June 1, 2010

DRUG INDUSTRY DAILY

Overly Complex REMS Can Be Too Burdensome
FDA News
Drug Industry Daily

When developing a risk evaluation and mitigation strategy (REMS), drugmakers and the FDA should ensure that its requirements are not too burdensome for physicians and patients.

A case in point is the iPledge patient-registry program that was required as part of the REMS for Accutane (isotretinoin), used to treat severe nodular acne. The registry added work for doctors and patients with little perceived benefit, Edward Fotsch, CEO of PDR Network, which publishes the Physicians Desk Reference, said during a Regulatory Affairs Professionals Society webcast last week.

Designed to educate patients about the dangers of becoming pregnant while taking isotretinoin, Roche’s iPledge program was the most rigorous risk management program approved by the FDA (DID, Aug. 2, 2007). As a result of the program’s requirements, Accutane prescriptions dropped by nearly 50 percent, Fotsch said. “It may have been well-intentioned, but nonetheless it was additional work that was unreimbursed,” Fotsch said.

Overburdening physicians and patients is one of the problems the FDA is trying to solve, using its classwide REMS for opioids as something of a test project, Susan Nicholson, the pharmacovigilance strategy leader for North America pharmaceuticals scientific affairs at Johnson & Johnson, said during the webcast. “The complexity of the REMS itself really speaks to the complexity of the planning that needs to go into the launching, assessing and being ready to mitigate [the REMS] in case there are any problems,” she said.

Drugmakers are not without resources in producing effective REMS. Fotsch advised using patient advocacy groups, such as the American Cancer Society, to develop communication plans and ensure REMS requirements are not overly burdensome. Advocacy groups have asked to be included in the REMS development process. The American Society of Clinical Oncology, for instance, sent a letter to the FDA last month citing concerns that it had been excluded from the agency’s development of a classwide REMS (DID, April 15).