The FDA should do more to establish a clear line between drug manufacturing and compounding, write Michael Carome and Sarah Sorscher of Public Citizen's Health Research Group in response to statements by FDA Commissioner Dr. Margaret Hamburg and agency official Howard Sklamberg. Compounders that act as manufacturers should be regulated as manufacturers, which is well within the FDA's authority, Sorscher and Carome write.
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Mr. Carome and Ms. Sorscher of Public Citizen are staunch advocates of patient safety, and I am glad to have them calling for more protection from rogue compounding pharmacies. But they miss the point. The FDA could "try to inspect" compounding pharmacies, but would first have to identify them (these pharmacies don't register with the FDA, so the FDA would have to expend even more resources Googling, or otherwise identifying rogue pharmacies). When they show up for an inspection, what would the response be? Ed Bayo, a defense attorney that represents pharmacies has called these inspections, "regulatory colonoscopies". The pharmacies could easily say, "Where's your search warrant? Get the heck out of here."
And even after an inspection and a 483 letter is issued by the FDA, what happens then? "Stop! Or I'll yell Stop again!" The FDA would either have to file criminal charges or a civil lawsuit. To win a criminal case, the FDA would need evidence "beyond a reasonable doubt", a pretty high standard to meet. So, the FDA (and FTC), if they want to pursue things, will file a civil lawsuit instead (as they only need "clear and convincing evidence"). Do these lawsuits succeed. Nope. Just look at United States vs. Franck's Lab, Inc. 816 F. Supp. 2d 1209 (M.D. Fla. 2011) (http://www.courthousenews.com/2011/10/11/40528.htm and http://www.hunton.com/files/Publication/11154d9b-4493-4062-b8fe-5b1ac20ebfb5/Presentation/PublicationAttachment/ddbec7ab-6db1-435b-91b5-a3040dd6f658/ContractPharma_July-Aug_2012.pdf). FEDERALISM ISSUES are raised by the defense, and they generally win. Once a business has a pharmacy license, it is now "regulated by the states" and the Federal Government (including the FDA), has no standing to enforce the law.
No. What we need is Congress to rewrite Section 353a of the Federal Food, Drug and Cosmetic Act in a "constiutional way". That would give the FDA clear authority to protect us.
Kenneth N. Woliner, M.D.
www.holisticfamilymed.com
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