PHARMACY

Court grants injunction against Maine prescription law

BY Adam Kraemer

BANGOR, Maine The U.S. District Court for the District of Maine on Dec. 21 granted the preliminary injunction sought by IMS Health, Wolters Kluwer Health and Verispan to block enforcement of Maine’s Prescription Restraint Law.

In granting the injunction, U.S. District Judge John Woodcock ruled that “the Law amounts to an unconstitutional abridgement of the First Amendment of the United States Constitution.”

The law, which bans the use of physician prescribing information for marketing, was enacted in June and was scheduled to go into effect on Jan. 1, 2008.

“We are pleased with Judge Woodcock’s thoughtful 42-page decision. We believe that restrictions on the dissemination of information of crucial public interest are neither good healthcare policy nor consistent with our society’s core beliefs in the free flow of information,” said Robert Steinfeld, IMS senior vice president and general counsel.

This is the second federal injunction against such a law. New Hampshire’s prescription restraint law was ruled unconstitutional and struck down in a 53-page federal court ruling on April 30, 2007. The three companies also have a suit challenging a similar law in Vermont and expect a ruling in 2008. The executive director of the Vermont Medical Society, Paul Harrington, said his group “is disappointed that the drug companies are seeking to overturn the law passed in Vermont and Maine. We feel the laws are appropriate in that they keep the physicians’ prescribing information out of the hands of the drug company marketers and curtail the drug companies being able to effectively go into the physicians’ offices, having the prescribing information, and tailoring their marketing, knowing what the physician is prescribing.”

Provider-identifiable prescription information is used by a wide variety of healthcare stakeholders, including the FDA, the DEA, academic researchers, health economists, biopharmaceutical companies and others to monitor public health patterns, identify variations in patient care, maintain drug safety and drive clinical trial best practices. Patient privacy is federally protected under the Health Insurance Portability and Accountability Act of 1996, so the information in question does not identify patients by name. In addition, IMS, Wolters Kluwer Health and Verispan add further safeguards, including encryption, to ensure that patient privacy is vigilantly safeguarded.

“While we appreciate the demands on Maine legislators to manage healthcare costs for its citizens, this type of legislation is counterproductive and inconsistent with the national trend toward more transparency in healthcare practices. It’s vital that provider-level prescription information remain accessible, as it has proven value in efforts to monitor safety and manage quality, treatment variability and healthcare costs,” said Randy Frankel, IMS vice president for External Affairs.

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Stake in drug-testing contractor purchased in $3 billion-plus deal

BY Adam Kraemer

NEW YORK In a deal worth a reported $3 billion-plus, One Equity Partners’ stake in drug trial manager Quintiles Translational is being sold to its chief executive and other buyout firms, including Bain Capital and TPG Capital, according to The New York Times.

Dennis Gillings, founder of Quintiles and its chief executive officer and chairman, has teamed up with Bain and TPG to take control of the stake from One Equity, the private equity arm of JPMorgan Chase, which also sponsored the company’s $1.7 billion buyout in 2003.

Gillings had previously offered to buy the company in 2002 for $1.3 billion, but that number was rejected as being too low.

Quintiles, based in Research Triangle Park, N.C., has more than 19,000 employees. At the time of its founding in 1982, Gillings was a professor of biostatistics at the University of North Carolina. The company went public in 1994.

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Jazz, Solvay receive approvable letter from FDA regarding extended-release Luvox

BY Adam Kraemer

PALO ALTO, Calif. The Food and Drug Administration issued an approvable letter for Jazz Pharmaceuticals’ Once-a-Day Luvox CR (fluvoxamine maleate), which the company is trying to market as an extended-release capsule indicated for the treatment of social anxiety disorder and obsessive compulsive disorder.

Jazz has teamed up with Solvay Pharmaceuticals to market the drug. The FDA earlier this month approved the regular formulation of Luvox for the treatment of OCD.

The companies are seeking clarification from the FDA and look forward to working with the FDA to resolve any issues as quickly as possible. They stressed that the approvable letter did not raise any questions related to the safety or efficacy of Luvox CR.

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