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FDA ENFORCEMENT BILL GAINS MOMENTUM AS UPJOHN, MERCK, AND SEARLE SOFTEN RESISTANCE TO DRAFT SUBSTITUTE; HEALTH SUBCOMMITTEE MARKUP SLATED FOR OCT. 8

Executive Summary

Upjohn, Merck and Searle are indicating a readiness to negotiate with Reps. Dingell (D-Mich.) and Waxman (D-Calif.) on an FDA enforcement authorities bill. An amended proposal was floated on Capitol Hill during the last week of September ("The Pink Sheet" Sept. 30, p. 18). The amendment is gaining momentum as individual companies soften their resistance to the legislation. Reportedly, a number of other firms plan to express qualified support for the revised bill. Waxman tentatively has scheduled an Oct. 8 markup of HR 2597 by his Energy & Commerce/Health Subcommittee. An earlier markup had been set for Oct. 2. Many subcommittee members had expressed opposition to the bill during a July 17 hearing on the measure. Waxman presumably now has enough subcommittee support for the bill to report it out to the full committee. More than 60 trade groups representing FDA-regulated industries, led by the Pharmaceutical Manufacturers Association, had formed a coalition against HR 2597 ("The Pink Sheet" Sept. 16, In Brief). However, since the release of the compromise legislation by Dingell and Waxman, cracks have begun to appear in the coalition. In Sept. 30 letters to Waxman and Dingell, the principal cosponsors of the legislation, Upjohn CEO Theodore Cooper, MD, said the company supports "the intent of the committee to begin the legislative process regarding this important legislation." However, Cooper noted that Upjohn still has "some reservations" about the particular provisions of the substitute proposal. Cooper pointed to the substitute amendment in explaining why Upjohn was persuaded to break with the coalition of opponents to the bill. "While we shared many of the reservations expressed by others in our industry regarding HR 2597," Cooper explained, "we commend you . . . for your efforts to address those concerns through the substitute amendment." The substitute measure adds "procedural safeguards" to assure due process to FDA-regulated industries at the same time it provides FDA with greater authority. For example, the bill's administrative recall powers are more tightly defined in the substitute proposal and include a provision for industry-requested hearings. While the bill gives FDA authority to order recalls, the substitute also gives companies procedures to appeal such orders. However, Upjohn also offered several recommendations on how the bill could be improved. For example, Cooper suggested that "the committee would benefit from further consideration of the need for FDA to possess the subpoena authority provided in the bill." He also advised the committee to "bring the civil penalty provisions of HR 2597 more in line with those contained" in the 1990 medical device act. Merck Senior VP John Zabriskie, in an Oct. 3 letter, said his firm is "encouraged by the significant modifications to the original bill." However, he added, Merck continues "to have reservations about" the presence of several enforcement tools included in the bill "and the absence of additional procedural safeguards." Zabriskie explained that Merck is concerned "particularly with the embargo authority, the subpoena authority and the civil penalty provisions as currently drafted." The company "would welcome the opportunity to discuss these concerns . . . as the committee moves through the legislative process." Searle CEO Sheldon Gilgore met with Waxman personally on Oct. 2 to discuss the company's shift in position. In a public statement, Searle said it "believes HR 2597 as amended is an improvement that we are very much interested in working on with the congressman and his staff." However, the company added: "Searle does have specific concerns that need to be addressed." PMA President Gerald Mossinghoff was scheduled to meet with Dingell during the week. However, the congressman opted out of the meeting, and the association met instead with Dingell's staff. A PMA spokesperson said the association did not express any softening of its opposition to the bill, nor did the association offer a counter proposal. The American Association of Blood Banks was among the organizations expressing qualified support of the enforcement bill in Sept. 30 letters to Waxman and Dingell. "We offer our support for the effort of the [House Energy & Commerce] Committee in considering this important legislation," AABB said. The association was not a member of the coalition opposing the enforcement bill and had not publicly expressed a position on the legislation. However, HR 2597 as introduced concerned AABB, particularly the provision authorizing FDA to use electronic recording and photography in inspections. That provision was amended in the substitute measure, circulated Sept. 27. "The substitute amendment . . . represents a significant advancement over the bill as it was introduced in achieving its intent to provide strong, effective and fair FDA enforcement authority," AABB said. The substitute amendment "goes far" to "ensure that the FDA possess the necessary authorities to protect the public health," AABB added, " while protecting the rights of those that may become subject to such enforcement actions."
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