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Executive Summary

House legislation to enhance FDA's authority for enforcing statutory and regulatory requirements affecting all agency- regulated industries would give FDA "sweeping new police powers" with few procedural safeguards, the Pharmaceutical Manufacturers Association testified at a July 17 hearing on the bill. PMA President Gerald Mossinghoff told the House Energy & Commerce/Health Subcommittee that the "police powers" provided in the legislation (HR 2597) "are open ended, lack needed definition and are largely devoid of procedural safeguards." The legislation is also unnecessary, Mossinghoff suggested. "FDA already has significant enforcement powers," he said. Any problems perceived in FDA's "enforcement records through the 1980s with respect to the research-based pharmaceutical industry . . . have not resulted from lack of adequate FDA authority." PMA was one of four trade associations to testify against the bill, which was jointly introduced by subcommittee Chairman Waxman (D-Calif.) and full committee Chairman Dingell (D-Mich.) on June 7. The subcommittee is not expected to mark up the bill before September. The lack of definition for HR 2597's powers, Mossinghoff said, is illustrated by the fact that there are "no limits" proposed for the bill's subpoena power provision. "Financial data and other confidential commercial or personnel information that are of no relevance to FDA" would be inappropriately subject to an FDA subpoena, he said. The bill also lacks "procedural safeguards," such as "any forum for objecting to a subpoena that is unduly burdensome or otherwise improper." Expanded inspection authority that would permit FDA to photograph or use electronic recording devices would jeopardize trade secrets such as "proprietary processes and manufacturing methods," Mossinghoff continued. Authority to assess civil money penalties "in effect" would make FDA "policeman, prosecutor, judge and jury all in one." Mossinghoff said that the bill's embargo authority, which would expand to all FDA-regulated products power currently limited to regulation of medical devices, "does not incorporate basic due process requirements such as the ability to seek immediate review of an embargo order when the product is potentially perishable or at risk of irreparable damage during the detention period." Mandatory recall authority is unnecessary, PMA added, because "the voluntary manufacturer-initiated recall system has worked very well in the research-based pharmaceutical industry for decades." The Nonprescription Drug Manufacturers Association in written comments contended the legislation is unnecessary because FDA "already enjoys enforcement authority that is virtually unparalleled by the authority of any other federal regulatory body." NDMA, which was not among the witnesses to testify at the hearing, said that criminal prosecution of corporate officers whose firms violate the Consumer Product Safety Act, the Occupational Safety and Health Act and the Federal Aviation Act must prove knowledge or intent of the officer, whereas corporate officers whose firms violate the FD&C Act can be criminally liable "solely because an individual holds a responsible corporate position." The association also maintained that "there simply is no justification to confer upon FDA employees unbridled discretion to impose recalls and embargoes on nonprescription drugs." Regarding HR 2597's proposed subpoena power, NDMA argued that it "would grant the agency sweeping authority to conduct unlimited fishing expeditions through company files" and would jeopardize proprietary information. Subcommittee Republicans read opening statements that foreshadowed industry concerns about the bill's alleged infringement of due process. The subcommittee's Ranking Minority Member Rep. Dannemeyer (Calif.) suggested that the provisions of HR 2597 abridges due process protections for businesses in a way that Rep. Waxman would never support if they applied to investigations of individuals. Legislation authorizing a government agency to enter a business, inspect its records, seize its products and impose penalties "is not America," he said; "that's a police state." Rep. Lent (R-N.Y.) remarked that the legislation calls for "the sort of investigatory procedures that Mr. Gorbachev is trying to phase out in the Soviet Union." Lent also suggested that he would consider supporting HR 2597 if Waxman would sponsor legislation to provide its powers to the Drug Enforcement Agency in its fight against illicit drugs. Waxman replied that DEA employs most of the enforcement tools the bill would provide to FDA. Rep. Dingell argued in his opening statement that the legislation is needed to update the FD&C Act and make its provisions consistent. "The agency is operating under enforcement tools and procedures enacted 50 years ago," the Michigan Democrat said. "Its regulatory authority differs from one product category to the next. It is time for FDA's enforcement arsenal to be brought into the modern world and to be applied equally to all the products it regulates." Health Research Group Director Sidney Wolfe, MD, and American Association of Retired Persons Legislation and Public Policy Division Director John Rother endorsed the bill as part of a consumer panel. Wolfe cited support for the bill expressed by FDA enforcement officials, who testified previously (see preceding story) about "how time consuming and labor intensive it is for the inspectors in the field not to have some of these [enforcement] tools." Asked by Waxman whether he agrees with industry groups that "FDA enforcement is more vigorous than ever," Wolfe remarked that "it's more vigorous than ever during the last 10 years, but that is sort of a pitiful basis for comparison." The HRG director said the agency has "reached all-time lows in many respects over the last four or five years. Yes, it's gotten better, but it is nowhere near good enough." Wolfe further noted that HR 2597 represents "the first significant set of enforcement additions in half a century, practically . . . and if we're going to move safely into the next century with all of the more complicated distribution systems and everything, I think we need more authority. What we have now is not enough." In fact, not only did Wolfe support the bill, but he also urged the subcommittee to consider adding five other enforcement provisions. The HRG head suggested, for example, that "public disclosure of safety and efficacy data" should be required for drugs, devices and diagnostics "at appropriate stages of FDA review": that distribution of drugs or devices should be restricted in "certain circumstances"; that FDA should be able to require that a drug or device "whose use for unapproved purposes poses a significant health hazard be distributed only through specified channels"; and that FDA should be granted "independent litigating authority at trial and appellate levels." Wolfe also proposed that GMP requirements be installed for foods and cosmetics. AARP's Rother, who served on HHS' (Edwards) Advisory Committee on FDA, testified that HR 2597 is needed to streamline the agency's current procedural requirements in enforcing the FD&C Act. "The Edwards Committee was alarmed to find the enforcement of the current FDA laws hampered by so many seemingly unnecessary procedural steps," Rother noted. The current enforcement system "is a very unwieldy, very slow, very cumbersome process and clearly not an efficient use of FDA resources." Rother noted the Edwards Committee recommendation that "Congress should review the FDA's current mixed bag of enforcement tools and enact legislation to streamline, expand and modernize them" ("The Pink Sheet" May 20, p. 12). He added that FDA should have the same . . . flexible enforcement tools that most other agencies already have" and that "these tools should be available uniformly across the entire FDA jurisdiction." The AARP official pointed out that HR 2597 "is not an incidental bill" but "is crucial to continued ability of the FDA to keep up with the ever greater demands that it faces."

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