July 26, 2010 / 8:07 PM / 9 years ago

Pharma seeks FDA clarity on risky drug safeguards

WASHINGTON (Reuters) - The U.S. 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 are often 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 PhRMA.

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-minimizing strategies for more than 120 drugs.

The FDA’s most common requirement is a medication guide, which outlines the most important risks in plain English. Less frequently the FDA demands stricter measures, such as training and certification of physicians who prescribe the medications.

For example, patients taking the painkiller OxyContin, made by privately held Purdue Pharma, must receive a guide describing the risk of addiction, while physicians must go through training before prescribing it.

The companies also have to conduct patient and provider surveys to see if the measures are effective.

PhRMA said that the FDA should implement the medication guides outside of the REMS framework, something the agency has done in the past. That would eliminate the burden of evaluating the guides, PhRMA’s Francer said.

“This improvement would enable the FDA to focus its resources on implementing REMS for medicines with the highest risk and decrease burdens on patients, health care professionals and the FDA itself,” Francer said.

Among those expected to attend the hearings on Tuesday and Wednesday are researchers, industry groups and representatives of companies such as Eli Lilly and Co and CVS Caremark Corp.

The two-day hearing is intended to get input on proposed FDA guidance but will not result in any immediate changes.

Reporting by Jon Lentz

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