House Energy and Commerce Committee staffers are discussing adding drug-tracking requirements to import safety legislation that Energy and Commerce Chairman John Dingell is readying for a reintroduction, industry and congressional sources said.
Prompted by the recent heparin scandal, staffers are weighing the possibility of tacking new drug provisions on the import bill, including imposing a so-called pedigree requirement on drugmakers, sources said.
Pedigrees would help track drugs and active pharmaceutical ingredients through the supply chain. The blood thinner heparin was linked to 62 deaths between January 2007 and the end of March after FDA determined the active ingredient in the heparin was contaminated.
Reps. Jim Matheson, D-Utah, and Steve Buyer, R-Ind., are crafting a pedigree requirement with drug and distribution industry help that has the potential to be the basis for language in the final import bill, industry sources said.
Discussions on the pedigree bill surround a risk-based implementation scheme, industry sources said, starting with drugs that are most often counterfeited or diverted to the black market. FDA potentially would have discretion to mandate pedigrees for drugs with less risk in the supply chain.
Buyer has been working on a pedigree bill and distributed a discussion draft in October, an industry source said.
The Prescription Drug Marketing Act passed in 1988 set minimum pedigree standards, but states have adopted a patchwork of more stringent approaches. Legislation would aim to align all states under a federal standard.
Committee staff also are discussing a third-party inspection regime for pharmaceuticals, though it likely will not be as straightforward as FDA certifying private companies to inspect drug plants, and might include additional safeguards to avoid fraud and conflicts of interest, an aide said. Committee staffers were briefed by the medical device manufacturers, who have had a somewhat fledgling third-party inspection program, the aide added.
The import safety bill Dingell will reintroduce soon is a reworking of a measure he introduced in September with Oversight and Investigations Subcommittee Chairman Bart Stupak, D-Mich., and Health Subcommittee Chairman Frank Pallone, D-N.J.
The original bill charged food and drug companies user fees to raise money for additional import inspections, though the fee is likely to be tweaked to meet concerns in the reintroduction.
Once the bill is introduced, a hearing is tentatively scheduled in early May with a quick markup to follow. Originally, the idea was to follow that timeline closer to the end of April, but that has been pushed back.
This article appears in the April 19, 2008 edition of NJ Daily.