New FDA program signals shifttoward cooperation with industry

FDA accedes to pressure for third-party review

The Food and Drug Administration has extended an olive branchto the medical device industry in the form of two pilot programsthat promise to ease the regulatory burden on medical imagingvendors, and on the rest of the medical device industry as well.

The FDA announced the program on April 3 in what some agencyobservers believe is an effort to preempt more radical attemptsat reform being contemplated by the Republican Congress. The initiativesinclude the establishment of a pilot third-party review process,as well as changes in the GMP (good manufacturing practices) process.

The establishment of a third-party review program addressesaccusations that the FDA is too slow in reviewing new device applications.Despite recent improvements in device review times, industry groupsbelieve that the FDA still lags behind its counterparts in othercountries.

The Health Industry Manufacturers Association charged in Februarythat patients in the U.S. wait three times as long as those inEuropean countries for government approval of new devices. Breakthroughmedical devices in Europe were approved in 80 to 120 days, accordingto a HIMA study, while similar devices in the U.S. took an averageof 773 days. Lower risk devices entered the European market withno delay, while similar products in the U.S. took an average of178 days to be certified.

These low- and moderate-risk devices are the focus of the agency'sthird-party review initiative. Such devices, which include electronicthermometers and surgical gloves, do not require clinical dataon safety and effectiveness, according to the FDA. The agencyreceives about 1500 applications a year for these types of devices,which are handled through the 510(k) process. It is doubtful whethermedical imaging devices would be included in the program.

Under the program, manufacturers can choose to have most ofthe review conducted by a third party, or can leave it up to theFDA. If a company opts for third-party review, the device applicationwill be submitted to an FDA-recognized third party, which willreview the product, make a recommendation, and forward the applicationto the FDA. The agency said that it will decide on the applicationin 30 days.

The program is scheduled to begin this summer and run for twoyears. The FDA said that it will announce the date for a meetingto provide vendors with more details about the program.

Building cooperation. The second branch of the FDA's road toreform deals with GMPs, the rules and regulations with which vendorsmust comply in order to be able to manufacture and market productsin the U.S. The proposed new rules relax some of the more controversialaspects of the FDA's enforcement efforts:

• The FDA will give advance notice of upcoming inspectionsrather than relying on surprise inspections as in the past;

• Inspectors will tell companies about violations as theyare uncovered. If those violations are corrected prior to completionof the inspection, the corrective action will be noted on theFD-483 form, which is a list of an inspector's observations; and

• The FDA will provide a closure document after an inspectionis completed, formally noting when the company has resolved issueslisted on an FD-483.

Because the program is focused on field operations, it is notexpected to have a direct effect on the review of device applications.It should, however, go a long way toward improving relations betweencompanies and field offices that in recent years have been increasinglyadversarial and enforcement-oriented.

The agency's new program is a sign of a deeper and potentiallyfar more significant change in the culture of the FDA. The programwas developed after the FDA held a series of grassroots meetingsacross the country last year, aimed at improving communicationsbetween the agency and companies in the various FDA regions inthe U.S.

"In these meetings, all of the companies expressed thedesire that communications with the agency be improved vastly,and we are really taking that to heart," said Ed Esparza,southwest regional food and drug director.

The grassroots meeting held in Denver for the southwest regiongave rise to the national initiative that is about to go intoeffect. That meeting led participants to form a deputation thatlast year presented to commissioner David Kessler major ideasabout how the GMP process might be improved. And officials invarious regions have continued to build on these meetings in otherways.

Representatives of medical device companies in the 11 statesthat constitute the southwest region are preparing to participatein cross-training programs with FDA staff. The objective of theprograms is for the FDA and corporate staff to examine how thetwo sides can work together more effectively during the FDA inspectionprocess.

In the same vein of cooperation, the Los Angeles district ofthe Pacific region is planning to launch an ombudsman projectin which a staffperson will be assigned to help companies experiencingregulatory problems.

"That person will shepherd them through the system toresolve the issue, whether they have a PMA (premarket approval)hung up or something else has gone wrong," said Pacific regionalfood and drug director Ron Johnson.

This change in attitude at the FDA has come in the wake ofunprecedented industry criticism of the agency and, more importantly,the introduction of several FDA reform bills pending in the Houseof Representatives and Senate. But whether the FDA has launchedthe current initiative to blunt the reform momentum or whetherthe agency has simply awakened to the need for an attitude adjustmentis not known.

FDA officials insist, however, that the attitude shift is genuine.

"We know the vast majority of the industry wants to providegood, safe products for use," Esparza said. "To remaincompetitive, they have to do this. If we can achieve good, qualityproducts, safe products, through cooperative, voluntary efforts,that is great. Then we don't have to go the old enforcement route."