September 24, 2015—The senior Democrat on the House Oversight Committee asked the head of Turing Pharmaceuticals yesterday for all documents about the company’s 340B pricing of Daraprim – which Turing recently bought from another company and immediately raised the price of by over 5,000 percent. [ms-protect-content id=”2799″]
Rep. Elijah Cummings (D-Md.) wrote to Turing CEO Martin Shkreli the day after state AIDS drug assistance program (ADAP) directors complained to federal health officials that the company was forcing them to jump through hoops to purchase the drug at 340B pricing, in alleged contravention of 340B program guidance. The National Alliance of State and Territorial AIDS Directors asked the Health Resources and Services Administration to investigate Turing’s alleged violations of the 340B program non-discrimination requirement and impose “appropriate penalties.”
HRSA’s Office of Pharmacy Affairs said today that it received NASTAD’s letter and “will respond directly” to the group. Turing has not responded to a request for comment.
Turing has b
een at the center of a media firestorm since The New York Times reported this weekend that the company raised the price of Daraprim, used to treat toxoplasmosis, malaria, and a certain type of pneumonia, from $13.50 to $750 a tablet after buying it in August. On Sept. 21, Rep. Cummings and Sen. Bernie Sanders (I-Vt.) asked Turing to provide them with information by Oct. 9, including total gross revenues from sales of the drug; prices paid for all sales; the drug’s prices in foreign markets; and the identity of company officials responsible for setting the drug’s price.
In a Sept. 22 letter to HRSA Office of Pharmacy Affairs Director Capt. Krista Pedley, NASTAD said that “several ADAPs have experienced difficulty in acquiring Daraprim at the 340B price” since Turing acquired the antiparasitic medication.
NASTAD explained that the company’s website, Daraprimdirect.com, directs “hospital pharmacists (including: institutions and 340B facilities)” to order the drug for their patients by telephone or email through a drop-ship arrangement with ICS Connect, an AmerisourceBergen division. All other prescribers are directed to order for their patients through Walgreens Specialty Pharmacy.
The state ADAP directors note that HRSA guidance “requires manufacturers to make 340B prices available to covered entities through the same distribution channels available to other purchasers.”
“Without this protection, manufacturers could attempt to limit participation in the 340B program by placing additional barriers in the way of covered entities, ultimately harming patients,” NASDAD continued. “Indeed, Turing’s restrictive purchasing program for 340B covered entities has harmed patients.”
“Georgia has removed Daraprim from its ADAP formulary because it was unable to purchase Daraprim at the 340B price,” NASTAD said. “Georgia, like many states, is only able to purchase drugs through vendors that have gone through state approval processes and is unable to make one-off drug purchases through ICS Connect. Because the 340B price was not available through Walgreens Specialty Pharmacy and thus not available through any of the Georgia ADAP’s standard purchasing channels, Georgia was forced to remove Daraprim from the formulary because of the excessive price.”
“It is apparent that Turing has violated HRSA’s non-discrimination requirements for the 340B program, and NASTAD believes that this discriminatory restriction on purchasing at the 340B price is ongoing,” the group concluded. “NASTAD requests that HRSA investigates Turing’s violations of the non-discrimination requirement and imposes appropriate penalties.”
In his letter to Turing the next day, Rep. Cummings said he was writing “to request documents and information regarding extremely serious allegations that your company, Turing Pharmaceuticals, is harming AIDS patients by delaying the provision of Daraprim in direct violation of federal anti-discrimination regulations.”
“Boosting corporate profits at the expense of AIDS patients is reprehensible, and we have an obligation to investigate this matter immediately,'” the Congressman wrote.
In a press release on its website dated Sept. 18, Turing said it learned during a meeting earlier that week with “a leading patient advocacy organization” that “some healthcare facilities have encountered challenges securing Daraprim for patients diagnosed with toxoplasmosis.” It attributed the problem “to the company’s recent acquisition of Daraprim from Impax Laboratories.”
Turing notes in the statement that it has executed a 340B Pharmaceutical Pricing Agreement “and is also working diligently with Turing’s specialty distribution network that had been experiencing challenges having timely orders filled for their patients.”
“We have corrected all known outstanding access issues, and regardless of the type of insurance a patient has, they should be able to have their prescriptions filled quickly,” the company said, adding that it “is strengthening access to Daraprim for hospitals and clinics through additional efforts.” [/ms-protect-content]