Senate Passes FDA Device User Fee Bill, Obama to Sign

By a vote of 92-4, the U.S. Senate approved the final version of the Food and Drug Administration Safety and Innovation Act (S.3187) and therefore the collection of $6 billion in medical device user fees throughout the next five years. If President Obama signs it into law, the funds collected under the bill will in part be used to pay for an FDA review process that certifies the sale and marketing of new pharmaceuticals and medical devices. The Hill-watching website Politico described the measure as “a rare case of bipartisan cooperation in a mostly gridlocked Congress” that had to be approved prior to the Supreme Court ruling on the Patient Protection and Affordable Care Act “in part to protect it from the political fallout of the high court decision.”In a joint statement, co-sponsors Tom Harkin (D-IA) and Mike Enzi (R-WY) praised the bill as helping to “bring critical drugs and medical devices to market faster, protect patients from drug shortages and manufacturing problems, and enhance the availability of low-cost generic drugs.” Gail Rodriguez, Executive Director of the Medical Imaging and Technology Alliance (MITA) released a statement that the bill reflects “an agreement that will improve the pre-market review process for medical imaging and radiation therapy technologies.”According to HIMSS, the bill will speed the FDA review process for new medical devices by introducing greater accountability, transparency, and communication with device makers. “Among the reforms the legislation would restore the Investigational Device Exemption (IDE) standard, require FDA to withdraw the 510(k) modifications guidance, require FDA to provide rationale for major decisions and expedited appeals, streamline the de novo classification process for novel medical devices, and reform the Humanitarian Device Exemption for devices for adults with rare conditions,” the group said.