Medical device industry takes its case for reform of the FDA to Capitol Hill

Initiatives hope to ride the Republican wave

Two professional associations representing the medical deviceindustry have launched lobbying programs aimed at getting theFood and Drug Administration off the backs of manufacturers andon to the review of new product submissions.

The National Electrical Manufacturers Association and the HealthIndustry Manufacturers Association are asking that Congress getinvolved in reforming the way the agency and its Center for Devicesand Radiological Health conduct business.

HIMA and NEMA have developed position papers calling for fundamentalchange at the agency. Both are sending the papers to Capitol Hillas initial steps in getting legislators involved in reform ofthe FDA. HIMA's paper is entitled Report on Public Policy Reformand the U.S. Health Care Technology Industry; NEMA's report iscalled Re-Inventing the Regulation of Medical Devices: A Challengefor the 21st Century.

"The FDA has veered from its core mission," saidSusan Zagame, director and counsel for technology and regulatoryaffairs for HIMA. "It has veered so sharply that we needCongress to bring it back into line."

An example of the FDA's regulatory digression, according toZagame, is the agency's use of clinical utility criteria in evaluatingdevices, a step beyond the safety and efficacy criteria that theagency has long applied. The FDA used this new logic in proposingto classify full-field-of-view digital mammography equipment asclass-three devices, subjecting these systems to the rigorousand time-consuming premarket approval (PMA) process (SCAN 1/18/95).

"Effectiveness should be limited to whether the deviceperforms as the manufacturer claims it will," Zagame said."The FDA should not try to regulate the practice of medicine."

The NEMA paper will be sent to key Republicans in the Houseand Senate: Sen. Nancy Kassebaum (R-KS), Senate Labor and HumanResources Committee chairman; Rep. Tom Bliley (R-VA), House CommerceCommittee chairman; and House Speaker Newt Gingrich (R-GA). NEMAhas already begun preliminary discussions on the subject of FDAreform with these and other legislators and their staffs, accordingto Robin Wiley, NEMA manager of legislative and regulatory affairs.

One congressperson has come forward to volunteer support forindustry's efforts to get the FDA back on track. Rep. Fred Upton(R-MI) planned to introduce legislation by the end of Februarythat will make it easier for American firms to sell medical devicesand pharmaceuticals overseas.

"FDA regulations prohibit the manufacture of any typeof medical device or pharmaceutical unless it is approved fordomestic consumption," said David Woodruff, Upton's presssecretary. "That means if a company has developed a drugthat has not been approved by the FDA but has been approved inCanada or Japan or Great Britain, you have to go outside the U.S.to manufacture it. That costs companies a lot of money and italso takes jobs away from American workers. This legislation wouldcorrect that situation."

Device review is targeted. Both HIMA and NEMA are hoping thatUpton's ideas are shared by others in Congress. In their whitepapers, the two associations call for sweeping changes at theFDA. HIMA's paper recommends more than 40 specific actions thatthe association believes would improve the agency. These actionsfall generally into three major areas: redefining the FDA's mission,streamlining the product review process and harmonizing regulationon a global basis.

Similarly, the NEMA paper suggests actions that would havea positive effect on the availability of devices over both theshort and long term. Suggestions aimed at making FDA operationsimmediately more efficient focus on ensuring an appropriate balancein the resources assigned to application review and to enforcement.The agency's fiscal year 1994 budget, for example, allocated fundsfor 770 full-time staff assigned to surveillance and enforcementand 420 assigned to product evaluation.

Regulatory relief is also targeted; specifically, rolling backcertain regulations passed in the wake of the Safe Medical DevicesAct of 1990, such as those pertaining to recalls and user reporting.NEMA would also like to see the FDA move toward a global harmonizationof regulation, negotiating a mutual regulation recognition withEurope, particularly in the area of good manufacturing practices(GMPs).

Over the long term, NEMA hopes to promote a reinvention ofthe regulatory process, Wiley said. That would involve establishinga private-public partnership for device regulation, whereby productapproval and GMP inspections would be contracted to third parties,with the FDA maintaining oversight of the process.

If adopted, the CDRH would continue to be in charge of enforcement,using such techniques as postmarket surveillance, standards developmentand education. But product review activities and GMP inspectionswould be assigned to one or more third parties. These review bodieswould function in a way similar to those recently adopted in Europefor the regulation of medical devices.

NEMA and HIMA agree that the road to an improved FDA must bepaved by a more timely and efficient review process. Review timesfor device applications submitted under the 510(k) program havemore than doubled since 1989, Zagame said.

"The pendulum is at the far point of the cycle, wherethere is a reluctance at the agency (to clear devices for market)out of fear of congressional oversight," Zagame said. "Theybelieve it is easier to endure criticisms of industry for delaysthan from Congress if unsafe products get on the market."

The task of getting good devices on the market quickly whilekeeping bad ones off can be accomplished, and does not necessarilyrequire more staff or higher budgets. Review times by Europeanregulatory agencies, for example, are much shorter than thoseof the FDA, although the FDA employs hundreds more people thanthe European agencies do.

HIMA and NEMA have consistently emphasized the need to developa cooperative relationship with the FDA. Both have held numerousmeetings with agency officials during the last few years. Takingthe industry's complaints directly to Congress is an acknowledgmentthat these efforts have failed.

But going to Congress could also be viewed by the FDA as anend run by industry and could sour an already strained relationship.

"We hope they don't think that," Zagame said. "Wehave briefed them on what we are doing and our requests are nothingnew. I think they would expect us to do what we can to seek legislativerelief."