In July, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (whimsically pronounced fah-day-zha). FDASIA entails significant regulatory improvements.
With overwhelming bipartisan approval, FDASIA is just a first step Congress is making to reform FDA. Jeffrey Shapiro, a partner with Hyman Phelps and McNamara observes: “It’s telling that FDASIA is the only piece of legislation that has passed in several months.
Shapiro told me that a key staffer for a high-ranking member of the House on a committee with FDA oversight has said that there will likely be more reform legislation in the pipeline. “Congress on both sides of the aisle seems intent on further FDA reform, including the Device Center,” says Shapiro.
|"FDA user fees charged to pharmaceutical and device companies are expected to increase by about $3.2 B in the 2013-2017 time period. This represents a 103% increase over 2008-2012 fees. User fees for medical devices more than double in FDASIA..." — Our Perspective: 2012 Food and Drug Administration Safety and Innovation Act, PwC|
FDASIA aims to solve FDA’s eternal underfunding, with a significant boost to user fees. User fees will more than double from $277 million in 2008-2012 to $609 million in 2013-2017. The funding adds 200 full-time equivalents (a.k.a., employees) involved in device approvals by 2017.
“If history is an indicator, increasing user fees helps manufacturers get to market faster,” says Joseph Markmann, manger in PricewaterhouseCooper’s Pharmaceutical and Life Sciences R&D Advisory Services. PwC released a 5-page overview of the key aspects of FDASIA. “The funds increase resources that FDA can devote to ensuring timely submission approvals and clearances,“ he explains.
The act introduces some significant statutes for devices. Among the key changes is a revamping of the device approval process, particularly in assigning risk categories and holding FDA to strict deadlines in the appeals process.
Shapiro, whose firm released a 75-page analysis of FDASIA, says he is pleased with an amendment to the appeals process. “The appeals process has been notoriously unpredictable and lengthy,” he says. “It is a daunting process, especially for smaller device companies.”
FDASIA says that if FDA issues a significant decision regarding an IDE, 510(k) or PMA, it must document the scientific and regulatory rationale. The statute introduces an expedited supervisory review appeal process. An appeal must be filed within 30 days. Then, FDA must issue a decision within 30 days if the appeal is by phone or within 45 days if an in-person meeting is held. The concept is that FDA has a mandatory timeline. “Even the maximum, 75 days to decision, is reasonable compared with the 6-8 months it sometimes has taken,” he explains.
Another key change is that FDA can now reclassify devices by administrative order rather than by regulation. In the past, reclassification has been rare, because although there are numerous methods to reclassification, they have proven slow and cumbersome. FDASIA states that any proposed order to reclassify must be published in the Federal Register and is subject to a classification panel meeting.
Shapiro says that giving FDA a simpler path to reclassification improves efficiency. Of course, Shapiro notes, it remains to be seen whether FDA will put its new authority to good use. Nonetheless, he views it as a step forward.
Markmann says another step forward is the emphasis on harmonization, particularly in premarket studies. “Data from studies conducted outside of the United States can now be shared with FDA,” he says.
A possibly alarming change enacted by FDASIA is an adjustment to the Sentinel program, by which FDA monitors field use of devices. Markmann notes that FDA will soon use commercial and insurance data to help with device monitoring. “FDA can monitor passively collected data, rather than rely on adverse event reporting from physicians.”
Overall, however, Markmann says that FDASIA puts great effort into establishing an FDA partnership with industry. “FDA is more accessible. The relationship reduces the burden of uncertainly of what FDA needs to make a decision.”
Both Shapiro and Markmann agree that, although this legislation does not “fix” FDA, it is a positive move. “The regulation reflects that FDA and Congress have heard the concerns from the patient community and manufacturers,” says Markmann.
Heather Thompson is editor-in-chief of MD+DI