When a drug to prevent babies from being born too early won federal approval in February, many doctors, pregnant women and others cheered the step as a major advance against a heartbreaking tragedy.
Then they saw the price tag.
The list price for the drug, Makena, turned out to be a stunning $1,500 per dose. That’s for a drug that must be injected every week for about 20 weeks, meaning it will cost about $30,000 per at-risk pregnancy. If every eligible American woman were to get Makena, the nation’s bloated annual health-care tab would swell by more than $4 billion.
What really infuriates patients and doctors is that the same compound has been available for years at a fraction of the cost — about $10 or $20 a shot.Oh, it gets worse. I've probably pushed the bounds of fair use here so I'll just let you go to their website to read the whole thing. But please read it, because it's as profound an indictment of our system as anything I've ever seen. SO, let me see if I have all of the factoids from this story straight:
- There's a drug that the FDA just "approved" to help prevent premature births. That's the good news.
- A full course of the drug costs $30,000. And most moms in at-risk pregnancies don't have that.
- A full course of "the compound" (i.e., the same drug) has been available for about $200 to $400.
- Along with FDA approval, the company also got a patent and sole rights to manufacture "the compound."
- Which means it's now no longer available for $200 to $400.
- The company that now owns the patent says it's charging that amount to recoup the costs for FDA-mandated clinical trials.
- The leading advocacy groups and medical specialists were apparently surprised by the new price. Seriously.
- The "main study" to prove the drug's effectiveness was apparently an NIH (i.e. taxpayer) funded study, but the taxpayers receive no return on this investment.
A form of progesterone known as 17P was used for years to reduce the risk of preterm birth, but it fell out of favor after the manufacturing company stopped making it. In 2003, the NIH study showed that 17P could cut the risk of preterm delivery if given in the first 16 to 24 weeks of pregnancy. That led to a resurgence in the use of 17P. Because no companies marketed the drug, women obtained it cheaply from “compounding” pharmacies, which produced individual batches for them.
Doctors and regulators had long worried about the purity and consistency of the drug and were pleased when KV won FDA’s imprimatur for a well-studied version, which the company is selling as Makena.So this company basically did some research to verify the safety and efficacy of a drug that people were already using but either did or didn't already have FDA approval. And here is where it REALLY gets weird:
In an interview with The Washington Post on Friday, an FDA official said that, if requested, the agency could approve a lower-priced generic version of the drug for another use that doctors could prescribe “off label.”So an unnamed FDA official is telling the Washington Post that they could approve a generic drug that would be prescribed off-label? And they won't enforce the company's right to market the drug as the sole provider - a right that FDA itself granted - because they're too busy?
In addition, the official said the agency would not prevent compounding pharmacies from continuing to provide 17P unless patient safety is thought to be at risk.
“We have our hands full pursuing our enforcement priorities,” said the official, who spoke on the condition of anonymity because of the sensitive nature of the issue. “And it’s not illegal for a physician to write a prescription for a compounded drug or for a patient to take a compounded drug. We certainly are concerned about access of patients to medication.”
If by the FDA's own admission it's ok to prescribe drugs off-label, then why do we have an FDA in the first place?
So, to sum up: our systems of drug approval, intellectual property and taxpayer-funded research have taken a relatively well-known and commonly-used drug that cost about $300 and made it $30,000 for the next 7 years. It costs that much because now we really know it's safe and effective - after all, this company and the taxpayers have invested millions to make sure.
Of course the company gets a financial return on its investment but the taxpayers don't. But then again, the company loses too - because the company that invested its own money and time in creating this drug will now have to compete with a gray market that the FDA tacitly condones. And that's because the FDA has anonymously suggested to the Washington Post that patients and providers ignore the very reason we created the FDA in the first place - making sure drugs aren't marketed or prescribed "off label."
Compounding pharmacies can look forward to lawsuits from the company that actually got FDA approval.
The company that got approval can look forward to ridiculously bad publicity - even though it played by the rules.
Moms with at-risk pregnancies now get to choose between: a) that worry in the back of their mind that the medicine they're getting isn't really FDA approved or b) a $30,000 price tag
Someone at the FDA gets to explain to his or her boss why they just undermined the mission of the FDA in the Washington Post.
But hey, lawyers and PR guys are probably gonna get paid, so it all works out.