The AAFP and other health care organizations that focus on providing care for pregnant women and their children are applauding the FDA's decision to not prevent compounding pharmacies from continuing to produce 17-hydroxyprogesterone caproate, or 17P, for the prevention of preterm births. In an April 1 joint statement(www.acog.org) developed by the American College of Obstetricians and Gynecologists, or ACOG, in conjunction with seven other organizations, including the Academy, the groups also criticize manufacturer KV Pharmaceutical Co. for its plan to charge $690 per dose for Makena, its branded version of the medication.
"Although there are clear benefits to having an FDA-approved version of 17P, there is no evidence that Makena is more effective or safer than the currently used compounded version," said the statement. "In fact, the evidence used to obtain FDA approval for Makena relied primarily on data obtained using the compounded product."
Compounding pharmacists produce 17P at a cost of $10 to $20 per dose, according to a March 17 letter(www.brown.senate.gov) 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(www.fda.gov) 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(www.kvph.com) 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(www.kvph.com) 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."