Report: FDA hitting PDUFA targets, critics be darned

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The latest word from the Government Accountability Office: back off the FDA. According to the government research agency, the FDA is plowing through new- and biologic- drug applications at a speedy pace and has met PDUFA goals for both high-priority and standard review applications between fiscal years 2000 and 2010. With the exception of 2008, a year when the agency failed to hit review goals (REMS implementation was one reason cited), the regulator's overall performance is just where it should be.

The report responds to a requirement for added transparency on the approval times, passed last year in an amendment to the FDA appropriations bill. The amendment, spearheaded by Sen. Richard Burr (R-NC), calls for submission of information to Congress on the average number of calendar days it takes for NDAs and BLAs to get sanctioned. According to FDA Law Blog, Sens. Burr and Tom Coburn (R-OK), two long-standing critics of the agency, have also threatened to delay passage of the latest PDUFA legislation unless FDA hastens approval times.

The GAO report does not completely exonerate FDA. Although the FDA is hitting its PDUFA marks, the report found a slight increase in the amount of time spent on reviewing drugs. Average review times -- the amount of time between when the FDA receives an application and when it sends out an action letter -- crept up from below 200 calendar days in 2000 to more than 200 days in 2010 for priority reviews. The average for standard reviews also rose over the last decade, from the low 300s to a level that's still well below 350 days.

The GAO, however, said that its calculations of average FDA review times come with a caveat: fewer than 90 percent of submissions had received a final action such as approval, denial, or withdrawal.

Still, for the drug industry, which has long complained that the FDA has been dragging its feet, the report offers some evidence. The agency began to turn things around in 2007, when it began to trim review times for NDAs, and again in 2008, when it shrank the amount of time for priority applications so that they were closer to the time it took to clear them in 2000.

Among other data, the GAO found that the FDA has been somewhat flaky in terms of first-round approvals, with a major drop from FY 2000 to FY2001, then a major increase from 2001-2007, only to decline yet again between 2007 and 2010. About 44% of all original NDAs and BLAs were approved on the first round of review between FY2000 and FY2010, and the FDA ultimately approved 75% of all applications.

The GAO fielded the expected stakeholder complaints about the regulatory agency, such as the lack of review consistency. Stakeholders also complained that the FDA does a poor job of saying just why applications are deficient, information which would make subsequent reviews go much more smoothly. Patient advocates said they wanted the FDA to take patients into account more frequently, “because patients might weigh the benefits and risks of a certain drug differently than FDA reviewers.”

What didn't surface: complaints that FDA members lack the expertise to keep up with increasingly complex science, a topic which was discussed at the March PhRMA conference. Also excluded was another PhRMA conference complaint that the Sunshine Law was keeping doctors off of advisory panels because of possible conflicts of interest.

GAO's Director of Health Marcia Crosse told MM&M said that the criticism is out there, but was not provided to the GAO in the context of affecting FDA review times.
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