U.S. Rep. Ben Ray Luján
From the Office of U.S. Rep. Ben Ray Luján
WASHINGTON, D.C. – U.S. Rep. Ben Ray Luján (D-NM) this week sent letters to the Commissioner of the Food and Drug Administration (FDA) and the Director of the National Institutes of Health (NIH) to inquire about their progress on research into non-addictive, non-opioid pain medications.
In his letters, Lujan asked both officials a number of questions related to the scope, structure and resources committed to this line of research.
[full text of both letters are below]
Francis Collins, M.D., Ph.D.
Director of National Institutes of Health
National Institutes of Health
9000 Rockville Pike
Bethesda, Maryland 20892
Dear Director Collins:
Thank you for our past communications concerning your commitment and the commitment of the National Institutes of Health (NIH) to research and develop alternatives to using opioids in pain management treatments. I appreciate our shared concerns over this issue. Our previous communications after your November 30, 2017 testimony in front of the House Energy and Commerce Committee focused on how critical it is that research understands how patients experience pain in order to avoid addiction.
I am encouraged by the $2 billion dollar increase to the funding of NIH contained in the recently passed budget. I am hopeful about the possibilities of the use of this additional funding for research into safe, effective, non-addictive strategies to manage chronic pain. I am interested in working together to find novel therapies that allow Americans to treat the pain they feel while avoiding highly addictive opioids.
I would like to stay involved as NIH moves through the process of researching innovative treatment options to address the opioid epidemic. I have some follow-up questions to our communications based on your November 30, 2017 testimony. Can you please provide me information to the following questions:
1. What are the details about the series of meetings between the FDA and NIH?
Commissioner Gottlieb wrote in a letter to me on November 7, 2017, “We [at FDA] have been involved in discussions with the National Institutes of Health in a series of meetings to facilitate development of non-addictive pain treatment.”
Please provide further information on this series of meetings, including:
What is the structure of this series of meetings?
Who is the designated point person at NIH for these meetings? Can I communicate directly with those point people for the meetings?
What are the goals of these meetings?
Are these meetings open to the public?
How many meetings are in the series? How many have already been held? How many are scheduled to occur? When do these meetings occur? Where do these meetings occur?
2. What are all of NIH’s current efforts to promote non-opioid pain management?
NIH’s website describes how NIH is providing scientific solutions to help end the opioid crisis:
To provide scientific solutions to help end the opioid crisis, NIH is supporting a wide range of research on pain and addiction, from basic science of the complex neurological pathways involved in pain and addiction, to services and implementation science to develop and test treatment models, to integrating behavioral interventions with medication-assisted therapy, to forging strategic partnerships to advance safer, non-addictive treatments for pain.
Would you please expand on how NIH is forging these strategic partnerships and what
they have achieved thus far? Please elaborate on what roadblocks NIH is currently facing in these efforts. If there are places where I can be helpful, please identify those as well.
NIH’s website includes the following paragraph:
NIH also is pursuing an Opioid Initiative with public and private organizations to identify areas of opportunity where the NIH, academia, and biopharmaceutical companies could combine efforts and resources to accelerate the development of better pharmacological treatments for pain and opioid use disorder.
Please expand on NIH’s Opioid Initiative. Specifically, what are the goals of the Initiative? What is the Initiative’s timeline? What funding does the Initiative currently have? Which public and private organizations are currently involved? Please also elaborate on what roadblocks NIH is currently facing in these efforts.
On September 20, 2017, you announced a new $81 million, six-year interagency partnership focusing on managing pain for veterans and service members without prescription drugs. My understanding is that the collaboration between Health and Human Services, Defense, and Veterans Affairs will develop, implement, and test nondrug alternatives. You described the initiative as follows:
Finding solutions for chronic pain is of critical importance, especially for military personnel and veterans who are disproportionately affected. Bringing the science to bear through these real-world research projects will accelerate our search for pain management strategies for all Americans, especially as we work to address the nation’s opioid crisis.
The National Center for Complementary and Integrative Health (NCCIH), part of NIH, is contributing more than half of the total funding, and it is the lead for this multi-agency initiative called the NIH-DoD-VA Pain Management Collaboratory, which is modeled on the successful NIH Health Care Systems Research Collaboratory. This initiative also addresses the need to focus on “advancing better practices for pain management,” which is outlined in HHS’ five-point strategy to combat the opioid crisis. These projects will provide important information about the feasibility, acceptability, safety, and effectiveness of nondrug approaches in treating pain. Types of approaches being studied include mindfulness/meditative interventions, movement interventions (e.g., structured exercise, tai chi, yoga), manual therapies (e.g., spinal manipulation, massage, acupuncture), psychological and behavioral interventions (e.g., cognitive behavioral therapy), integrative approaches that involve more than one intervention, and integrated models of multi-modal care.
