Washington, DC -- The Food and Drug Administration (FDA) met 112 times with the pharmaceutical industry to develop a revised policy for drug review, according to data provided by the agency to the House Appropriations Committee in response to questions submitted earlier this year by Congressman Maurice Hinchey (D-NY).  With the House Energy & Commerce Subcommittee on Health set to take up the reauthorization of the Prescription Drug User Fee Act (PDUFA) tomorrow and the House Appropriations Subcommittee on Agriculture set to debate the FDA's budget for Fiscal Year 2008 on Friday, Hinchey and Congressman Bart Stupak (D-MI) today 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."

"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 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. 

###

FDA Negotiations With Industry On

Reauthorization of the Prescription Drug User Fee Act

The Prescription Drug User Fee Amendments of 2002, passed as Title V of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (P.L. 107-188), required the Food and Drug Administration to consult with:

·        The House Committee on Energy and Commerce;

·        The Senate Committee on Health, Education, Labor, and Pensions;

·        Appropriate scientific and academic experts;

·        Health care professionals;

·        Representatives of patient and consumer advocacy groups; and

·        The regulated industry.

The Food and Drug Administration transmitted its recommendations for the third reauthorization of the Prescription Drug User Fee Act of 1992 (PDUFA) to Congress on March 16, 2007.  In his letters of transmission, Health and Human Services Secretary Michael Levitt stated: "FDA has worked with various stakeholders, including representatives from consumer, patient and health provider groups, and the pharmaceutical and biological prescription drug industries, to develop a reauthorization proposal for PDUFA that would build upon and enhance the success of this program."

But while the FDA engaged in months of extensive negotiation with representatives of regulated industry, the agency held only five meetings with representatives of patients, consumer groups, and healthcare professionals.  According to the FDA: ""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)

Facts on FDA Negotiation with Industry

·        Between October 25, 2005 and December 6, 2006, the Food and Drug Administration held 112 meetings with representatives of regulated industry on PDUFA IV.

·        The meetings took a.t least 224 hours, or 28 business days

·        A grand total of 72 FDA staff members participated in meetings with industry.  While no one staff member attended all 112 meetings, these individuals did accrue a combined 1,852.5 hours of meeting time, or 231.5 business days.

·        Forty-nine reprerentatives of the regulated industry met with the FDA.  While there was not one individual within this group to attend all 112 meetings, the individuals accrued a combined 2,116 hours of meeting time, or 264.5 business days.

·        The FDA's 112 meetings were divided among six panels:

o       The FDA-Industry Steering Group, which held 23 meetings;

o       The Finance Subcommittee, which held 11 meetings;

o       The Pre-Market Review Subgroup, which held 15 meetings;

o       The Postmarket Safety Subgroup, which held 19 meetings;

o       The IT/IM Subgroup, which held 22 meetings; and

o       The DTC Subgroup, which held 22 meetings.

·        Of the 72 FDA staff members who participated in the meetings with industry, there was not one individual who attended at least one meeting from each of the six panels convened on PDUFA IV.

·        Of the 49 industry representatives who participated in the meetings, there were two individuals who attended at least one meeting from each of the six panels convened.  One of the representatives was from PhRMA, and the other was from BIO.

·        There was only one FDA staffer who attended at least 40 percent of all of the meetings held with industry on PDUFA IV: Jane Axelrad, the Associate Director for Policy in the Center for Drug Evaluation and Research's Office of Regulatory Policy.

·        There were six industry representatives who attended at least 40 percent of the meetings:

o       Andrew Emmett, the Director of Science and Regulatory Affairs for BIO, attended 84 percent of the meetings.

o       Alan Goldhammer, the Deputy Vice President of Regulatory Affairs at PhRMA, attended 75 percent of the meetings.

o       Sara Radcliffe, the current Vice President for Science and Regulatory Affairs at BIO, attended 63 percent of the meetings.  During her involvement on PDUFA IV, Ms. Radcliffe was an employee of PhRMA.

o       Scott Lassman, the Senior Assistant General Counsel at PhRMA, attended 50 percent of the meetings.

o       Kay Holcombe, Senior Policy Advisor for Genzyme Corporation, attended 45 percent of the meetings.

o       Donna Peterson, a staffer at Amgen (can't confirm current title, but as of 2005 she was Associate Director for Regulatory Affairs), attended 41 percent of the meetings.

·        FDA Commissioner Andrew C. von Eschenbach did not attend one meeting.  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.  It appears that the seniormost participant from FDA to attend more than one meeting was Theresa Mullin, the Assistant Commissioner for Planning, Office of Policy and Planning. 

Facts on FDA Consultation with Consumer and Patient Groups

·        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:

o       The 10/25/2005 FDA-Industry Steering Group meeting addressed "public accountability / consultation on reauthorization;"

o       The 5/25/2006 FDA-Industry Steering Group meeting addressed "areas of concern that were expressed by the Patient Advocacy and Consumer Groups at the May 22 and 23, 2006 PDUFA IV stakeholder meetings with FDA;" and

o       The 10/12/2006 Postmarketing Safety Subgroup meeting addressed the Institute of Medicine Report on drug safety that had been released that month.

·        It appears that the Food and Drug Administration held a grand total of only five meetings that included consumer and patient group representatives on PDUFA reauthorization:
o       A public meeting on November 14, 2005,
o       A meeting in May 2006 with patient advocacy groups (referenced in Theresa Mullin's April 17 testimony before the House Energy and Commerce Subcommittee on Health),
o       A meeting in May 2006 with consumer advocacy groups (referenced in Theresa Mullin's April 17 testimony before the House Energy and Commerce Subcommittee on Health),
o       A meeting in June 2006 with health care professionals (referenced in Theresa Mullin's April 17 testimony before the House Energy and Commerce Subcommittee on Health), and
o       A public meeting on February 16, 2007.

·        The Food and Drug Administration also accepted the submission of written comments from all interested parties at two points during the development of their PDUFA IV negotiations - for one month surrounding the November 2005 hearing, and for one month surrounding the February hearing.

FDA-Industry Agreements on PDUFA IV

·        The first authorization of PDUFA (in effect from 1992-1997) required FDA to use fees to turn around drug applications quickly, completing priority reviews in six months and standard reviews in 12 months.  The legislation also required FDA to complete manufacturing supplement reviews and resubmitted applications within six months. 

·        PDUFA II (in effect from 1997 - 2002) upgraded the timeline for FDA to complete standard drug reviews to 10 months, manufacturing supplement reviews to four months, and certain resubmitted applications to two months.  PDUFA II also instituted new standards for responses to industry requests for meetings and resolutions of disputes appealed by industry, among other items. 

·        PDUFA III (in effect from 2002 - 2007) continues all of the standards outlined in PDUFA I and upgraded in PDUFA II, and adds requirements that FDA will issue discipline review letters, report substantive deficiencies in New Drug Applications, and complete reviews of efficacy supplements within certain periods of time, while also enhancing electronic applications receipts and reviews by the end of Fiscal Year 2007.

·        The FDA-Industry Agreements proposed for PDUFA IV would continue all of the standards outlined in PDUFA I and upgraded through PDUFA II & III, and add a number of additional requirements, including proprietary name and first cycle performance reviews, performance goals on agency reviews of direct-to-consumer advertising, and completion of a number of studies to improve FDA efficacy.  FDA indicates that it will transmit its final plan for PDUFA IV user fees after the legislation is passed by Congress.