FDA Official Voices Risk Management Concerns

The FDA is growing increasingly concerned about its own practice of requiring companies to provide risk management plans (RMPs) as a condition of drug approvals, a high-ranking agency official said last week.

The FDA believes that RMPs, while important in some instances, may be too prevalent, Scott Gottlieb, the agency’s deputy commissioner for medical and scientific affairs, said in a June 12 speech before the American Medical Association. As the requirement for RMPs becomes more pervasive, the burdens could become too much for physicians and their patients. “I worry about the future,” he said.

An RMP is a method the agency uses to assess the risks and benefits of a drug and minimize the risks while maximizing the benefits. But Gottlieb believes these plans — which many times include physician training programs for proper use of the drug, public notices about its dangers and drug registration programs — could become too much of a burden and restrict doctors’ discretion.

Risk View Too Narrow?

Meanwhile, regulated life science companies are waiting for the FDA to clarify, and perhaps loosen, its risk assessment requirements for erecords, company officials and consultants have told PIR. While these latest agency comments refer to risk and drugs, some told PIR they hope it also represents a preview of a “kinder, gentler” FDA approach to risk assessment in erecords, too.

“The more we promulgate plans that attempt to guide or even control [medical] decisions, the more we encroach on professional autonomy,” Gottlieb said. This is especially problematic when busy clinics do not have the time to go through the various steps these plans require, he added.

Industry groups such as PhRMA have also expressed concerns with the burden RMPs can represent. The group has argued that while it supported the idea of RMPs, the agency needs to ensure that they do not impose overwhelming burdens on the medical community. “Care must be taken not to overburden the healthcare system by using too many resource-intensive tools in RMPs,” the group said in a risk management presentation.

Both the FDA and the medical community are to blame for this trend, Gottlieb told PIR in a follow-up interview. While doctors have not always done everything possible to police themselves, the agency has not always created opportunities for physicians to be involved in ensuring safe drug use, he said.

Seeking Better Cooperation

The agency believes that greater cooperation between the FDA and the medical community is the solution. “I believe some of the same safety goals embodied in the RMPs could be achieved if we had more ability to collaborate more closely and effectively with physician organizations,” he added.

To reach this goal, the agency is working to establish an office that will ensure more regular collaboration and communication about clinical issues with medical organizations, Gottlieb said. Terry Toigo, the agency’s acting associate commissioner for external relations, is heading the team that is developing this new office, he added.

Gottlieb raised his concerns at a time when the agency has made RMPs a common requirement in granting drug approvals. For example, the FDA recently allowed multiple sclerosis drug Tysabri to be sold after the product was pulled from the market, but only if the company provided an RMP. — Stephen Langel, Michael Causey