FDA sends Wyeth a warning letter

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FDA sends Wyeth a warning letter
	2006-05-31 19:30:04
tried to convince lawmakers that importing drugs from Canada was unsafe.--Catherine] Associated Press/NEW YORK By THERESA AGOVINO AP Business Writer FDA sends Wyeth a warning letter MAY. 30 5:14 P.M. ET The FDA sent Wyeth a warning letter over various violations of good manufacturing practices at a plant in Puerto Rico. The letter, which regulators posted on its Web site on Tuesday, said there were problems in the manufacture of several drugs including birth control pill Triphasil, hormone replacement Prempro, antidepressant Effexor and over-the-counter pain reliever Advil. Among the violations noted in the May 3 letter from the Food and Drug Administration is the failure to clean and maintain packaging equipment to prevent contamination and not adequately inspecting packaging and labeling machines prior to use to insure all previous products had been removed. The letter also noted Wyeth's failure to submit some necessary reports to the FDA in a timely manner and its decision not to investigate evidence of contimination in several drugs. The inspection was conducted between Nov. 7, 2005 and Dec. 15, 2005. Wyeth spokesman Doug Petkus said none of the problems effected the safety or effectiveness of the drugs produced in the plant, and that the company was working with the FDA to rectify the problems. However, last Friday Wyeth issued a voluntary recall of 20 lots of Triphasil from wholesale distributors. There has not been a consumer recall. Petkus said pills carried no additional medical risk and that Wyeth was taking the action "to be conservative." However, the FDA letter expressed concern that Wyeth's investigation of the problem was taking too long and that affected lots remained in the market. In the letter, the FDA said the quality control unit failed to adequately investigate manufacturing operations and assure that corrective actions were detmined and implemented to prevent further problems. The disclosure comes as Merrill Lynch analyst David Risinger downgraded Wyeth to "Neutral" from "Buy" on concerns the company's late-stage pipeline may be weak after less-than-stellar study results for a next-generation antidepressant. Wyeth shares fell $1.55, or 3 percent, to $46.32 on the New York Stock Exchange at above-average volume. Shares have traded between $40.90 and $50.49 over the past 52 weeks. Last week at a meeting of American Psychiatric Association, Wyeth released data on the experimental drug DVS-233 that showed higher-than-expected nausea rates and elevated blood pressure for those patients taking the drug. Risinger, in a note, said that Wyeth is developing one version of DVS-233 to treat depression and succeed Effexor, and another version to treat menopause symptoms. But with the noted side effects, he added, the drug seems less attractive. Risinger also said that Wyeth's kidney cancer drug temsirolimus did not seem to be that effective, and called the effectiveness of an antipsychotic medication candidate "questionable." Other analysts couldn't determine the impact of the FDA's warning letter on future operations. In a note, Prudential analyst Tim Anderson said that the ";best guess is that this will have only a marginally negative impact on Wyeth." He also noted that Wyeth doesn't have "the best track record from a regulatory perspective." In 2000, Wyeth agreed to pay $30 million after the FDA determined it was not meeting manufacturing standards at plants in Pennsylvania and New York. It also pledged to have experts conduct a comprehensive inspection of the plants and review and certify quality efforts. Regards, Catherine