Obama Orders FDA To Help Reduce Drug Shortages
The order contains new guidelines for the Food and Drug Administration (FDA) to broaden the FDA’s reporting of potential drug shortages, accelerate reviews of applications to change production of drugs facing potential shortages and give the Justice Department more information about possible instances of price gouging, the Associated Press reports.
The FDA reported 178 drug shortages last year, an amount which is expected to increase this year.
Causes of the drug shortages are said to be quality or manufacturing problems, or delays in receiving components from suppliers, AP reports.
The president ordered the new steps without congressional approval, and the executive order is targeted at congressional Republicans who are blocking the president’s $447 billion jobs bill, USA Today reports.
In a statement, the Obama Administration outlined its steps aimed at carrying out this executive order:
-- Send a letter to drug manufacturers reminding them of their legal responsibility to report the discontinuation of certain drugs to the FDA. The letter also encourages companies to voluntarily notify FDA about potential prescription drug shortages in cases where notification is not currently required.
-- Increase staffing resources for the FDA's Drug Shortages Program to address the increased workload that will result from additional early notification of potential shortages by manufacturers.
-- Release a report from the Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation that assesses the underlying factors that lead to drug shortages, and an FDA report on its role in monitoring, preventing, and responding to these shortages.
This order is the newest addition to Obama’s “We Can’t Wait” campaign.
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