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The United States has passed a bill intended to set up a national system for tracking pharmaceutical products through the supply chain to prevent counterfeit medicines from accessing the market.
The Safeguarding America's Pharmaceuticals Act of 2013 requires pharmaceutical companies to provide various documentation such as electronic transaction histories when moving medications through the supply chain. The rules will come into effect in 2015 and seven years later wholesale drug distributors will only be allowed to move products that have an identifier attached to them.
A need for such a law has become more pressing lately, as a number of counterfeit medical products have been detected on the U.S. market. Such fake drugs have reached pharmacies and patients across the country, putting public health at risk. Any drug that is legally sold in the country has been approved by the U.S. Food and Drug Administration (FDA) and lack of the regulator's approval means that there is no guarantee that the product is safe for consumers, Modern Healthcare reported.
One of the recent instances of counterfeit production occurred in February, when investigators discovered fake batches of Genentech's cancer drug Avastin. Dealing with counterfeit products is hard because there is no national tracking system for pharmaceutical drugs in the United States at present.
Under the new legislation the FDA will have to issue proposed regulations for a national tracking system by 2027.
The bill has been slammed by a number of Democrats, who claimed it was too lenient. House Energy and Commerce Committee ranking member Rep. Henry Waxman (D-Calif.) is one of those who are unhappy with the bill. He explained that individual lots of drugs should be tracked as soon as possible because 2027 is too long a period in to start implementing the new identification rules.
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What is more, there is no requirement that the rules will ever be finalized and, even if they are eventually finalized, they cannot come into effect for further two years, thus postponing the actual regulation indefinitely, Waxman claimed.
Waxman and his colleagues tried to include a deadline in the House bill but the proposal was rejected with the motive that shorter deadlines and more aggressive implementation would be too expensive.
Meanwhile, the opinion of the pharmaceutical industry on the matter has been mostly positive but with some reservations. According to the Pharmaceutical Distribution Security Alliance, the bill establishes a uniform national system that would facilitate patient safety protection and would ensure the domestic pharmaceutical supply chain is safe. The organization added that it was ready to cooperate with the House and the Senate to make sure that the bill is as strong and as effective as possible before it goes to the president for his approval.
The California Board of Pharmacy, however, stated that it was against the regulation because its implementation would prevent the state law on electronic transaction histories from coming into effect. It also claimed that the Safeguarding America's Pharmaceuticals Act was not strict enough to enhance the safety of the national drug supply chain.