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Wednesday, July 11, 2012

FDA releases safety measures for prescription pain relievers.

The New York Times (7/10, B2, Meier, Subscription Publication) reports, "The Food and Drug Administration, overriding the advice of an expert panel, said Monday that it would not require doctors to have special training before they could prescribe long-acting narcotic painkillers that can lead to addiction." The FDA, however, "said companies that make the drugs...would be required to underwrite the cost of voluntary programs aimed at teaching doctors how to best use them." The Times adds, "In introducing the plan on Monday, both Dr. Margaret A. Hamburg, the F.D.A. commissioner, and R. Gil Kerlikowske, President Obama's top drug policy adviser, said they were hopeful that Congress would eventually enact mandatory physician training," although the Obama administration has not yet drafted legislation.
        The Wall Street Journal (7/10, Martin, Dooren, Subscription Publication) reports that during a teleconference with reporters, Kerlikowske said, "The most cost-effective and efficient way to stem our nation's prescription-drug-abuse epidemic is by stopping abuse before it ever starts."
        The Columbus (OH) Dispatch (7/10, Torry) reports, "Hamburg said that more than 20 companies which produce these painkillers will offer educational programs to the nearly 320,000 prescribers on the safe use and disposal of these drugs. Hamburg estimates than within three years, 60 percent of the prescribers will have taken the program," although she added that "we would like to see the number even higher."
        According to the Philadelphia Inquirer (7/10, Sell), "Endo, Pfizer and Janssen said Monday they support the FDA's move."
        The AP (7/10, Perrone) reports, "The FDA has issued a number of warnings on prescription pain relievers in recent years but with little effect." Government statistics indicate that "inappropriate use of the drugs caused nearly 425,000 emergency department visits in 2009." The medications "were blamed for 15,600 deaths that year, up from 14,800 in 2008."
        MedPage Today (7/10, Fiore) reports, however, that "critics cite a number of problems with the guidance, including its reliance on industry sponsorship of education, even with middle-man medical education companies. Also, extended-release and long-acting opioid analgesics training will not be mandatory for prescribers." Meanwhile, "the program will not cover powerful short-acting opioids such as hydrocodone (Vicodin) that have an equally high potential for abuse." Also covering the story are Reuters (7/10, Yukhananov), Medscape (7/10, Jeffrey), and the Pittsburgh Tribune-Review (7/10, Harding).

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