FDA acts to keep cost of preemie prevention drug affordable
Last week we found out about KV Pharmaceutical and its exclusive approval from the FDA to sell the drug Makena, a premature birth preventive progesterone drug. While the drug had been made in compounding pharmacies for years, and provided for about $20 an injection, KV Pharmaceutical decided, since they had the advantage of monopoly, to use it and hike the price of the drug to $1,500 an injection.
Sen. Sherrod Brown jumped in, sending a letter to the CEO of KV urging the company to reverse course. He also requested an antitrust investigation of the company’s practices with the Federal Trade Commission, and called for a federal investigation of what the price hike would mean for the Medicaid program. Most effectively, at a hearing March 30 with Health and Human Services Secretary Kathleen Sebelius, Brown pushed for FDA action. And got it.
The Food and Drug Administration took the unusual step Wednesday of inviting specialty pharmacies to make an end run around a company that obtained exclusive rights to a pregnancy drug and promptly raised the price from $20 a dose to $1,500….
In its statement, the FDA noted that the drug was important and K-V “received considerable assistance from the federal government in connection with the development of Makena by relying on research funded by the National Institutes of Health to demonstrate the drug’s effectiveness.”
KV had contacted pharmacies, “threatening that the FDA would punish them if they compounded their own versions of the drug.” The FDA just said it would do no such thing. In response, KV has said they would “do more” to bring down the cost of their own drug. Sometimes raising hell works. No fooling.
Forget $1500 a dose: Pharmacies will resume low cost generic
Pregnant women in southern Arizona will not have to pay $1,500 a dose for a drug to prevent premature births after all. A local compounding pharmacy now has confidence it can continue making a low cost version without getting sued.
9 On Your Side has been following the case of a drug a company which used federal rules to turn a generic drug to a private brand and jack up the price 15,000% in the process.
A drug commonly called 17P has been available for about 50 years. It helps prevent premature births. The market for it is small, so big drug companies stopped making it but doctors and patients could still get compounding pharmacies like Reed’s Pharmacy to make the drug for about eight dollars a dose.
That was, until KV Pharmaceuticals convinced the FDA to give it rights to the drug. KV renamed it Makena and started charging $1,500 a dose. KGUN 9 On Your Side has been asking politicians about the drug—and the price.
The FDA relented, telling compounding pharmacies they will not face federal penalties if they still make their low priced generics. But pharmacies still worried KV Pharmaceuticals would sue. Now their trade association has assured them KV has no patent rights, just the exclusive right to mass market the drug. They should be safe from lawsuits if they inform doctors Makena is available, then decide with doctors the cheaper, compounded version is best for the patient, and document the decision process.
All that makes Reed’s Compounding Pharmacy feel safe to make the drug again.
“What do you think of this whole tortuous exercise?” KGUN9 reporter Craig Smith asked pharmacist Dana Reed-Kane.
“I think it’s been wonderful. I think the outreach that we’ve had from patients, from different organizations, medical organizations, the March of Dimes; it really shows the power of the people and when you speak up, and Channel 9, you guys have been great covering this story. I think that all of the media attention that has been brought to this product is why the FDA came out with that statement,” Reed-Kane responded.
Dr. Monique Schoenhage specializes in getting moms through problem pregnancies. She’s happy an important drug will stay available, and affordable.
“I’m happy to say the public responded. All of the governing bodies, ACOG, SFMN, the March of Dimes rallied behind what is the right thing for moms and babies,” Dr. Schoenhage said. She still hopes KV Pharmaceuticals will lower the price for their version.
The company is not answering KGUN9′s questions, just firing off an occasional press release. One of the latest acknowledges the concern over the drug price, says the company is finalizing solutions to those concerns and will announce them at the end of the week.
Accused FDA inside trader had pharmacy degrees from Iowa
The U.S. Food and Drug Administration chemist who was charged this week with illegal insider trading received two pharmacy degrees from the University of Iowa in the early 1990s.
Federal officials filed criminal and civil charges against on Tuesday against Cheng Yi Liang, 57, and his son, Andrew Liang, 25, claiming the men used confidential FDA information to buy and sell stocks of drug companies that had applications pending for products.
The Liangs, who live in Gaithersburg, Md., allegedly made more than $2.7 million off the illegal trades, according to a Department of Justice news release.
Cheng Liang had reportedly worked for the FDA since 1996.
University of Iowa Records show he received a master’s degree in pharmacy from the Iowa City school in 1991 and a Ph.D. in pharmacy in 1993.
A criminal complaint says the illegal trading on inside information goes back to at least November 2007. Prosecutors told reporters that the father and son used proceeds from their trades to pay for travel, credit card bills and to buy new cars.
The criminal complaint says Cheng Liang accessed an internal FDA database that is used to track and receive drug applications and show when the agency would make decisions and what they would be.
The information was used to buy and sell the stocks of pharmaceutical companies days ahead of formal announcements by the FDA.
Federal officials reportedly installed software on Cheng Liang’s work computer that enabled them to track his actions.
The criminal charges of securities violations and wire fraud carry prison terms of up to 20 years and fines of up to $5 million.
The U.S. Securities and Exchange Commission has also filed civil charges against the Liangs seeking an unspecified amount of restitution from the men.