New European Laws to Improve Child Drug Safety
Financial incentives for high-quality pediatric drug research
FRIDAY, Dec. 14 (HealthDay News) -- Legislation introduced by the European Parliament will help the pharmaceutical industry to produce high-quality research into pediatric use of drugs and should stimulate interest in pediatric clinical pharmacology, according to an editorial in the Dec. 15 issue of BMJ.
Imti Choonara, M.D., of the University of Nottingham in Nottingham, U.K., writes that a number of studies in the past 10 years have revealed the widespread practice of unlicensed or off-label prescribing to children, and that extensive consultation by the European Parliament on the issue led to the new legislation in December 2006.
The new laws take account of the higher costs incurred in developing drugs for children, and offer drug companies financial incentives to produce high-quality research in this field, with extended patent protection for drugs that have been subjected to a pediatric investigation plan.
"The financial incentives are considerable, but experience in the United States has shown that the drug industry is more likely to study drugs that are prescribed extensively in adults and generate the most profit than those that infants and children require clinically," the author writes. "The European Medicines Agency and its pediatric committee will be responsible for ensuring that the drugs studied will benefit children and will not just provide the most profit to drug companies."