Leaders Lead

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  • 08/18/2014

FDA Should Lead Ongoing Opioid Debates, Former Agency Official Says

FDA Week                                                                                                                                         
By Stephanie Beasley 

Former FDA Associate Commissioner for External Relations Peter Pitts said the agency has been too quiet in escalating debates about opioid regulation and has missed recent opportunities to explain the science behind its decisions. FDA should be the lead voice on the issue of abuse deterrence and safe use of opioids but instead the conversation has been dominated by state and federal lawmakers, lawyers and advocacy groups, said Pitts, now president of the Center for Medicine in the Public Interest.

In "Who 'Lost' Opioids?" -- an article that appears in the July issue of the Journal of Commercial Biotechnology -- Pitts said FDA is losing the "struggle" to control the national conversation about opioid abuse. He said lawmakers, state attorneys general, medical groups and others have pushed FDA to reverse it's recent approval of pure hydrocodone Zohydro and for the agency to require all opioids be abuse deterrent. But the agency's scientific basis for not taking those actions has been overlooked, he said.

He notes that during testimony in the Senate earlier this year, FDA Commissioner Margaret Hamburg indicated that the agency would be reluctant to require all opioids use abuse-deterrent formulations until there is more evidence to prove they actually deter abuse. Further, he notes that while many critics of FDA's Zohydro approval have correctly cited the fact that the decision was made against the recommendation of an advisory committee, they failed to mention that the experts also affirmed there was no evidence suggesting Zohydro had greater abuse or addiction potential than other opioids.

FDA needs to bring more attention to these factors and talk about what it is doing to progress abuse deterrent opioid development, he said. "The FDA needs to continue to speak out regularly on what it is doing to help further the initiatives that it has put in place," Pitts told FDA Week. "The FDA has many, many important issues to address and opioids is only one of them, but this doesn't excuse either inaction or lack of communications. Leaders lead."

He said, for example, FDA could have spoken about progress made on abuse deterrence when it approved Purdue Pharma's abuse-deterrent oxycodone last month (see FDA Week, July 24). That was a missed opportunity to talk about the significance that kind of drug might have on the development of abuse-deterrent formulations, Pitts said. He added that FDA has also been meeting with opioid manufacturers to address issues related to abuse deterrence but has provided no information about what solutions have been proposed or when they might be implemented.

In September, FDA updated the Risk Evaluation and Mitigation Strategy for extended-release opioids to require a statement that the products were appropriate for pain severe enough to require daily and continual long-term treatment, among other changes. The agency also issued guidance on abuse deterrence last year, but has yet to release a separate guidance for abuse-deterrent generics, although agency officials have said they do not plan to require generics use the same technology as innovators.

Pitts was also critical of lawmakers that have pressed the agency to reverse its Zohydro approval. Democratic Sens. Joe Manchin (WV) and Charles Schumer (NY) have been active on the issue. Manchin introduced a bill that would reverse the approval while Schumer has urged HHS to overturn the decision. Twenty-eight state attorneys general have also called for FDA to reverse its Zohydro approval.

"Whatever your position on the issue of opioids, the proper venue for this decision is not the office of the Secretary of HHS or the halls of Congress or the courts -- but rather the office of the FDA Commissioner," Pitts said.

He also took issue with groups like Consumers Union that are weighing in on the issue but that he said were ignoring the science behind FDA policy. Last month, CU's Consumer Reports released an article warning consumers about the dangers of painkillers and specifically asking FDA to reconsider its Zohydro approval and limit acetaminophen to 325 milligrams per pill. The group further said that while 90 percent of long-term chronic pain sufferers are prescribed opioids, there is little evidence that the drugs are beneficial or safe for long-term use. It is also safer to use short-acting opioids that stay in the body for less time and avoid taking large doses of acetaminophen, according to the article.

Pitts called the article "error filled" and criticized Consumer Reports for misrepresenting the information as fact-based and non-biased. But Lisa Gill, lead editor for the article, said the group stood by its story. It is important to remember that Consumer Reports is coming at the topic from a consumer, not regulatory perspective, she said. Gill added that the report was also released in direct response to Centers for Disease Control and Prevention data identifying opioid misuse and abuse as a public health crisis.

"The story evolved out of the CDC calling opioid abuse a public health crisis," Gill said. "Because it is still an issue we wanted to cover it in a profound way."

She said the point of the article was to address common misconceptions among consumers and help them make healthcare decisions and also noted that Consumer Reports does feel FDA could be doing more to address opioid abuse, like requiring prescriber education for providers prescribing Zohydro.

Pitts also called for more education on opioid dispensing and the development of best practices. Those best practices could be developed by continuing medical education groups and prescription drug monitoring programs, he said.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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