The US House of Representatives has approved legislation to establish a nationwide "track and trace" system throughout the pharmaceutical supply chain, and its supporters say they hope to have a final bill, reconciled with the Senate version, on President Barack Obama's desk by the August recess.
The bipartisan Safeguarding America's Pharmaceuticals Act of 2013 (HR 1919), co-sponsored by Republican Bob Latta and Democrat Jim Matheson, would establish a national standard of tracing requirements for manufacturers, wholesale distributors, pharmacies and repackagers based on changes in ownership. It would also establish "a collaborative, transparent process between the Food and Drug Administration and stakeholders to study ways to even further secure the pharmaceutical supply chain," says Representative Latta.
HR 1919 would prevent duplicative federal and state requirements from being imposed on drugmakers, wholesale distributors and pharmacies, he noted. "By replacing the current patchwork of multiple state laws with a uniform national standard, we improve safety, eliminate duplicative regulations and create certainty for all members of the pharmaceutical supply chain," said Rep Latta, speaking during the floor debate on the bill, which passed easily on a voice vote.
The legislation would also help prevent increases in drug prices, avoid additional drug shortages and eliminate "hundreds of millions of dollars-worth of duplicative government red tape on American businesses that is harming growth," added Republican Fred Upton, chair of the House Energy and Commerce Committee.
"Because of the hard work that has already been put in on this issue and the importance of protecting our families from counterfeit drugs, I am hopeful we can get a product to the President's desk by the August recess," said Rep Upton, who also co-sponsored the bill, together with Health Subcommittee chairman Republican Joe Pitts and Democrat John Dingell.
The House bill now has to be reconciled with the Senate version, the Pharmaceutical Distribution Supply Chain Act (S 957), which is sponsored by Democrats Michael Bennet and Tom Harkin and Republicans Richard Burr and Lamar Alexander.
S 957, which was passed by committee on May 22, would establish a “workable pathway” for transitioning the current lot-level tracing system to a unit-level system during the course of a decade. Over seven years, the major sectors of the pharmaceutical supply chain – manufacturers, repackagers, wholesale distributors, and dispensers – would all be passing and holding onto transaction information and history, as applicable, for each drug product, it says.
Within that time, the FDA would publish guidance for the supply chain on uniform standards to create an interoperable electronic tracing system, and conduct a small-business dispenser assessment to examine the feasibility of such a system. The bill also requires the FDA to conduct pilot projects on unit-level tracing and to hold public meetings to ensure broad stakeholder input on a workable, interoperable, electronic, unit-level system within a decade, say the sponsors.
The House version does not set a date for such a system to be introduced, and some House Democrats oppose it because it does not go as far as S 957, which has yet to reach the floor of the Senate.