This was successfully posted to your pofile.
This box will close automatically in a few seconds. Close this window
We don't have an e-mail address on file for you. To use AAFP Connection, you must have an e-mail address in our records. Click Here
Academy Joins ACOG, Others in Blasting Price of Drug Used to Reduce Preterm Birth Risk
FDA Won't Stop Pharmacies From Compounding Cost-effective Equivalent
By News Staff
Compounding pharmacists produce 17P at a cost of $10 to $20 per dose, according to a March 17 letter from Sens. Amy Klobuchar, D-Minn., and Sherrod Brown, D-Ohio, to the Federal Trade Commission, or FTC. In their letter, the two senators asked the FTC to investigate "anticompetitive conduct" by KV Pharmaceutical.
In an accompanying news release, Brown referred to the company's actions as "price-gouging" that "undermines public health and fleeces taxpayers," and Klobuchar called for the FTC to ensure that KV Pharmaceutical "isn't taking advantage of (the FDA's) orphan drug determination to monopolize the market and engage in price-gouging."
The FDA approved Makena in February under its accelerated approval program and gave KV Pharmaceutical seven years of exclusivity under the Orphan Drug Act, which is intended to spur pharmaceutical firms to invest in producing drugs and biologics for rare conditions and diseases. Because 17P is a sterile injectable and there is a risk of contamination with compounding such medications, the availability of an approved product is thought to provide greater assurance of patient safety.
However, the FDA said March 30 that it will not prevent compounding pharmacies from making 17P. The agency's statement followed an announcement that Ther-Rx Corp., a subsidiary of KV Pharmaceutical, planned to charge $1,500 per dose for Makena.
Also in its statement, the FDA flatly denied claims KV Pharmaceutical is purported to have made in letters to pharmacists -- specifically, that the agency planned to enforce the manufacturer's exclusive rights to the drug.
"In order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products," the agency said.
Ther-Rx Corp., which said it has committed to investments of more than $250 million related to bringing the drug to market, including $50 million in research and clinical costs, issued a March 30 news release that said its patient assistance program will reduce out-of-pocket costs for some patients and eliminate out-of-pocket costs for others.
Two days later, the manufacturer announced it had cut its list price for Makena by more than half to $690. Ther-Rx Corp. also said that supplemental rebates would reduce costs for Medicaid agencies and that it had capped the costs for a full course of therapy to a maximum of three vials, or 15 injections.
In their statement, however, ACOG and the other health care organizations asserted the changes do not go far enough.
"Although this may seem like a relatively significant price reduction, unfortunately, it remains a woefully inadequate response," said the statement. "This 'lower' price still remains prohibitively high for a safe and effective treatment that is currently available at a much lower price in the form of compounded 17-hydroxyprogesterone caproate. The U.S. health care system simply cannot be expected to absorb the cost of Makena at its current prohibitive price without significant negative repercussions."
American Family Physician: "Preterm Labor"
American College of Obstetricians and Gynecologists news release: "Makena Price Reduction Is Inadequate"
(April 1, 2011)
FDA Statement on Makena
(March 30, 2011)
CDC: Premature Birth