An MD&DI February 1997 Column
The resignation of FDA's most controversial leader in years presents FDA reformers
and the medical device industry with a new challenge.
No FDA commissioner in the past quarter-century has made as deep an impact on FDA and its regulated constituencies as has David Kessler, who quit in November after six years and is expected to depart before winter's end. Despite the disillusionment of device manufacturers, Kessler's performance was undeniably extraordinary in a position that one distinguished incumbent, the late Alexander Schmidt, once said burns out anyone in about two years.
Given the accelerating intensity of daily pressure on FDA and its shrinking resources, the next commissioner will probably not make such an impression. Indeed, all the political indicators (and it will be naked politics that will install the next FDA commissioner) point to the selection of a successor who won't continue Kessler's crusade.
Despite editorial pleas that President Clinton choose a successor who will, in the words of the New York Times, "preserve David Kessler's legacy," political reality presses him not to. Such a nominee would almost certainly be denied confirmation by the Senate Labor and Human Resources Committee, which, after the November elections, is more conservative than before.
Kessler was the first FDA commissioner in history whose nomination had to be approved by the Senate. In the aftermath of the generic drug corruption scandal and amid fear that the contamination had spread to device regulators, Kessler's confirmation was whisked through the Senate October 28, 1990, as the chamber hastened to adjourn for its midterm elections.
No such casual glance will be afforded Clinton's nominee for commissioner this time. He or she will likely be scrutinized (with the acquiescence of committee chairman James Jeffords [R-VT], who doesn't care much about FDA) by Dan Coats (R-IN), a deceptively affable critic of FDA with good connections to his home state's politically potent medical device manufacturers. Coats was the senator who, also on the Labor and Human Resources Committee, toughened the 1996 FDA-reform bill so that its stringency in such areas as third-party review exceeded what then-chairwoman Nancy Kassebaum (R-KS) intended. Fellow FDA critics Judd Gregg (R-NH) and Bill Frist (R-TN) assisted him in this endeavor.
While it's premature, in the absence of a known nominee, to speculate on what tactics Coats and his allies will use, one can assume that they will be fishing for promises that the next commissioner will roll back some of Kessler's initiatives in the Center for Devices and Radiological Health (CDRH). An obvious target is Kessler's attempt to "take science up a notch" at CDRH by adding more clinical parameters to the review of 510(k) submissions.
How much pressure the Republicans are willing to put on the nominee may depend on how much energy the device industry chooses to expend on the selection process, through lobbying both Clinton's search committee and their senators. More may be gained, however, by taking advantage of internal reforms at the agency, especially CDRH director Bruce Burlington's current "reinvent CDRH" initiatives.
Even with Kessler still at the helm, HIMA president Alan Magazine acknowledged that progress has been made internally at FDA. "There has been some improvement at CDRH," he said after the resignation announcement and before he had had a chance to think much about Kessler's successor. "Clearly, 510(k) approvals have improved, and the backlog is down. But what I think is more important than any of those statistics is that I'm noting an attitude in the people that we deal with that's more conciliatory and more cooperative than before.
"That doesn't mean that FDA isn't going to continue to regulate--that's their job. But I sense a willingness to try to understand the problems of industry and to find a reasonable middle ground that will ensure patient safety while trying to approve products. Now that's not going to happen all the time. We will continue, I'm sure, to disagree, but there is some movement in that direction."
Magazine is especially pleased by changes in the compliance area and by FDA associate commissioner for regulatory affairs Ron Chesemore's willingness to work with, not against, industry. At first, this conversion went against the grain for both Kessler and Chesemore--as it did for the deep-rooted, tradition-driven culture of the entire agency--but it was propelled into being by Vice President Al Gore's Reinventing Government programs, by the need for FDA to emulate its overseas regulatory counterparts who are not as adversarial toward industry as U.S. regulators are, and by industry representatives who have been able to convince skeptical FDA leaders of the need for a better industry-FDA relationship.
Among the most effective of the industry players has been HIMA's Nancy Singer, who was actually able to get inside the change process at FDA. In addition to breaking down barriers of suspicion and doubt, in November Singer began questioning why FDA investigations should not be positive experiences for companies.
Traditionally, Singer points out, animosity and mutual suspicion have characterized FDA inspections, as illustrated in an old joke that still evokes laughter from both government and industry personnel:
Question: What are the two biggest lies in FDA regulation?
