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12:00 AM
 | 
Apr 18, 2011
 |  BioCentury  |  Regulation

Contradicting itself

FDA contradicts itself on Makena, particularly on role of price in decisions

When FDA declared it would not prevent compounding pharmacies from selling products that compete with Makena hydroxyprogesterone caproate from KV Pharmaceutical Co., it solved a short-term political problem by guaranteeing access to low-cost versions of the pregnancy drug. But in the process, the agency created the impression it is willing to accept lower quality manufacturing, looser safety oversight, and the absence of an approved label in trade for lower cost.

FDA's action appears to contradict three long-standing agency policies. It has consistently stated that it does not and cannot take price into consideration when making regulatory decisions. In addition, the agency has tried to prevent compounding of approved drugs. Moreover, in 2006, FDA launched an initiative to remove unapproved drugs from the market.

The agency's Makena announcement on March 30 was celebrated by medical groups, state Medicaid agencies, and politicians who were outraged by the cost of the drug. Makena, a synthetic caproate ester of naturally occurring 17 alpha-hydroxyprogesterone (17P), was approved in February and has Orphan exclusivity to prevent pre-term delivery by pregnant women who have had a previous pre-term birth.

KV then slashed Makena's list price by more than half to $690 per injection and instituted cost caps and patient assistance programs. But the compounded product is far cheaper. State Medicaid programs, which pay for over 40% of pregnancies in the U.S., will save as much as $400 million a year if they use compounded product rather than Makena (see BioCentury, April 4).

By one interpretation, FDA was moved to assert its regulatory authority.

The agency's announcement noted that KV had "sent letters to pharmacists indicating that FDA will no longer exercise enforcement discretion with regard to compounded versions of Makena. This is not correct."

KV "crossed a line" by claiming in its letters that it spoke for FDA, according to William Vodra, former associate chief counsel for drugs at FDA. This "gave FDA an opening to make a statement that it otherwise would have been reluctant to make," he told BioCentury.

It is also true, however, that FDA could simply have asserted its authority and rebuked KV without giving compounding pharmacies a green light to produce cheaper versions of 17P.

Principle or price

FDA did not explicitly state that its decision on compounding of 17P was based on price, but it is difficult to find other explanations for a reversal of the agency's long-standing opposition to marketing unapproved versions of approved drugs.

FDA said it was taking the action "to support access to this important drug, at this time and in this unique situation." It did...

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