Rights advocacy organization, said the AMA opposes the bill "for the wrong reasons," and noted how the bill fails to give patients control over their own medical data. "How ironic that D.C. plans to legalize the illegal and unethical use of prescription records for detailing and research, just as the public is starting to understand their prescriptions are being data-mined, sold and used to discriminate against them," Peel said in an e-mail to Health IT Strategist.
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