We support policies that promote cautious, evidence-based prescribing of opioids and other controlled drugs.

PROP Submits Comment to CDC Docket on Acute and Chronic Pain

In a comment to a CDC docket, PROP urges CDC to stay on course and NOT weaken its opioid prescribing recommendations.

PROP WEIGHS IN AGAINST FDA APPROVAL OF OXYCODEGOL

In a comment to the FDA docket, PROP urges FDA to reject Nektar Therapeutics new drug application for Oxycodegol.

HHS Pain Management Task Force

In 2015, when the CDC was finalizing its guideline calling for more cautious opioid prescribing, opioid makers did their best to block CDC from releasing the document. A Purdue Pharma-funded group threatened litigation against CDC and a Congressional Committee was asked by opioid front groups to investigate CDC. When they failed to block CDC from releasing the guideline, opioid makers came up with a new tactic- they lobbied for creation of the HHS Pain Management Task Force (PMTF) with representatives from opioid front groups. Their goal was to create alternative prescribing guidance that would compete with the CDC Guideline and they pretty much succeeded.

PROP sent Secretary Azar a letter expressing our concern about the draft report after an early draft was made public. Senator Wyden also sent Secretary Azar a letter outlining concerns about financial ties between some of the PMTF members and opioid makers.

When a draft of the reports was posted to a federal docket, PROP submitted a comment detailing some of our concerns.

We believe that PROP’s advocacy led to minor improvements – for example, some of the language that explicitly contradicted the CDC Guideline was removed. But overall the final report is still a step backwards. It includes language supporting the dangerous and inappropriate combination of opioids and benzodiazepines and language opposing guidance for prescribers on dose and duration.

PROP JOINED OTHER GROUPS PETITIONING THE FDA FOR REMOVAL OF ULTRA HIGH DOSAGE UNIT OPIOIDS

On August 31, 2017, International Overdose Awareness Day, PROP joined the Association of State and Territorial Health Officials (ASTHO), the FED UP! Coalition, National Safety Council and Shatterproof in a petition to the FDA for the removal of ultra high dosage opioids from the market.

View news coverage of the petition: TODAY Show, CNN, The Seattle Times, Markets Insider, MedPage Today,

Read the Petition

Read the Fact Sheet

PROP URGES FDA TO FIX OPIOID REMS PRESCRIBER CURRICULUM

PROP submitted a comment letter to the federal docket urging FDA to fix its draft curriculum for the opioid REMS. FDA’s draft curriculum is not consistent with recommendations from the CDC and the VA/DOD calling for more cautious prescribing.

CMS responds to PROP petition on patient satisfaction

We are pleased to announce that CMS has agreed to remove the financial incentive for prescribing pain medication. Starting in October 2017, scores on the pain medication questions will be removed from Hospital Value-Based Purchasing Program. CMS wrote in its letter to PROP, “We believe this will help eliminate any unintended confusion and pressure to overprescribe pain medication.”

We are grateful to the all the hospitalists, emergency medicine docs, nurses and other folks who brought this issue to PROP’s attention.

Joint Commission Responds Defensively to PROP Request for revised pain standards

Last spring, when PROP petitioned CMS, the same coalition of organizations, state health officials, and medical experts sent The Joint Commission (TJC) a letter requesting revisions to their pain standards. Unfortunately, TJC responded defensively to our request. It issued public statements denying any relationship between its Pain Management Standards and opioid overprescribing.

TJC even denied having participated in the ‘Pain is the Fifth Vital Sign’ campaign, which is strange because the slogan was used in widely distributed Joint Commission materials.

The Opioid Lobby Spent $880 Million to Influence Federal and State Government

The Associated Press and the Center for Public Integrity teamed up to investigate the influence of pharmaceutical companies on state and federal policies regarding opioids. The news agencies tracked proposed laws on the subject and analyzed data on how the companies and their allies deployed lobbyists and contributed to political campaigns. Findings from their investigation were published as a two-part series carried by newspapers across the US and abroad. You can click here to learn more about the investigation.

PROP petitions CMS for removal of the HCAHPS pain questions

HCAHPS Letter- Final 04 11 16

Pursuant to section 553(e) of the Administrative Procedure Act, the undersigned organizations and individuals submit this Petition requesting that the Centers for Medicare and Medicaid Services (CMS) remove questions pertaining to pain treatment from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey.

PROP organizes coalition seeking changes to Joint Commission’s Pain Standards

TJC Letter – Final 04 11 16

The undersigned organizations and individuals are writing to request that the Joint Commission reexamine the Pain Management Standards (PC.01.02.07, PC.01.02.01 RI.01.01.01). Although we commend TJC for its recent clarification of PC.01.02.07, affirming that treatment strategies may include non-pharmacological approaches, we believe the Pain Management Standards continue to encourage unnecessary, unhelpful and unsafe pain treatments that interfere with primary disease management.

Bill to de-link HCAHPS pain questions from hospital reimbursement, PROP Act, receives bi-partisan support

Sen. Ron Johnson (R-Wis.), joined by his colleagues Sens. Joe Manchin (D-W.Va.), John Barrasso (R-Wyo.) and Richard Blumenthal (D-Conn.), introduced legislation Thursday to reduce the pressure doctors currently face that may lead to overprescribing painkilling drugs called opioids.

