Proposed FDA rules on painkillers in U.S. Rile cancer community.

Undertreatment of cancer pain remains a substantial problem, according to a new survey conducted by the American Cancer Society. Published in May, the survey found that 65% of interviewees had moderate or severe pain. Now, an initiative from the U.S. Food and Drug Administration could make it even more diffi cult for cancer patients to get adequate pain relief by limiting access to opioids, according to some oncologists. The impetus for this initiative was the FDA Amendments Act of 2007, which gave the agency authority to require a Risk Evaluation and Mitigation Strategy (REMS) for drugs and biologics if necessary to ensure that the benefi ts of an agent outweigh its risks. To carry out this mandate, the agency has proposed new rules requiring companies seeking approval for certain drugs — extended-release opioids containing morphine, fentanyl, oxycodone, hydrocodone, and methadone — to present a REMS. If a drug is already on the market, companies must submit a REMS as a condition of its continued sale. And if a company does not satisfactorily fulfi ll the new REMS requirements, the FDA can pull the drug from the market. The proposed rules are the FDA’s response to rising rates of prescription opioid diversion, abuse, and overdose, especially by teens and youth in their 20s, and it has the strong support of parent groups. But among oncologists and others in the cancer community, the measure has produced alarm and severe criticism. “We agree that there are dangers associated with these drugs, but they need to be available for cancer patients and we need to be able to prescribe them,” said Kathleen Foley, M.D., attending neurologist in the pain and palliative care service at New York’s Memorial Sloan – Kettering Cancer Center. With 1.5 million patients diagnosed with cancer each year, two-thirds of whom eventually have advanced cancer pain, and millions of cancer survivors who have treatment-related chronic pain, the availability of opioids is a more signifi cant issue, Foley said. Others express similarly strong reactions to the FDA’s initiative. “We are terrifi ed about the impact the new regulations will have on our patients,” said Judi Lund Person, vice president of regulatory and state leadership at the National Hospice and Palliative Care Organization in Alexandria, Va. Sean Morrison, M.D., professor of palliative care at New York’s Mount Sinai School of Medicine, acknowledged that abuse of opioids was a problem. “But it is dwarfed by the cancer pain crisis.” In the FDA’s proposed rules, the REMS program would require that health care providers receive special training, pharmacies and practitioners receive special certifi cation, drugs be given to patients only in certain health care settings, and safe use be documented through lab tests. Patients using these drugs would also have to enroll in a registry. Still in the formative stage, the REMS initiative was the subject of several meetings this spring between the FDA and stakeholders. Questions for consideration appeared in the April 20 Federal Register . By the time the period of public comment closed on June 30, the agency had received more than 800 submissions, an indication of how seriously stakeholders are taking REMS, said Sidney Scholl, M.D., Ph.D., clinical professor of internal medicine and psychiatry at the Medical College of Virginia in Richmond.