Extended Risk Management Proposals Challenge Manufacturers - The FDA seeks new strategies for improving the safe use of opioids and other high-risk medicines, including erythropoiesis stimulating agen


Extended Risk Management Proposals Challenge Manufacturers
The FDA seeks new strategies for improving the safe use of opioids and other high-risk medicines, including erythropoiesis stimulating agents.

BioPharm International
Volume 22, Issue 7

To get the project started, the FDA invited 16 brand and generic firms, including Purdue and Johnson & Johnson's Ortho-McNeil-Janssen, to a meeting in March to discuss the goals and design of a REMS for the opioid class. An Industry Working Group of 25 companies was formed to hash out the details of a class REMS program. Another agency meeting in February with physicians, pharmacists, and patient advocates similarly aimed to elicit support from these groups for the opioid REMS project. FDA officials explained how the FDA and other government agencies regulate pain medications and how a class REMS program might be established.

Everyone voiced his or her proposals and concerns at an open public meeting in May. A panel headed by Douglas Throckmorton, deputy director of the Center for Drug Evaluation and Research (CDER), and John Jenkins, director of CDER's Office of New Drugs, heard from parents of teens who died from OxyContin overdoses, who demanded removal of these dangerous painkillers from the market. Representatives of the pain community, though, insisted on continued access to these medicines, and warned that restricted distribution systems and complex oversight programs could be harmful to patients and costly to the healthcare system.

Physicians supported additional training and certification for pain management, but raised concerns about potentially redundant educational programs. Pharmacists and distributors said they already had tight controls and tracking systems to prevent drug diversion and advised that any certification program should fit pharmacy workflows and be tied to the existing Drug Enforcement Agency (DEA) registration system. Hospital and nursing home pharmacists, moreover, sought exemptions from REMS restrictions for their closed treatment systems that they consider less open to abuse.

The opioid class REMS is unique in that it requires brand and generic manufacturers to collaborate on devising a single shared system to monitor safety and risks of dozens of products. Manufacturers supported the shared-system concept, but there is tension over how much cooperation there will be among competitors, including brand and generic firms. Some elements of the program may involve collaborative efforts, such as a system for confirming that patients have received appropriate information on pain treatment.


FDA officials hope to present a REMS proposal to advisory committees later this year. Meanwhile, Jenkins suggested that there might be some immediate actions that manufacturers could take while the agency finalizes and tests a long-term program. After the FDA issues a REMS proposal for these drugs, it will be up to each manufacturer to file an implementation plan and carry it out. The FDA says it won't hold up the review and approval of new opioid products in the pipeline while REMS development goes on, and will continue to grant priority review status to drugs in this class to speed new products to market.

Success with the opioid REMS may encourage similar FDA initiatives to enhance the safety of other risky medicines. The FDA is working with Amgen on a REMS for erythropoiesis stimulating agents. Manufacturers of botulinum toxin products have been advised to implement REMS programs to alert prescribers and patients to serious adverse events associated with expanded product uses. In recent years, the FDA has requested stronger label warnings and other risk management strategies for widely used drugs that raise safety concerns, such as COX-2 inhibitors, antidepressants, and anti-epileptics, and more REMS programs may be on the horizon for these widely used products.

Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634,

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