FDA Endorses CDC Opioid Guidelines

By Pat Anson, Editor

In a move that may have more to do with politics than healthcare, the U.S. Food and Drug Administration has set aside the advice of its own experts by endorsing the CDC’s controversial guidelines for opioid prescribing.

The move is part of several sweeping changes the FDA is making in its opioid policies, including some that the agency has resisted in the past. The most significant change is support for the CDC’s proposed opioid guidelines, which are designed to combat the so-called epidemic of opioid addiction and overdoses.

“We are determined to help defeat this epidemic through a science-based and continuously evolving approach,” said Dr. Robert Califf, FDA Deputy Commissioner for Medical Products and Tobacco.

“Things are getting worse, not better, with the epidemic of opioid misuse, abuse, and dependence. It’s time we all took a step back to look at what is working and what we need to change to impact this crisis.”

Califf’s nomination to be the next Commissioner of the FDA has been held up in the U.S. Senate, in large part by senators who want the FDA to go much further than it has in restricting access to opioid pain medication.  



“We need to change the culture of the FDA, and that will not happen if the person at the helm is not a champion who is committed to pushing back against the pressure to continually approve new opioid medications given the significant risks to public health,” said West Virginia Sen. Joe Manchin (D), who has criticized Califf for his ties to the pharmaceutical industry and threatened to filibuster his nomination.

In a news release issued late Thursday, Califf said FDA would “re-examine the risk-benefit paradigm for opioids,” use tougher language in warning labels on extended release opioids, and prioritize development of non-opioid alternatives for pain.  The FDA also promised to convene an expert advisory committee before approving any new drug applications for opioids that do not have abuse deterrent properties, one of Manchin's key demands.   

“I was very disappointed that Califf would release a statement like this as talk of blocking his nomination for FDA Commissioner grows in the Senate amid concerns that he was ‘soft’ on a range of issues, including genetically modified salmon, e-cigarettes, and regulation of opioids,” said Anne Fuqua, a chronic pain sufferer and patient advocate.

“I am concerned his desire for career advancement is interfering with the oath he took to ‘first do no harm’ when he became a physician.  This statement is heavily focused on the potential harms of opioids. Though it says they will seek to balance individual and societal risks, it seems that the need to prevent people from making poor choices will be given priority over providing care to individual pain sufferers for whom opioid therapy has proven to be an essential element of care. “

The FDA’s opioid policy changes are further outlined in a “special report” in the New England Journal of Medicine that was co-authored by Califf.

“We will start by launching a broad reexamination of our approach, considering how best to apply existing policies to this problem, which policies need to be improved and updated, and whether new policies must be developed,” Califf wrote.

“Accordingly, we are supporting the CDC’s Guideline for Prescribing Opioids for Chronic Pain. The draft guideline received extensive public comment, and we look forward to participating in the process when the CDC finalizes it soon. We are also supporting the Surgeon General’s efforts to engage the clinical community in a concerted approach to curbing inappropriate prescribing and proactively treating opioid addiction, while reinforcing evidence-based approaches to treating pain in a manner that spares the use of opioids. Until clinicians stop prescribing opioids far in excess of clinical need, this crisis will continue unabated.”

Some of the FDA’s own experts have been highly critical of the CDC’s proposed guidelines, which discourage primary care physicians from prescribing opioids for chronic pain. As many as 11 million Americans use opioids daily for chronic pain and many fear losing access to them if the guidelines are adopted.

“I think we need to recognize that CDC wants to substantially limit opioid prescribing. Period,” said Sharon Hertz, director of the FDA’s Division of Anesthesia, Analgesia and Addiction Products, at a December meeting of a federal pain research panel. Hertz said the evidence cited to support the guidelines was “low to very low and that’s a problem.” Other panel members said they were “appalled” by the guidelines, calling them an “embarrassment to the government.”

The CDC planned to implement the guidelines last month, but delayed doing so after widespread complaints about its secrecy and lack of transparency during the guidelines' development. The CDC is now reviewing changes to the guidelines recommended by an advisory committee.

“I guess it shouldn't surprise me that the FDA is selling out by endorsing the CDC guidelines,” said Kim Miller, a pain sufferer and patient activist. “Could it be the FDA was not wanting to be made to look irrelevant in light of the CDC taking care of what many see as the FDA’s territory? Either way, it's an extremely gloomy looking horizon if you're a pain patient. Just when you think it can't get any worse, it always does.”

"It is a sad day for chronic pain patients in this country. The unintended consequences of these guidelines will bring about a true epidemic; not the media manufactured so-called epidemic of overdoses from opioids," said Chrystal Weaver, a Florida woman who suffers from Complex Regional Pain Syndrome. "The last figure I heard quoted for veterans taking their life is around 42 per day. When you take away the only tool we have to help lessen the pain from war injuries you'll see that number skyrocket from 42 per day to perhaps 500 per day. It will be the same story for non-veterans as well."

Earlier this week, the Obama administration said it would ask Congress for $1.1 billion in extra funding to help fight the opioid abuse epidemic. Most of the money would be used on expanding addiction treatment programs.