WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) is one step closer to receiving authority to order drug and medical device recalls. According to raps.org, the U.S. House of Representatives Committee on Appropriations voted to approve the FDA’s $3.212 billion budget that not only funds the agency for 2021 but also takes one step forward toward granting the FDA the authority some believe the agency should have to perform its mission of keeping the American public safe from dangerous medicines and medical devices. But the bill limited the authority of the FDA to recall only unsafe or dangerous prescription and drugs sold over-the-counter. The bill passed by a “voice vote” and will move to the full House of Representatives for debate and a vote.
The FDA’s budget measure was amended by legislators to give the FDA recall power. Under the current state of federal law, the FDA can only recommend drug recalls and has no legal authority to compel a drug manufacturer to remove dangerous drugs from store shelves. The FDA can exert significant influence on drug makers to recall unsafe medications. However, any recall campaigns undertaken by drug manufacturers must be labeled “voluntary,” even though the FDA has the discretion and authority to approve or deny a drug for use in the first instance.
The budget bill sent to the House of Representatives contains a provision for $70 million earmarked to develop medical products in a more accelerated fashion, which is consistent with the 21st Century Cares Act. The bill also includes money to improve flu vaccinations by improving the technology that manufacturers the immunizations. At this time, the committee devoted $31 million to help fight the spread of COVID-19 by reviewing potential therapies and vaccines as scientists begin to discover antidotes for the deadly virus.
Lastly, the FDA will receive funds to develop regulations for the emerging cannabis market, as well as resources to respond to foodborne illnesses faster, as well as funds dedicated to ensuring the safety and cybersecurity of all medical devices.
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