You have said that new funding is needed to get this effort off the ground.
Will a portion of the recently appropriated $2 billion be used for this effort? If so, how much? Is this sufficient?
In a Senate hearing on December 7, 2017, you said that NIDA’s budget has not increased as much as other NIH institutes, despite the high disease burden of the opioid epidemic.
How much additional funding does NIH need Congress to appropriate to help NIDA increase its workload? What is NIDA’s strategic plan to combat the opioid epidemic?
3. What concrete steps do you need Congress to take to enable NIH to move faster on research connected to the opioid epidemic?
Finally, please let me know what concrete steps you need Congress to take to enable NIH to move faster on research connected to the opioid epidemic.
I am heartened by your commitment to developing alternative ways to address pain to keep people from becoming addicted to opioids. Republican and Democrat Members of Congress have suggested a willingness to give NIH special flexibility to move faster on research connected to the opioid epidemic. As you said in the December Senate hearing on the federal response to the opioid crisis, “we need to know more about nondrug approaches to treating pain, and that’s another way to keep people from getting addicted to opioids.”
You have said that receiving a special exception from Congress through other transaction authority would enable NIH to advance programs on non-addictive pain medicines. Specifically, you said, “other transaction authority allows us to do something in six weeks that might otherwise take six months.” You testified that this would let NIH advance programs on non-addictive pain medicines by proactively approaching companies or universities instead of waiting for them to submit grant requests.
4. Will you please elaborate
You said that such a move also could empower NIH to hold contractors accountable if they are not meeting the terms of their work agreements. How many NIH contractors fail to meet the terms of their work agreements? What barriers does NIH currently face to holding contractors accountable if they fail to meet the terms of their work agreements?
I look forward to your responses to, and discussion of, the foregoing questions. Once again, I appreciate your support in moving these vital efforts forward.
Dear Dr. Gottlieb:
Thank you for our past communications concerning the steps the Food and Drug Administration (FDA) will take to enable and communicate the availability of safe and effective, non-opioid drug products. The recently passed budget provides an increased $2 billion dollars to the budget of the National Institutes of Health (NIH). I am excited about the possibilities of the use of this additional funding for research into safe, effective, non-addictive strategies to manage chronic pain.
As you know, I am interested in working together to find novel therapies that allow Americans to treat the pain they feel while avoiding highly addictive opioids. It is important that the FDA test these alternatives and approve them in a timely manner to address this public health crisis that everyday claims the lives of more than 115 Americans. With the recent influx of funding at NIH designated to the area of non-opioid pain management, we must ensure that the innovations that stem from these dollars are quickly made available to the public.
You have not yet responded to my letter dated December 7, 2017 containing follow-up questions to your November 7, 2017 letter. Please find a copy of those questions below. I would appreciate your office sending me information related to my follow-up questions at your earliest convenience.
1. Risk Evaluation and Mitigation Strategy (REMS).
You wrote, “For the first time, FDA announced its intention to require immediate-release (IR) opioid analgesic products to be subject to the same REMS requirements.” You also note that you expect the modified REMS to include revisions related to prescriber education.
What is the agency’s timeline to finalize a modified REMS? What considerations is the agency taking into account when considering changes to the education requirements related to the REMS?
2. Broader effort to ensure that providers are properly informed about prescribing pain medication.
You wrote, “The new training will be aimed at making sure providers are prescribing opioids only for properly-indicated patients, and only under appropriate clinical circumstances […as] part of a broader effort to take new steps to make sure providers are properly informed about suitable prescribing and the risks and benefits associated with opioid drugs.” (italics mine)
What additional activities does FDA’s broader effort include? Who within FDA is responsible for this broader effort to inform providers about suitable prescribing?
3. Alternatives to non-opioid drugs available to patients in the face of non-opioid drug shortages.
You wrote, “There have been a small number of non-opioid drug shortages over the past few years, but there continue to be multiple alternative options available to patients.” (italics mine)
What are these multiple alternative options to non-opioid drugs that are available to patients? How many alternative options to non-opioid drugs are available to patients?
4. Classes of analgesics.
You wrote, “There are few existing classes of analgesics.” In Division Director of the Division of Anesthesia, Analgesia, and Addiction Products Dr. Sharon Hertz’s March 1, 2016 presentation to the FDA Science Board, she listed existing analgesics as opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), anticonvulsants, antidepressants, local anesthetics, and “other (capsaicin and ziconotide).”
Are these six classes a comprehensive list of existing analgesic drug classes? If not, what additional or alternative classes are there?
5. Clinical and nonclinical challenges to drug development.
You wrote, “Drug developers may encounter both clinical and nonclinical challenges specific to their drug development program.”
