Clinton Urges US Regulators To Examine Daraprim Price Hike

By Amanda Becker

WASHINGTON (Reuters) -- Democratic presidential candidate Hillary Clinton on Monday urged U.S. regulators to determine how to bring lower-cost generic drugs to market more swiftly and combat anticompetitive practices in the pharmaceutical industry.

Clinton's requests to the Food and Drug Administration and the Federal Trade Commission were prompted by what she called the "egregious actions of Turing Pharmaceuticals," according to letters reviewed by Reuters.

The company drew fire from Clinton last month after news reports that it had raised the price of Daraprim, a 62-year-old treatment for a dangerous parasitic infection, to $750 a tablet from $13.50 after acquiring it.

Clinton's criticism sent drug industry stock prices tumbling. Turing Chief Executive Officer Martin Shkreli promised to lower Daraprim's cost to an unspecified price, and Turing is in the midst of a rebranding effort after being mocked on "Saturday Night Live."

In her letter to the FDA, which regulates food and drug safety, Clinton said that Turing has still not "meaningfully lowered the price." The company's decision to "artificially increase the price" exploited vulnerable patients dependent on the drug, which is often used by those with compromised immune systems, Clinton said. (reut.rs/1W2o8Sc)

"The FDA should expedite any pending reviews, and encourage applications for review, of other generic alternatives to Daraprim," Clinton wrote.

The FDA told Reuters it will review the letter and respond directly to the sender, but noted that the agency's review of medicines are a matter of public record.

In her letter to the FTC, a consumer protection agency, Clinton acknowledged it has only "limited authority to address price gouging when it is the result of unilateral action in a market with no competition," but urged it to examine both the industry overall and Turing specifically. (reut.rs/1hO1NF4)

"I believe it would be a great service to the Congress and the Administration if the FTC would study and make recommendations on whether and how our laws might be amended to address this problem," Clinton wrote, offering an indication of how she might attempt to overhaul pharmaceutical practices if elected president in November 2016.

Clinton also asked the FTC to investigate whether Turing's decision to increase Daraprim's cost amounts to the type of anticompetitive behavior the agency can regulate.

The FTC did not immediately respond to a request for comment.

Drug prices are also being scrutinized by Democrats in Congress and U.S. prosecutors. Most pharmaceutical companies regularly raise prices, saying it reflects the drugs' value in the market.

The head of Valeant Pharmaceuticals International Inc, which has also come under fire for raising drug prices and is being investigated by the government, said Monday he predicts lower price increases are ahead for the whole industry.

"The pharmaceutical industry is being aggressively sort of attacked for past pricing actions," CEO J. Michael Pearson told investors. "I do think, given that environment, the pricing that pharmaceutical companies will take in the future will be more modest."

The Daraprim price increase was unusual because it was so large. In interviews, Shkreli has defended the steep hike, and Turing last week announced it was making "improvements" to Daraprim's affordability and accessibility to "clarify any misunderstandings about Turing's pricing and distribution," according to a release.

A Turing spokesman on Monday did not respond to requests to comment on Clinton's letters to the FDA and FTC.

Clinton last month unveiled a plan for a $250 monthly cap on out-of-pocket prescription drug costs and other measures to stop what she calls "price gouging" by pharmaceutical companies.

Turing's Daraprim and Shkreli were featured in a television advertisement run by Clinton's campaign about how she plans to take on "skyrocketing out-of-pocket costs."

"Nobody in America should have to choose between buying the medicine they need and paying their rent," Clinton says in the ad.

(Reporting By Amanda Becker in Washington; Additional reporting by Bill Berkrot andCaroline Humer in New York; Editing by Jonathan Oatis and Grant McCool)