Opening Statement of Senator Mike Enzi

The purpose of today’s hearing is to evaluate the performance of FDA’s device center.

There are two main premarket pathways for medical devices. Premarket approval applications – or PMA’s – are for high risk devices. Few devices go through PMA.  The vast majority of devices go through a different pathway, known as 510(k).

According to FDA’s own data, product review times have skyrocketed. The average time to approve a PMA doubled between 2000 and 2008. The average time to clear a 510(k) rose 51% from 2002 to 2010.

The device user fee program was intended to reduce review times. The program started in 2002. Since then, review times have increased, not decreased. 

In addition, FDA has made it much harder for manufacturers to get products to market.  According to FDA’s own data, the percentage of 510(k)’s found not substantially equivalent or withdrawn doubled between 2006 and the first three quarters of 2011.

FDA has been slow to acknowledge these trends.  A few months ago, an FDA official testified in the House that the agency had been meeting its performance goals for – quote – 95% of its submissions.

I am an accountant, so I like to work through the numbers. This number reflected FDA meeting its 510(k) performance goals for 2008 and 2009. Since 95% of the device center’s premarket submissions are 510(k)’s, the agency argued it was on target 95% of the time.

This claim was misleading. First, FDA has not reported 510(k) performance data beyond 2009. 

Second, the device center has failed to achieve 55% of its user fee performance goals.

Third, user fee performance goals are based on a metric called “FDA days”.  FDA days accrue when FDA, not the manufacturer, is working on an application. To reduce “FDA days”, FDA can offload work on to manufacturers. 

Fourth, the metric that matters to innovators and patients in the real world is total review time, or calendar days.  FDA’s total review times have increased dramatically.

American device manufacturers are moving jobs overseas because of the regulatory environment here.  American patients have had to travel overseas to access devices they can’t get here. 

I expect FDA to testify today that the agency acknowledges these trends and is working to address them.  But I’ve reviewed FDA’s October 19 action plan, and I’m skeptical. 

In a chart accompanying the action plan, twenty-one action items are checked off as completed. When you look at the details, however, some of the actions are trivial. None of them have produced any measurable improvement in performance.

Some of them may make the problem worse.  For example, the agency recently issued guidance on when device modifications require a new 510(k).  A trade association analyzed the guidance, and found it would cause a 300-500% increase in the volume of 510(k) submissions.

I understand that meaningful change takes time. But current management has been in place for almost three years. 

The device center deserves credit for acknowledging its problems, formulating an action plan, and taking some action.  But the fact is, none of this activity has translated into improved performance. At the end of the day, we need the device center to deliver results, not good intentions. 

Having said that, I do agree with some of FDA’s analysis.  High employee turnover, insufficient training and supervision, and an increasingly complex workload are big challenges.  We all want device center reviewers to be well trained, well supervised and do a great job.  We all want a strong FDA.

And we all want FDA to keep being the global gold standard for safety. It goes without saying that safety is crucial.  An Institute of Medicine panel, whose Chairman will testify today, found that device safety does not pose a public health crisis.  Another witness today, Professor Hall, did a study and found no systemic safety issues.  Dr. Bill Maisel (my-ZELL), now the device center’s Deputy Director, has made similar findings.

In conclusion, I want to acknowledge that Dr. Shuren (SURE-in) worked very effectively with the HELP Committee during the last user fee reauthorization.  It’s my hope and expectation that he and his staff can work effectively with me, Chairman Harkin and the rest of the HELP Committee to find solutions to these problems.

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