PROP comments on the draft National Pain Strategy

Last May, PROP submitted a comment to the National Institutes of Health on its proposed National Pain Strategy. We objected to the proposal for a so-called “safe use campaign” for opioid prescribing and instead called for an educational campaign that discourages opioid use for conditions where risks are likely to outweigh benefits.

PROP’s position on Federal Bills

Bipartisan legislation introduced by Senator Joe Manchin (D-WVa) on April 15, 2015. Co-sponsors include Tim Kaine (D-Va), David Vitter (R-LA) and Shelley Moore Capito (R-WVa). The bill requires the FDA to establish an advisory panel for each application submitted to the FDA for approval of an opioid drug and report to congress any instance where approval is recommended when inconsistent with the advice of the panel. A drug approved inconsistent with the recommendations of the advisory panel shall not be introduced or delivered for introduction into interstate commerce until the report describing the approval has been submitted to Congress.

Bipartisan legislation introduced on July 30, 2015, by Senator Pat Toomey (R-PA) with co-sponsors Joe Manchin (D-WVa), Tim Kaine (D-VA), Sherrod Brown (D-OH), Rob Portman (R-OH). This bill would authorize the use of patient review and restriction (PRR) programs in Medicare, which can help prevent prescription drug abuse among beneficiaries. The use of PRR programs will assign patients who are at-risk for opioid dependence to predesignated pharmacies and prescribers to better manage appropriate care and monitor prescriptions of opioid drugs for Medicare beneficiaries.

The bill would limit the DEA from suspending the registrations of entities that pose an “imminent danger to the public health or safety.” This bill was lobbied for by corporations that distribute and sell opioid analgesics. We are opposed because it limits the authority of the DEA to suspend the registration of DEA registrants (manufacturers, wholesalers, retailers, pain clinics) who may be putting the public at risk.

This bill is bipartisan legislation introduced by U.S. Senators Edward Markey (D-Mass) and Rand Paul (R-Ky) on May 22, 2015, which will expand treatment for those suffering from prescription drug and heroin addiction. A companion bill was introduced in the House of Representatives by Representatives Brian Higgins (D-N.Y.), Richard Hanna (R-N.Y.), Paul Tonko (D-N.Y.), and John Katko (R-N.Y.). The legislation would expand the ability of addiction medical specialists and other trained medical professionals to provide life-saving medication-assisted therapies such as buprenorphine for patients battling opiate addiction. The bill will raise the limits on the number of patients a physician or nurse practitioner may treat from 30 to 100 in the first year and with no limit thereafter. Those providing treatment must receive additional training in addiction, use the Prescription Drug Monitoring Program (PDMP) and administer treatment in a qualified practice setting with defined oversight.

This legislation was re-introduced on February 15, 2015, by U.S. Senators Sheldon Whitehouse (D-RI) and Rob Portman (R-OH) and was co-sponsored by 13 additional Senators. A House of Representatives companion bill, HR 953 has also been introduced. This legislation will expand prevention and education efforts, expand access to the overdose-reversing drug Naloxone, support alternative treatment in lieu of incarceration, strengthen the Prescription Drug Monitoring Program and support expansion of the use of evidence-based treatment medications. CARA 2015 designates up to $80 million toward these efforts.

Bipartisan legislation introduced on June 23, 2015, by Senators Harry Reid (D-NV) and Dick Durbin (D-IL) with co-sponsors Leahy (D-VT), Markey (D-MA) and Whitehouse (D-RI). Companion bill offered in the House by Representative Edwards (D-MD), Carney (D-DE) and others. This bill amends the PHS Act to require SAMHSA to enter into cooperative agreements to purchase and distribute naloxone and to distribute education materials to the public, first responders, and health professionals on overdose prevention and response.

Bipartisan legislation introduced on March 11, 2015, sponsored by Senator Ed Markey (D-MA) with co-sponsors Kelly Ayotte (R-NH), Tim Kaine (D-VA) and Pat Toomey (R-PA). The bill limits civil liability for health care professionals who prescribe or provide naloxone and to trained laypersons who administer it in an overdose event. Companion bill introduced in the House by Representatives Neal (D-MA), Guinta (R-NH) and Comstock (R-VA).

Bipartisan legislation introduced on March 19, 2015, by Senator Mitch McConnell (R-KY) and Casey (D-PA) with co-sponsors Kelly Ayotte (R-NH), Rob Portman (R-OH) and others. Companion bill introduced in the House by Representative Clark (D-MA) with 72 co-sponsors. This bill requires the Agency for Healthcare Research and Quality to report on prenatal opioid abuse and neonatal abstinence syndrome (symptoms of withdrawal in a newborn). The report must include an assessment of existing research on neonatal abstinence syndrome, an evaluation of the causes, and barriers to treatment, an evaluation of treatment for pregnant women with opioid use disorders and infants with neonatal abstinence syndrome, and recommendations on preventing, identifying, and treating opioid dependency in women and neonatal abstinence syndrome. HHS is directed to develop a strategy to address gaps in research and programs and the CDC must provide technical assistance to states to improve neonatal abstinence syndrome surveillance and make surveillance data publicly available.

SUCCESS: Up-scheduling of Hydrocodone Combination Drugs

Controlled substances are classified based on their acceptable medical use and potential for 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.