EU Ombudsman: EMA Acted Properly in Rejecting OTC Migraine Medicine

The European Medicines Agency acted properly in rejecting a UK-based pharmaceutical company’s over-the-counter migraine medicine, the European ombudsman says.

The drugmaker, which remains anonymous in ombudsman proceedings, turned to the ombudsman in February 2013 after the EMA’s Committee for Medicinal Products for Human Use declined to recommend its drug in July 2011 and then again in February 2012.

The committee claimed that the OTC drug poses too many safety risks — including serious cerebrovascular and cardiovascular adverse events — to market without the medical monitoring and supervision that come with a prescription drug.

Erik Vollebregt of Axon Lawyers in the Netherlands said that since the company had allowed the three-month appeal period following the February 2012 rejection to lapse, it had no other option than to turn to the ombudsman. The outcome of the review was not unexpected, Vollebregt said.

The company challenged the EMA on three issues: (1) the agency’s failure to consider results from a bioequivalence study the drugmaker had submitted in support of its application; (2) its refusal to honor the drugs’ approval by individual EU member states based on the very same study; and (3) failure to take into account that the marketing authorization application was restricted to patients previously diagnosed with migraines.

The agency responded that risk minimization measures proposed by the company failed to allay the CHMP’s concerns and that its submitted study was not GCP-compliant.

In addition to supporting the EMA’s decision, the ombudsman took the unusual step of urging the agency to notify member states that they had approved the drug on the basis of a bioequivalence study that the EMA found violated GCP requirements. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.