Kaiser Permanente Charges FDA Drug Approval Process Excludes Healthcare Providers

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.

Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research has described REMS as "important safety strategies."

The law governing REMS is included under Section 505-1 of the Federal Food and Drug Administration Amendments Act of 2007 (FDAAA). FDA has the authority to require REMS if the FDA determines it is necessary to ensure that a drug's benefits outweigh its risks.

Under REMS, the FDA is required to obtain input from patients, physicians, pharmacists, and other healthcare providers "about how the elements to assure safe use for one or more drugs may be standardized so as not to be unduly burdensome on patient access to the drug," according to the petition.

REMS components include medication guides; patient package inserts; a communication plan for healthcare providers; requirements for those who prescribe, dispense, or use the drugs; and a timetable for REMS submission.

In the past three years, the FDA has approved about 90 REMS for new drugs and has required REMS for many new products. For the most part, it has failed to seek input from the public as stated under the law, Kaiser Permanente said.

"To our knowledge, neither of these statutory requirements have been met," according to Kaiser Permanente. "As a result, FDA is imposing REMS development without due consideration to existing healthcare delivery systems."