GOP Pledges Device Reforms at FDA

Posted in Regulatory and Compliance by Brian Buntz on September 20, 2012

Political party platforms never seem to amount to much after their quadrennial national conventions labor mightily to produce them, and the one adopted by the Republican convention this year will doubtless follow that historical course as well. But at least it said something about FDA and medical device reform, which the Democrats’ counterpart did not.

In it, the convention pledged, without giving any specifics, that the party and its nominees will reform FDA “so we can ensure that the U.S. remains the world leader in medical innovation, that device and drug jobs stay in the U.S., that U.S. patients benefit first from new devices and drugs, and that the FDA no longer wastes U.S. taxpayer and innovators’ resources because of bureaucratic red tape and legal uncertainty.”

According to the platform, FDA reform is needed because the country’s leadership in life sciences research and development and medical innovation is being threatened. Patients, innovators, and job creators have complained that the lack of predictability, consistency, transparency, and efficiency at FDA is driving innovation overseas, benefiting foreign, rather than U.S., patients, the platform asserted.

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