Lawmakers Introduce Bill to Speed Possible Withdrawal of Pediatric Cold Drugs

Proposed legislation would allow the FDA to amend or repeal OTC drug monographs more quickly than is currently possible.

Reps. Henry Waxman (D-Calif.) and Tom Allen (D-Maine), along with Sen. Edward Kennedy (D-Mass.), introduced the Non-Prescription Drug Modernization Act Nov. 6 in the wake of a recent FDA advisory panel recommendation that the FDA ban OTC cough and cold medications for children younger than 6. The FDA is not required to follow the recommendations of its advisory committees but usually does.

After the advisory committee meeting, Waxman called on drug companies to withdraw their OTC cough and cold products for children younger than 6 to help speed the process even before the FDA makes a final decision.

According to the lawmakers, if the FDA decides to follow the recommendation, the agency would have to go through a lengthy rulemaking process that could take years to complete. Under the Administrative Procedure Act, federal agencies, before issuing a final rule, must first issue a proposed rule and allow for a public comment period. Then they must publish the final rule 30 days before it becomes effective. Meanwhile, OTC cough and cold medicines could continue to be marketed to children younger than 6.

The legislative proposal would allow the FDA to bypass these procedures when a drug under monograph is found to pose a significant risk or after an advisory committee meeting shows a drug under monograph lacks evidence of effectiveness.

The bill, which had not been assigned a number as of press time, is available at oversight.house.gov/documents/20071106143446.pdf.