04/20/2010 A feature of the Administration’s
recently-enacted healthcare legislation calling for establishment of a Patient-Centered Outcomes Research Institute has
received little attention by the public, but may yet hold major implications for FDA and the pharmaceutical industry, according
to CDER director Janet Woodcock. Addressing the Drug Information Association-FDA annual statistics forum
4/19, she explained that, in deference to reform critics who continue to regard further federal involvement in healthcare
as intrusive and unwarranted, the new institute was authorized as a non-governmental, non-profit corporation, designed to
foster “comparative effectiveness research” — but without any mandate that use of information it produces
be required as a basis for practice by clinicians or as a basis for reimbursement by insurers. The role of the institute
is conceived as solely for research. Woodcock also noted (skeptically) that the legislation requires that methodologies for
conducting comparative effectiveness research be developed within a period of 18 months.
The budget for the institute, initially set at $500 million per year,
will inevitably exert certain pressures on FDA, Woodcock predicted. “Currently, ‘comparative effectiveness’
is not formally part of drug development, unless ethically required,” she said. “But technology assessors are
likely to be focused on comparative data, and this will exert significant pressure on regulators to put more patients in
clinical trials, to require additional evidence, and to focus more attention on what evidentiary standards are to be applied.”
Woodcock observed that drug regulators do not share the same conceptual paradigms as technology assessors, and furthermore,
comparative effectiveness methodologies are not fully worked out. For this reason, she expects extensive “push-pull”
over these issues, and suggested they will present “real challenges” for FDA over the next several years.
To read the full report, visit
FDA Webview (www.fdaweb.com)
