Life Science Compliance Update

January 04, 2016

New Hampshire Legislation Targets Boards that Govern Opioid Prescribers

This year the presidential primaries in New Hampshire are bringing to national attention the crisis of Opioid addiction.  In a small state like New Hampshire their rate of 400+ overdose deaths a year, brings the issue to the forefront. At New Hampshire town hall meetings candidates are asked hard questions about issues related to Opioid abuse.

The New Hampshire State House has proposed legislation that would require all state regulatory boards governing opioid prescribers to update their rules in light of the recent New Hampshire opioid epidemic. Such an update would have a wide-ranging effect, from anesthesiologists to veterinarians.

The Board of Medicine is currently working on "emergency rules" to better control the amount of opioids that are being prescribed to patients. However, under the new legislation sponsored by Representative Cindy Rosenwald, other boards covering nurses, dentists, ophthalmologists, and others would have to update their rules to reflect the best practices for prescribing prescription medications, especially opioids.

Senate Majority Leader Jeb Bradley is a co-sponsor of the bill and chair of the Joint Task Force for the Response to the Heroin and Opioid Epidemic in New Hampshire. Mr. Bradley believes these proposed changes will have to be in conjunction with prescribers so they can consider the needs of all patients. Mr. Bradley is planning to continue with this legislation that will place a new burden on many in the medical field, stating that "this will require a lot of give and take negotiations with physicians and everyone else."

Representative Thomas Sherman noted that only the Board of Medicine currently has emergency rules in place and suggested other boards begin to do the same. Sherman, a physician, is concerned that if other regulatory boards do not move forward now, the prescribers that they oversee will be working under the old rules while physicians will be under the new rules.

The Task Force reviewed Senator Bradley's proposal to require prescribers to take an online test on the safe prescribing of opioids and other controlled drugs when they renew their licenses. This would ensure that if a physician failed the test, he or she would have to take a continuing medical education program and then retake the test. Since each specialty and subspecialty is different, each regulatory board would need to work to develop their own test, or Senator Bradley posited, they could work together to create one master test.

Senator Bradley believes that this proposal is a compromise with some lawmakers who would like to mandate continuing medical education programs on opioids, a move many physicians and regulator boards oppose. As Louise Lavertu, executive director of the Joint Board of Licensure and Certification stated, the agencies do not have the technology for online tests. Lavertu commented that "it would have to be put out for bid" and that costs are a concern for such a requirement.

Sarah Blogett, the director of the board's Health Professions, indicated that other states do require continuing medical education programs, not a separate test. As such, Senator Bradley requested that the medical society and the dental society work together with their regulatory boards to attempt to reach an agreement on either a mandatory continuing medical education requirement, or additional testing.

The Task Force has convened to "look at a range of possible solutions to the state's substance abuse crisis, including harsher penalties on the distribution of fentanyl, establishing a statewide drug court program and requiring more involvement in the state's prescription drug monitoring program."

The state's Task Force will continue their work and issue a preliminary report by December 22, 2015, and a final report by January 6, 2016. The Task Force is working to determine which bills have broad agreement and will be able to be fast-tracked to the governor's, Maggie Hassan, desk by mid-January 2016, and which bills will take further discussion and a longer period of time to complete the legislative process.

Gov. Hassan is eager to find a resolution to the state's heroin/opioid epidemic that has claimed over 600 lives in the past two years alone. She called for a special session in November 2015, but the House and Senate were unwilling to act on Gov. Hassan's proposed legislation, creating the Task force instead.

December 15, 2015

Update on Risk Evaluation and Mitigation Strategies

For many years, we have written about the authority granted to the FDA from the 1997 Food and Drug Administration Amendments Act of 2007 which requires REMS (Risk Evaluation and Mitigation Strategy) from drug and biologics manufacturers for products to ensure that any serious risks are outweighed by its benefits. REMS requirements can impose special duties on manufacturers, wholesalers, pharmacists, physicians, and/or patients. Failure to comply with a REMS potentially has significant legal consequences and patient safety implications.

Years ago we saw CME under attack by critics charging the education representing a way around FDA's control of medical promotion. REMS changed this trend as the agency turned back to CME as the keystone to controlling a tough drug overuse/abuse situation. Specifically, FDA's REMS approach for long-acting opioid pain products relies on physician education with materials pre-approved by FDA as the key post-marketing control tool.

