Jim Benson Remembers When FDA Wasn't Talking

Originally Published MDDI May 2002

WASHINGTON WRAP-UP

The former head of FDA's device center, now retiring after a decade with AdvaMed, played an important part in improving FDA's relationship with the medical device industry.

James G. Dickinson

Associations Back FDA Reform Bill | FDA Sets Goals for 2003 | Companies Cited by FDA for Validation, Recordkeeping Violations

There was a time, remembered with discomfort by AdvaMed's Jim Benson, when FDA and medical device companies were barely talking. A 23-year FDA veteran when he joined AdvaMed in 1993, Benson spent his final years at the agency watching as political and legal pressures clamped down on communications between industry and the agency. Now, as he prepares to retire as the association's head of technical and regulatory affairs, Benson believes that his part in ending that impasse has been the distingushing highlight of a long and rich career.

The agency's refusal to talk grew out of the 1988 generic-drug scandal, in which some FDA employees were found to have taken bribes from industry. In that climate, any contact with industry was viewed with suspicion by the congressional investigators scouring CDRH for evidence of corruption. In reaction, the Office of Device Evaluation clamped down hard on informal meetings and telephone communications between its reviewers and device sponsors.

As an advocate of communication, this situation irked Benson. But as the director of CDRH, he had to support FDA's aggressive new commissioner, David Kessler, who had been explicitly instructed by the first Bush Administration to clean up FDA in the wake of the scandal.

Today, Benson takes satisfaction in seeing his values ultimately vindicated in the excellent relations the industry enjoys with FDA. Reflecting on "all the angst between the industry and the agency" during the Kessler era, he says, "we've gone from that point to having a positive relationship with the agency." He ranks the relationship now an 8 out of 10. "I'm not taking the credit for that, but I think I contributed to it."

Benson also takes satisfaction from having appointed the brilliant FDA lawyer Joe Levitt as CDRH deputy director. It was during Benson's three years in the commissioner's office that he first met Levitt, now the director of FDA's Center for Food Safety and Applied Nutrition. Early on, Benson recognized Levitt's communication skills—"being able to get people together and work out solutions to issues"—as something CDRH needed in its time of greatest stress.

Levitt's talent proved especially valuable for both sides after Benson left for AdvaMed (then known as the Health Industry Manufacturers Association). As deputy center director, Levitt "made a big breakthrough on the quality system reg and got the industry and the agency to sit down together," Benson says enthusiastically. "That epitomizes the attitude."

Could FDA-industry relations get even better than the 8 that Benson now gives them? "Probably not," he answers. Communications are about as good as they should be in a regulatory relationship, he explains.

Current CDRH director David Feigal, he adds, "has always been very open to discussing things. I think he does that in a very responsible way." Even his predecessor, Bruce Burlington (now at Wyeth), who had a harsher approach, "came around to having a positive attitude. As you go down into the organization, some of the people there are very open to proper discussions, and some people aren't. [But] I think more and more people are coming over to the let's-collaborate side of things."

What's he going to do after he retires? "I think I'll get a big van and travel around the country," Benson laughs. "Maybe go live in Australia." More seriously, however, with four and two-thirds grandchildren, he thinks he'll stay around Washington, spend some time with his family, and play golf. He may also accept some offers to join device company boards. "I'd like to keep my hand in."

Associations Back FDA Reform Bill

Third-party inspections, a new FDA office for combination products, and improved reporting of device malfunctions are among provisions of an industry-supported bill, HR 3580, that has been introduced by Congressman James Greenwood (R-PA).

Called the Medical Device Amendments of 2001, Greenwood's bill would require the establishment an Office of Combination Products and Product Jurisdiction. This new office would be responsible for designating which FDA center would have primary or exclusive responsibility for regulating certain drugs, devices, and biological products. Assignments would be based on the products' primary mode of action.

