Senator: Don't blame FDA for company drug-pricing

Consumers may be furious that the price of a common drug to prevent premature labor has gone up from $10 a dose to $1,500 a dose, but Sen. Sherrod Brown, D-Ohio, argues that the Food and Drug Administration did nothing wrong in granting KV Pharmaceutical orphan drug status for its new Makena product.

It is the company that is to blame, Brown said on Monday in a USA Today op-ed.

"The FDA did the right thing by approving this drug. Now it can regulate the quality of the medication and increase the quantity in the market," Brown said in a telephone interview.

"It's KV that didn't do the right thing. It's morally reprehensible what they are doing; they are basically fleecing pregnant American women. To raise prices from $10 to $1,500, they will make $3 billion if the same amount of women buys the drug this year as they did last year. It's simply outrageous."

In February, the FDA approved the St. Louis-based pharmaceutical company's application to manufacture a drug based on the hormone progesterone, used to reduce the risk of premature labor, under the orphan drug act. Orphan drug status is reserved for medications to treat rare diseases and gives the maker seven years of market exclusivity.

For years, 17-hydroxyprogesterone caproate has been sold as a compound prescribed by doctors and put together by pharmacists under the name 17P. KV Pharmaceuticals has done research to show the compound works safely, took it through the FDA approval process, and branded it with the name Makena.

Not long after the company was given FDA approval, it sent cease-and-desist letters to pharmacies to stop compounding treatments. On March 7, KV announced it would sell Makena at $1,500 per dose. That's a steep hike from the $10 to $15 compounding pharmacies charge.

Last week, Brown and Sen. Amy Klobuchar, D-Minn., wrote Federal Trade Commission Chairman Jon Leibowitz urging the agency to investigate what they called an "overnight monopoly".

The FDA's hands are tied when it comes to the pricing of the drugs, said FDA spokesman Jeff Ventura. Ventura said the agency tests the safety of the drug and "justification of costs would have to be directed to the manufacturer."

KV Pharmaceutical announced last week it would start a financial assistance program so more women could still afford the drug.

"We are scheduling meetings with key audiences-including payors and national organizations that are committed to the advancement of obstetric care and infant health," the company said in an e-mailed statement.

"We hope to meet with them at the earliest possible dates to discuss and address all of their concerns. We are committed to working closely with all parties to develop and implement plans that will ensure that this important, FDA-approved product will be covered by the payor community and available to all women who are prescribed Makena at an affordable cost."