Asthma Meds
Posted: 15 August 2006 03:14 AM   [ Ignore ]
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FDA Warns Three Pharmacies About Making Own Versions Of Brand-Name Drugs For Asthma, Other Respiratory Ailments
FDA in a press release Thursday said that it has warned three large pharmacies that they are in violation of federal law by producing and distributing unapproved “compounded” inhalation drugs, USA Today reports. Pharmacies are typically permitted to “compound,” or formulate, drugs only when they have legitimate prescriptions for patients who need products not produced by commercial manufacturers. Legitimate compounding could include the production of dye-free products or liquid dosages for patients who cannot swallow pills. Warnings were issued Wednesday to Orlando, Fla.-based Rotech; Clearwater, Fla.-based CCS Medical; and Reliant Pharmacy Services, owned by home oxygen company Lincare, who had not resolved issues highlighted by the agency in a December 2004 letter. According to the FDA, the pharmacies violated federal law by compounding brand-name drugs without any proven medical need for doing so. Specifically, the pharmacies were producing liquids that are poured into devices called nebulizers and inhaled by individuals with respiratory illnesses. Steve Silverman, assistant director of FDA’s Office of Compliance, said the agency expects the companies to either prove they are compounding medications for legitimate medical needs or halt compounding altogether (Appleby, USA TODAY, 8/10). According to Steven Galson, director of FDA’s Center for Drug Evaluation and Research, “[c]ompounded inhalation drugs are not reviewed by the FDA for safety and effectiveness, often are not produced according to good drug manufacturing practice and typically are not sterile” (Abruzzese, CQ HealthBeat, 8/10).
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Cole Peterson of CCS Medical said the warning is “inconsistent with prior communication” from FDA and revenue from the drugs in question was less than $80,000 of the firm’s $400 million annual revenue. Lincare spokesperson Joe Grillo said the company had no comment, and Rotech did not respond to an inquiry from USA Today. Sen. Charles Grassley (R-Iowa), who last month wrote FDA and Medicare with concerns about the safety of the drugs, on Thursday called FDA’s move “a big step in the right direction.” He added that Medicare also should help address the problem. The Consumer Health Alliance for Safe Medication also praised FDA’s actions but said there should be more effort put forth to notify patients who have received the potentially risky medications (USA Today, 8/10).

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