PhRMA Calls for Restraint in FDA’s Import Destruction Rule
The new rule establishing FDA powers to destroy suspected counterfeit and adulterated drugs could cause shortages if the agency doesn’t protect against officials destroying needed excipients that get caught up in an import dispute, according to PhRMA.
The industry association filed comments on the FDA rule last month, urging the agency to require investigators to work closely with industry before exercising the authority to destroy low-value excipients to be sure the actions won’t interrupt the industry supply chain.
The proposed rule would allow the agency to destroy drug imports with a value of less than $2,500 that are refused admission into the U.S. because the agency believes they are adulterated or counterfeit. Currently, the agency gives an importer 90 days to take back detained drugs.
Destruction of even relatively low-value amounts of certain excipients or ingredients could cause a shortage, PhRMA warned. PhRMA suggested that the FDA’s Drug Shortages Task Force monitor and report on the effects of the rule on the drug supply.
PhRMA asked that the FDA clarify when it would use its destruction authority.
Finally, PhRMA suggested the FDA create a database that ports can check to determine whether or not a shipper has made multiple attempts to import adulterated or counterfeit drugs into the U.S. The trade group was one of 21 stakeholders — mainly private citizens — to submit comments on the proposed rule.
The destruction authority wasn’t the only new power granted by the FDA Safety and Innovation Act to improve oversight of imports. The FDA recently finalized a rule that allows individual investigators to block suspicious drug imports, a power the agency previously only had for foods and medical devices.
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