From October 2005 to December 2006, US Food and Drug Administration officials met 112 times with pharmaceutical industry representatives to negotiate the agency’s proposal for reauthorising the Prescription Drug User Fee Act (PDUFA IV), but they held only five such meetings with consumer and patient groups, according to Democrat legislators Maurice Hinchey and Bart Stupak.

Moreover, say the Congressmen, when the FDA submitted its proposal for PDUFA IV on March 16 this year, the agency had claimed that its recommendations “were developed after discussions with regulated industry and consultation with appropriate scientific and academic experts, health care professionals and representatives of patient and consumer advocacy groups”.”

However, with Congressional committees now intensively debating PDUFA IV, these findings show that “the FDA has essentially become the government affairs office of the pharmaceutical industry,” said Rep Hinchey, who is a member of the House Appropriations Committee’s subcommittee on agriculture. “By treating the drug industry like a privileged client that deserves preferential treatment rather than a regulated industry, the FDA is jeopardising the health and safety of the American public,” he added.

Claimed Rep Stupak, who chairs the House Energy and Commerce Committee’s subcommittee on oversight and investigations: “the FDA’s 112 meetings with drug industry groups offer stark evidence of the cosiness between the FDA and the drug industry.”

Specifically, the Congressmen report that 72 FDA staff members participated in the 112 meetings with industry, giving a total of 231.5 business days, while 49 industry representatives met with the FDA, for a total of 264.5 business days. They also note that FDA Commissioner Andrew von Eschenbach did not participate in any of the meetings and that only one of his senior leadership team - Deputy Commissioner Janet Woodcock - appeared , at one meeting of the Pre-Market Review Subgroup. Just one FDA staffer - Jane Axelrad, Associate Director for Policy in the Center for Drug Evaluation and Research (CDER) Office of Regulatory Policy - attended at least 40% of all of the meetings held with industry, while six industry representatives attended more than 40% of the meetings, they add.

The 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 - 15 meetings; the Postmarket Safety Subgroup - 19 meetings; the IT/IM Subgroup - 22 meetings; and the DTC Subgroup, which also held 22 meetings.

Rep Hinchey is the author and Rep Stupak the chief cosponsor of the FDA Improvement Act, which proposes sweeping reforms at the agency. These include prohibiting the agency from collecting industry user fees, which would instead be paid into the general fund of the Treasury.

Regulators and drugmakers questioned on ‘quality of life’ claims

Meantime, as part of their current investigations into the FDA, Rep Stupak and John Dingell (Democrat), chairman of the House Energy and Commerce Committee, have asked Health and Human Services (HHS) Secretary Michael Leavitt to explain why the agency did not act more quickly to stop manufacturers using unapproved ‘quality of life’ claims for a group of anaemia treatments, or to prevent misleading direct-to-consumer advertising for the products, based on these claims, from being issued.

In a letter to Sec Leavitt, Reps Dingell and Stupak point out that at a meeting held May 10, FDA officials and members of the agency’s Oncology Drugs Advisory Committee (ODAC) had expressed scepticism not only about the safety claims being made by manufacturers for their erythropoiesis-stimulating agents (ESAs) - including Amgen’s Aranesp (darbepoetin alfa) and Epogen (epoetin alfa) and Johnson & Johnson’s Procrit (epoetin alfa) – but also the ‘quality of life’ claims contained on their labels. However, on March 9, the FDA had instituted an ESA class label change, which eliminated all references to improvements on quality of life from the labels.

“The question remains, however, as to why these claims were allowed on ESA labels when the only approved indication for ESAs is to reduce the need for blood transfusions,” say Reps Dingell and Stupak.

Moreover they add, the unapproved “quality of life” claims contained in the patient information section of the labels had paved the sway for misleading DTC advertising, “which led patients and doctors alike to the unsubstantiated belief that ESAs improve quality of life.”

Therefore, the Committee “is interested in learning why FDA did not act sooner to both correct the labels and prevent the misleading advertising that was based upon the labelling,” they tell Sec Leavitt in their letter, which goes on to ask him to provide records of communication between the manufacturers, the HHS and the FDA relating to these claims. They have also asked the manufacturers to provide this information. By Lynne Taylor