Transforming FDA 1593Transforming FDA
Changes in Congress and FDA could reshape the way CDRH regulates industry. MD&DI is launching an online and print project that will follow these issues diligently.
January 1, 2007
FROM THE EDITORS
The world of Washington is a busy one, with a seemingly never-ending rush to get things done. In that climate, the big picture often gets lost in the shuffle, and planning for FDA and other federal agencies becomes haphazard at best.
But the coming months present a rare moment for Congress, FDA, and industry to take stock of things and to make some thought-out, long-term decisions about how the agency will be run in the future. This is a chance that had best not be blown.
The opportunity has presented itself in three ways: the Democrats taking over Congress; Andrew von Eschenbach finally being approved as permanent FDA commissioner; and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), which must be ratified by October 1, 2007, awaiting reauthorization. This means there is new blood being given the chance to shape legislation that will affect how CDRH is run over the next few years.
“There [will be] a confluence of legislation in the coming year,” Scott Gottlieb, deputy FDA commissioner for medical and scientific affairs, told The Scientist. “There are some big, must-pass bills, and that will create an environment where a lot of people will be proposing a lot of different ideas.”
Perhaps the most important question that needs to be considered is CDRH's funding. One of the problems with the original MDUFMA is that Congress, then under Republican control, failed to come up with all of the increased funding for the CDRH budget that it had promised. Although Democrats are not considered to be as industry-friendly as their Republican counterparts, here is one case in which they might be in a better position to help industry. Traditionally, Democrats have been more willing to spend for domestic programs than have Republicans. Perhaps, then, the new Democrat-controlled Congress may be willing to fund the CDRH budget at a higher level than its Republican-controlled predecessor was.
That could also mean that Congress is willing to rethink the user-fee program and third-party program. (Many Democrats vigorously opposed the third-party inspection program.) The user-fee structure needs radical reworking; a solution that gives CDRH the funds it needs without overburdening industry is seriously overdue. Another option to be considered when MDUFMA is reauthorized is a structure that provides incentive for both quick reviews of applications and prioritizing presubmission activities that streamline the development process and produce better applications.
Also to be rethought is CDRH's approach to postmarket surveillance. The Postmarket Transformation Leadership Team issued a comprehensive report with proposed reforms. Will this be enough to satisfy Congress, or will the Democrats want more? Since postmarket surveillance has been politicians' favorite topic on which to bash FDA recently, let's hope the debate is a forum for substantive discussion, not grandstanding.
Indeed, Congress has already started weighing in. Senators Charles Grassley (R–IA) and Christopher Dodd (D–CT) have proposed a bill that, among other things, would give FDA more teeth to require postmarket studies and penalize firms that fail to complete them.
Congress and the new commissioner will spend this year taking a fresh look at CDRH. So will we at MD&DI as we launch a special project: . The changes may be so sweeping as to affect all of our readers, not just those who deal with regulatory affairs. Therefore, we will make a concerted effort to identify and thoroughly cover all issues that could have an effect on transforming CDRH—and the companies and products it regulates. These stories will appear in print and on our DeviceTalk blog (www.devicelink.com/mddi/blog), and also be collected online at www.transformingfda.com. You will be able to identify them by the icon with each story.
We welcome reader suggestions about topics and angles to explore. Please send them to [email protected].
Erik Swain for the Editors
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