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And that's what this is... an intellectual property issue, not an example of "over regulation."
Seems to be some discrepancies here though, this drug was being made by others beforehand:
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That's because the drug, a form of progesterone given as a weekly shot, has been made cheaply for years, mixed in special pharmacies that custom-compound treatments that are not federally approved.
But last month, KV Pharmaceutical of suburban St. Louis won government approval to exclusively sell the drug, known as Makena (Mah-KEE'-Nah). The March of Dimes and many obstetricians supported that because it means quality will be more consistent and it will be easier to get.
......and
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Makena is a synthetic form of the hormone progesterone that first came on the market more than 50 years ago to treat other problems. Hormone drugs came under fire in the 1970s, following reports they might damage fetuses in early pregnancy. In the 1990s, the early incarnation of Makena was withdrawn from the market.
The R&D that goes into developing a new medication is horrendously expensive. If there's no way for the company to protect their intellectual property, how can they recoup that immense investment?
In general terms, medicine is exactly the kind of situation where government - through enforcement of intellectual property rights - can help private companies leverage the market forces. The government protects the monopoly for X number of years, the drug composition is public knowledge after that, everybody benefits somewhat. We can bicker over the details, but in general, patent law is necessary for research to pay off.
According to the article in post #2 the costs of R&D was mostly shouldered by others than this company.
According to the article in post #2 the costs of R&D was mostly shouldered by others than this company.
Yeah, I just read that. Now, that puts things in another light. If the R&D is in the public domain already? That's price gouging right there. If that's legal, it ought not to be.
The FDA has no way of knowing this company's intentions.
The FDA's interest was in assuring the availability and consistency in quality of the product. And the March of Dimes, among other organizations, supported the company's application.
I think that the March of Dimes and the other organizations that supported KV Pharmaceuticals should now apply to the FDA for relief, along with insurance companies and other parties that pay for this drug. It is an unwarranted price hike, a spectacular price hike, and the company should not only be required to defend this case of price gouging, and pay fines for its actions, but should have all of its current offerings, production costs and pricing matrices audited. While the FDA doesn't have pricing authority, it does have regulatory authority. If the company thought they could use that regulatory authority to their advantage, then there should also be some disadvantages.
With some further research there is special designation given to this drug, "orphan drug". This gives special rights to drug companies so they have an incentive to develop drugs where the market is small.
The FDA has no way of knowing this company's intentions.
The FDA's interest was in assuring the availability and consistency in quality of the product. .
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no way of knowing this company's intentions.
how could they NOT know...what happens with a monopoly...just look at the PUBLIC unions
its just more OVER- REGULATION by the government...the FDA should be disbanded
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