A report from the European Ombudsman calls on the European Medicines Agency (EMA) to increase the transparency surrounding its pediatric medicines testing requirements after finding an inconsistent application of regulations and a lack of disclosure from the agency.
The inquiry was launched after two pharmaceutical companies-kept anonymous in the complaint, but reportedly Takeda and AstraZeneca-complained they were subject to an unfair application of EMA's 2006 Paediatric Regulation, which is intended to increase the amount of medicines with information about safe prescribing in children. At the time of the regulation's passing, noted the Ombudsman, just 50% of medicines administered to children were specifically authorized, and had undergone testing, for pediatric use.
The two companies had applied for waivers to the Paediatric Regulations, arguing other companies manufacturing similar drugs were the recipients of waivers, and based on precedence they should be afforded the same leeway. EMA refused, and the companies filed a complaint with the ombudsman alleging the decision "Was not based on an objective and fair assessment and was not reasoned."
While the Ombudsman agreed EMA had the authority to make such a judgment, it nevertheless chided the agency for conducting its review process without "adequate transparency" and as a result "failed to provide adequate reasons for those decisions."
"In the Ombudsman's view, systemic changes are needed to avoid similar maladministration in the future," wrote the Obudsman, whose office released an accompanying draft recommendation for EMA to implement.
"[I]t is vital for paediatric patients, parents, and practitioners that the European Medicines Agency always correctly applies the Paediatric Regulation," explained the Ombudsman. "More generally, given the major societal implications of the Agency's work, it is vital that its stakeholders and European citizens trust the Agency and have confidence in its work."
EMA has been asked to respond to both the report and its recommendations by 30 September 2012.
EU Ombudsman - Draft recommendation of the European Ombudsman in his inquiry into complaint 2575/2009/(TS)(TN)RA* against the European Medicines Agency