Expanding US FDA Mandatory Recall Authority To All Drugs Gets House Appropriators’ Approval
Appropriators’ FDA FY 2021 budget includes amendment to expand its mandatory recall authority introduced by chairman of subcommittee with oversight of agency’s budget, Rep. Sanford Bishop. He said the agency should be able to force drug product recalls as it already can for vaccines, medical devices and products containing ingredients also scheduled as controlled substances.
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Senate Appropriations Committee has bills for federal agencies’ FY2021 budgets. The committee, which also published each subcommittee’s report accompanying its appropriation legislation, has not scheduled hearings to vote on the bills.
Support To Grant US FDA Authority To Order Recalls Of All Drugs Grows With Bill Introduced In Senate
Sen. Gary Peters says FDA should have the authority because relying on drug marketers to voluntarily recall products the agency has deemed unsafe isn’t sufficient to protect public health. He notes that manufacturers of OTC hand sanitizers imported from Mexico and found to contain methanol haven’t cooperated with the FDA on recalling the products.
In addition to a large and growing number of products made in Mexico and found to contain methanol on recall, sanitizers made by a Washington state dental whitening product firm contain ethanol at below labeled levels and the presence of undeclared isopropyl alcohol. Recent recalls also include injectable CBD formulations a Seattle firm marketed OTC and a New Jersey’s firm dandruff shampoo produced with water that failed US Pharmacopeia specifications