US drug law change raises supply chain security fears

9 May 2017

A proposal to allow the import of pharmeceutical drugs into the US has sparked concerns over counterfeits entering the supply chain.

A Senate health committee is considering recommending the law, which currently prohibits drug imports, is changed to allow imports as a way to lower the cost of medicines.

In response, two representative bodies of pharmaceutical distributors have voiced their opposition to the plans, warning that importing drugs from foreign markets could undermine the anti-counterfeit security of the US supply chain.

In a blog published by The Hill, The National Association of Chain Drug Stores (NACDS) and the Healthcare Distribution Alliance (HAD) warned lawmakers to uphold previous efforts to protect the supply chain. 

“The US pharmaceutical supply chain is a sophisticated, efficient and highly secure system and in 2013, Congress made a firm commitment to further strengthening it by passing the Drug Supply Chain Security Act,” they wrote. 

“This federal law—which was enacted to establish a uniform national framework for tracing prescription medicines—was supported by the entire supply chain.”

They added that they hoped the Senate Health, Education, Labor and Pensions Committee, which is considering the amendments, would protect patients and the safety of the supply chain.

“We, and ultimately the patients we serve, simply cannot afford to risk the entrance of substandard, unsafe medicines into one of the safest and strongest supply chains in the world.” 

The Drug Supply Chain Security Act, introduced in 2013, was set up as a national system to track and trace pharmaceuticals to close gaps where counterfeit drugs could enter the supply chain.

Manufacturers, wholesalers and pharmacies were required to adopt data-sharing practices and increase documentation across the supply chain for all purchases to increase transparency.

The legislation up for amendment, the Prescription Drug User Fee Act (PDUFA), was originally passed in 1992 to allow the US Food and Drug Administration (FDA) to collect fees from drug sponsors to expand staffing so that new drugs could be reviewed more quickly.

The Act has been periodically reviewed and expanded through reauthorisations and is currently in its fourth iteration.

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