Providing for Congressional Disapproval of A Rule Submitted By the Corps of Engineers and the Environmental Protection Agency--Veto--
Floor Speech
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Ms. COLLINS. Madam President, I rise today with my friend and colleague, the Senator from Missouri, Mrs. McCaskill, to inform our colleagues of an important development in the investigation underway by the Special Committee on Aging as we examine the sudden and dramatic price hikes for certain decades-old prescription drugs.
First, let me provide the Presiding Officer and our colleagues with some background on our investigation to date. Given that 90 percent of seniors take at least one prescription drug every month, the egregious price increases we have witnessed on these older drugs that are no longer under patent protection could inflate the cost of health care by hundreds of millions of dollars each year. Concerned not only about the high costs but also about the potential risk that patients will not be able to access the prescription drugs they need, we launched a bipartisan investigation early last November into the causes, effects, and potential solutions to these massive and unjustified price increases.
Our investigation is focused on four companies that recently acquired six drugs that were decades old--drugs whose patents had expired long ago--and then these companies, after purchasing these drugs, dramatically hiked their prices. The four companies are Turing Pharmaceuticals, Valeant Pharmaceuticals, Retrophin, Incorporated, and Rodelis Therapeutics.
Of these four, Turing Pharmaceuticals, previously led by its founder Martin Shkreli, is the company that has received the most attention. In August of last year, Turing acquired the drug Daraprim. Daraprim is considered to be the gold standard for the treatment of toxoplasmosis, a disease resulting from a parasite infection that can be particularly harmful to infants born to infected mothers.
Despite the fact that Daraprim has been on the market for 63 years, Turing bought the drug and then promptly raised its price from $17.63 to a whopping $750 per pill.
The other three companies also dramatically increased the prices of the drugs they acquired from between 300 to 2,000 percent.
On November 4, we wrote to the companies asking for detailed information regarding their pricing decisions.
Around the same time, Turing CEO Shkreli was actively engaged in online postings and other communications discussing Turing business, using what appeared to be his own personal electronic devices.
On November 12, 2015, the Aging Committee asked the counsel for Turing to take reasonable steps to ensure that any business records on Mr. Shkreli's personal devices be properly preserved and produced. Turing still has not provided the Aging Committee with clear assurances that it will do so, notwithstanding the fact that they have told us that Mr. Shkreli was ``principally involved for Turing in all aspects of the transactions and the decisions covered by'' our November 4 letter.
On December 9, 2015, we issued a subpoena for documents to Mr. Shkreli in his capacity as CEO, compelling Turing to produce the information that had been sought by our November 4 letter. On December 15, 2015, we learned that Mr. Shkreli had been indicted on seven counts unrelated to Turing and predating the company's corporate existence. The next day Turing announced Mr. Shkreli's resignation as CEO but left unclear whether or not he remained on its board of directors.
The fact that the company has not made it clear that it would act to preserve Turing business records in its former CEO's possession left the committee deeply concerned that we might not receive all documents relevant to our investigation. Therefore, on December 21 of last year, the committee requested that Turing provide detailed information on the steps it was taking to preserve these records. Once again, however, Turing failed to produce an adequate response to our request.
Consequently, the Special Committee on Aging issued another document subpoena--this one directly to Martin Shkreli himself--on December 24. It directed him to produce substantially the same documents sought by the committee's December 9 subpoena. By a letter dated January 12, 2016, counsel informed our committee that Mr. Shkreli was categorically invoking the act of production privilege under the Fifth Amendment to the Constitution and was therefore refusing to produce any documents in response to the December 24 subpoena. So this is the important new development. He has chosen, in response to a document subpoena for Turing documents that may be in his personal possession, to invoke the Fifth Amendment.
To be clear, Mr. Shkreli is essentially arguing that the very act of producing and authenticating documents that are seemingly unrelated to the charges filed against him may incriminate him. The committee has asked him through counsel for an explanation of the rationale for this argument, and we are awaiting a response. The committee is troubled by his unsupported invocation, given that the Turing documents we have requested appear to be unrelated to the charges brought against him. Absent a valid justification of the grounds for invoking the Fifth Amendment, Mr. Shkreli's assertion could hinder our important investigation.
Our committee is seeking to understand how companies can acquire prescription drugs--drugs for which they had nothing to do with the research and development, drugs that in some cases are more than half a century old--and then suddenly impose dramatic price increases on those drugs at the expense of infants, vulnerable seniors, and others with devastating diseases for which in some cases these drugs are the gold standard for treatment.
So far the Special Committee on Aging has received nearly 20,000 documents over the course of this investigation. The documents the Senator from Missouri and I are seeking on behalf of the committee likely include information that is essential in order for us to fully understand why this phenomenon is happening and to develop the legislative and regulatory solutions to end this disturbing practice.
Mr. Martin Shkreli, Chief Executive Officer, Turing Pharmaceuticals LLC, Avenue of the Americas, 39th Floor, New York, NY.
