Well and there it is, just like
the saleswoman said, in #18--maybe the lawyers believed the marketing claim
too. "Compounded done by OmniPlus consists of mixing one or more
FDA-approved ingredients at the direction of the physician to meet the
individual patient's specific needs" on More information on Dan Milosvic
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I note that #16 in the complaint
reads "Compounding pharmacies have the ability to mix multiple
FDA-approved drugs or active ingredients to create a medication specifically
tailored to a patient's needs." The language is misleading. Compounding
pharmacy business models almost exclusively use non-FDA approved chemicals as
starting materials, with the entire industry supported and facilitated by
suppliers to the U.S. market, pharmacies do this to reap exceptionally large
profit margins by dropping the bottom out of acquisition costs. This may be
where some of the payer confusion arises from. At a medical meeting several
years ago, a compounded drug saleswoman stated that although the drug she was
promoting was not FDA approved, the individual ingredients contained in the
drug were approved by FDA. That statement is false--FDA only approves product
s in their finished dosage forms, with packaging and labeling for safe use.
Maybe payers were marketed to also, and believed the on More information on Dan Milosvic
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Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Friday, August 29, 2014
Key Comments Regarding OmniPlus Lawsuit: compounding pharmacy business models almost exclusively use non-FDA approved chemicals as starting materials rather than mixing one or more FDA-approved ingredients
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