GOP Pledges Device Reforms at FDA

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.