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House Democrats want tougher drug-tracking legislation

By Jonathan Block
Posted: June 4, 2013 - 5:15 pm ET

A U.S. House-passed bill to establish a national system for tracking pharmaceutical drugs through the supply chain to thwart counterfeit medicines faces opposition from some Democrats, who say they want a tougher bill.

The Safeguarding America's Pharmaceuticals Act of 2013 (PDF),” (H.R. 1919) sponsored by Rep. Bob Latta (R-Ohio) and Rep. Jim Matheson (D-Utah), passed the House on Monday and now goes to the Senate, which is considering its own traceability bill, S. 957 (PDF).

The House bill would require that a pharmaceutical manufacturer apply an “identifier on each package and homogenous case of a prescription drug product intended to be introduced in a transaction.”

Beginning in 2015, drug companies will need to provide documentation such as electronic transaction histories, known as pedigrees, when moving medications through the supply chain. And seven years after the legislation goes into effect, wholesale drug distributors would only be allowed to move product that has an identifier attached to it.

Drug tracking legislation is seen as necessary following cases where counterfeit drugs have entered the supply chain and been distributed to pharmacies and patients. For example, in February, federal investigators found fake batches of Genentech's cancer drug Avastin in the supply chain, the second time such a discovery had been made. There currently is no national tracking system for pharmaceutical drugs in the U.S.

But House Energy and Commerce Committee Ranking member Rep. Henry Waxman (D-Calif.) wants to see the provision providing traceability for each individual lot of a drug take effect much sooner than 2027, which is when the House bill would require it.

The Senate bill—which passed the Health, Education, Labor, and Pensions Committee on May 22—would require such a tracing system for individual lots of medication in 10 years. That is similar to a California state law set to take effect in 2015.

“By 2027, 14 years from now, FDA will be required to issue proposed regulations for such a system," Waxman told The Hill. “But there's no requirement that these regulations ever be finalized, and if they are ever finalized, they cannot go into effect for at least two more years.”

An attempt to include such a deadline in the House bill was defeated when the bill was under review in the Energy and Commerce Committee. Critics said more aggressive implementation would prove too costly.

Last month, Sen. Tom Harkin (D-Iowa), chairman of the Health, Education, Labor and Pensions Committee, told Modern Healthcare that he is pushing for the full Senate to vote by July on final, combined legislation.

Drug wholesalers, distributors and pharmacist groups largely lauded the passage of the House bill, with some opposition.

“This legislation establishes a single, uniform and national system for protecting patient safety and securing the domestic pharmaceutical supply chain …” the Pharmaceutical Distribution Security Alliance, a coalition of more than 25 stakeholders including pharmaceutical companies, distributors, pharmacies and logistics providers, said in a statement.

“We commend the House for passing this bill and look forward to working with the House and Senate to ensure that a strong and effective bill is sent soon to the president for his signature.”

The House-passed bill would create one national standard to help safeguard the security of our nation's drug distribution system, Chris Krese, a spokesman for the National Association of Chain Drug Stores, said in an interview. “NACDS looks forward to remaining engaged in this process in the Senate as well.”

However, the California Board of Pharmacy, in a letter, said that it opposes H.R. 1919 because it would preempt the California law on electronic transaction histories, and that it does not go far enough to increase drug supply-chain security.

Follow Jonathan Block on Twitter: @MHjblock

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