States that want to prevent drug companies from using physician prescribing practice data to market brand products should not be discouraged by a June 23 U.S. Supreme Court decision that struck down Vermont's prohibition of the practice.
Rather, say authors of a paper in today's New England Journal of Medicine, "clever lawmakers may, however, be able to write their way around the Court's ruling" by passing laws that prohibit "untruthful or misleading statements in detailing conversations, since such speech receives no First Amendment protection. The District of Columbia has already enacted such a law."
Michelle Mello, an attorney from the Harvard School of Public Health's Department of Health Policy and Management, and Noah Messing, an attorney with Yale Law School, suggest that states could also adopt policies that promote the use of generic drugs with initiatives such as prior authorization requirements for branded drugs, mandatory generic substitution, tiered formularies, and educational outreach to physicians.
Also, Mello and Messing wrote, physicians "can simply close their doors to such marketers."
The issue arose nationally because of physicians' concerns that pharmaceutical manufacturers send sales reps, also called "detailers," to promote their brand-name drugs to physicians' offices, and often come armed with the physician's prescribing history. The practice is called "data mining," and the authors say it is known to enhance sales calls.
"Pharmaceutical companies buy these reports from prescription drug intermediary (PDI) companies that obtain prescription records from pharmacies" and match them to physician information they purchase from the American Medical Association.
But doctors and others say that such practices boost the sale of more expensive brand-name drugs, thereby raising healthcare costs, and jeopardizes patient safety by promoting new drugs about which safety and efficacy data are limited, Mello and Messing wrote. It also may violate patient and physician privacy.
The Vermont law, which the court struck down in Sorrell v. IMS Health, Inc. on grounds that it violated the right to free speech, prohibited pharmacies and PDIs from selling, licensing, or exchanging prescriber drug information or using it to promote pharmaceutical products. Two similar laws in Maine and New Hampshire are expected to be challenged or to fall next as a result of the high court ruling.
The AMA allows doctors to exercise the AMA's Physician Data Restriction Program, which allows doctors to withhold their prescribing practice data from the pharmaceutical sales reps.
However, to date, Mello and Messing wrote, "few physicians (approximately 4%) have signed up for the PDRP, perhaps because the AMA's financial interests cut against strongly promoting the program. The AMA realizes substantial revenue from the sale of physicians' professional data, and widespread physician opt-out would reduce the usefulness of the data to PDIS."
Asked for a comment, a spokesman for the AMA declined, but sent its June 23 statement, issued after the Supreme Court ruling in the Vermont case. That statement urged doctors who don't want their data shared with pharmaceutical detailers to use the PDRP.
The PDRP "enables physicians to ‘opt out’ of such disclosure quickly and easily, while still allowing their data to be available for academic and governmental research," the AMA statement said.
“We believe the PDRP balances individual physician concerns regarding prescription data with First Amendment freedoms and the fundamental public interest in robust medical research."
Mello and Messing said the Supreme Court decision "may offer an unexpected dividend to opponents of data mining: The surrounding publicity might alert physicians to their right to opt out of sharing their prescribing information through the PDRP."