The FDA was petitioned by pediatric experts and consumer groups on Thursday to pull off the market, or at least make available subscription-only, children’s over-the-counter cough and cold subscription medicine, due to potential grave side-effects. The FDA is in no hurry though, and said that although they would change the decades-old federal regulations governing the drugs’ distribution, it would take a long time, perhaps years.
Thursday the FDA called a meeting with the interested parties in order to discuss how the regulations should be changed. The new proposed regulations would exert tighter control on drug makers, requiring them to seek approval for their over-the-counter drugs, in a similar manner to prescription drugs.
The change is needed, experts say, because the current legislation, which was designed to grandfather 1960s over-the-counter medicine by making certain active ingredients – those found in decongestants included – to not require FDA approval for each product, have been found to be faulty where children are concerned. Studies that established their safety were done mostly with adults, and safe doses for children were simply calculated by reducing the adult dosage.
While the agency does recognize the inherent inflexibility of current regulations, and the need to change them, it is wont to outright ban the children’s cough medicine, for fear that it will simply prompt parents to switch to adult medicine, an option which is even worse. It has however offered a range of alternative measures that should remedy the situation, such as stricter labeling and packaging requirements, and an awareness raising campaign among consumers.
"Parents should know that there is less evidence than ever to support the use of over-the-counter cough and cold medicines for young children said Baltimore’s City Commissioner of Health, Dr. Joshua Sharfstein.