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Committee Approves Latta Bill to Safeguard American Families Against Counterfeit Pharmaceuticals

Washington, DC, May 15, 2013 | Laura Strange (202-225-6405)

The House Energy and Commerce Committee today approved legislation introduced by Congressman Bob Latta (R-OH) that will strengthen and secure the nation’s pharmaceutical distribution supply chain. The Committee, chaired by Rep. Fred Upton (R-MI), approved H.R. 1919, the Safeguarding America's Pharmaceuticals Act of 2013 by a voice vote.

“The pharmaceutical supply chain touches every part of the health care system and it is imperative that we get the structure and segments of it connected in a safe, secure and effective manner that provides the best protection for patients,” said Congressman Latta. “H.R. 1919 will make improvements to the current supply chain, while providing a clear path for industry stakeholders towards enhanced supply chain protections, and I am pleased to see its passage out of Committee.”

Chairman Upton, offered the following opening statement during the markup of H.R. 1919:

“This bill would work to protect American families against counterfeit drugs and eliminate hundreds of millions of dollars worth of duplicative government regulations that saddle American drug manufacturers, wholesale distributors, and pharmacies.”

As approved by the Committee, H.R. 1919 will:

  • Establishing lot-level tracing requirements for manufacturers, wholesale distributors, pharmacies and repackagers based on changes in ownership. 
  • Requires the affiliates of the supply chain, including third-party logistics providers to undertake verification and notification activities regarding suspect or illegitimate products.
  • Require members of the supply chain to only transact with registered or licensed entities.
  • Requires the FDA to establish and report to Congress on pilot projects and hold biannual public meetings in order to foster collaboration with stakeholders regarding moving to unit-level traceability.

 

A markup refers to the Congressional committee process in which legislation is debated, amended, and voted on. To read opening statements, or watch a webcast of today’s markup, click here.

 

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