Now, many years later, FDA recently launched REMS@FDA, a REMS database website. The user-friendly website contains a table of all currently approved individual and shared REMS, as well as a link to historical REMS. The table provides an at-a-glance overview of elements included in each REMS and links to detailed pages for the REMS. All REMS materials are downloadable in PDF format.

FDA has developed a number of REMS-related priority projects and in an October 2015 Federal Register announcement, the agency introduced a pilot project for the submission of final approved REMS and certain REMS summary information electronically in a standard Structured Product Labeling (SPL) format. The goal is to make it easier for these documents to be integrated into pharmacy and hospital IT systems. 

FDA says that stakeholders have "expressed concern that information about REMS materials, tools, and requirements are not communicated … in a clear and consistent manner," and that "REMS materials and requirements may be difficult to locate," and "difficulty integrating REMS materials and procedures into their existing health information systems and healthcare delivery processes." FDA says it is looking for no more than nine volunteers to take part in the pilot and asks interested parties to apply by December 7, 2015. 

Also recently, twenty health care provider and patient advocacy organizations forces announced an effort to counter what they view as recent efforts to weaken REMS linked to certain FDA-approved drugs. The move comes as generic drug advocates raise concerns that brand-drug makers are using REMS restrictions to delay generic competition. The group, Patients Alliance for Drug Safety Protections, says patients, policy makers and other key stakeholders have an extensive knowledge gap about how REMS work. The goal of the alliance and the website is to educate the public on FDA's use of REMS to approve high-risk medications that would otherwise not be on the market and to keep them from being diverted to the black market. 

Among the priority issues for the Alliance will be to preserve the integrity of safety programs like REMS with Elements to Assure Safe Use (ETASU). Drugs that are covered by REMS with ETASU face the greatest set of restrictions, including the use of registries, education programs for providers, pharmacies and patients, monitoring, and restrictions on distribution. Although these programs can add time and administrative requirements for health professionals and can be expensive for manufacturers to develop and operate, these extensive safety measures are required by the FDA under federal law to ensure that a drug's benefits will outweigh its risks. ETASU components are rare, as only 36 drugs as to date have these programs.


August 07, 2013

FDA REMS Open Public Meeting Explored Need for Flexibility in REMS Programs

The Food and Drug Administration (FDA) held a meeting on July 25th and 26th, 2013, to discuss Risk Evaluation and Mitigation Strategies (REMS). The FDA posted information about the meeting, including FDA slide presentation, agenda, and further reading.

We have covered this topic on many occasions. As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA), FDA has committed to standardizing REMS to better integrate them into, and reduce their burden to, the existing and evolving health care system. As part of the PDUFA commitments, FDA will also seek to develop evidence-based methodologies for assessing the effectiveness of REMS.


A key delivery method for REMS programs has been through accredited CME. Murray Kopelow, M.D., President and CEO of the Accreditation Council for Continuing Medical Education (ACCME), delivered remarks at the meeting. Dr. Kopelow explained that the ACCME has a long-standing commitment to supporting public health priorities and described how accredited CME for prescribers supports the goals of FDA REMS.

Moving forward, Dr. Kopelow suggested that the FDA consider continuing to standardize the REMS process, but allowing more flexibility in content. He stated that the strength of CME lies in its expertise in producing educational activities targeted to physicians based on their professional practice gaps, individualized needs, and stages of learning and change. With more flexibility, accredited prescriber education related to REMS could go further in addressing individual prescribers' educational and practice needs.

He also said that the effectiveness of REMS could also be measured in terms of how successfully it promotes access to education, mobilizes the education community to an issue, and draws the medical professions' attention to a problem. Dr. Kopelow further emphasized that accredited prescriber education related to REMS will be independent of commercial influence and will meet the requirements of the ACCME Standards for Commercial Support.

"I was honored to have the opportunity to present at the FDA REMS meeting," said Dr. Kopelow. "We appreciate that the FDA recognizes the value of accredited education. The ACCME has a long-standing commitment to supporting the role of accredited CME as a strategic partner in public health and safety initiatives. Certainly, accredited CME should be considered as a strategic asset to all those trying to improve drug safety."


