FDAnews Drug Daily Bulletin

New congressional legislation for track-and-trace drug pedigrees is unnecessary and probably will not move out of a House committee in the near future, according to an executive from the National Association of Chain Drug Stores (NACDS).

The Safeguarding America’s Pharmaceuticals Act of 2008, H.R. 5839, which was introduced earlier this year by Reps. Steve Buyer (R-Ind.) and Jim Matheson (D-Utah), probably will not be passed as a stand-alone bill. Efforts by the congressmen to have it attached to the FDA Globalization Act, which is still in discussion in draft form, have proven unsuccessful, Paul Kelly, NACDS vice president of government affairs, said.

Rep. John Dingell (D-Mich.), chairman of the House Energy and Commerce Committee, as well as other congressional leaders, supports the FDA globalization legislation. The bill’s provisions include one that would require electronic pedigrees to track drug ingredients but not finished pharmaceuticals, he said.

“We remain very pleased that Chairman Dingell has decided not to include an electronic pedigree requirement, and more importantly the track-and-trace requirement, in that bill,” Kelly said.

Although Kelly was hesitant to predict whether pedigree legislation would pass after the election, he said he thought it was unlikely that the FDA globalization legislation would move forward early next year without input from the new administration.

“A lot will depend on the election and who’s controlling the committees and who’s controlling the White House,” Kelly said. “We will have a new president. That means we will have a new FDA commissioner, and who knows what all that will mean.

“It seems unlikely that they would move a major food and drug bill early next year given that you’re going to have a new administration who’s going to want to have their imprint on anything major like that.”