The Pharmaceutical Journal
Vol 279 No 7475 p458
27 October 2007

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Regulators should encourage development of better drugs

European medicines regulators should change their focus so that the licensing system encourages the development of better medicines. This is the view of two Italian researchers writing in last week’s BMJ (2007:335:803).

Silvio Garattine and Vittorio Bertele’, director and head of the regulatory policies laboratory at the Mario Negri Institute for Pharmacological Research, Milan, respectively, believe that it is wrong that manufacturers only have to show that new medicines are of good quality, safe and effective, independent of any reference to comparator drugs that might already be available.

This engenders, they say, overuse of placebo trials and comparator trials that are designed to show only equivalence or non-inferiority to current treatments, rather than that a new drug offers better treatment.

They say: “It is unethical to experiment on patients with the sole aim of obtaining a marketing authorisation. New drugs should be required to have some added value (greater efficacy or less toxicity) to current treatments or be cheaper.”

They state that the US Food and Drug Administration is apparently changing its mind on the suitability of non-inferiority trials and hope that the European Medicines Agency will follow the same path.

They are also concerned that reports prepared by manufacturers for regulatory authorities tend to maximise the benefits of a new drug and minimise its risks. They suggest that this tendency should be balanced by a requirement that independent research be conducted by non-profit organisations.

“For example, the regulatory agency could require one phase III trial (usually two pivotal trials are needed) to be planned and carried out by an independent organisation credited by the agency, particularly for drugs that are going to be reimbursed by national health services.”