The FDA met with the industry trade group on a regular basis to discuss PDUFA legislation, but hardly met with consumer or patient advocacy groups, according to an interesting tally released this afternoon by a pair of FDA critics in Congress - Maurice Hinchey of New York and Bart Stupak of Michigan, both of whom are Democrats.

How do they know? The data was provided by the FDA. This comes on the eve of PDUFA hearings to be held by the House Energy & Commerce Subcommittee on Health. And the House version of the PDUFA bill requires the FDA to include patient and consumer groups in future negotiations.

FDA commish Andy von Eschenbach, who talks about openness and collaboration, was a no-show: he didn’t attend any of the meetings. So here’s the rundown….

Facts on FDA Negotiation with Industry:
· Between October 25, 2005 and December 6, 2006, the FDA met 112 time with industry reps;
· The meetings took at least 224 hours, or 28 business days.
· A total of 72 FDA staff members participated, accruing 1,852.5 hours of meeting time, or 231.5 business days.
· 49 industry reps met with the FDA, accruing 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 staffers who participated, there was not one individual who attended at least one meeting from each of the six panels convened on PDUFA.
· Of the 49 industry reps who participated, 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 with industry: Jane Axelrad, the Associate Director for Policy in the Center for Drug Evaluation and Research’s Office of Regulatory Policy.

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

o Andrew Emmett, BIO’s director of science and regulatory affairs, attended 84 percent of the meetings.
o Alan Goldhammer, PhRMA’s deputy vp regulatory affairs, attended 75 percent of the meetings.
o Sara Radcliffe, BIO’s vp for science and regulatory affairs, was a PhRMA employee while attending 63 percent of the meetings.
o Scott Lassman, PhRMA’s senior assistant general counsel, attended 50 percent of the meetings.
o Kay Holcombe, Genzyme’s senior policy advisor, attended 45 percent of the meetings.
o Donna Peterson, Amgen (in 2005, she was associate director for regulatory affairs), attended 41 percent of the meetings.

· Of Andy’s leadership team, only one person, Janet Woodcock, appeared - at one meeting of the Pre-Market Review Subgroup, on July 28, 2006. It appears that the most senior FDA staffer to attend more than one meeting was Theresa Mullin, the assistant commish 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 FDA held five meetings that included consumer and patient group reps:

o A public meeting on November 14, 2005,
o A meeting in May 2006 with patient advocacy groups*,
o A meeting in May 2006 with consumer advocacy groups*
o A meeting in June 2006 with health care professionals*
o A public meeting on February 16, 2007.

* - referenced in Theresa Mullin’s April 17 testimony before the House Energy and Commerce Subcommittee on Health.