Answer: During an investigation an FDA inspector says, "I'm from FDA and I'm here to help you" and industry replies, "Welcome, we're glad you're here."
Singer, who is HIMA's associate vice president and special counsel, says that the fact that this evokes laughter is symptomatic of a system that needs to be fixed. But change won't come quickly, Singer warns--it requires a lot more work like that currently taking place in the grassroots meetings and in various follow-up activities.
FDA's Southwest regional director Ed Esparza led such a follow-up, which was recognized with a Hammer Award by Al Gore's National Performance Review Board for developing a successful relationship between government and the private sector. His team focused on effective interaction between industry and front-line regulators (investigators) during an April 1996 grassroots meeting in Dallas. The two-day gathering produced a list of 44 recommendations for remedial action by both industry and FDA, including:
- Giving forms for evaluating FDA and industry pilot-program participants to firms and discussing ground rules for inspection.
- Stating reasons for record requests (e.g., by saying "I know you are not required to supply this record, but here is what it can be used for") and incorporating such clearly stated language into communications courses for investigators.
- Setting up a joint FDA/trade association training committee to identify technical areas for which training is required by FDA and to coordinate the provision of such training by industry.
Such substantial gains don't, however, lessen the need for reform legislation. Even though Kessler's resignation announcement might be perceived as decreasing that need, HIMA's Magazine points out that HIMA has always followed a dual-track approach to reform--both legislative and administrative.
"I think it's important to have legislation because, clearly, the pendulum can and does swing back and forth, depending upon who's leading FDA. It's important to provide some assurance and continuity," Magazine said. "I think it's very important for Congress to make it clear what kind of a role they see FDA playing in the regulatory arena. We never approached this in a partisan way, yet I was very pleased to see the kind of Democratic support we received for FDA reform."
In spite of Magazine's determination to maintain a dual-track approach, as long as improvements continue to be made at FDA the urgency of legislative reform must recede. The confirmation of a moderate new commissioner could also make FDA reform a low priority with the new Congress. With Kessler gone, there may be a perception that the problem also has gone--or at least abated. There also could be a general sentiment for waiting to see what the new commissioner does before trampling on his or her toes with a new law.
As with any Washington scenario, however, this one is easily capable of being upset by unforeseeable events. For instance, if the Clinton administration is embattled by renewed Republican efforts to probe its various scandals, it might go public with its demand for a tough new regulator to follow in Kessler's footsteps. It could gain political capital by accusing the Republicans of trying to emasculate America's number one consumer protection agency.
If a public health issue were to arise from what was, arguably, lax FDA regulation--say a rash of injuries from a defective product--it could muffle Republican antagonism toward selection of a tough Kessler-type commissioner.
However, absent such upsets, it seems probable that the momentum already established by the Clinton administration's Reinventing Government initiative will guide Clinton in nominating a moderate choice--someone who will be less a crusader and more a manager and facilitator. And FDA does have an undeniable need for both better management and substantial restructuring.
Even though each of its main operating centers (for devices, drugs, biologics, veterinary medicine, and foods) has undergone numerous reorganizations, these changes have tended to be piecemeal and implemented without industry input.
At the agency's top level, beyond his controversial creation of five equal deputy commissioners who bumped existing associate commissioners down a notch, Kessler ignored agency infrastructure issues in order to focus single-mindedly on tobacco, food labeling, and silicone breast implants. His buffer zone of new deputies worsened morale in the agency's high command, a problem to which Kessler has been oblivious.
According to many knowledgeable observers, including former deputy commissioner and Upjohn executive vice president Mark Novitch, the agency urgently needs restructuring that comes from within. "There needs to be a lot of rebuilding inside," Novitch says. Although he ranks Kessler as equal in stature with FDA founder Harvey Wiley and Nixon-era commissioner Charles Edwards, Novitch faults him for "stepping outside the food and drug arena when he got into tobacco and made it the centerpiece of his recent tenure." In doing that, he neglected the infrastructure, and now his successor will need to examine it critically, asking such questions as: Is the agency well organized? Do employees see enough of the commissioner? Do they feel a unity with the agency's management?
After the often-controversial activism of David Kessler, an institutionally introspective commissioner-manager might appeal to both industry and members of the Senate Labor and Human Resources Committee. And perhaps even to the Clinton administration.