As part of his continuing effort to end the inappropriate close relationship between the Food and Drug Administration (FDA) and the pharmaceutical industry, Congressman Maurice Hinchey used his position on the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies to formally request information on meetings the agency had with drug company representatives as it put together the administration's proposal for the reauthorization of the Prescription Drug User Fee Act (PDUFA) IV.

The FDA recently responded to Hinchey's request by providing information that shows the agency met 112 times with the pharmaceutical industry to develop a revised policy for drug review. Hinchey and Congressman Bart Stupak (D-MI), a fellow leader in holding the FDA accountable, said the new findings, combined with the fact that the FDA met only a handful of times with patient and consumer groups on PDUFA, show how out of whack the agency remains. Hinchey and Stupak called on Congress to take immediate action to break up the inappropriately close bond between the FDA and the drug industry to ensure the health and safety of the American public is protected.

Between October 2005 and December 2006, the FDA held 112 meetings lasting 224 hours, or 28 business days, with representatives of regulated industry to negotiate the agency's proposal for PDUFA IV -- the fourth authorization of the law that lays out the drug oversight and review process. In describing its proposal for PDUFA IV, which it submitted to Congress on March 16, 2007, the FDA said: "These proposed recommendations were developed after discussions with regulated industry and consultation with appropriate scientific and academic experts, healthcare professionals, and representatives of patient and consumer advocacy groups." (emphasis added)

"The FDA has essentially become the government affairs office of the pharmaceutical industry," said Hinchey, who is a member of the House Appropriations Subcommittee on Agriculture. "The data surrounding the FDA's meetings on PDUFA IV make it more clear than ever that the agency and drug industry continue to have a relationship that is far too cozy and inappropriate. By treating the drug industry like a privileged client that deserves preferential treatment rather than a regulated industry, the FDA is jeopardizing the health and safety of the American public. There is no reason for the FDA to meet nearly two dozen times as often with the drug industry than it does with consumer and patient groups. It's time for Congress to step in and fix a broken system so that the American people are the only clients the FDA serves."

Stupak said, "The FDA's 112 meetings with drug industry groups offer stark evidence of the coziness between the FDA and the drug industry.  Congress must work to provide sunshine and transparency to the new drug approval process.  At a minimum, Congress must ensure consumer advocates are present as we move forward with re-authorization of the Prescription Drug User Fee Act.  The health and safety of the American people are at risk when drug industry representatives are the only individuals in the room advocating new drugs and keeping harmful drugs on the market."

Seventy-two FDA staff members participated in the 112 meetings with industry, combining for a total of 1,852.5 hours of meeting time, or 231.5 business days. Forty-nine representatives of the regulated industry met with the FDA, combining for 2,116 hours, or 264.5 business days.

The FDA's 112 meetings were divided among six panels: the FDA-Industry Steering Group, which held 23 meetings; the Finance Subcommittee, which held 11 meetings; the Pre-Market Review Subgroup, which held 15 meetings; the Postmarket Safety Subgroup, which held 19 meetings; the IT/IM Subgroup, which held 22 meetings; and the DTC Subgroup, which held 22 meetings.

FDA Commissioner Andrew von Eschenbach did not participate in a single one of the 112 meetings on PDUFA IV. Out of his senior leadership team, only one person, Dr. Janet Woodcock, appeared - at one meeting of the Pre-Market Review Subgroup, on July 28, 2006. Only one FDA staffer -- Jane Axelrad, the Associate Director for Policy in the Center for Drug Evaluation and Research's Office of Regulatory Policy -- attended at least 40 percent of all of the meetings held with industry, while six industry representatives attended more than 40 percent of the meetings.

Despite consulting with industry representatives 112 times on PDUFA IV, the FDA apparently only had discussions with consumer and patient groups five times. Additionally, from the summaries provided of the FDA-industry meeting topics, it appears that there were only a few meetings that addressed the concerns of patients, consumers, and the general public.

"The Hinchey-Stupak data is not  just a smoking gun, it's a blazing gun showing how incestuous the FDA's relations with the regulated industry have become," said Bill Vaughan, Senior Policy Analyst for Consumers Union, the independent publisher of Consumer Reports. "For the sake of the public interest, this system must be reformed by passing the Hinchey-Stupak bill which breaks the web of ties that comes with the user fee system."

PDUFA was first authorized in 1992 to allow the FDA to collect user fees from industry in order to review drug applications. As part of PDUFA, the industry was able to negotiate how the FDA spent the user fee money. As a result, the FDA became beholden to the needs of industry rather than the public. PDUFA has since been reauthorized twice and each time industry has gained more control over the process.

Hinchey is the author and Stupak is the chief cosponsor of the FDA Improvement Act (FDAIA), which is a sweeping FDA reform bill. Among a variety of other things, the FDAIA would prohibit the agency from collecting fees paid by companies it regulates.  Instead, those funds would be deposited into the general fund of the Treasury.  The FDAIA provides mandatory spending levels to ensure that the FDA continues to fully function without the fees being paid directly to the agency.

Detailed Information on the PDUFA Reauthorization Meetings Between the FDA & Drug Industry

• To view the formal FDA response to Congressman Hinchey's question regarding meetings the FDA had with members of the drug industry regarding the reauthorization of PDUFA...Click Here
  
• To view a detailed summary of Congressman Hinchey's findings on the FDA's 112 meetings with the drug industry regarding the reauthorization of PDUFA...Click Here
  
• To view a comprehensive list of all 112 meetings with FDA had with the drug industry regarding PDUFA IV...Click Here
  
• To view a list of the FDA officials who attended the PDUFA reauthorization meetings with drug industry officials and to see which meetings they attended...Click Here
  
• To view a list of the drug industry officials who attended the meetings with the FDA to discuss the reauthorization of PDUFA...Click Here
  
• To view a chart that details the similarities and differences between PDUFA, PDUFA II, PDUFA III, and the FDA's proposal for PDUFA IV...Click Here