Medical Device Daily Washington Editor

WASHINGTON — The first day of the FDA Regulatory and Compliance Symposium, sponsored by the healthcare policy journal Health Affairs, offered in high relief all the controversy that has dogged the agency and its regulated industries over the past few years. FDA commissioner Margaret Hamburg, MD, started the session by reiterating the message that enforcement will be vigorous (see accompanying article, p. 6), but Nancy Buc, former chief counsel at the agency and now a partner at the law firm of Buc & Beardsley (Washington), had a few words for FDA. They were not the kind of words that provoke a warm and fuzzy feeling, either.

"Over the past several months, FDA has emphasized science and getting tough," she said, but the agency is also conveying the notion "that FDA is not just the primary arbiter, but the sole arbiter of what is good science."

Buc indicated that she has a problem with some of the assumptions underlying the responses provoked by the Menaflex 510(k) decision, which has been the subject of so much ink and outrage. "We have seen numerous cases ... where the argument seems to be that when senior management overrules" reviewers, "it's somehow unscientific," she said. However, the idea of being overruled by those with similar qualifications is hardly novel, she noted, drawing a parallel between the relationship between Supreme Court judges and judges on lower courts, who all have jurisprudence doctorates, and center directors and product reviewers, who nearly all possess MDs and/or PhDs.

Few objections if any are raised when an appeals court overturns a lower court's decision, "but if a center director reaches a different decision from those also with MDs, PhDs or both" it is seen as a departure from "good science," Buc remarked. She also noted that FDA "has been strikingly unable and/or unwilling to defend the principle that senior management" should be able to make final decisions that conflict with a reviewer's viewpoint without having their integrity impugned.

Buc also intimated that FDA reviewers could take a more objective stance to work with them each day. "I have been at many a meeting that seemed to suggest that sponsors should just do what FDA wants it to do," she commented, pointing out that "one-sidedness" in science is by definition unscientific. She also suggested that a degree of bias has crept into the discussion from FDA's side when it comes to determining what constitutes good science. "FDA seems to assume that industry people are not entitled to be a part of that process because their views are tainted" by the profit motive, Buc said.

"The current meetings procedure is at odds" with the idea that an honest exchange of ideas is necessary to break an impasse over an application, Buc said. "I think FDA should give greater consideration to the idea that exchanges of written documents may not be as productive as an active discussion" during which each side listens to the views expressed by the other. However, meetings can only take place as an enforcement action or when "FDA can tell the sponsor what to do," she charged.

As an example of the trend, Buc said FDA's new inspection enforcement regime, which requires that a firm respond no later than 15 days after the issuance of a 483, makes clear that firms have no recourse if they disagree with the findings in the 483. "The tone of warning letters is particularly odious," she added, and lack "even a hint that they're allegations" rather than established facts. Buc also noted that "the media treat them accordingly."

"Despite the 483s and warning letters, companies are not necessarily violating the law" when these documents are written, Buc said. This attitude suppresses dialogue, but "instead of discouraging a debate about compliance, FDA should be encouraging" such talks. "It's hard, time-consuming and vexing" to engage in this kind of dialogue with stakeholders, but "is nevertheless necessary" to avoid an inflexible FDA that ends up needlessly holding up devices that have a legitimate place in the market.

As for whether media coverage is driving some of the reaction at FDA, Buc observed, "there's no question that whistle-blowing and easy answers make better stories," but she remarked, "I think FDA has sometimes been the victim and sometimes the exploiter of that kind of media focus." As for whether the media should make more of an effort to frame events in a larger context, Buc said she agreed, but added, "I think FDA has a correlative responsibility ... to explain complexity where there is complexity."

Mark McCarty, 703-268-5690;