2012 User Fee Legislation Likely to be Bipartisan

Reauthorization of FDA user fees, scheduled for consideration by Congress next year, is expected to pass on a largely bipartisan basis and is unlikely to involve the kind of political controversy currently surrounding the Obama administration’s healthcare legislation. This consensus view was expressed by agency officials, industry representatives and a key Congressional staff member who spoke at a 2/10 conference entitled Health Leaders Dialog 2011: The 112th Congress and the Future of Drug & Device Policy, in Washington, DC. The meeting was co-sponsored by the regulatory consulting firm Greenleaf Health, LLC, and by government affairs consultants, Venn Strategies, LLC.

Participants on the “Congressional outlook” panel included health policy advisor on the majority staff, Senate Committee on Health, Education, Labor and Pensions William McConagha; former FDA assistant commissioner for legislation and White House legislative liaison officer, now serving as senior director of federal affairs with Pharmaceutical Research and Manufacturers of America David Boyer; and FDA assistant commissioner for legislation Jeanne Ireland. The opinions expressed by panel members were in near-total agreement, although it was clearly stated that their views were personal, and no direct quotations or attributions were permitted (a new First Amendment violation by the sponsors).

Since passage of earlier user-fee legislation, the panelists said concerns expressed by patient and consumer advocates, suggesting the integrity of the FDA review process would be compromised by industry funding, have been largely muted. These groups now recognize the need for the agency to be adequately resourced and, indeed, some have even called for higher user fees in view of limitations on Congressional appropriations. It was pointed out that FDA has held monthly meetings with industry and other stakeholders to obtain their views on the shape of future user fee legislation, for inclusion in legislative proposals to be delivered by FDA for Congressional consideration early next year. Paradoxically to the conference’s First Amendment constraints, it was felt that the open nature of these meetings, and the transparency of the process have been a major factor in allaying stakeholder concerns.

The expectation for continued bipartisan treatment for FDA user fee legislation is based in part on the fact that Senator Michael Enzi (R-WY), formally chair of the Health, Education, Labor and Pensions Committee and now the committee’s ranking member, Senator Tom Harkin (DIA),
have been meeting regularly on the user fee issue and they are known advocates for a strong FDA. Although newly-elected House members are expected to be far more conservative than those they replaced, the panelists speculated that, because user fees are consistent with fostering innovation and can serve to bolster American competitiveness in drugs, devices, and biopharmaceuticals, such legislation would be regarded favorably by conservatives. Advocates for user fees can justifiably make their case in terms of jobs creation and expanded exports for medical products.

The impact of partisanship is most likely to be felt over such substantive elements or provisions of any legislative proposal, such as the role of Risk Evaluation and Mitigation Strategies (REMS). Other issues with potential for controversy could include incentives for innovation, particularly incentives targeted toward development of new pediatric products; treatments for rare diseases; discovering new antibiotics; and developing new and improved oncology drugs. Although none of these issues is controversial on its merits, the cost to implement such efforts — ultimately to be borne by consumers — could prove problematical.