According to The Washington Post, last Friday the FDA—just days after you started contacting them in protest over their pregnancy drug Makena—has reversed their stance. Keep up the pressure!
As we reported last week, KV Pharmaceutical’s new orphan drug, Makena—a form of progesterone called 17P that has been in use for decades to help patients with high-risk pregnancies—has sparked outrage across the country because the price was raised from $10 per dose to $1,500, or as much as $30,000 over the course of a pregnancy. Each insurance company and state Medicaid program must decide whether to cover the drug. But even women whose insurance will pay for it could face thousands in out-of-pocket costs to satisfy co-payments and deductibles.
Because no companies had been marketing the drug, women obtained it cheaply from compounding pharmacies, which produced individual batches for them. But the approval of Makena gave the KV Pharmaceutical seven years of exclusive rights, and KV immediately fired off letters to compounding pharmacies, warning that they could no longer sell their versions of drug. “Continuing to compound this product after FDA approval of Makena renders the compounded product subject to FDA enforcement for violating certain provisions of the Federal Food, Drug and Cosmetic Act, as well as FDA guidance,” the letter says.
Last Tuesday we issued an Action Alert, and you flooded the FDA with messages. Then, in an interview with The Washington Post on Friday, an FDA official said that 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.”
The Post article also indicates that several more members of Congress have sent letters to KV complaining about the price and demanding justification. They have asked the Centers for Medicare and Medicaid Services and Federal Trade Commission for investigations.
Well done! Never doubt the power of collective action. Your grassroots activism changes lives.
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I think it is wonderful that the FDA prevented KV from claiming exclusive rights to an old drug that has basically been on the market for years. My husband and I were totally outraged when we heard that KV wanted to charge so much for a shot that had been relatively inexpensive.
That kind of profiteering should be outlawed, especially when it comes to some one’s health. It is a well known fact that premature babies have health problems that can persist throughout their lives. We need healthy children , and what KV was doing was a very good way to undermine full term deliveries that would prevent problems that preemies have.
Why did the FDA reject this? This isn’t like them……. (seriously).
THE FDA, for many years, has depended upon the US citizen to be apathetic, good hearted, and assume that the FDA has the US citizenry best interest at the fore front. The FDA DOES NOT AND NEVER HAS !!! Does the FDA have a purpose? YES…. But it needs to be redefined quickly. HERE IS A LITTLE HISTORY about the FDA’S HUMBLE BEGINNINGS….. 1) The original board members of the FDA when it was first formed is a Who’s who from corporate america…Yes. Read there history, they included the CEO’s of 2 chemical companies, a sugar company, & 3 food companies etc…………healthcare will not get cheaper if we do not change it now. I HOPE THAT THE NEW CITIZENS WHO HAVE RECENTLY JOINED THIS ORGANIZATION TO VOICE YOUR DISSATISFACTION ON THIS RECENT ISSUE… PLEASE… PLEASE..PLEASE STAY INVOLVED.
Good RX has it now for 5500 for 4 doses.