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PROCESS VALIDATION PROBLEMS WILL TRIGGER DISTRICT ENFORCEMENT ACTION, FDA's DAVIS TELLS FDLI; AGENCY "CAN'T VERIFY" REPORTS OF INCONSISTENT ENFORCEMENT

Executive Summary

FDA field officials will take immediate regulatory action when problems with process validation are discovered during inspections, FDA Mid-Atlantic Region Director Richard Davis told the Food & Drug Law Institute Dec. 11. "Any time we find problems with respect to . . . the shipment of products without validated processes, we're going to initiate an action out of our offices," Davis said. "We think there has been plenty of warning about validation of manufacturing processes." There will be "no more letters," he said. "It is time for us to get on with the process of validating our systems." Process validation has been a key issue raised by FDA in preliminary injunction actions taken against Zenith, West-ward, Able, and Biopharmaceutics ("The Pink Sheet" Nov. 25, p. 7). The issue was also prominent in FD-483s issued to Barr Labs in September ("The Pink Sheet" Nov. 11, p. 15). "Significant changes to manufacturing processes without prior approval and supplements" will also lead to "regulatory action," Davis cautioned Davis appeared on a panel at the FDLI meeting that discussed FDA's increased emphasis on enforcement. Other members of the panel were Deputy Associate Commissioner for Regulatory Affairs Gary Dykstra, Chicago District Director Raymond Mlecko, and Philadelphia District Field Investigator Charles Edwards. FDA Chief Counsel Margaret Porter also addressed the session. Dykstra told FDLI that FDA has to "tell people what we're doing and why we're doing it." He said the agency has four major enforcement "priorities for 1992," including: (1) preapproval inspections "in all areas, not just drugs"; (2) blood and AIDS- related products; (3) medical devices; and (4) seafood. "If you work in any of these areas, you are likely to see a food and drug investigator over the coming year," Dykstra said. Porter echoed Dykstra's comments on the need for the agency's enforcement agenda to be public. "Guidance documents, points to consider, speeches, precedential consent decrees are all valid indicators of FDA's interpretation of the law as it applies to specific cases," she said. "FDA is exploring ways of making these documents more readily accessible to the public, such as through a dockets system, and would welcome your suggestions in that regard." The FDAers addressed criticisms raised by a panel of food and drug lawyers who also appeared at the meeting. All five agency representatives responded to criticisms that FDA's new enforcement initiatives are not being applied uniformly. "We take the perception [of nonuniformity] very seriously," Dykstra said. "In most cases we can't verify it, quite honestly. . . . We are trying to do things in a very serious way to make sure that we are as consistent as is reasonably possible in all of our activities." Porter addressed an area of particular concern: warning letters. "There is a system in place for being sure that those are issued at the district director level only when the policy is pretty well established," Porter said. "You folks are not the only ones who read them eagerly and compare them one to the other. There is an effort in FDA to be sure that inconsistencies don't arise," she noted. "If there are what looks like inconsistencies, often that's a function of a different set of facts." In addition to retroactive reviews of actions, "we also have a vigorous training program in our region to bring people up to speed very quickly," Davis said. In addition to its existing programs, the regional office is "formulating . . . training conferences" on FD-483 inspection reports, Edwards said. The FDAers also assured FDLI that its enforcement activity does not signal a return to a "cops and robbers" type of agency. "This is not going to be an age . . . where we're going to regress to 'cops and robbers'," Dykstra declared. "That simply is not going to happen if I have anything to say about it. Maybe I won't, but I'll certainly try." Enforcement actions by FDA have increased. At a Dec. 10 FDLI session, Associate Commissioner for Regulatory Affairs Ronald Chesemore reported that referrals to the Justice Department increased to 43 in fiscal 1991 from 25 in 1990. Injunction requests increased to 21 from nine the year before, while seizure actions increased to 167 from 144. The increases were the result of "new procedures," Dykstra said. "We are not in the numbers business." Porter noted that an Oct. 23 Executive Order on civil justice reform published in the Oct. 25 Federal Register requires government agencies, including FDA, to take steps to avoid litigation and streamline lawsuits wherever possible. FDA "is taking that Executive Order seriously. We've had extensive instruction on how it should be implemented. We are participating in a draft Department of Justice guidance on the matter." Porter added that the order "embodies" FDA's current approach to litigation. "It is the view of the Justice Department officials who are familiar with the Executive Order -- who have worked with the Competitiveness Council -- that it is not intended to force the executive branch and specific regulatory agencies to enter into settlements that are adverse to the government, and that would essentially make us not achieve compliance in certain areas where compliance is warranted," Porter added.

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