Track-and-trace, the ability to follow a drug product from manufacturer to pharmacy, has been a longtime goal of the FDA. The agency believes it would help foil drug counterfeiting and expedite recalls for any reason. Drugmakers have said they thought it was a good idea but were reluctant to commit to a date certain since the system requires investments and coordination from every link in the supply chain. Now, a bill poised for passage has put a timeline to it: 10 years to have all the pieces in place and the system operational.
The Drug Quality and Security Act sets out the steps that must happen in that 10-year timeline. Assuming passage, it includes putting unique identifiers on individual units in four years. The bill was passed by the U.S. House of Representatives Saturday and was expected to be passed by the Senate this week before the government shutdown put that into question.
While it will still be a decade before it is set to be fully in place, Allan Coukell, a drug policy expert at the Pew Charitable Trusts, which supports the legislation, said the timeframe is more aggressive than a proposal put forth last year by industry. He thinks it is a workable plan. "Our goal has always been unit-level tracking by a date certain. This gets us there in 10 years, and it does give time for industry to roll it out," Coukell said by phone Monday.
The industry supports the bill "big time" now, Mark Grayson, deputy vice president of international public affairs for PhRMA, said today by phone. In a letter to leaders in both the House and Senate, PhRMA pointed out the proposed law now has support from not just drugmakers but also wholesalers, logistics companies and others. "This vital legislation will protect patients from counterfeit drugs by establishing a uniform, national system for securing the pharmaceutical distribution supply chain."
One of the factors that motivated the industry to rally around the legislation was a California law that would have required unit-level tracking happen between 2015 and 2017. Assuming the federal legislation gets passed, it would preempt the California law and any other state laws. Momentum also built around the discovery this year that doctors had bought what they believed was Roche's ($RHHBY) Altuzan, the trade name in Turkey for the cancer drug branded Avastin in the U.S., but which turned out to be counterfeits. Counterfeit versions of Avastin also slipped into the U.S. drug supply last year. "This will harden the system against insertion of counterfeit drugs and stolen drug and diverted drugs being reintroduced into the system," Coukrell said.
The provisions of the bill require drugmakers in four years to provide electronic transactions information and histories. They also will have to begin providing unique identifiers on each package so the products can eventually be tracked electronically through every step from plant to truck or plane and warehouses along the route until they reach a final destination.
The bill actually tackles two priorities of the FDA. It also clarifies the agency's powers over drug compounders and sets up a voluntary program for those compounders who chose to be regulated by the FDA.
- see the bill (PDF)
- here's a backgrounder
- read the letter from PhRMA (PDF)