Pharma

Drug pricing, FDA protections gone 15,000 percent wrong

The National Women’s Health Network is asking its members to protest the 15,000 percent increase […]

The National Women’s Health Network is asking its members to protest the 15,000 percent increase in the price that KV Pharmaceuticals is charging for its premature labor prevention drug. The price increase, covered in this AP story, will hike the cost of pregnancy for women at risk of early labor by $30,000. In its action alert sent out this week, NWHN says:

Drug companies often try to justify high prices by claiming they need to recoup research and development costs; but that argument holds no water in this case because the clinical research that KV Pharmaceuticals used to get its approval was conducted by the National Institutes of Health and paid for with tax-payer dollars.

This appears to be another case of market exclusivity incentives gone awry. The drug in question, called Makena, is an injected form of progesterone. It has been around since the 1950s and sold as Delalutin.  When its original manufacturer stopped making it in 1999, compounding pharmacies stepped into the breach, selling their formulations for $10 to $20 a shot.

But that meant there was no approved drug on the market for that condition. KV, seeing an opportunity, apparently used NIH funds to carry out clinical trials, which showed a series of shots starting during the second trimester prevented pre-term births in about 37 percent of women at risk of early deliveries. It then applied to the FDA for accelerated approval, which the company received, according to the February FDA press release. The release doesn’t mention why the company received market exclusivity rights, although I’m guessing it is because women at risk of premature labor constitute a rare disease community. If anyone knows, please let me know.

In any case, a $20 shot was turned into a $1,500 shot through the magic of having exclusive rights to the market. The weekly injections begin as early as 16 weeks into a 39 month pregnancy. You do the math.

Somebody should investigate the use of marketing exclusivity incentives throughout the FDA, which were established by Congress to get companies to do things that otherwise wouldn’t be done. Seven years market exclusivity is given for developing drugs for rare diseases; a priority review voucher (which can get a me-too drug to market six months faster) is given for developing drugs for neglected diseases of the developing world; six months patent extensions are given out for testing drugs in children. I suspect such an investigation would turn up many more such abuses of these programs, such as the Coartem scandal I wrote about a few years ago.

The author, Merrill Goozner, is an award-winning journalist and author of “The $800 Million Pill: The Truth Behind the Cost of New Drugs” who writes regularly at Gooznews.com.

Merrill Goozner

Merrill Goozner is an award-winning journalist and author of "The $800 Million Pill: The Truth Behind the Cost of New Drugs" who writes regularly at Gooznews.com.

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