One fact isn't in dispute. There are no fat-busting injectables approved by the FDA. Practitioners use different recipes that are prepared by a compounding pharmacy or in a physician's office. Such custom mixes, using ingredients approved for other uses, fall into a regulatory gray area. One combination used by many practitioners is phosphatidylcholine and sodium deoxycholate, or PCDC for short.
Lipodissolve clinics say their injections are legal because states
regulate pharmacy practice, including compounded drugs. Some doctors, however, including Joel Schlessinger, an Omaha dermatologist and president of the American Society of Cosmetic Dermatology and Aesthetic Surgery, have written to
the FDA, urging the agency to halt "the practice of unapproved
medicine.".......The FDA says that "in virtually all cases," it "regards compounded drugs as unapproved drugs." The agency says it's evaluating lipodissolve, but "we do not discuss pending investigations or enforcement matters."
Tuesday, June 12, 2007
Wall Street Journal joins the party on Mesotherapy
Apparently not wanting to be left out of the growing issue on the practice of mesotherapy, the Wall Street Journal chimes on today with a story "The Objections to the Injections Aimed at Fat" (who's rhyming quality sounds like Jesse Jackson).
This many stories from different sources profiling controversial aspects of mesotherapy seems likely to quickly force the FDA to step in and regulate this IMO.
From the story:
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4 comments:
Joel Schlessinger needs to keep current on the facts. Has he heard about the midland decision ruling from the bench tha compounded drugs are NOT new drugs. His comments make him look bad.
Dr. Schlessinger-
Check out this link:
http://www.iacprx.org/site/PageServer?pagename=Comp_News_P2C2#Midland
http://www.accessmylibrary.com/coms2/summary_0286-17465379_ITM
Whether technically legal or not, expect such far off-label uses of medicines (as in the case of mesotherapy) to be restricted signifigantly by state medical boards.
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