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Feb 26 2014

Manchin, Vitter Question Pay-to-Play Involvement in FDA Approval of Highly Addictive Painkillers

Senators call for answers in latest pay-to-play allegations on FDA approval of Zohydro

Washington, D.C. – U.S. Senators Joe Manchin (D-W.Va.) and David Vitter (R-LA) today sent a letter to the Dean of the School of Medicine and Dentistry at the University of Rochester, Dr. Mark Taubman, regarding reports that the university hosted pay-to-play meetings between pharmaceutical manufacturers and officials at the Food and Drug Administration (FDA) who oversee safety regulations of painkiller medicine. Industry reportedly paid upwards of $25,000-$35,000 per conference to have a seat at the table with these FDA officials. Senators Manchin and Vitter are questioning the role these meetings may have played in the recent approval of Zohydro ER, a controversial new prescription painkiller. Zohydro ER has up to 10 times as much hydrocodone as Vicodin and Lortab and will come in a formulation that can be easily crushed, snorted or injected. FDA approved Zohydro despite the FDA’s own Anesthetic and Analgesic Drug Products Advisory Committee voting 11-2 against approval.

As part of the effort to better understand the role played by University of Rochester employees, federal employees and pharmaceutical companies in altering the FDA’s approval process for prescription painkillers, the Senators are requesting answers to an array of questions, including information on these meetings, payment transfers and lists of attendees.

Senator Manchin also sent a letter to FDA Commissioner Margaret Hamburg in October of 2013 requesting answers to these pay-to-play allegations and has yet to receive a complete response.

Background:

Senator Manchin sent several letters to FDA Commissioner Margaret Hamburg expressing concerns on the FDA’s authorization process of highly addictive drugs, including the rescheduling of hydrocodone and the approval of Zohydro. He strongly believes that FDA should not compromise patient safety for financial gain. 

The full text of Senator Manchin’s letter to the Dean of the School of Medicine and Dentistry at the University of Rochester is below.

Dear Dr. Taubman:

We write regarding reports on the improper relationship between the Food and Drug Administration (FDA) and the pharmaceutical industry.  We are deeply troubled by allegations that the FDA gave manufacturers of prescription drugs the opportunity to pay thousands of dollars to the University of Rochester Medical Center (URMC) for the privilege to attend private meetings with FDA officials.  The Washington Post and the Milwaukee Journal Sentinel reported in October of 2013 that each company paid as much as $25,000-$35,000 to participate in these pay-to-play meetings, giving them undue influence over FDA’s approval process for prescription painkillers.

We have expressed to FDA Commissioner Margaret Hamburg our dismay with these pay-to-play meetings and the role they may have played in FDA’s failure to protect and promote public health through the regulation and supervision of prescription painkillers. The FDA’s approval process should not compromise patient safety for financial gain.

We are also troubled by the role the pay-to-play meetings may have played in the recent approval of Zohydro ER, a controversial new prescription painkiller. Zohydro ER has up to 10 times as much hydrocodone as Vicodin and Lortab and will come in a formulation that can be easily crushed, snorted and injected.  FDA approved Zohydro despite the FDA’s own Anesthetic and Analgesic Drug Products Advisory Committee voting 11-2 against approval.

As part of our effort to understand the role played by University of Rochester employees, federal employees and pharmaceutical companies in altering the FDA’s approval process for prescription painkillers, please provide the following information:

1) Provide a detailed account of all payments/transfers received by your institution from pharmaceutical companies in relation to pain conferences for the period of 2001 to the present, including payments related to IMMPACT, ACTTION and any neuropathic pain conferences. For each payment identified, please provide:
a. Name of company making payment;
b. Date of payment;
c. Amount of payment; and
d. Description or purpose of payment.

2) Please provide a detailed account of all payments/transfers received by your institution from pharmaceutical companies in relation to pain conferences for the period of 2001 to the present, including payments related to IMMPACT, ACTTION and any neuropathic pain conferences.  For each expense please provide:
a. Name of payee
b. Date of payment
c. Amount of payment
d. Description or purpose of payment

3) For each meeting of IMMPACT (including “mini-IMMPACT” meetings and planning meetings), ACTTION, and any neuropathic pain conferences please provide:
a. Date of meeting
b. Location of meeting
c. List of attendees
d. List of attendees paid honorarium and amount of each honorarium
e. Total cost for meals & beverages
f. Average per person cost for meals & beverages
g. Detailed account of all expenses paid to support the meeting.


We look forward to hearing from you by no later than March 30, 2014.

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