FDA Needs ‘Substantial, Timely Reform’: Foundation
A Heritage Foundation legal memorandum says there can be no doubt that “the existing FDA regulatory system is less than satisfactory and requires substantial and timely reform. Now is the time to begin seriously to explore the contours of such reform.”
The paper says that much of the discussion about agency reform centers on the concern that FDA regulatory processes, based primarily on lengthy clinical trials designed to approve drugs and medical devices that have broad application, have not kept up with dramatic changes in biogenetics and information processing that allow medications to be targeted more precisely to individual needs.
“Research indicates that current regulatory norms and the delays they engender unnecessarily bloat costs, discourage research and development, slow the pace of health improvements for millions of Americans, and harm the American economy,” the foundation says. It says that one particular reform that appears to be unequivocally beneficial and thus worthy of immediate consideration is the prohibition of any FDA restrictions on truthful speech concerning off-label drug uses, speech that benefits consumers and enjoys First Amendment protection.
The paper cautions that FDA reform must be undertaken carefully, with due concern for the multiple interests of patients, manufacturers, scientific researchers, and the medical community.
The author discusses the excessive costs of current FDA regulation and reviews a number of proposals that have been raised. The memo also critiques FDA’s proposed regulation of genomic tests and reviews disincentives to innovate due to state tort legislation based on FDA-approved labels and congressional proposals for FDA reform, including the 21st Century Cures Act.
“The legislative outlook for the various FDA-related bills currently before Congress is most uncertain,” the report concludes.