Life Science Compliance Update

December 05, 2017

FDA Offers Draft Guidance on E-Submissions of REMS Documents

Guidance

The FDA recently released draft guidance describing how FDA plans to implement the requirements for the electronic submission of Risk Evaluation and Mitigation Strategies (REMS) documents in certain submissions under new drug applications, abbreviated new drug applications and biologics license applications.

FDA Comments on Stakeholder Feedback

In the guidance, FDA describes three years of engagement and analysis of stakeholder feedback regarding REMS standardization. The agency’s findings were published as a report: “Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS).” As the report describes, some stakeholders expressed concern about the clarity and consistency with which information about REMS materials and requirements are communicated to stakeholders. They told FDA that REMS materials and requirements may be difficult to locate, and that specific activities and requirements of various stakeholders (e.g., prescriber, pharmacist) are not always clearly outlined.

Some stakeholders expressed the need to have better ways to integrate REMS materials and procedures into their existing health information systems and health care delivery processes. Stakeholders also expressed the desire to avoid spending excessive time trying to locate, understand, and comply with different REMS requirements while ensuring safe use of drugs with REMS.

To help address these concerns, FDA intends to require applicants of NDAs, ANDAs, and BLAs to submit the content of their REMS documents in Structured Product Labeling (SPL) format. SPL can be used to capture and present REMS information in a format that is easily shared with stakeholders and readily incorporated into health information technology.

Structured Product Labeling

REMS documents will be required to be submitted in electronic format using Structured Product Labeling (SPL). SPL is a Health Level Seven (HL7) standard based on Clinical Document Architecture and HL7 Reference Information Model (RIM) accredited by the American National Standards Institute (ANSI) for the exchange of product information. Structured Product Labeling documents include a header and body. The header includes information about the document such as the type of product, author and versioning. The body of the document includes product information in both structured text and data element formats. The FDA uses SPL documents to exchange information covering a growing number of product related topics.

Requirements That Must Be Followed for Electronic Submission of the Content of REMS Documents

Under section 745A(a) of the FD&C Act, electronic submissions “shall be submitted in such electronic format as specified by [FDA].” This guidance addresses electronic submission requirements for certain documents that are part of a REMS. A REMS document, which is part of the REMS that is approved by FDA, concisely describes the goals and requirements of the REMS.

FDA has determined that the content of a REMS document must be submitted electronically in SPL format, using specifications outlined in the FDA Data Standards Catalog. REMS materials are all materials that are included as part of the REMS (e.g., communication and educational materials, enrollment forms, prescriber and patient agreements) that are also approved and enforceable, and are appended to the REMS document. REMS materials must be referenced in the SPL file. REMS supporting documents should not be submitted in SPL format.

May 23, 2017

FDA Public Meeting on Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics

Public-meeting

In 2012, FDA instituted a risk evaluation and mitigation strategy (REMS) for extended-release and long-acting (ER/LA) opioids that required companies marketing ER/LA opioids to provide a medication guide and make training available to prescribers.

Under the REMS, the training must be provided by accredited providers and cover all elements of the agency's Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics. However, while the agency set goals for prescriber participation, prescribers were not required under the REMS to go through with the training.

On May 9th and 10th, 2017, the Food and Drug Administration held a public meeting, discussing how to train health care providers on pain management and the safe use of opioid analgesics. This meeting follows a May 2016 joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee to discuss whether the risk evaluation and mitigation strategy (REMS) for ER and LA opioids would reach intended goals.

In addition to the joint Advisory Committee advice on prescriber education, a Request for Information (RFI) was posted by the Department of Health and Human Services (HHS) Assistant Secretary of Planning and Education on July 8, 2016, seeking comments on the most promising approaches in prescriber education/training programs and effective ways to leverage HHS programs to implement/expand them.

The FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain (May 2017) lists draft revisions to the FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids. The proposed Blueprint broadens the current Blueprint to include information on pain management, including the principles of acute and chronic pain management; non-pharmacologic treatments for pain; and pharmacologic treatments for pain (both non-opioid analgesic and opioid analgesic). The draft also provided context for discussions at the public meeting.

Electronic or written comments to the Blueprint may be submitted by July 10, 2017.

The 2017 public workshop on May 9 and 10 attempted to build on one of the requests outlined in that RFI: the request for suggestions of additional activities HHS and its federal partners can implement to support universal prescriber education on appropriate pain management and opioid analgesic prescribing.

The workshop had three main goals. First, participants discussed the role that health care provider training plays – within the broader context of ongoing activities – to improve pain management and the safe use of opioids. Second, participants commented the best way to provide health care providers who prescribe or are directly involved in the management or support of patients with pain appropriate training in pain management and the safe use of opioids. Finally, participants discussed various issues and challenges that are associated with possible changes to federal efforts to educate health care providers on pain management and the safe use of opioids.

Opening Session

During the opening session, Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research (CDER), discussed the extent of opioid prescribing and considerations in addressing prescriber training. She said that there are 200 million prescriptions for opioids dispensed annually, contributing to a “surge in opioid-related substance abuse disorders.”

Dr. Woodcock said that historically, “the liabilities of prescribing opioids were minimized” for an “entire generation of prescribers.” She cited alternative modalities, such as physical therapy and cognitive and behavioral therapy, and said the selection of a pain treatment modality should be a “sophisticated decision that weighs costs and benefits.” She noted that although opioids will remain a “mainstay in many situations,” including acute trauma, there should be a “renewed understanding that any opioid prescription confers risk.”

