TSCL Comments on FDA Report “FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology”

Michael Harless Administrative Law, Health Law

On behalf of TREA Senior Citizens League (“TSCL”), we filed comments with the Food and Drug Administration (“FDA”) in opposition to the FDA’s Science Board Report Entitled “FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology.”

The Report asserts that the FDA is in danger of not being able to perform its mission without a vast and unprecedented doubling of funding. The Report admits that Subcommittee was “not [asked] to assess available resources,” yet it nevertheless focused on the inadequacy of current funding. The Report claims that American lives already are at risk because of work that the FDA has been unable to do, and that nothing would change without additional funding.

The Report relies on “outside” sources with close ties to current and former board members, and in that way gives up much credibility. And because the Subcommittee chose this all-or-nothing approach, its Report is flawed having: (a) failed to set meaningful priorities, (b) drawn suspect conclusions, and (c) overstated the FDA’s need for additional resources.

The Report also fails to understand three factors which militate against the enhanced scientific and technological capacity that would result if the Report’s recommended increases in funding would be adopted.

First, the Report ignores the intractable fact that the FDA’s need for a “mission driven” science means that the agency will always lag behindthe “cutting edge science.”

Second, the Report ignores that the administrative regulatory model is ill-suited to deal with the coming “paradigm shift … that medicine will move progressively from the assessment of drug efficacy and safety based on large average effects detected in clinical trials” into a new “era of the personalization of medicine.”

Third, the Report fails to come to grips with the dangers posed to theprivacy of individual medical records by an increasing centralization of government power in a single federal agency.

Moreover, if the Report’s findings and recommendations are flawed, as FDA Commissioner Andrew Von Eschenbach in Congressional testimony has suggested they are, then steps other than throwing money at the problem as proposed by the Report should be explored in order to protect the individual health needs of the American people.

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