Κυριακή, 21 Αυγούστου 2011

Pfizer seeks OTC version of Lipitor

American Pharmacists Association

Could a behind-the-counter category be appropriate for the cholesterol medication?
Pfizer is pursuing an OTC version of atorvastatin (Lipitor) because the cholesterol medication—the world’s best-selling drug with annual sales of $11 billion—loses patent protection in November, according to news reports.
It’s likely Pfizer will have trouble gaining FDA approval for OTC atorvastatin; the agency hasn’t approved OTC versions of other statins in the past, according to news reports. Asked if in that case, the company would consider a behind-the-counter (BTC) category for nonprescription atorvastatin, Pfizer replied in an e-mail statement: “We can confirm that we have strategic plans in place for Lipitor’s loss of exclusivity, but we don’t have any further comment at this time.”
FDA, however, has signaled that BTC may be an option for drugs that treat chronic conditions. At the Food and Drug Law Institute’s annual conference in Washington, DC, on April 5, FDA Center for Drug Evaluation and Research Director Janet Woodcock, MD, said that the so-called “third class,” or BTC category, would be the most effective way of making prescription drugs available on a nonprescription basis, “particularly to help treat chronic conditions,” reported an April 11 article in the Tan Sheet newsletter.
At a November 2007 FDA public meeting to hear from stakeholders on the issue of a third class of drugs, organized pharmacy supported the concept but the American Medical Association opposed it. In related December 2007 comments to FDA, APhA said that “a substantial body of evidence” showed that “certain prescription drugs can be safely made available without a prescription by requiring their storage behind the pharmacy counter and a substantive, clinical interaction with a pharmacist.”
Other countries with BTC-status drugs include Australia, Canada, France, New Zealand, United Kingdom (UK), Denmark, Germany, Italy, Netherlands, Sweden, and Switzerland, according to a March 2009 APhA Government Affairs Issue Brief on the matter. The Wall Street Journal reported on August 4 that nonprescription simvastatin, another cholesterol drug, is sold BTC in UK pharmacies, “requiring interaction with pharmacists.”
According to a special feature, “Risks, Benefits, and Issues in Creating a Behind-the-Counter Category of Medications,” in the January/February 2011 issue of the Journal of the American Pharmacists Association, BTC implementation “probably is feasible in the United States [but] the optimal model remains uncertain and various aspects of a program need to be prioritized and rigorously tested.”
The Wall Street Journal was the first to report on Pfizer’s plans.



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