Lancet: EMA needs better transparency for licensing, drug decisions

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The European Medicines Agency (EMA) has failed to release documentation of severe adverse events that have the potential to occur with certain medicines and also on its decisions to license rosuvastatin, hindering transparency, according to an editorial featured in the May 22 issue of the Lancet.

According to the editorial, on April 22, 2008, Liam Grant of Dublin submitted a complaint asking the EMA report on serious adverse reactions to the drug isotretinoin, used to treat severe acne, after his son committed suicide in 1997 while on the drug.

Grant reportedly asked EMA to provide further information of adverse drug effects including: death, life-threatening illness, requires hospital admission, or causes congenital anomalies, birth defects or disabilities or incapacities.

According to the editorial, “These requests were refused by EMA, which argued that EU transparency rules did not apply to serious adverse reaction reports.”

After refusal from the EMA to agree to the transparency actions, Grant brought his complaints to Nikiforos Diamandouros, European ombudsman, who called on EMA to reconsider their refusal.

“The Ombudsman concluded that EU rules on access to information apply to all documents held by EMA,” the editorial stated. “In his view, this rule does not mean that adverse reaction reports must automatically be accessible, since some exceptions contained in the transparency rules might apply.”

Diamandouros urged that the EMA review their policies and refusal on the issue and suggested that they “provide additional context designed to render such data and their significance more readily comprehensible by the public.”

Additionally, a letter published in the same issue of the Lancet written by Paul M. Ridker and Robert J. Glynn, of the Brigham and Women’s Hospital and Harvard Medical School in Boston, said that the EMA licensed and approved rosuvastatin (Crestor, Astrazeneca) for the prevention of major cardiovascular events (MACE) for patients at high risk for a initiate CV event based on post-hoc subgroup analysis rather than on results of the JUPITER trials primary endpoints.

"Although we believe this expanded indication for statin therapy to be a move in the right direction, it should be noted that this regulatory recommendation was not made on the basis of the trial’s prespecified primary endpoint, did not take into account the enrollment criterion in JUPITER that required all participants to have an hsCRP of 2 mg/L or greater, which augmented absolute risk, and does not address most of the patients actually studied," the authors wrote.

The editorial suggests that the EMA implement improved transparency initiatives that would alleviate these problems much like the FDA did after it formed an internal Transparency Task Force to provide the public with information regarding drug approvals and other matters.

“Citizens of EU member states should welcome and support transparency initiatives within EMA, which might bring about more openness on licensing decisions and suspected adverse reactions,” the editorial stated.

“Since EMA plays an important part in the supervision and approval of medicines in the EU market for the benefit of public health, it should consider providing the widest possible public access to the requested reports in any form, including web-based resources, and pursue a proactive information policy for the public.”

According to the Lancet, the EMA is set to respond to Diamandourous’s demands by July 31.