In addition, Ann Karty, M.D., medical director of the American Academy of Family Physicians' (AAFS) Division of Continuing Medical Education, delivered a presentation on REMS requirements that pertain specifically to extended-release and long-acting (ER/LA) opioids. Karty stated the FDA needs to continue prescriber involvement when determining whether and how risks posed by certain classes of drugs and biologics will be mitigated. Because the REMS for ER/LA opioids is the first to involve a specific CME component, it "serves as a sort of case study," she said.

According to Karty, if REMS-related CME was mandatory for prescribers, the overall continuing professional development of physicians, which includes a variety of information and procedural skill acquisition, could be diluted.

Karty explained: "I explained that REMS CME needs to be voluntary for prescribers, not mandatory," Karty told AAFP News Now after the meeting. "(Physicians and other medical professionals) really need to keep patient outcomes in mind, and if the FDA is planning to include CME in their risk evaluation and mitigation strategies for products going forward, (the agency needs) to have a good reason for it." She noted mandating CME to prescribe specific drugs could have an impact on patient access to those medications.

Asked in the question-and-answer session after her meeting presentation why she so strongly stressed the need for prescriber education to remain voluntary, Karty said mandatory CME has the potential to create a significant amount of confusion for physicians.

"Physicians, on average, have multiple licenses in multiple states, each of which may have different requirements," she said. "So, for example, you have a physician who has two to four different licenses, many of which have different CME credit requirements that may or may not be reciprocal from state to state.

"You also have to consider those folks practicing in states that are already required to have topic-specific CME to maintain their license, as well as requirements for board certification," Karty said. "On top of that, with the consideration by the FDA regarding recommendations for additional REMS-specific CME to be able to prescribe certain drugs, you can see how it gets confusing."

"If you start adding more requirements, sooner or later, there is the potential that some people will not participate," she said. "And then, for example, you'll have a critical-access physician who isn't able to meet the requirement and, suddenly, nobody in that region can prescribe a certain drug, thereby cutting off patient access."

Karty said she thinks some form of prescriber education -- whether formal CME or not -- will continue to be a component of REMS going forward.

"As long as it continues to be an ongoing conversation, we are on the right track," she said, referring to discussions with the FDA during public forum sessions. "In the meantime, family physicians need to participate in (REMS-specific CME) as it becomes available, because that will demonstrate to the FDA that we can self-regulate."

"Participation is the current metric by which we are going to be judged by the FDA, so the continued recommendation is that physicians engage when presented the opportunity."


Opening the FDA's remarks was Theresa Toigo, Associate Director for Drug Safety Operations at the FDA's Center for Drug Evaluation and Research (CDER). Toigo outlined a brief history of the REMS provisions in the Food and Drug Administration Amendments Act (FDAAA) of 2007, noting about 200 REMS have been approved since 2008. She stressed the agency is "listening to patients and health care providers" about REMS along with the pharmaceutical industry and FDA reviewers. The FDA continues to learn about REMS, and recognizes challenges facing the agency as: "the science and statutory framework for pharmaceutical risk management continues to evolve."

Currently, the REMS Policy Workgroup, a component of the agency's REMS Integration Initiative, is developing a draft guidance with several areas of focus in mind: (1) How to apply the statutory criteria to determine whether a REMS is necessary to ensure that the benefits of a drug outweigh the risks; (2) Describe considerations FDA takes into account in current benefit-risk assessments of drugs to maximize the Agency's consistency in decision-making about the need for REMS; and (3) Provide information about when it may be appropriate to employ measures other than a REMS to address a serious risk. The FDA guidance and REMS Integration Initiative involves many parts and can be found here.

Adam Kroetsch, Operations Research Analyst in the FDA's Office of Program and Strategic Analysis spoke about standardizing REMS, describing a three step process: (1) characterizing existing REMS; (2) identifying best practices, including getting feedback from internal and external stakeholders; and (3) ultimately creating standardized REMS. Gary Slatko, Director of the Office of Medication Error Prevention and Risk Management at the Center for Drug Evaluation and Research (CDER), described the FDA's goal of a "science-based, healthcare intervention assessment framework for assessing REMS," noting that the FDA will evaluate a new "proposed framework against prior programs".


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