US Supreme Court decisions could affect prescribing practices

September 1, 2011

Two US Supreme Court rulings could have wide-reaching effects on physicians who prescribe drugs and the patients who take them.

Two US Supreme Court rulings-both made on June 23-could have wide-reaching effects on physicians who prescribe drugs and the patients who take them. In one case, the Court ruled that data firms can sell information on a physician's prescribing history and drug companies can use the information without a doctor's consent unless he or she explicitly opts out of the process. In the other case, the justices ruled that generic drug makers are not liable for labeling errors made by brand-name companies that manufactured the original version of a medication. The rulings were reported online July 4 in American Medical News ( http://www.ama-assn.org/amednews/2011/07/04/gvsa0704.htm).

In the first case, IMS Health Inc sued Vermont Attorney General William Sorrell over enforcement of a state law, approved by the Vermont legislature in 2007, that banned companies from selling prescribing information for marketing purposes and use of the data by drug companies unless prescribing doctors consented. IMS Health argued that the ban hindered its First Amendment right; a district court sided with the state, but the 2nd US Circuit Court of Appeals overturned the decision on constitutional grounds. The Supreme Court, in striking down the ban, said that transmission of the information is protected by free-speech laws.

In the second case, Gladys Mensing sued generic drug company Pliva, claiming that she developed tardive dyskinesia after using the drug metoproclamide. Although research showed that extended use of the drug could result in this condition, neither the brand-name nor the generic drug labels included a warning, according to the lawsuit. Following a ruling favorable to Pliva by a lower court and partial reversal of that decision by the 8th US Circuit Court of Appeals, the Supreme Court ruled that although state laws require drugs to be labeled with the latest safety warnings, the federal label "sameness" statute preempted those rules. Under this "sameness" requirement, generic labeling must be identical to the brand-name language because the original labeling is the basis for generics' approval by the US Food and Drug Administration (FDA).

Dr. Lockwood comments: The Supreme Court's recent decision that "that data firms can sell information on a physician's prescribing history, and drug companies can use the information without a doctor's consent unless he or she explicitly opts out of the process" represents sophistry at best, and a violation of basic medical ethics at worst. I do hope that all COG readers will avail themselves of the AMA Physician Data Restriction Program, which allows them to opt out of such disclosures ( http://www.ama-assn.org/go/pdrp). Given all that has transpired in Washington over the past few months I truly wonder what our Founding Fathers would think. I suspect they would all have second thoughts!