When the U.S. Food and Drug Administration evaluates new drug products for possible approval, the review process includes a risk-safety analysis known as Risk Evaluation and Mitigation Strategies (REMS).
Kaiser Permanente, the nation's largest publicly integrated healthcare delivery system, says the FDA has improperly excluded health insurers and others out of the REMS process, which was designed to improve drug safety.
The REMS process has had a "substantial" impact on the healthcare delivery system, notably contributing to higher costs, Kaiser Permanente says. The company did not detail those costs.
The Oakland, CA-based-Kaiser Permanente made its argument in a citizen petition filed with the FDA, saying it wants the federal agency to revise its "standards, procedures and guidelines" in developing and implementing REMS to comply fully with the law governing the policy.
In its petition, Kaiser Permanente was sharply critical of the FDA, saying the agency's REMS actions are "unduly burdensome" and "providers and patients continue to have little or no input into the development of these programs, which are intended to enhance safety for certain hazardous drugs."
A citizen petition filing with the FDA is not unusual. Members of the public are allowed to file the petitions, in part, to prompt the FDA to take certain action. They can be accepted or rejected. FDA officials declined to comment on the Kaiser Permanente petition.
Kaiser Permanente urged the FDA to form an advisory committee to deal with the issue. Among other things, it also asked that drug companies "not use requirements in REMS programs to give preferential treatment to certain health care providers."
The Kaiser Permanente petition was signed by Benjamin Chu, MD, MH, MACP, regional president of the Southern California Kaiser Foundation Health Plan Inc., Kaiser Foundation Hospitals; Sharon Levine, MD, associate executive director of the Permanente Medical Group; and Jed Weissberg, senior vice president, Quality and Care Delivery Excellence, Kaiser Foundation.
Neither FDA nor Kaiser Permanente officials would discuss the citizen's petition. But REMS has been a controversial tool used by the FDA, triggering some complaints over the years, ranging from concern that REMAS has slowed down the drug approval process to statements that the FDA has not clearly defined its message.