March 10, 2014

Manchin, Vitter, Lee Want Investigation Into Big PhRMA Allegedly Paying FDA for Drug Approval Process

Washington, D.C. – U.S. Senators Joe Manchin (D-WV), David Vitter (R-La.) and Mike Lee (R-Utah) and are asking for an investigation into reports that pharmaceutical drug companies paid $25,000 - $35,000 to attend private meetings between the U.S. Food and Drug Administration (FDA) and the University of Rochester Medical Center (URMC) to potentially influence prescription drug testing and approval. They have asked the U.S. Department of Health and Human Services (HHS) to open an investigation.

On February 26, Manchin and Vitter wrote to the University of Rochester seeking answers and have yet to receive a response. Click here to read Manchin and Vitter's letter.

Below is the text of the letter the Senators sent today asking for an investigation.

March 10, 2014

The Honorable Daniel Levinson
Inspector General
Department of Health and Human Services
200 Independence Avenue SW
Washington, DC 20201

Dear Inspector General Levinson:

We write with serious concerns over disturbing reports on the improper relationship between FDA employees and the pharmaceutical industry. The Washington Post and the Milwaukee Journal Sentinel reported on October 6, 2013, that each company paid as much as $35, 000 to the University of Rochester Medical Center (URMC) to participate in private meetings, giving them undue influence over FDA policy and its regulatory and approval process.

Given the nature of these accusations and the potential risk to public safety, we request the Office of the Inspector General run a complete investigation on the FDA’s participation in these pay-to-play meetings and answer the following questions:

1. Were FDA employees invited to participate or contribute to meetings held by IMMPACT, ACTTTION, or any other neuropathic pain conferences for the period of 2001 to the present? Please provide the following information:
a. Name of employee
b. Position held at the FDA
c. Dates of conferences

2. Following the participation in IMMPACT or ACTTION meetings, did the FDA host official business with members of these groups? Please provide the following:
a. Name of pharmaceutical companies
b. Name of FDA employee(s)
c. Date of meeting
d. Purpose of meeting
e. Any FDA official action including the approval of any drugs or regulatory action regarding their product
f. Date of official action

3. Did FDA employees receive honoraria of any kind to attend these conferences? Please provide the following information:
a. Date of payment
b. Amount of payment
c. Description or purpose of payment
d. Cost of meals and beverages
e. Cost of travel expenses including hotel, air fare, or any other transportation

4. Were any payments made to the FDA or to FDA employees through the Continuing Professional Education of the University of Rochester Medical Center (URMC)?
a. Date of payment
b. Amount of payment
c. Name of payee
d. Name of

The FDA approval process should not compromise patient safety for personal financial gain. We look forward to your detailed report by no later than April 30, 2014.