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Revisit standards for approving long term drugs

BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f1927 (Published 26 March 2013) Cite this as: BMJ 2013;346:f1927

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The European Medicines Agency (EMA) approved 200 brand new drugs between 2000 and 2010. The 161 standard medicines—not orphans—included 84 destined for long term use, by patients with asthma, for example. A review of the regulator’s public reports found that standard drugs had been tested in a mean of 1708 volunteers and patients before approval. More than half had been tested in fewer than 2000 people, and 20 had been tested in 500 or less.

The 84 drugs for long term use had been tested in a mean of 2338 volunteers and patients before approval. They weren’t tested for long enough to establish safety, say the authors. There are no hard and fast rules, but European and US regulators both follow international guidance recommending that at least 1000-1500 patients receive drugs for long term use before approval, including at least 300 treated for six months and at least 100 treated for 12 months. Four fifths of new long term drugs in the review met these standards (69/84 for six months and 67/84 for 12 months), and the authors think the recommendations should be more demanding. The total number of people exposed to drugs before approval has changed little since the 1980s. A re-evaluation is long overdue.

Notes

Cite this as: BMJ 2013;346:f1927