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Big Pharma dodges bullet, still fears bill amendment

BY Alaric DeArment

Drug companies narrowly missed a big blow to their business with the passage of the healthcare-reform bill as an amendment that would have banned reverse settlements was removed, but the danger hasn’t gone away yet.

Following the bill’s passage, Sen. Herb Kohl, D-Wis., pledged to press for a ban on the settlements, in which a generic drug company that wants to market its version of a drug ahead of the expiration of patents covering the branded version agrees not to immediately launch in exchange for monetary payment or an agreement by the brand drug maker not to launch its own “authorized generic” to compete with the generic during the latter’s six-month market exclusivity period. Kohl introduced in February 2009 the bill S.369, the Preserve Access to Affordable Generics Act; Sen. Patrick Leahy, D-Vt., filed a written report on the bill in February 2010.

Critics of the settlements—including Kohl and the Federal Trade Commission—deride the settlements as “pay-for-delay” deals, charging that they deny patients timely access to generic drugs and violate antitrust laws. Supporters, such as the generic and branded drug industries, say the deals actually result in generic drugs entering the market earlier than they would if most patent litigation suits went to trial.

“It’s driven by two different issues: One is a general perception both among some members of Congress and the Federal Trade Commission, and others, that brand-generic settlements result in a denial of lower-cost generic drugs to consumers…as well as a general perception that the entry of generics into the market immediately reduces prices, and if the brand companies would simply move out of the way, prescription drugs would be cheaper for everybody,” David Farber, a litigator and lobbyist with the Washington law firm Patton Boggs who represents drug and healthcare companies and has followed the patent-settlement issue, told Drug Store News.

Farber disputed the perception that the settlements are anti-competitive, saying that in many instances, the generic company has a weak case to begin with, and the cases carry significant risks for litigants. “Opportunities to settle are often rational agreements between very sophisticated parties that balance the risks of the litigation,” Farber said. “There are many Hatch- Waxman patent challenges that I’ve seen that result in shorter exclusivity through a settlement than if the branded manufacturer had taken the case to trial and won.”

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Schnucks’ O’Brien to serve on Department of Agriculture advisory committee

BY Alaric DeArment

ST. LOUIS An executive from Schnuck Markets will serve on an advisory committee of the Department of Agriculture, Schnucks said this week.

Agriculture secretary Tom Vilsack announced that Schnucks VP produce and floral Mike O’Brien would be one of 25 people appointed to a two-year term on the USDA’s Fruit and Vegetable Industry Advisory Committee. O’Brien is also vice chairman of the Produce Marketing Association.

 

“I am honred to represent Schnuck Markets and the retail produce industry as a member of this committee,” O’Brien said. “I am looking forward to the opportunity to contribute and to make a difference for families across the nation.”

The committee, originally chartered in 2001, advises the secretary of agriculture on industry issues related to fruits and vegetables.

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Gilead commences phase 3 trial for single-tablet HIV treatment

BY Alaric DeArment

FOSTER CITY, Calif. Gilead Sciences has started a late-stage clinical trial of an investigational 4-in-1 treatment for HIV, the drug maker said.

Gilead announced the initiation of a phase 3 trial of its “Quad” HIV drug, a single-tablet treatment that combines elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate. The study will compare the Quad regimen with the standard of care among adults with HIV-1 who have not taken antiretroviral treatments. The company is also investigating cobicistat as a standalone boosting agent for antiretroviral drugs.

“We are pleased to announce that the Quad phase 3 clinical program is underway,” Gilead EVP research and development and chief scientific officer Norbert Bischofberger said. “Efficacy and safety results from the phase 2 study suggest that the Quad may represent an important new option for patients with HIV.”

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