Dear Mr. Shkreli: The United States Senate Special Committee on Aging is conducting an investigation into the pricing of off-patent drugs in certain circumstances. We seek your cooperation with this investigation so that the Committee may better understand drug pricing and related regulatory and public policy concerns.
In particular, the Committee wishes to learn more about Turing Pharmaceuticals' recent acquisition of the rights to sell Daraprim, a drug used to treat and prevent infections, from Impax Laboratories and Turing's subsequent decision to increase the price of Daraprim from $13.50 per tablet to $750.00.
In order to assist us in our investigation, we ask that you provide us with the documents set forth in Schedule A and the information set forth in Schedule B by December 2, 2015. Please submit the material responsive to this request as it becomes available, rather than waiting to provide it all at once. In order to facilitate this production, we request that you schedule a time to meet and confer on the Request with Committee Staff as soon as it is practicable for you to do so.
The jurisdiction of the Special Committee on Aging is set forth in Section 104 of S. Res. 4, agreed to February 4, 1977.
We appreciate your attention to this matter. Should you have any questions, please do not hesitate to have your staff contact Samuel Dewey of the Majority Staff at (202) 224-2798, or Cathy Yu of the Minority Staff at (202) 224-7752. Please direct all official correspondence to the Committee's Chief Clerk, Matt Lawrence. Sincerely, Susan M. Collins,
Chairman, U.S. Senate Special Committee on Aging. Claire McCaskill,
Ranking Member, U.S. Senate Special Committee on Aging. SCHEDULE A
1. Any analysis conducted by Turing relating to the price of Daraprim.
2. Any analysis in Turing's possession, custody, or control relating to the price of Daraprim; exclusive of documents responsive to Schedule A, Specification 1, herein.
3. My communications with Turing's Board of Directors relating to Daraprim.
4. Any documents generated by the Turing Board of Directors relating to Daraprim.
5. My projected or historical financial data relating to Daraprim, including, but not limited to, costs, revenues, profits, losses, and cash flows.
6. Any projected or historical financial data relating to Turing's research and development, including, but not limited to, research and development relating to Daraprim.
7. Any documents evaluating any product market that includes, directly or indirectly, Daraprim, regardless of the definition of the geographic market, including, but not limited to, analysis of barriers to entry thereto.
8. Any documents evaluating any market share that includes Daraprim, or the market power of that market share, for any product market or geographic market; exclusive of documents responsive to Schedule A, Specification 7, herein.
9. Any communications with Impax relating to Daraprim.
10. Any documents relating to Impax's sale of Daraprim to Turing.
11. Any contracts entered into by Turing that are related to the production, marketing, and sale of Daraprim.
12. Any marketing or pricing plans prepared for, or being used in, the sale or advertisement of Daraprim, including all documents related thereto.
13. My documents relating to Patient Assistance Programs relating to Daraprim.
14. My documents relating to Daraprim and Imprimis.
15. Any documents relating to the price of Daraprim that have been produced pursuant to an investigative inquiry by any federal, state, or local government entity.
16. My analysis relating to Daraprim and any statute or regulation administered by the FDA.
17. Any communications with the FDA relating to Daraprim; exclusive of documents responsive to Schedule A, Specifications 15 or 16, herein.
18. Any documents relating to Daraprim and the Health Resources and Services Administration's 340B Drug Discount Program; exclusive of documents responsive to Schedule A, Specifications 13, 16, or 17, herein.
19. Any projected or historical financial data related to Daraprim and Medicare or Medicaid; exclusive of documents responsive to Schedule A, Specifications 5, 6, or 15-18, herein.
20. Any documents notating, memorializing, or summarizing a communication, or a portion thereof, responsive to Schedule A, Specifications 3, 9, or 17, herein. SCHEDULE B
1. State:
a. A list of all countries where Daraprim is sold (or is expected to be sold in the next two years from the date of this letter) and the corresponding price or planned price for each country.
b. In detail, how Turing reached the price for each country.
c. How the revenue, costs, and any discounts associated with international sales are accounted for within Turing.
2. State in detail any changes Turing has made, or plans to make, to Daraprim or the administration of the drug.
3. Identify the Turing employee responsible for setting the price of Daraprim.
4. Identify the names and addresses of all companies owned in whole or in part by Turing that are involved in the production, marketing, and sale of Daraprim and any of its components.
5. State the total expense to Turing related to the acquisition of Daraprim.
6. State in detail all known uses of Daraprim by medical professionals, including both on-label and off-label uses.
7. State in detail all known protocols, of which Daraprim is a component, used by medical professionals, including both on-label and off-label uses.
8. For each discrete communication that did not occur via document, but which would have been responsive to Specifications 1-19 of Schedule A if made via document, state:
(a) The method of communication.
(b) The date and time of the communication.
(c) The author and addressee of the communication.
(d) The relationship of the author and addressee to each other.
(e) A general description of the communication.
Information responsive to this question should be produced in a native Excel file.
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Ms. COLLINS. Madam President, I yield now to the ranking member of the Special Committee on Aging, my colleague Senator McCaskill.
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