Bill Introduced to Give FDA Authority to Recall Unsafe Drugs

Despite the authority the U.S. Food and Drug Administration has in the approval process of prescription drugs, the federal agency currently lacks the authority to recall unsafe prescription or over-the-counter medications. A bill introduced by Rep. Rosa DeLauro (D-Connecticut) seeks to change that.

Update June 11, 2017: Since being referred to the House of Representatives Subcommittee on Digital Commerce and Consumer Protection on Feb. 17, 2017, there has been no further actions taken on H.R. 1108 Recall Unsafe Drugs Act.  There are a total of 24 representatives who serve on that subcommittee including Rep. Robert Latta (R-Ohio, District 5) as Chair and Rep. Gregg Harper (R-Mississippi, District 3) as Vice Chair.

On February 16, 2017, DeLauro introduced H.B. 1108, the Recall Unsafe Drugs Act, that seeks to expand the FDA’s authority to recall both prescription and over-the-counter drugs. Currently, the federal agency has the authority to recall unsafe medical devices, biologic agents, infant formulas and tissue products. When it comes to prescription and over-the-counter medications, the most the FDA can do is provide warnings to the public of its findings and request that manufacturers of the unsafe products voluntarily issue a recall.

House Bill 1108 was referred to the House of Representatives Committee on Energy and Commerce for consideration, the first of many steps before the action can become law. The U.S. Congress is in recess this week; whether the committee members begin to take action on the Recall Unsafe Drugs Act is unknown, but constituent and public interest in this issue in the form of phone calls to elected officials could potentially spur committee action.

A recent issue of concern for the FDA has been its inability to force a recall of a homeopathic over-the-counter teething product manufactured by Hyland’s for which the federal agency has received in excess of 350 adverse reactions. Infants and children taking the product have experienced reactions ranging from tremors to seizures, even death. After conducting a laboratory study of the teething tablets, the FDA determined that the amount of belladonna, a potentially neurotoxic substance, was greater in some of the teething tablets than in others.

Related Reading: Homeopathic Teething Products Subject of FDA Warning

In DeLauro’s press release announcing the introduction of H.B. 1108, she explained:

“As it stands, the FDA would have to go through an arduous legal process to take action against manufacturers such as Hyland’s. This is unacceptable and threatens the health and safety of American families. The Recall Unsafe Drugs Act will enable the FDA to step in and issue a mandatory recall of drugs that have been found to cause serious health consequences or death. The lack of mandatory recall authority must be corrected and Congress should enact my legislation to take products off the market that are deemed a threat to consumers. The American people deserve to know that what they are using is safe .”

Dr. Michael Carome, director of the nonprofit consumer rights advocacy group, Public Citizen’s Health Research Group, lent his support to DeLauro’s proposed legislation, saying,

“The FDA currently lacks the authority to order recalls of drugs, leaving the agency with insufficient means to protect patients from potentially dangerous medications that have already been distributed to pharmacies, doctors and patients. Representative DeLauro’s bill will close this safety loophole and provide the FDA with an essential tool to better protect public health.”

The FDA must go through an investigative process when it receives adverse reaction notifications about a drug, whether it be a prescription medication or an over-the-counter product, such as the teething tablets. In the case of the teething tablets, the agency compiled data over a three to four-year period before ascertaining that the adverse reactions that occurred were in fact linked to the homeopathic tablets.

The Recall Unsafe Drugs Act would not preclude the investigative processes already in place but would provide the FDA the authority to issue a recall on any medication it deemed unsafe.

If you’re interested in following this, or any other federal legislation, or that of your state, you may want to use one or more of the resources listed here:

Non-Media Dependent Resources to Track Federal and State Legislatures


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