A Food and Drug Administration official said in a Senate hearing that the agency needs greater authority to implement a “track and trace” system that would help prevent counterfeit and contaminated drugs from getting into the U.S. supply chain.
FDA needs greater authority on drug tracking, official says
The Senate Health, Education, Labor and Pensions Committee hearing, which was held Wednesday, addressed concerns about securing the pharmaceutical supply chain.
Deborah Autor, FDA’s deputy commissioner for global regulatory operations and policy, provided testimony about the impact of globalization on the safety of the U.S. supply chain.
“The drug supply chain is a complex path that medical products travel from raw source materials to finished products for consumers,” Autor said during the hearing. “At every stage of this process, opportunities arise for the product to be contaminated, diverted, counterfeited or otherwise adulterated.”
Under the FDA Amendments Act of 2007, the FDA is tasked with developing a national “track and trace system” that will show ownership of products from the manufacturer to the patient. Autor said the current law does not state whether the system is enforceable or if it would be a violation for companies not to comply.
Autor also said that the FDA has no authority to prevent drugs from getting into the U.S. unless there is evidence that the products are unsafe, including being contaminated or counterfeited. Under current law, manufacturers outside of the U.S. are not required to grant FDA officials access to conduct inspections before shipping drugs to the U.S.
“It’s not a matter of if, it’s a matter of when,” she said about the possibility of another drug crisis, such as the heparin contamination that led to more than 200 deaths in 2008.
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