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FDA ENFORCEMENT ACTIVITIES: FLEXIBLE APPLICATION

Executive Summary

FDA ENFORCEMENT ACTIVITIES: FLEXIBLE APPLICATION of all options "is preferable" to focusing on criminal prosecution, FDA said in a Nov. 4 response to a 1984 petition from an FDA consumer safety officer. "The agency believes that a balanced approach afforded by use of a variety of sanctions is more efficient and effective than the single-sanction policy you suggest," FDA's response states. In addition, FDA said that "the uncertainty about the agency's choice of remedy itself creates a deterrent effect." The petition, submitted by Manufacturing and Product Quality Division CSO Paul Sage, requested that FDA adopt a new enforcement policy that would discourage marketers of unapproved or inadequately tested drugs through the routine use of criminal sanctions ("The Pink Sheet" July 23, 1984, T&G-10). FDA's increased emphasis on fighting health fraud is "reflected in a significant increase in fiscal year 1988 in full-time equivalent field personnel (22 to 43) allocated to health fraud," the agency asserted. FDA also pointed out that in fiscal year 1987, the enforcement actions approved by the Center for Drug Evaluation and Research's Health Fraud Branch included "38 regulatory letters, seven seizures, three injunctions, and one grand jury investigation to look into potential criminal violations." In a Nov. 29 petition for reconsideration, Sage responded that FDA's increase in field personnel shows "that the agency recognizes that not enough is being done." The CSO added that "the depth and strength of FDA's commitment cannot properly be measured in terms of the amount of field manpower devoted to investigating violations. This is particularly true when the investigations fail to produce evidence of problems that are serious enough to warrant consideration of criminal prosecution. One must consider FDA's enforcement policy." In addition, Sage asserted that none of FDA's FY 1987 enforcement actions involved the recommendation for a single criminal prosecution. "These are depressing statistics," Sage stated. "Violative marketing practices obviously continue, much the same as was the case in 1984." The agency emphasized that, in addition to its usual enforcement actions, it has initiated a major public education campaign to inform consumers about the facts of health fraud and has sponsored national and regional conferences on the subject. The health conferences represent "a national campaign of cooperative and complementary enforcement activity with each federal, state, and local agency utilizing its own unique resources, abilities and enforcement methods to best effectuate the common goal." Sage responded that "FDA has mistakenly equated sponsorship of educational materials and health fraud conferences with a campaign of enforcement activities." The CSO's original petition was prompted by a series of infant deaths in 1984 linked to the use of E-Ferol, an unapproved injectable vitamin E product. Sage referred to the incident in his petition as an example of "the potential for tragedy associated with the marketing of inadequately tested, unapproved drugs." FDA, in its response, cited the E-Ferol matter as an instance of when the agency has "dealt aggressively with purveyors of the more egregiously violative products." That case "resulted in a criminal prosecution" and "after a lengthy trial, the defendants were found guilty of multiple felony violations and are now exposed to stiff sentences," FDA noted.
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