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Regulatory News | 19 October 2015 | By Zachary Brennan
In two letters sent Monday, Democratic presidential hopeful Hillary Clinton called on the US Federal Trade Commission (FTC) and US Food and Drug Administration (FDA) to take action against pharmaceutical companies that inflate drug prices and keep generics off the market.
In her letter to FDA acting commissioner Stephen Ostroff, Clinton echoes a number of similar calls by politicians such as those by Rep. Elijah Cummings (D-MD), that Turing Pharmaceuticals' 5,000% price hike of its toxoplasmosis treatment, which has been on the market since 1953, puts "many people at risk of being unable to acquire the life-saving drug."
In Turing's defense, CEO Martin Shkreli has claimed most patients don't pay out of pocket for the drug, known as Daraprim, many patients receive the drug at no cost, and that the price hike is linked to his company's investment in new research to develop a better toxoplasmosis treatment.
Following the outcry over the price hike, Shkreli said publicly that he would lower the drug's cost, though as Clinton notes in her letter, Turing "has not meaningfully lowered the price."
Clinton calls on FDA, which does not regulate or deal with drug pricing, to "explore whether it has the authority and discretion, given the special circumstances involving the potential shortage of a critical drug, to accelerate approvals or allow for temporary importation from other OECD [Organization for Economic Co-operation and Development] countries."
The question for FDA will be whether there is actually a shortage of Daraprim in the US. As Clinton notes, FDA in the past has allowed for the temporary importation of drugs to the US if a treatment is in shortage, and Clinton is calling the issue an "effective shortage" because of the prohibitively high price.
Clinton also calls on Ostroff to reduce the generic drug backlog, as she did last month.
Letter to FTC
In a separate letter, Clinton calls on FTC Chairwoman Edith Ramirez (as Sen. Amy Klobuchar (D-MN) did before her) to investigate whether Turing's restricted distribution of Daraprim "amounts to anticompetitive behavior."
The controlled distribution of Daraprim effectively limits the ability of generic drug companies to obtain samples of the drug that are necessary to launch a generic, though it's worth noting that in the case of Daraprim, it was switched to a controlled distribution program two months before Turing purchased the drug.
However, Turing isn't exactly eager to do away with the controlled distribution program. Jon Haas, director of patient access at Turing, told the Boston Globe's Pharmalot earlier this month that the company would not help a generic company trying to obtain samples to launch a Daraprim generic.
"This kind of anti-competitive price gouging with no meaningful innovation combined with a restricted distribution program deserves careful scrutiny," Clinton writes.
She also notes that the case of Turing, which may just be an extreme example, raises heightened concerns about anticompetitive behavior in a market where "the cost of prescription drugs are rising much higher than other health costs."
And although FTC has limited authority to deal with what Clinton calls "price gouging," she calls on the commission to "study and make recommendations on whether and how our laws might be amended" to address the lack of generic competition around some drugs.
Clinton letter to FDA
Clinton letter to FTC
Tags: FTC, FDA, Ostroff, Hillary Clinton, Daraprim, Turing Pharmaceuticals