SUCCESS: Up-scheduling of Hydrocodone Combination Drugs

abuse and addiction. Medications containing hydrocodone (i.e. Vicodin) had been misclassified as Schedule III. At PROP’s first meeting with FDA in 2011, we advocated for correcting this mistake. We believed that placing these drugs in the correct category (Schedule II) would help reduce overprescribing, harm to pain patients, and inappropriately easy access for nonmedical use. We urged FDA to hold an advisory committee meeting to review scientific evidence on this topic.

In 2013, when the FDA finally held an advisory meeting on up-scheduling of hydrocodone combination drugs, we testified in favor of up-scheduling, submitted comments to the federal docket and encouraged PROP’s members and supporters to submit their own comments. The meeting resulted in a strong vote in favor of the change.

When the FDA failed to follow through on the vote of its scientific advisors, we joined a coalition of like-minded organizations and individuals for the 2013 Fed UP! Rally to demand that the FDA act on the vote. A few weeks after the rally, the FDA issued a formal request for the schedule change; hydrocodone combination drugs are now in the Schedule II category, where they belong.

PARTIAL SUCCESS: Opioid Label Changes

In 2012, PROP petitioned the FDA to narrow the indication (i.e., the appropriate uses of a medication) on opioid labels and to add a suggested maximum dose and duration of use. We did this because we wanted to end drug company marketing of long-term and high-dose opioids for common, moderately painful conditions (such as lower back pain), and we wanted to send a strong signal to the medical community that risks for patients may outweigh benefits when opioids are prescribed in this manner.

Our label change effort was strongly opposed by Purdue Pharma, Endo Pharmaceuticals, other opioid makers, their consultants and the pain organizations they fund. Our effort was strongly supported by consumer advocacy groups and by public health authorities in New York City, Los Angeles, Denver and other municipalities.

In September 2013, the FDA issued a response to our petition. The agency agreed to make changes to the label of extended-release opioids—changing the indication from “moderate to severe pain” to “pain severe enough to require…”—and added new warnings related to addiction risks and use during pregnancy. The FDA also agreed with our argument that evidence is lacking to support long-term and high-dose use. Instead of narrowing the indication in a manner that would end marketing of opioids for chronic pain (which was our primary goal), for the first time FDA required pharmaceutical companies to conduct post-marketing studies on long-term opioid use.

Inexplicably, the FDA limited all of its actions to extended-release opioids, leaving immediate-release opioid labels unchanged.

PARTIAL SUCCESS: State Medical Board Opioid Policies

When the Federation of State Medical Boards (FSMB), representing the 70 medical boards of the US and its territories, drafted a deeply flawed policy on opioid use for chronic pain, PROP spearheaded an effort to block its ratification.

Called the Model Policy on the Appropriate Use of Opioid Analgesics in the Treatment of Pain, its stated intent was to guide physicians on appropriate opioid prescribing. Unfortunately, the policy was similar to a previous version underwritten by pharmaceutical company grants to FSMB. The new version, released as a draft in 2013, had the same problems as the previous industry-funded version– it encouraged aggressive and inappropriate prescribing. Despite PROP’s concerns about the draft, FSMB planned to have it ratified at its annual meeting. PROP intervened by sending a letter to state medical board directors urging them to oppose the proposed policy and by reaching out to the Substance Abuse and Mental Health Services Administration.

Thanks to our efforts, the policy was not ratified, and FSMB agreed to make revisions. The final version of the model policy was improved but still has serious problems, including the false statement that “risk of opioid addiction is low.” PROP is continuing to advocate for improvements in the model policy.

UNSUCCESSFUL: FDA’s Opioid Risk Evaluation and Mitigation Strategy

In 2010, the FDA proposed its Extended Release/Long Acting Opioid Risk Evaluation and Mitigation Strategy (ER/LA REMS) program to an advisory panel. Despite the panel’s strong vote against the proposal, which requires drug companies to sponsor voluntary physician education programs, FDA went ahead with its plan. In 2011, the FDA issued its Blueprint, a draft curriculum for these programs. PROP voiced strong objections to the proposed curriculum, which we described in a letter signed by some of the nation’s leading experts in the fields of pain, addiction, primary care, public health, and other specialties. Unfortunately, the FDA refused to make changes to the Blueprint.

Today, ER/LA Opioid REMS programs are ubiquitous, and they are one of the main ways health care providers are informed about opioid prescribing. While some are better than others, many of the REMS programs leave clinicians with the false impression that opioids are a safe and effective for long-term use. And many are taught by faculty with significant industry relationships. PROP is continuing to monitor the situation and advocate for change.