Industry "vulnerability" to private litigation is concern of FDA's Office of Enforcement.

INDUSTRY "VULNERABILITY" TO PRIVATE LITIGATION IS CONCERN TO FDA, Enforcement Office Director Daniel Michels told a Regulatory Affairs Professionals Society meeting Feb. 28. Michels reported that his office received "in excess of 240 requests for testimony of FDA employees" in 1994 in "an increasing number of private suits being brought against your firms, between firms as well as corporate stockholder suits."

FDA declines the "vast majority" of the requests in an attempt to keep FDA from "spending virtually all of our staff time, reviewer time, investigator time in court testifying on behalf of one side or another," Michels noted. However, the increase in such requests is a concern to the agency.

"Are your products coming off the line in a quality fashion so that you are not vulnerable to a private suit?" Michels asked the conference attendees. "Is your corporate behavior in terms of its development of new products, its ethics in managing data, at a sufficiently high level that your stockholders are comfortable with and are not going to be unhappy about the next time FDA comes in, finds a problem and says: `You guys screwed up'?" Michels noted that the Securities & Exchange Commission is "very active" as an FDA liaison in the regulatory arena.

FDA's partnerships with other regulatory agencies, such as the SEC, the Federal Bureau of Investigations, the Federal Trade Commission and the U.S. Customs Bureau, "are increasing," Michels reported. FDA is also "working hard with our foreign counterparts in a variety of forums to calibrate one another and assure we're all doing the right thing and minimizing our respective investments."

Another FDA partnership focus is in the area of third-party certification, which Michels said "probably has about a thousand different definitions and program applications."

Michels said that while the issue is under careful consideration by the agency, "there are a lot of different definitions that we have to work through. And each one of those...will have its own kind of structure." Michels mentioned medical reviews of applications and certification of private laboratories as possible avenues of exploration in the area.

"My personal view is [third-party certification] will happen -- I think it will happen slowly, and I think we all need to have a good level of comfort with it, both in the government as well as the industry side," Michels said. "Stay tuned, but it's not an answer that is going to be coming forward tomorrow," he cautioned.

In response to a question regarding certification by a manufacturer in response to a warning letter, Michels said that while certification is not an official requirement of the agency, "at least under the device compliance program, that is part of the equation that we urge upon firms to employ." Michels added that while "in some areas, [FDA is] already moving in that direction...now is the right time for us to take a look at the issue overall."

FDA Assistant Mid-Atlantic Regional Director Joseph Phillips echoed the theme of agency partnership at a March 1 meeting of the International Society of Pharmaceutical Engineers. Phillips told the ISPE conference that "one of the things we're going to have to do since we are downsizing [and] streamlining [is] we're going to have to partner much more." Phillips noted that FDA will "continue to enhance" agreements with state regulatory agencies that perform inspectional work, as well as agreements with trade associations such as ISPE. He noted that the pharmaceutical engineers' association has volunteered to draft a bulk pharmaceutical chemical guidance document on facility construction for the agency.

"Probably the biggest challenge that FDA is facing today...is the effective management of complexity in a period of diminishing resources," Phillips said. He pointed out that the Mid-Atlantic region had "lost some key players" in 1994 due to the agency's "early out" retirement plan. However, the FDAer continued, "I'm happy to say that we were able to fill back those positions." Phillips introduced Mid-Atlantic Region Director-designate Susan Setterberg, who has been tapped for the position vacated by Richard Davis upon his retirement and move to head regulatory compliance at DuPont Merck in September. Setterberg was formerly deputy director of the Office of Resource Management.

Phillips said that "a milestone" was coming up in August of this year regarding the agency's final decision on Good Manufacturing Practice regs for labeling issues. "The final rule will likely issue," he said. However, "I don't know how it falls in line with the [congressional rulemaking] moratorium, but at least you know we have an interest."