What are some examples of clinical and nonclinical challenges that drug developers have faced? Is there a trend of where in the development or regulatory processes the challenges are faced? For example, are the challenges primarily in the review or in the post-market phase? What are some potential incentives to increase the number of non-opioid drugs in the pipeline? Is the main challenge increasing the number of drugs entering the pipeline, or increasing the number of drugs coming out of the pipeline? Do you consider FDA barriers to be clinical or nonclinical?
6. FDA collaboration with sponsors who are interested in developing new potential treatments.
You wrote, “The Agency is open to working with sponsors who are interested in developing new potential treatments.”
Have any sponsors already asked FDA to work together to develop new potential treatments? If so, what did FDA respond?
7. Targeted advice to manufacturers and drug developers.
You wrote, “Moving forward, we strongly encourage manufacturers and drug developers to contact the Division of Anesthesia, Analgesia, and Addiction Products in the Center for Drug Evaluation and Research so that we can provide targeted advice specific to their drug development program.”
Have any manufacturers contacted DAAAP in CDER to request targeted advice specific to their drug development programs? Has FDA provided targeted advice specific to drug development programs?
8. Draft guidance on developing drug and biological products for analgesic indications.
You wrote, “For more information, please see our draft guidance entitled Analgesic Indications: Developing Drug and Biological Products, which, when finalized, will provide the Agency’s recommendations on such development.”
The draft guidance was released in February 2014, “for comment purposes only.” It had a 60-day comment period. Since February 2014, approximately 190,000 Americans have died due to opioid overdoses. Is FDA currently in the process of finalizing the guidance? If available, when does FDA anticipate publishing the finalized guidance?
9. Series of meetings with NIH.
You wrote, “We have been involved in discussions with the National Institutes of Health in a series of meetings to facilitate development of non-addictive pain treatment.”
What is the structure of this series of meetings? Who is the designated point person at FDA and who is the designated point person at NIH for these meetings? Can I communicate directly with those point people for the meetings? What are the goals of these meetings? Are these meetings open to the public? How many meetings are in the series? How many have already been held? How many are scheduled to occur? When do these meetings occur? Where do these meetings occur?
10. Expedited review of products to treat a serious condition for which there is an unmet medical need.
You wrote, “Novel non-opioid medications with the potential to provide effective pain relief, and that satisfy the applicable legal criteria, may be appropriate candidates for such programs,” referring to “programs, such as Fast Track and Breakthrough Therapy Designation, which are intended to facilitate the development and expedite the review of products that, for example, are intended to treat a serious condition for which there is an unmet medical need.”
How many non-opioid products are currently under review for management/treatment of pain? Of the current products under review, how many/what percentage have applied for and been awarded one of these designations? Are there other tools at your disposal to move these applications through in a timely fashion? If not, what can Congress do to help? In addition to new product approvals, please describe how manufacturers can seek new indications, expanded labels and/or different concentration approvals for non-opioid products already available to patients.
Additionally, please address remaining concerns from my previous letter that you did not address in your November 7 letter:
1. Use of unapproved non-opioid products and unapproved uses of non-opioid products.
How will FDA address the use of unapproved non-opioid products or unapproved uses of non-opioid products for treatment of acute and chronic pain management? Does the agency intend to incorporate guidance for healthcare practitioners related to the use of unapproved non-opioid products or unapproved uses of non-opioid products for pain management?
2. Non-opioid drug shortages.
In my letter on August 31, 2017, I asked: Is FDA aware of any shortage of non-opioid drug products that have been approved to date for the treatment of pain? If so, please provide further information related to the non-opioid drug products that are in shortage, the duration of such shortages, and the steps the agency has taken to address such shortage.
You wrote in your November 7, 2017 letter, “There have been a small number of non-opioid drug shortages over the past few years,” but you did not provide further information related to the non-opioid drug products that are in shortage, the duration of such shortages, and the steps the agency has taken to address such shortage.
As a result, I now ask that you address the following questions:
1. How many non-opioid drug shortages have occurred between 2007 and 2017?
2. Which non-opioid drug products have been in shortage?
3. What was the duration of each shortage?
4. What was the shortfall in each of those shortages?
3. FDA interpretation of “serious condition.”
I asked: Would acute or chronic pain meet FDA’s interpretation of “serious condition” for purposes of the agency’s expedited programs? If FDA does not interpret current legal authorities to allow such application, why not? What revisions might enable the use of such authorities? Would FDA support such revision? In your November 7, 2017 letter, you did not answer these questions. Please do so now.
I look forward to your responses to, and discussion of, the foregoing questions. Once again, I appreciate your support in moving these vital efforts forward.