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We wanted to make you aware of an opportunity to submit public comments to the Food and Drug Administration (FDA). Specifically, the FDA would like the public’s views on two main issues:

  1. What criteria the FDA should use to evaluate new opioids to treat pain
  2. What new incentives are needed to better support and encourage the development of new treatments for pain

On Sept. 17, the FDA held a public hearing called “Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction.” While the public hearing has passed, the FDA is accepting written comments until Nov. 18 at 11:59 pm EST.

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The Centers for Medicare and Medicaid Services (CMS) opened a Request for Information (RFI) to solicit input into the development of an Action Plan on the opioid crisis and the treatment of acute and chronic pain as specified in the SUPPORT Act.

The deadline for comment was Oct. 11.

National Director of Policy and Advocacy Cindy Steinberg submitted on behalf of U.S. Pain Foundation, outlining 10 recommendations for ways CMS could improve pain care.

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Shari Ling, MD, Deputy Chief Medical Officer of CMS, left, with Steinberg

The Center for Medicare and Medicaid Services (CMS) convened a public meeting on Sept. 20 to solicit input into the development of an Action Plan on the opioid crisis and the treatment of acute and chronic pain as specified in the SUPPORT Act. The Action Plan is due to Congress June 1, 2020.

Cindy Steinberg, National Director of Policy and Advocacy, was among the meeting’s speakers as a member of a panel, “Personal Perspectives on Pain and Substance Use Disorders.” To read about her comments on the panel, click here.

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National Director of Policy and Advocacy Cindy Steinberg will speak at a Sept. 20 public meeting at the Centers for Medicare and Medicaid (CMS). At this meeting, CMS is slated to present its Action Plan to address the opioid crisis and pain management, called for in Section 6032 of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act passed by Congress in 2018.

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Efforts to disseminate and begin implementing recommendations from the new report from the Pain Management Best Practices Inter-Agency Task Force (PMTF), released in May, are underway.

Most notably, according to a June 3 report from Fox News, Sen. Lamar Alexander—chair of the Senate Health, Education, Labor and Pensions Committee—said that he plans to hold a hearing before the committee that will focus on the task force’s findings. The pain community can take part in an action campaign to encourage a hearing by clicking here.

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The new report on pain management, mandated by Congress and finalized on May 30, is an important milestone for people with pain. The report emphasizes the need for access to affordable, multidisciplinary care, and urges an individualized approach to pain management–instead of broad one-size-fits-all limits and policies.

But how do we move it forward from a piece of paper to actual change?

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Golden, left, and Steinberg.

On May 9 and 10, the Pain Management Best Practices Inter-Agency Task Force–an advisory group convened by Congress and overseen by U.S. Department of Health and Human Services (HHS)–held its last public meeting to finalize a report on improving pain care in America. The task force, comprised of 29 members, includes Cindy Steinberg, U.S. Pain’s National Director of Policy and Advocacy, the only patient and patient advocacy representative.

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An incredible 6,000 groups and individuals stepped up to give feedback on the draft report from the Pain Management Best Practices Inter-Agency Task Force during the comment period that ended April 1. Among the groups was a coalition of pain-patient related organizations, including U.S. Pain Foundation, which submitted a united letter outlining their feedback.

On May 9 and 10, the task force will hold its last public meeting to vote on the final version of the report and discuss plans to disseminate it. The meeting will run from 10 am to 5:30 pm EST Thursday and from 9 am to 12 pm EST on Friday in Washington, D.C.

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Last month, the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) reacted to the unintended harm to people living with chronic pain as a result of policy measures intended to ameliorate the opioid crisis.

On April 9, the FDA issued a Safety Announcement citing “serious harm,” including “withdrawal symptoms, uncontrolled pain, psychological distress and suicide” as a result of sudden discontinuation or rapid dose decreases in opioid pain medication. The FDA will now require changes to the prescribing information for health care professionals that will provide guidance on how to safely reduce or taper patients off opioid medications. The agency states that there is no standard opioid tapering schedule; rather, a schedule must be tailored to each patient’s unique situation considering a variety of factors, including the type of pain the patient has.

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The 90-day public comment period for the Pain Management Best Practices Inter-Agency Task Force’s (PMTF) draft report came to a close April 1, with more than 6,000 individuals and organizations submitting feedback.

Among those to comment was the Consumer Pain Advocacy Task Force (CPATF), a coalition of pain patient-related nonprofits, including U.S. Pain Foundation, which submitted a 25-page joint letter. In addition to U.S. Pain Foundation, the CPATF letter was signed by the Center for Practical Bioethics; CHAMP (Coalition For Headache And Migraine Patients); Chronic Pain Research Alliance; For Grace: Women In Pain; Global Healthy Living Foundation; Headache and Migraine Policy Forum; International Pain Foundation; Interstitial Cystitis Association; RSDSA (Reflex Sympathetic Dystrophy Syndrome Association); and The Pain Community.

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