Originally Published MDDI June 2005
Time to Turn Talk into Action
FDA, industry, and Congress all say they want to work together to fix MDUFMA. But teamwork involves a lot more than just talk.
Judging from recent discussions about reforming the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), everyone is being a team player in the effort—or at least says they are. It is extremely crucial in the next few months that all parties back up their talk about teamwork with action.
There is no denying at this point that parts of MDUFMA need fixing. The funding scheme is too volatile and has led to unsustainably high fee increases from year to year. Congress hasn't lived up to its end of the bargain, failing to increase CDRH appropriations as promised. Questions remain about whether FDA's performance goals should be raised and whether $30 million or less in annual sales is the appropriate definition of a small business, which qualifies for reduced fees.
At May's annual meeting of the Medical Device Manufacturers Association (MDMA), all MDUFMA stakeholders agreed that changes need to come and that all parties need to work together to make them happen. Seeing the spirit of cooperation in the air is wonderful. But it won't mean anything if it doesn't translate into a real solution. And work needs to begin soon. Congress's failure to fully fund the promised appropriations triggers a provision causing the law to sunset at the end of FY 2005. Since the realities of today's government spending mean Congress won't make up the shortfall, the only way to keep MDUFMA going is to take out the trigger provision before the end of the fiscal year.
The harder part is deciding what else should be fixed, as well as how and when. Some or all of these issues may arise during discussions about the trigger fix. Then we will see whether all this talk about teamwork is more than lip service.
“The number of fee-paying applications has fallen short of industry and FDA projections. That means PMA fees have had a greater increase than expected,” acting FDA Commissioner Lester Crawford said at the MDMA meeting. “We will work to find a solution. We will bring all parties' concerns to the table. My office is open to you. Let's stick together.”
Indeed, Crawford said, MDUFMA has brought many benefits to FDA aside from the fees themselves. “The culture has changed as a result of user fee programs,” he said. “You cannot imagine the aloofness of FDA when I was there before. [Crawford has served four separate tenures at the agency.] We have gotten past that. The associations that deal with FDA have helped us to reform the organization. Fee programs bring us face-to-face with industry, which can help us determine goals for the future.”
Congress appears willing to negotiate as well, according to a congressional aide present at the meeting who asked not to be identified. “With user fees, everything is on the table,” the aide said. “Deals are deals. Congress broke its end by not allocating enough appropriations to keep it running. We have an opportunity to right-size the program and make it work for everybody.”
MDMA, which in the past was staunchly opposed to user fees, has taken a more conciliatory stance lately as well. “We are cognizant that user fees are here, and our goal is to make them work for industry as effectively as possible,” said Paul Touhey, president and chief operating officer of Fujirebio Diagnostics Inc. (Malvern, PA) and a past MDMA chairman. “We are engaged, and the commissioner is listening.”
But seeds of discontent could also be heard in his presentation. “We can't sustain the current increases in cost, and at some point, we will have to push back,” he said. “That's now.”
It will take an extraordinary level of cooperation to agree on reforms that work for all parties. Perhaps those in Washington can learn from the outstanding design teams that MD&DI is profiling in this issue. All of them convened parties from a wide variety of perspectives to tackle enormous design challenges, resulting in successful products. If that can work for product development, why can't it work for lawmaking?
Copyright ©2005 Medical Device & Diagnostic Industry