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DINGELL GENERIC DRUG OVERSIGHT HEARINGS IN PLANNING FOR JUNE 21 AND JUNE 28; HOUSE ENERGY & COMMERCE CHAIRMAN MAY PURSUE SUBJECT OF ANDA SLOWDOWN

Executive Summary

Rep. Dingell (D-Mich.) is tentatively reserving two dates, June 21 and 28, for continued oversight hearings on the generic drug industry. Specific agendas have not been set, but likely topics include the nearly complete shutdown of FDA's ANDA review process, generic company officials yet to be named in criminal informations or HHS Inspector General enforcement authority for felony violations of the FD&C Act. All but five members of the full Energy & Commerce Committee have signed on as cosponsors of Dingell's generic drug reform bill (HR 4810). The major holdout is House Health Subcommittee Chairman Waxman (D-Calif.), author of the 1984 generic drug approval (ANDA) legislation. The other four non-signers are also Democrats: Bruce (Ill.), Richardson (N.M.), Sharp (Ind.), and Swift (Wash.). Only Waxman and Bruce have actually declined to sign onto the bill. The Dingell bill will be referred to Waxman's Health Subcommittee. The California Democrat reportedly is not cosponsoring the measure due to concern that it sanctions target solely the generic and not the brandname drug industry, and that proposed reinstatement of the HHS Inspector General's enforcement authority might inappropriately supersede FDA's regarding investigations into felony violations of the FD&C Act. Waxman also has major pieces of FDA reform legislation cooking in the food labeling and medical device areas. The situation might be ripe for bundling several of the FDA changes together, instead of a piecemeal approach. With the short legislative season left before the 1990 elections, Waxman might also be reluctant to sign onto a piece of legislation that could be superseded by proposals in 1991. A hearing and markup have yet to be scheduled in Waxman's subcommittee, but dates may be agreed upon before the Memorial Day recess. A Senate bill sponsor has not been identified; however, Labor & Human Resources Committee Chairman Kennedy (D-Mass.) is a natural choice for Dingell. The "Emergency Food and Drug Enforcement Act of 1990" was introduced on May 15, as expected ("The Pink Sheet" May 14, In Brief and May 7, p. 5). In a May 16 Energy & Commerce Committee press release, Oversight Subcommittee Ranking Minority Member Bliley (R-Va.) said the legislation "is aimed at cleaning up an industry that is vital to the future of affordable health care in America." The bill signals to the generic drug industry that it provides "an important service to the American public" but is expected "to be squeaky-clean," Bliley said. "If you aren't spotless, you will be caught and prosecuted," he declared. To expedite FDA's ability to seek penalties in court, the bill would eliminate a current requirement that FDA notify companies before it recommends that they be prosecuted. A section in the measure to authorize FDA assessments of civil monetary penalties would delete an existing statutory requirement for "notice before the secretary recommends criminal prosecution for any violation of the FD&C Act," according to a summary of the legislation. The proposal does not include a provision to strengthen FDA's recall authority, although Dingell has said an increase in agency recall power is needed. In an effort to facilitate quick passage during this Congress, which only has approximately 45 legislative days remaining, the bill focuses solely on generic drug regulation. Reportedly, the Michigan Democrat felt that enhanced recall authority could not reasonably target generic drug recalls only. Recall authority could be addressed in broader legislation that may be introduced in the next Congress. Dingell has said patients were endangered when carbamazepine remained on the market while FDA and the drug's manufacturer, Pharmaceutical Basics, Inc. (PBI), debated the urgency with which the product should be recalled. Under another provision, FDA may deny generic drug marketing approvals for up to 18-36 months. The legislation provides that temporary denial of approvals may be based on "probable cause" that an applicant has bribed or paid illegal gratuities to an HHS official, has "knowingly made...a pattern of false statements or representations" regarding a marketing application or has "endangered the public health through multiple violations" of the FD&C Act. The agency currently withholds approvals for manufacturers that receive adverse inspections and are placed on an "alert list." The legislation codifies this practice. The legislation also provides FDA with authority to debar individuals permanently and companies for periods of at least three years from the generic drug review and approval process. The agency must debar persons convicted of felony violations of the FD&C Act, the act states. In addition, FDA may debar those convicted of other FD&C Act violations, including bribery, paying illegal gratuities, fraud, perjury, false statements, racketeering, blackmail, extortion, falsification or destruction of records, obstruction of justice. Furthermore, anyone named as an unindicted co-conspirator in such crimes may be debarred by the agency, and a company that employs a debarred person may itself be debarred.
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