In response to a citizen petition submitted by clinical pharmacologists from around the U.S., the FDA is seeking comment on specific questions relating to the use of pain drugs containing codeine in children younger than 12 subsequent to CYP2D6 genetic testing. Currently, such drugs are contraindicated for children in that age group. The citizen petition asked the agency to rethink that stance as children younger than 12 who are in acute pain may not be able to access appropriate opioid painkillers, according to a notice published in Monday’s Federal Register. Codeine is partially metabolized to morphine through the CYP2D6 pathway, a polymorphic enzyme that can lead to a high degree of variability for metabolism of codeine because of underlying genetic differences. Because of that variability, patients may be at risk for therapeutic failure or for opioid-related toxicity. Comments should be submitted to Docket No. FDA-2020-N-1046 by Aug. 28, 2020.
The FDA issued a draft guidance Monday on developing anti-infective drugs for children. Besides providing general recommendations on the pediatric development of the drugs, the draft discusses the timing of initiation of pediatric trials, enrollment strategies, extrapolation of efficacy and other considerations. Comments on the draft should be submitted to Docket No. FDA-2020-D-1518 by Sept. 29, 2020.