FDA taken to task over opioid approval process

Back in June, the U.S. Food and Drug Administration (FDA) released a draft guidance for overhauling the opioid approval process, which one member of the audience said was woefully inadequate.

Michael Carome, director of Public Citizen's Health Research Group in Washington, claimed the FDA should have addressed the opioid crisis two years ago when the National Academies issued their recommendations in an article printed by the Louisville Courier Journal. Carome called the entire draft guidance inadequate because of its "cursory content" and "non-directive" nature, he told the newspaper.

"There is no sound medical reason for using a different approach for assessing the benefits and risk of currently marketed opioids than the agency uses for evaluating applications for future unapproved opioids," Carome told the newspaper.

Emily Walden, executive director of Fed Up Coalition, lost her son T.J. to opioid addiction in July of 2012.

“The FDA did not have any oversight of the misleading marketing of opioids, they failed to do their job by protecting public health and ensuring the safety of drugs,’’ Walden told FDA Health News. "In 2002, they started pay-to-play meetings with the pharmaceutical companies to change the clinical trials allowing for fast approvals of opioids and a total disregard for safety. The first example of this was the approval of oxymorphone in 2006, removed from the market in 1979 due to abuse, denied approval in 2003 for safety reasons, and only after clinical trial design changes, it was approved in 2006. The drug did not change from 2003 to 2006, and every opioid since then has used the same clinical trial 'enriched enrollment.'

Walden said the FDA also allowed for a label change to include chronic pain without scientific evidence, thus leading to long-term use and more prescriptions.

“There are long-term employees at the FDA who have been involved in these decisions from the beginning and continue to make decisions that further this epidemic such as continued approvals of new dangerous opioids and even the approval of oxy for children in the midst of this epidemic,’’ Walden said. “They have not taken any real actions to correct the past or to improve the future. Had they done their job from the beginning, we would not be where we are today. In the last couple of years they have taken blood pressure meds off the market due to potential cancer-causing agents, most recently Zantac, yet opioids have killed over 400,000 and [there's been] no real action to prevent deaths.’’

The Fed Up coalition started in 2012.

“We are families who have been ripped apart by opioids," the group's mission statement says. "We have lost loved ones to death or addiction. We are medical experts and advocates who understand that the root cause of the problem is overprescribing. This is a grassroots coalition, all seeking action from the federal government to bring this public health crisis to an end. We accept no money from pharmaceutical companies or their affiliates and 100 percent of the donations we receive are directly applied to managing the costs of holding our Fed Up rallies and coordinating our advocacy efforts. We are beholden to no one – except our lost loved ones or our family members struggling with addiction. We have come together to save lives."