Pharma seeks FDA clarity on risky drug safeguards

The US Food and Drug Administration should better explain its reasons whenever it requires additional safeguards for risky drugs, a pharmaceutical industry group said on Monday. That recommendation is one of dozens expected this week at a public meeting on the FDA's risk evaluation and mitigation strategies, or REMS, a set of tools to protect consumers from drugs with potentially serious side effects. Among the FDA's tools are requiring drugmakers to provide information about those risks to patients and healthcare providers.

The Pharmaceutical Research and Manufacturers of America, the major industry group, said that patients and provider groups often are confused about why precautions are put in place or find their use inconsistent or burdensome. "So we just are asking for the FDA to be more straightforward within its communications to describe the risks that are being mitigated in addition to describing the benefits of the drug," said Jeffrey Francer, assistant general counsel for the industry group, known as Pharma. The FDA declined to comment in advance of the hearing. The tools are among new FDA powers included in a 2007 law. Since the law took effect in 2008, the FDA has mandated risk-minimising strategies for more than 120 drugs.