In response to threats KV Pharmaceuticals has made to compounding pharmacies that want to continue making low-cost versions of its high-priced Makena preemie drug, the FDA has just issued a statement saying the agency will not take any "enforcement actions" against compounders.
The "FDA understands that the manufacturer of Makena, KV Pharmaceuticals, has sent letters to pharmacists indicating that FDA will no longer exercise enforcement discretion with regard to compounded versions of Makena. This is not correct," the FDA statement says.
"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 FDA, of course, can revisit the decision.
The move comes amid a growing outcry over Makena, which is actually a form of progesterone that has been available for decades from compounding pharmacies at roughly $10 to $20 a week (read this). KV Pharma, however, is charging $1,500 and has a lock on the market, because Makena is the only drug approved by the FDA for this purpose.
UPDATE: The decision is sending KV stock plunging, since the drugmaker had hoped to prevent compunders from continuing to make versions of the same medication. You may recall that KV, which does not have a patent on Makena, was awarded exclusivity under the Orphan Drug Act (read here), but the FDA action, effectively, tears down the barrier to competition. As of 12 noon EST, KV shares have fallen 33 percent.
Over the past three weeks, both the US Federal Trade Commission and the Centers for Medicare & Medicaid Services have been asked to investigate the KV pricing (see this ). And the March of Dimes and other groups have been similarly pressuring KV to lower its price (see this).
Recently, David Miller, executive director of the International Academy of Compounding Pharmacists, told us that his organization believes KV, which sent cease-and-desist letters to compounders, is off base. "It’s important to note many of the letter’s assertions that the compounding of an FDA approved product is prohibited are not supported by the legal citations it references.” Whether KV files a petition with the FDA is uncertain.
For those who would compare this situation with the gout medication - colchicine - that caused a similar stir, here is a quick primer. Two years ago, the FDA approved a version of colchicine which, like progesterone, had been used for ages to treat gout. The agency later ordered a halt to unapproved versions (read this). However, these colchicine pills, which cost pennies, were not made by compounders, but instead were manufactured by other drugmakers. As with KV and Makena, the episode gained attention because Mutual Pharmaceutical dramatically began charging about $5 for the price of its Colcrys pill.