FDA Encouraged Illegal Compounding, K-V Tells DC Circ.
Law360, Washington (December 13, 2013, 2:51 PM ET) -- Bankrupt drugmaker K-V Pharmaceutical Co. on Friday urged a D.C. Circuit panel to prevent the U.S. Food and Drug Administration from allowing unapproved compounding ingredients into the country that are used to create products that compete with its prenatal drug Makena, alleging the agency has encouraged unlawful behavior.
K-V launched a two-prong attack on the FDA's refusal to prevent unapproved versions of its orphan drug from hitting the market, asking the court to prevent the compounds' Chinese-imported active pharmaceutical ingredient from entering the country and to...
K-V launched a two-prong attack on the FDA's refusal to prevent unapproved versions of its orphan drug from hitting the market, asking the court to prevent the compounds' Chinese-imported active pharmaceutical ingredient from entering the country and to...
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1 comment:
This case is interesting and confusing as to all the implications, especially if KV wins. Let me explain:
1. KV took a drug that was "not FDA-approved", but commonly available cheaply through compounding pharmacies, and went through the FDA-approval process and got "orphan-drug status" and patent protection and market exclusivity.
2. Knowing they had "no legal competition", KV raised the price of this drug overnight by 1500%.
3. Prescribers, insurance companies (including Medicaid) and the FDA all balked at this "price gouging", and used compounded versions of this drug 17-OH-Progesterone, instead.
4. Compounding shouldn't be done for price reasons alone, but for the best interests of a patient that needs an allergy free drug, or a dose that is not commercially available. So on the face of it, KV has a strong legal case.
5. But due to KV's practices of price-gouging, it isn't politically popular to support KV as it attempts to extort patients, insurance companies, Medicaid, etc - into paying an exhorbinantly high price just to make KV's stockholders rich.
6. If KV does win, what could happen next? Imprimis and other vulture capitalistic Pharma companies will take cheap tried and true remedies that never needed FDA-approval before, but go through the same process to get market exclusivity and gouge the public.
The best analogy is: "If someone decided to patent "the wheel" and then charge everyone exhorbinant licensing fees To make anything that required a wheel (from bicycles to automobiles, to wheelbarrels, etc) - should the government allow that to happen?
This question is far more interesting than figuring out how many angels can dance on the head of a pin. I'm eager to see how it plays out.
Kenneth Woliner, MD
www.holisticfamilymed.com
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