National Electrical Manufacturers Association (NEMA) members back this change. According to NEMA vice president Robert Britain, "Products are becoming more complicated. This issue has become important to us with the work that's being done with the Centers for Medicare and Medicaid Services on positron emission tomography machines." The legislation also is being supported by AdvaMed. Both AdvaMed and NEMA were involved in drafting the language that ended up in the bill.

Britain says NEMA also favors sections of the bill that would permit third-party inspections and would improve and streamline reporting of malfunctions. Under the proposed law, 510(k) devices would be eligible for review by accredited third-party reviewers. However, the agency could exclude by regulation a type of device or specific devices within a type.

Greenwood's legislation emphasizes speedier review for advanced technologies. It calls for a Center for Devices Fellowship Program to augment the scientific expertise of CDRH. It would also create a special process for breakthrough technologies. Such devices, to be classified as priority devices, would be reviewed within 120 days.

FDA Sets Goals for 2003

CDRH expects to fall well short of the legally required number of facility inspections in FY 2003, according to a new FDA performance plan. In its next fiscal year, beginning October 1, the device center plans to conduct 290 bioresearch monitoring inspections, 20% more than the 238 in FY 2001. CDRH also plans to inspect 20% of the roughly 5000 high-risk Class II and III device manufacturers, the same percentage as in FY 2001. FDA's statutory performance requirement calls for 50% to be inspected, but resource constraints have prevented the agency from meeting that goal.

The performance plan calls for the center to perform a "first action" review on 95% of PMAs and PMA supplements within 180 days in FY 2003. In addition, the center says 95% of 510(k)s should also be reviewed within 90 days.

For 510(k)s, which represent most of the device review work, the center says it will rely more on its third-party review program and abbreviated and special 510(k) options. In FY 2001, third-party-reviewed devices were processed 29% faster than FDA-reviewed devices. During the same period, special 510(k)s were reviewed within 32 days, and all abbreviated submissions were acted on within 90 days.

The performance plan may be viewed at http://www.fda.gov/ope/FY03plan/part2_med.html.

Companies Cited by FDA for Validation, Recordkeeping Violations

FDA documented quality system regulation deficiencies with Biomet Merck Ltd.'s manufacturing of implantable orthopedic prosthesis devices, according to a warning letter sent to the company on February 19. It said an inspection of the firm's South Wales, UK, manufacturing plant last September found problems with sterilization process validation. Specifically, FDA said the bioburden on simulated product did not represent that on the manufactured product. The company's response to this finding was inadequate, FDA said, because the modified procedure being proposed to address validation issues had not been approved by senior management.

The warning letter also cited the firm for failing to investigate the cause of product nonconformities and failing to identify actions to correct and prevent such problems. For example, FDA said that dose audits in December 2000 and February 2001 listed nine positive sterility samples, yet there was no documented failure investigation into the matter.

FDA told the company that because of the "serious nature of these violations," its devices may be detained from entering the United States until the problems are corrected.

In another warning letter in February, FDA said it will not approve any PMAs or certificates of export for Class III devices made by Medicomp Inc. (Gainesville, FL) until it comes into compliance with the quality system regulation. An inspection in December found numerous QSR violations, according to the February 6th letter. These included failure to implement and record changes in methods and failing to take steps to ensure that corrective actions don't adversely affect finished devices. The company manufactures and distributes electrocardiograph monitors.

According to FDA, the inspection found Medicomp had failed to validate a new surface-mount pick-and-place machine and hand-soldering operations used for all of its products, and and lacked any procedures for process validation. Additionally, according to the letter, there were no records that explained to the responsible individuals how to prevent or correct product deviations. FDA said that Medicomp lacked design input requirements, design review results, procedures for validating a device design, and procedures for making sure the design was correctly transferred into production.

The warning letter acknowledged receipt of two Medicomp response letters in January and February. The agency noted that the first letter indicated that validation of the pick-and-place machine was complete. However, it said that the second letter failed to address the validation process that the company will use to ensure that changes are effective and do not affect device quality. FDA also reminded Medicomp that it needs to provide examples of training files for the agency to review.

Copyright ©2002 Medical Device & Diagnostic Industry