REP. DINGELL GENERIC DRUG HEARING SET FOR MAY 1: COMMISSIONER KESSLER

Executive Summary

REP. DINGELL GENERIC DRUG HEARING SET FOR MAY 1: COMMISSIONER KESSLER and HHS Inspector General Richard Kusserow are scheduled to testify at the House Energy & Commerce/Oversight Subcommittee hearing. HHS General Counsel Michael Astrue was invited to testify but will not appear due to a scheduling conflict: he is scheduled to argue a court case for the department on the day of the hearing. An Oversight Subcommittee hearing that had been tentatively scheduled for April 25 has been canceled. That hearing was expected to examine the reasons for FDA's continued slow pace of ANDA approvals. The May 1 hearing is expected to focus on issues issue indicative of sloppy agency regulation of the industry. One such issue reportedly is the lack of legal authority for FDA's "alert list." The agency places companies on the list when inspections show them to be seriously non-compliant noncompliant with GMPs (good manufacturing practice regulations), and it will not approve pending marketing applications of listed firms until they rectify their compliance problems. Presumably because the procedure has no official legal foundation, FDA continues reviewing listed sponsor's sponsors' pending applications that it will not approve. Generic drug enforcement legislation drafted by subcommittee Chairman Dingell (D-Mich.) would codify the alert list procedure by granting FDA authority for "temporary denial of review or approval." Drug companies with clean enforcement records have argued that FDA review of their applications should not be delayed while the agency processes those of alert-listed firms. Dingell and Rep. Waxman (D-Calif.) met on April 16 to discuss their differences on the Michigan Democrat's legislation and resolved to continue negotiations. Waxman reportedly agreed not to oppose out of hand FDA enforcement legislation that is specific to the generic drug industry, although he would prefer a bill that applies to all agency-regulated related industries. On the other hand, Waxman, the Energy & Commerce/Health Subcommittee chairman, believes FDA should have greater discretion in imposing mandatory debarment penalties penalities than a draft of Dingell's bill would allow. Waxman also opposes the measure's retroactivity under which penalties penalities would apply to violations previously committed in the generic drug scandal, and he is said to be wary of the bill's application of corporate debarment based on the actions of one or two employees within a firm. Dingell is believed to have more than enough votes to move his debarment bill through his committee. However, if Dingell can persuade Waxman to sign on to the legislation, schedule a Health Subcommittee subcommittee markup, and refer the measure with a unanimous vote, the bill's prospects for enactment would be greatly enhanced.