Dr. Doug Throckmorton, CDER’s Deputy Director for Regulatory Programs, said the meeting would focus on improving prescriber education while continuing access to appropriate treatment. He said healthcare worker education is a part of the FDA’s Opioid Action Plan. He pointed to a variety of inter-agency efforts, such as the Department of Health and Human Services’ multi-pronged opioid plan, the Surgeon General’s efforts, National Institutes of Health Centers of Excellence in Pain Education, and Centers for Disease Control and Prevention (CDC) opioid prescribing guidelines.

Veterans Affairs Experience

Dr. Bernie Good, Chair of the Medical Advisory Panel for Pharmacy Benefits Management at the VA, provided an overview of the VA’s efforts to ensure appropriate prescribing of opioids and combat opioid abuse. He said that in 2000, the VA mandated pain as fifth vital sign, encouraging veterans’ feedback on their pain severity. Approximately 30,000 VA prescribers had written at least one opioid prescription and the thought was that if veterans have to provide regular feedback on their pain severity, perhaps less prescriptions would be written.

In 2014, the VA started an academic detailing programs on opioid medications involving one-on-one meetings between a clinical pharmacist and prescriber. The VA has 285 academic detailers, and 10,436 clinical staff have been detailed. Dr. Good said that there has been a 58 percent reduction in high-dose opioid prescribing among those receiving detailing compared with 34% reduction among those without detailing.

Dr. Good noted that VA providers have mandatory training on opioids and that as part of the VA’s Opioid Safety Initiative, the VA distributes individualized prescriber and regional reports and identifies high-risk patients.

Risk Evaluation and Mitigation Strategies (REMS) Options and Considerations

Doris Auth, Acting Director of the FDA’s Office of Medication Error Prevention and Risk Management, discussed options and considerations for using FDA REMS authority under Federal Food, Drug, and Cosmetics Act (FFD&CA) to assure prescriber training on opioid medications. She noted that REMS can have elements to assure safe use and can be restrictive or non-restrictive.

She provided examples of how prescriber education could be required under REMS. For instance, the acne drug isotretinoin has a REMS known as the iPLEDGE program to prevent fetal exposure and reduce the risk of birth defects. It requires informing providers and patients about the risk of fetal exposure, initial documentation of a negative pregnancy test, pharmacy authorization from the REMS program, a medication guide with each prescription, a voice or web-based authentication prior to dispensing, patient enrollment and informed consent, an ongoing monthly negative pregnancy test for female patients, and other dimensions.

Ms. Auth reviewed a potential structure for an opioid REMS involving training. She said there could be:

  • No patient enrollment or patient-specific requirements; and
  • Required prescriber training prior to dispensing.

She believes that such a program would be quite a bit larger than any existing REMS and at least double the size of the current extended-release/long-acting opioid REMS. If pursued, it would involve ninety manufacturers, some of which would have multiple products.

Andrew Rosenberg, JD with the CME Coalition, Thomas Sullivan of Rockpointe and others gave comments at the meeting to reinforce that education is a valuable tool in fighting the opioid epidemic.  To encourage clinician's to participate in the Opioid REMS the CME Coalition recommended that FDA work with CMS to include Opioid REMS CME as an improvement activity in the Quality Payment Program.

Overall the value of continuing education in the REMS program is perhaps the most valuable tool that the government and others can engage to help reduce opioid deaths.

April 20, 2017

FDA Public Workshop on Opioid Training

FDA-pills

The Food and Drug Administration (FDA) has announced a public workshop to obtain input on issues and challenges associated with federal efforts to train prescribers on pain management and the safe use of opioids.

The workshop has three major goals. First, participants will be asked to discuss the role that health care provider training plays, within the broader context of ongoing activities, to improve pain management and the safe use of opioids. Second, participants will be asked to comment on how best to provide health care providers, who prescribe or are directly involved in the management or support of patients with pain, appropriate training in pain management and the safe use of opioids. As a part of this discussion, current training efforts by States, hospitals and health care systems, Federal Agencies, professional associations and other groups will be considered in order to strategize how best to facilitate training for these health care providers. Finally, participants will also be asked about issues and challenges associated with possible changes to Federal efforts to educate health care providers on pain management and the safe use of opioids.

The public meeting, “Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics – Exploring the Path Forward,” is scheduled for May 9th and 10th, 2017, from 8:30 am to 5:00 pm on the 9th and 8:30 am – 4:30 pm on the 10th. The event will be hosted at the Sheraton in Silver Spring, Maryland.

Seating for this event is limited and the FDA may limit the number of participants from each organization. If you are interested in attending, either in person or via webcast, you can register here. Registration closes for the event on May 1, 2017.

During online registration, you may indicate if you wish to provide a statement during the Open Public Comment Period. The FDA will do what it can to accommodate requests to make public comments based on time allocated for public comment. Individuals and organizations with common interests are urged to consolidate or coordinate their comments, and request time for a joint presentation. Following the close of registration date, the FDA will determine the amount of time allotted to each commenter and the approximate time each oral comment is scheduled to begin; commenters should arrive ahead of their scheduled time in case the agenda moves ahead of schedule so as to be sure not to forfeit their speaking time. All requests to make oral comments must be received by the close of registration on May 1, 2017. No commercial or promotional material will be permitted to be presented or distributed at the public workshop.

If time and space permit, the FDA will allow for onsite registration on the day of the workshop, starting at 7:30 am.

Comments can be submitted either electronically or written by July 10, 2017.  

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