Can the FDA recall dangerous medicine on its own?
The answer is disturbing.
From the FDA:
A drug recall is the most effective way to protect the public from a defective or potentially harmful product. A recall is a voluntary action taken by a company to remove a defective drug product from the market. Drug recalls may be conducted on a company’s own initiative or by FDA request. FDA’s role in a recall is to oversee a company’s strategy, assess the adequacy of the recall and classify the recall.
Class I: A dangerous or defective product that could cause serious health problems or death.
Class II: A product that might cause a temporary health problem, or pose slight threat of a serious nature.
Class III: A products that is unlikely to cause any adverse health reaction, but that violates FDA labeling or manufacturing laws…
However, if a company does not issue public notification of a recall, FDA may do so if the agency determines it is necessary to protect patients. Patients also may learn that their medicine has been recalled through notification from the manufacturer, their health care professional or pharmacist…
If a recall is determined to be ineffective FDA will request the company take additional actions.
Given this reality, in an Emergency Use Authorization (EUA) situation, the most effective way to end the proliferation of dangerous products would be to withdraw the EUAs.
This is not a good way to protect American citizens. Our FDA cannot respond to dangerous drugs appropriately without the power to force, not “request”, recalls.
Currently, the FDA has mandatory recall authority over other products the agency regulates, such as medical devices, biological products, and food such as Dark Chocolate Coconut Bites. It is important the FDA has that authority, because failure to declare ingredients risks injuring people allergic to cashews.
But we could point the FDA to a problem that has injured over two million people and the FDA has yet to act.