BY Ben Moscovitch

The Senate's champion of drug safety legislation is eying ways to expand a measure that would provide FDA with mandatory recall authority and quality management plan oversight, considering a slew of options that could include an inspection user fee or mandating a uniform track-and-trace system, sources said. While Democrats pushed drug safety legislation in the last Congress, the pending Senate bill is expected to gain GOP support within the next month.

Sen. Michael Bennet (D-CO) introduced a drug safety bill last Congress that included some elements of similar legislation backed by House Energy and Commerce Committee Democrats, but their measure included user fees for inspections that were omitted in the original Bennet bill (see FDA Week, Aug. 6, 2010).

Bennet intends to introduce new drug safety legislation this Congress that will expand on his previous measure, possibly including user fees for inspections. "It'll be a larger bill," a congressional aide said, adding that user fees are "one of the things were still looking at."

The concept of an inspection user fee is gaining traction as generic drug manufacturers and active pharmaceutical ingredient makers prepare for generic user fee negotiations. Inspection fees are included as part of the generic drug user fee proposals pushed by the parties negotiating the program, including the Generic Pharmaceutical Association, the European Chemical Industry Council's fine chemicals group (EFCG) and the Society of Chemical Manufacturers and Affiliates' (SOCMA) Bulk Pharmaceutical Task Force (see FDA Week, March 4).

Further, the new Bennet bill could include a mandate for a uniform track-and-trace and drug pedigree system.

"A practical and comprehensive approach at the federal level will increase safety, facilitate efficient interstate commerce and minimize the inconsistencies among the current patchwork of competing state requirements," Bennet said this week at a roundtable on drug safety organized by the Pew Charitable Trusts. "A uniform system is a necessary step to further enhance the security of the nation's prescription medicine supply chain."

Legislation implementing a uniform drug pedigree system has not been championed in the Senate, with Rep. Jim Matheson (D-UT) and former Rep. Stephen Buyer (R-IN) spearheading past legislative efforts to establish a national pedigree standard. While Buyer did not seek reelection last year, the measure is expected to be reintroduced this Congress in the House (see FDA Week, Feb. 18).

Bennet added that he hopes to have a bipartisan cosponsor on the legislation within the next month. In the last Congress, Rep. John Dingell (D-MI), backed by the Democratic leadership of the Energy and Commerce Committee, introduce a bill that would give FDA a slew of new drug safety powers, but that legislation's passage in the House was complicated by the GOP House takeover.

Senate health committee chair Tom Harkin (D-IA) has indicated that his committee could shepherd drug safety legislation through Congress, especially if House Energy and Commerce Committee Chair Fred Upton (R-MI) does not advocate providing FDA with new powers to oversee the global drug supply chain.

New drug safety authorities for FDA could either be passed as a stand-alone measure or as part of the reauthorization of prescription drug user fees.