PHARMACY

Vermont makes changes to data mining law in attempt to avoid successful challenge

BY Drew Buono

VERMONT Vermont has amended its data mining law to try to avoid constitutional issues that have blocked other states from preventing companies from collecting information on which drugs doctors prescribe most often and then selling the information to pharmaceutical companies, according to published reports.

IMS Health, Wolters Kluwer Health and Verispan are challenging Vermont to block the state from enacting laws to prevent the collection and disclosure of the information. A similar New Hampshire law was struck down in U.S. District Court in April on constitutional grounds of violating the guarantee of free speech. Maine was also the subject of a similar trial and lost as well.

To prevent a similar result, Vermont lawmakers suggested the following changes, some of which are part of a new “corrections” bill being proposed to the legislature:

  • Vermont’s law allows doctors to opt into having their Rx information shared.
  • Vermont assistant attorney general Julie Brill and others recommended deleting a provision that had required manufacturers to provide physicians who opted into the system with evidence-based information about other products in the same therapeutic class.
  • Some “relatively minor” language changes are being suggested through the corrections bill to the data mining provisions as well as to the consumer fraud section of the statute, which would have allowed Vermont to bring a cause if a manufacturer receives a warning letter from the FDA.

“We are seeking to make some changes so that the law will stand a better chance of passing constitutional muster,” said Brill, who worked on the legislation.

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Ranbaxy, GSK settle over Imitrex litigation

BY Drew Buono

HARYANA, India Ranbaxy Laboratories has settled litigation with GlaxoSmithKline related to sumatriptan succinate tablets, the generic of GlaxoSmithKline’s drug Imitrex, according to published reports.

The settlement will allow Ranbaxy to exclusively sell the generic for 180 days starting December this year. Under the terms of the settlement, Ranbaxy can distribute a generic version of sumatriptan in 25 mg, 50 mg and 100 mg doses.

Analysts expect the company to make around $100 million in sumatriptan sales in the U.S. during the exclusivity period. Sumatriptan sales in the U.S. are worth $985 million, according to IMS data.

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FDA delays Kynapid decision pending final review

BY Drew Buono

VANCOUVER, Canada The Food and Drug Administration has delayed its decision on an application for the heart treatment drug Kynapid, according to published reports. The drug manufacturer Cardiome Pharma and its co-development partner Astellas Pharma US said yesterday that the FDA did not provide an action letter by the expected date of Jan. 19.

The application for Kynapid (vernakalant hydrochloride), based on a five-year clinical development program, was submitted in December 2006. In December 2007, the FDA’s cardiovascular and renal drugs advisory committee voted 6-2 in favor of recommending to the FDA that Kynapid be approved for the rapid conversion of acute atrial fibrillation to sinus rhythm.

“While we look forward to the FDA reaching a decision, we respect their need for additional time to review the Kynapid’s application,” said William Fitzsimmons, senior vice-president for research and development at Astellas.

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