NEW YORK—(ENEWSPF)—October 19, 2015. Today, Hillary Clinton sent letters to the heads of the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) urging the agencies to review actions they could take to protect consumers against the unfair prescription drug price hike executed by Turing Pharmaceuticals.
Last month, Turing CEO Martin Shkreli raised the price of a life-saving HIV drug, Daraprim, by more than 5,000 percent overnight, prompting Clinton to decry his actions. The public outcry about Shkreli’s decision forced the CEO to say he would lower the drug’s price; however, the price of Daraprim has not yet been meaningfully reduced. Clinton is now urging the FDA to expedite processes for approving a generic competitor for Daraprim or for allowing temporary importation of similar drugs. In addition, she is encouraging the FTC to investigate whether Turing’s practice of restricting the distribution of Daraprim amounts to anticompetitive behavior under federal law. Further, she is asking the FTC to study and provide recommendations to Congress and the Administration on how best to address price gouging when it is the result of unilateral action in a market with no competition.
Below (and in PDF here) is the full body of Clinton’s letter to the acting commissioner of the FDA:Stephen Ostroff, M.D., Acting Commissioner U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Dear Dr. Ostroff:
In recent months, we have seen dramatic price increases in certain drugs on the market simply because they have no generic competition. The FDA has guarded the safety and security of our drugs for decades. Consistent with this critical mission for our nation, I am writing to urge the FDA to do everything in your power consistent with the safety and efficacy of our drugs to bring lower-cost generics to American consumers more quickly and affordably.
As I am sure you are aware, there is an egregious case that has brought this problem to the forefront. Recently, after acquiring the exclusive rights to sell Daraprim® (pyrimethamine), Turing Pharmaceuticals increased the price by over 5,000 percent, putting many people at risk of being unable to acquire the life-saving drug. With no other generic competitor to drive the price down, there is no clear path to ensure that this drug will be affordable in the future.
This drug is used to fight a parasitic infection called toxoplasmosis, which is potentially life-threatening for people with weakened immune systems, including people suffering from HIV-infection or cancer. According to the HIV Medicine Association and the Infectious Diseases Society of America, under this new pricing structure the annual cost of treatment will now be between $336,000 and $634,500 per patient, a cost they describe as “unjustifiable for the medically vulnerable patient population in need of this medication and unsustainable for the health care system.”
Despite widespread public outcry and the company’s promise to make the drug “more affordable,” Turing has not meaningfully lowered the price. The reality is that Turing has created an effective drug shortage in which patients with life-threatening infections have no affordable way to access the supply of standard-of-care drugs. Turing’s decision to artificially increase the price of Daraprim by over 5,000 percent overnight exploits vulnerable patients whose lives depend on access to this critical medication.
The FDA should expedite any pending reviews, and encourage applications for review, of other generic alternatives to Daraprim, and make these drugs available to U.S. patients as quickly as possible consistent with safety and efficacy. Additionally, the FDA should 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 countries. Under Executive Order 13588, the FDA can “expedite its regulatory reviews, including reviews of new drug suppliers, manufacturing sites, and manufacturing changes, whenever it determines that expedited review would help to avoid or mitigate existing or potential drug shortages.”
In the past, the FDA has allowed for temporary importation of drugs that are a substitute of a treatment in shortage in the United States, after careful inspection of facilities and confirmation that the imported drugs meet safety standards. According to public sources, other pharmaceutical companies currently market versions of Daraprim in Britain and Canada. Given the effective shortage of Daraprim, the FDA should explore alleviating the shortage through this kind of temporary importation – as it has in the past.
Beyond the immediate case of Daraprim, the FDA should also work to reduce the generic backlog, and deserves further support from Congress to do so. Patients who rely on this treatment should not have their health and lives put at risk because of an unnecessarily anticompetitive market, and the FDA should act through all of its available authorities to remedy this situation as soon as feasible.
With appreciation and best wishes, I am
Hillary Rodham Clinton
Below (and in PDF here) is the full body of Clinton’s letter to the chairwoman of the FTC:The Honorable Edith Ramirez, Chairwoman Federal Trade Commission 600 Pennsylvania Avenue, N.W. Washington, D.C. 20580
Dear Chairwoman Ramirez:
Thank you for your leadership and commitment to fighting anticompetitive practices in the pharmaceutical industry to ensure that American consumers can access lower-cost prescription drugs.
I am writing today to express my concern about pharmaceutical companies that exploit their monopoly power to keep the prices of prescription drugs artificially high in a market with no competition, and my concern that some companies may be restricting distribution of their prescription drugs in order to stifle competition. These issues have come to the forefront because of the egregious actions of Turing Pharmaceuticals.
Recently, after acquiring the exclusive rights to sell Daraprim® (pyrimethamine), Turing Pharmaceuticals increased the price by over 5,000 percent, putting many people at risk of being unable to acquire the life-saving drug and suggesting potentially anti-competitive behavior. This drug is used to fight a parasitic infection called toxoplasmosis, which is potentially life-threatening for people with weakened immune systems, including people suffering from HIV-infection or cancer. According to the HIV Medicine Association and the Infectious Diseases Society of America, under this new pricing structure, the annual cost of treatment will now be between $336,000 and $634,500 per patient, a cost they describe as “unjustifiable for the medically vulnerable patient population in need of this medication and unsustainable for the health care system.”
After the dramatic price increase, the price remains artificially high in a market with no competition. I recognize that the FTC has limited authority to address price gouging when it is the result of unilateral action in a market with no competition, but I write today to urge the FTC to consider studying what has become an increasing problem in the pharmaceutical industry – dramatic price increases that result in drugs remaining artificially high and causing real barriers for consumers, while there is a very long lag in approval of potential competitors onto the market. On the one hand, the FTC may have limited ability to regulate this behavior as anticompetitive, and on the other, the FDA is severely delayed in approving generics to come on to the market, which may offer some competition. 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.
Furthermore, with regard to Turing Pharmaceuticals, I request that you investigate whether the restricted distribution of Daraprim amounts to anticompetitive behavior. Normally, we might expect such a dramatic price increase to encourage other companies to enter the market, seek approval for a generic version, and lower the price, but Turing has restricted distribution of Daraprim—making this sort of market response extremely difficult. In order to receive FDA approval, a generic manufacturer must acquire a limited amount of the branded product in order to show that its drug is equivalent to the marketed drug. However, Turing’s restricted distribution program serves as a roadblock for other generic competitors to enter the market. Without the ability to obtain sufficient quantities of Daraprim, competitors will not be able to develop generic alternatives and seek FDA approval—resulting in direct harm to consumers, who as a consequence are subjected to unconscionably high prescription drug prices with little or no means of relief.
This drug is providing a necessary treatment for toxoplasmosis, listed by the Centers for Disease Control and Prevention as one of the neglected parasitic infections in the United States. But there is no justifiable increase for an off-patent drug that has existed since 1953, has not been modified, and has decreased rather than increased access for the patients who need it most. This kind of anti-competitive price gouging with no meaningful innovation combined with a restricted distribution program deserves careful scrutiny.
I urge the FTC to investigate whether Turing’s restricted distribution program amounts to anti-competitive behavior in violation of the Federal Trade Commission Act. The importance of this investigation to consumers cannot be overstated—while Turing may be the most extreme case in recent years, the concerns it raises about anticompetitive behavior are serious in a market place where the cost of prescription drugs are rising much higher than other health costs. Thank you for your consideration.
With appreciation and best wishes, I am
Hillary Rodham Clinton