Post-Tylenol House bill vests FDA with recall power
Arming the FDA with its own recall authority is HR 5740's goal, introduced today by Ed Towns (D-NY), chair of the Committee on Government Oversight and Reform. Such mandatory recalls would augment the voluntary recalls made by drugmakers, which ultimately appear on the FDA website as supplied by the drugmakers.
FDA-initiated recalls may inspire manufacturers to be quicker and more thorough in their recall processes. "Too often, the FDA has been in the position of having to persuade companies to recall suspect products," Towns says in a statement. "Now the FDA will have the full authority to pull contaminated medication from the market."
The bill's filing on the same day that Johnson & Johnson is scheduled to submit a fix-it plan to the FDA concerning its multi-stage Tylenol recall is hardly coincidental. Towns said last May, in the early stages of the Congressional investigation into the matter, that he planned to introduce the legislation.
Under HR 5740, the FDA is authorized to demand a recall for drugs that have been adulterated or misbranded. The authority also extends to drugs that may kill or have serious health consequences for people and animals.
According to the bill, the regulator will be able to issue an order to immediately recall a drug and to provide for notice to those affected by the recall. "Any person who is subject to an emergency recall order shall immediately recall such drug and provide notification as required," the bill says. Drugmakers can appeal within 24 hours...[but] shall conduct the recall notwithstanding...the appeal."
The committee referred the bill to the House Committee on Energy and Commerce.