EMA Officials Caution Peers on Regulatory Risk Aversion

Senior European Medicines Agency (EMA) officials are cautioning their peers that when it comes to making regulatory decisions, high levels of risk aversion may do more harm than good.

Overevaluating a drug might actually lead to denial of marketing authorizations, market withdrawals or restrictions on uses of drugs that could turn out to cause more good than harm, the officials say in an editorial published Friday in Nature Reviews Drug Discovery.

The authors note the importance of being comfortable with a certain level of uncertainty, considering drugmakers’ limited R&D resources. And asking drugmakers for too much data could restrict their resources for other projects that might benefit public health, the officials say.

“The negative consequences of regulatory tolerance in allowing drugs onto the market that turn out to be unsafe are obvious, but the potential for adverse effects on public health owing to the absence of new drugs because of regulatory risk-aversion is less apparent,” says the article.

Therefore, the authors make the following suggestions to their regulatory peers:

• Determine ways to include public viewpoints on acceptable risk linked to medicines;

• Develop methods to include value judgments alongside hard data in evaluation standards;

• Elaborate on the “tolerability of risk” while addressing the absence of zero-risk scenarios;

• Develop tools to enable real-time knowledge generation; and

• Give regulators latitude to bring “opportunity costs,” defined as the unwillingness to accept some uncertainty, into standards.

The authors of the article include Hans-Georg Eichler, the EMA’s senior medical officer, and members of the agency’s Committee for Medicinal Products for Human Use.

Access the article at www.nature.com/nrd/journal/vaop/ncurrent/full/nrd4129.html. — Lena Freund

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