The pharmaceutical industry chalked up a pair of legal victories yesterday in two rulings by the U.S. Supreme Court.

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Supreme Court rulings mark win for Rx industry

June 24th, 2011

WASHINGTON – The pharmaceutical industry chalked up a pair of legal victories yesterday in two rulings by the U.S. Supreme Court.

In one decision, Sorrell v. IMS Health, the Supreme Court struck down a Vermont law that banned the sale of data on physician prescribing practices for use in the marketing of medicines. The court on Thursday ruled 6-3 that the statute, intended to protect privacy, was an unconstitutional restriction of commercial free speech.

And in the other case, Pliva v. Mensing, the high court ruled 5-4 on Thursday that generic drug makers can't be sued under state law over claims that their product labels inadequately warned consumers about potential side effects.

IMS Health hailed the Sorrell decision, noting that the Vermont law blocked the exchange of information that could improve health care.

"Today's ruling is clear and unmistakable: These types of laws violate the Constitution and do nothing to improve health care, reduce costs or protect privacy as proponents had claimed," Harvey Ashman, senior vice president and general counsel at IMS Health, said in a statement Thursday. "Transparency is vitally important to advancing health care. The availability of information on the prescribing practices of physicians enables communications about new medicines, best practices and safety updates. This information is essential to improved patient care and safety."

IMS Health added that laws in Maine and New Hampshire also will likely be found unconstitutional or repealed in the wake of the Supreme Court ruling. The health information company was joined in the suit by SDI, Source Healthcare Analytics (a subsidiary of Wolters Kluwer Pharma Solutions) and the Pharmaceutical Research and Manufacturers of America (PhRMA).

Data about physician prescribing practices for improving patient care, cost management and health outcomes is used by virtually all health care stakeholders, including hospitals, payers, government agencies, biopharmaceutical manufacturers and researchers, according to IMS Health. Key uses of such information include studying prescribing trends, monitoring the safety of new medicines, supporting safety-oriented risk management programs, preventing prescription drug abuse, recruiting patients for clinical trials, and assessing treatment variability, the company explained.

"Patients have a critical interest in ensuring that their doctors are fully informed about all current treatment options that could save or meaningfully improve their lives. This decision helps get cutting-edge information to physicians and helps advance the research and development of new breakthroughs," Sharon Terry, president and chief executive of the Genetic Alliance, a nonprofit health advocacy organization, said in a statement released by IMS Health.

Meanwhile, in the Pliva case, the Supreme Court reversed federal appeals court decisions finding that federal law didn't preclude suits under state law by two women who alleged they developed a neurological disorder after taking generic versions of Wyeth's branded prescription drug Reglan (metoclopramide) and claimed that the generic drug labeling failed to provide sufficient warning of possible adverse effects. The lower courts had ruled that the women could sue units of Teva Pharmaceuticals, Mylan and Actavis.

Justice Clarence Thomas, in writing the 5-4 decision, said the ruling addressed a discrepancy between federal and state law — with the federal law prevailing under the Constitution's Supremacy Clause.

"Brand-name and generic drug manufacturers have different federal drug labeling duties. A brand-name manufacturer seeking new drug approval is responsible for the accuracy and adequacy of its label. A manufacturer seeking generic drug approval, on the other hand, is responsible for ensuring that its warning label is the same as the brand name's," Thomas wrote, referring to Food and Drug Administration labeling requirements for generic drug makers.

"State law imposed on the manufacturers a duty to attach a safer label to their generic metoclopramide," Thomas explained in the decision. "Federal law, however, demanded that generic drug labels be the same at all times as the corresponding brand-name drug labels. Thus, it was impossible for the manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same."