drug

AstraZeneca tries to block generic drug approvals, gets slapped by court

Tuesday, July 17, 2012 by: J. D. Heyes
Tags: AstraZeneca, generic drugs, blocking

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(NaturalNews) Regular readers of NaturalNews.com know that we always advocate first for a natural solution or alternative to Big Pharma. Beyond that; however, when there is no other choice, you will find us regularly siding with you, the hapless consumer, who is constantly victimized by an out-of-control industry.

With that in mind and the cost of Big Pharma products being what they are, we believe the health consumer deserves, at the very least, to pay the lowest possible price for medications, when there are lower-cost alternatives out there.

Therein lies the problem. An alarming number of Big Pharma corporations are trying to hold onto their patented products for as long as possible - and in more cases, longer than allowed - because they don't want to see lower-cost options hitting the market.

The latest case involves AstraZenica, which has just been smacked by a federal judge for attempting to block the Food and Drug Administration's approval of generic versions of its antipsychotic drug Seroquel.

The drugmaker's patent for Seroquel expired in March, but the company contended in federal district court in Washington that safety data it provided to the FDA so the agency would approve two additional pediatric uses for the drug forced it to re-label its packaging, reflecting a warning about hyperglycemia (high blood sugar). That re-labeling, attorneys for the drug manufacturer alleged, entitles the company to exclusivity through December 2012.

Interpretation of the law would 'create a perverse incentive' to covet brand names

AstraZenica claimed the FDA acted arbitrarily and capriciously in rejecting its exclusivity rights by approving generic versions of Seroquel. But U.S. District Judge Beryl A. Howell ruled the FDA was reasonable in its interpretation and applied the Hatch-Waxman Act after determining the safety data submitted by the pharmaceutical company was not essential to the FDA's approval of the new pediatric uses.

"The FDA's interpretation of the statute is consistent with its past practice," Howell said. "The FDA has emphasized that generally applicable safety information in labeling should not be subject to exclusivity."

The company's interpretation of Hatch-Waxman - which says every change approved in a supplemental new drug application results in exclusivity - could lead all drug makers to keep exclusivity over their products forever, thereby barring generic competition altogether, by claiming labeling changes over unrelated uses for the drug, the judge said.

"AstraZeneca's interpretation would create a perverse incentive for pharmaceutical companies to drag out their presentation of vital safety data to the FDA in order to bar generic competition beyond the periods determined acceptable by Congress," Howell noted in his ruling. "While Congress was no doubt concerned that pharmaceutical manufacturers have incentives to continue research and development in order to discover vital new drugs, Congress plainly did not intend for these manufacturers to retain exclusivity into perpetuity."

AstraZenica filed its suit against the FDA in March, hours after the agency gave its approval for 10 companies to begin selling generic versions of Seroquel. Five of those companies - Mylan Inc., Teva Pharmaceutical Industries Ltd., Dr. Reddy's Laboratories Ltd., Lupid Ltd., and Sun Pharmaceutical Industries Ltd. - had said they were planning to sell the generic versions immediately.

Other Big Pharma corporations trying to keep generics at bay

The FDA granted exclusivity for just the two new pediatric uses. The agency, in a summary judgment motion, said the safety data submitted by Seroquel was not vital to the FDA's approval of the new pediatric uses. Further, the agency said its approval of the new uses, along with approval of the new labeling which incorporated the safety data, did not warrant extending the exclusivity for all Seroquel uses.

The drug and its variants have been huge moneymakers for AstraZenica, bringing in more than $5.8 billion in sales globally in 2011.

AstraZenica isn't the only Big Pharma corporation trying to improperly covet its products. Drug giant Pfizer and Indian pharmaceutical company Ranbaxy Laboratories Ltd., are being sued by five large U.S. retailers for allegedly conspiring to delay delivery of generic versions of Lipitor, the best-selling drug in history.

The anti-trust suit by Walgreen Co., Kroger Co., Safeway Inc., SuperValu, Inc. and HEB Grocery Co. accused the drug makers of running an "overarching anticompetitive scheme" to prevent generic versions of the popular cholesterol-reducing drug off the market until Nov. 30, 2011, some 20 months after the patent for the original formula expired, recent reports said.

Sources:

http://www.courthousenews.com/2012/07/10/48235.htm

http://www.law360.com

http://www.courthousenews.com/2012/07/10/AstraZeneca.pdf

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