GlaxoSmithKline Plc, the U.K.’s biggest drugmaker, plans to appeal fines levied by Argentina’s government over a lack of documentation in a company-funded study of the Synflorix vaccine against pneumococcal disease.
Glaxo and two researchers working on the trial were fined 1 million pesos ($232,200) by the Argentinean National Administration of Medicine, Food and Technology, the newspaper La Nacion reported today. The agency cited the drugmaker for a lack of documentation of patient records and administration of medicines, breaches of security controls and irregularities in authorization for the children to participate, La Nacion said.
The fines related to “administrative conduct” of the trial, the London-based company said in an e-mailed statement. Glaxo said that it disagrees with the agency’s ruling and plans to appeal against court proceedings.
“It is important to note that the ANMAT’s ruling does not in any way question the safety of the study vaccine, Synflorix,” Glaxo said. “The ANMAT’s ruling relates to the clinical trial process and not the vaccine,” which was approved by the agency for sale in 2009.
The study, dubbed Compas, was completed in June in the Argentinean provinces of Santiago del Estero, Mendoza and San Juan, Glaxo said. Almost 24,000 children between the ages of 6 and 16 weeks were enrolled in the trial in Argentina, Colombia and Panama beginning in 2007, according to a description on the U.S. government website clinicaltrials.gov.
Synflorix had global sales of 221 million pounds ($346 million) in 2010, according to data compiled by Bloomberg.