This may work its way to the Supreme Court. KV has legal grounds to sue compounders if they compound the same product. If you look at the FDA's decision, it was based on access to this critical drug. As long as KV has adequate supply and they are making it affordable to everyone through their PA program on legal grounds they can sue the compounders. Regardless of what the FDA says the Supreme court will have the final say here. Big Pharma is going to back KV on this. On another note don't expect the FDA not to approve Makena and overturn the advisory board. They cannot overturn based on price, only efficacy and studies.
If you read the Orphan Drug Act, it clearly gives marketing exclusivity to the approved PRODUCT versus another similar unapproved PRODUCT, and will not approve another similar PRODUCT for 7 years. but does NOT exclude compounded prescriptions, which are NOT MARKETED PRODUCTS....they are in fact prescription orders written by a physician. Compounded Rxs are allowed in all 50 States. Compounded Rxs are regulated by the States, as the act of compounding is part of the practice of pharmacy.... KV misinterpreted the ODA to think it could force the compounded 17P off the market. There is no history of any compounded Rx being taken off the market by the approval of any drug product that I can find. There are lawsuits against compounding pharmacies regarding patent issues dealing with exclusivity, but 17P is not covered by patent.
FDA does have the authority to take action against drug items in interstate commerce that have been determined to be dangerous to the population, and can do seizures and/or petition the Department of Justice to take criminal action. But, FDA does NOT have jurisdiction over the physicians right to use compounded prescriptions. FDA, on its website, reiterates it right to intervene to stop the use of compounded 17P if the practice is shown to be dangerous to public health, but FDA never had the right to stop compounding pharmacies from offering 17P compounded prescriptions.
"As always, FDA may at any time revisit a decision to exercise enforcement discretion."
Sparky this gives the FDA an out when they get sued.The Supreme court if it ever gets that far will tell they over stepped there boundaries.
Still designated Orphan Drug, Sparky. Just because the FDA doesn't feel like regulating the Orphan Drug Act, doesn't mean that it can't legally be enforced in a court of law. Last time I checked, no members of the FDA are on the Supreme Court . . . I could be wrong, though.
For such a smart guy, you sure don't take the time to look into ideas that conflict with views. Educate yourself . . .
I was thinking about this for a while, but it just came out from you.
But what is KV thinking about it. When will it come out with something like this or with any of the other FDA approvals?