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 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.
(http://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. (http://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.
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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 and Caroline Humer in New York; Editing by Jonathan
Oatis and Grant McCool)
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