Life Science Compliance Update

April 18, 2018

Gottlieb Discusses Opioids and Lays Out Vision

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On Wednesday, April 4, 2018, Food and Drug Administration (FDA) Commissioner Scott Gottlieb spoke at the National Rx Drug Abuse and Heroin Summit. Gottlieb opened by comparing recent opioid deaths to those that happened at the peak of the AIDS epidemic in 1995. He started off discussing different strategies the FDA has pursued to address the challenges presented by the current crisis, especially those that help reduce overall exposure to opioids and preserve access for the patients who need them.

He mentioned that often, the opioid addiction “starts with a prescriber’s pen, either directly or indirectly,” meaning either they are prescribed the drugs directly or they receive leftover, stolen, or otherwise acquired drugs, of family and friends. He noted there is a lack of evidence-based guidelines to inform clinical practice for opioid use, and this is hampering prescribers from providing personalized pain management and addiction treatment at the point of care.

Throughout his speech, Gottlieb highlighted four main areas for improvement to address the opioid epidemic: supporting education and training, developing evidenced based guidelines, enhancing enforcement, and advancing electronic prescribing systems and policies.

Supporting Education and Training

Commissioner Gottlieb did acknowledge the revised FDA Blueprint and the way its regulatory authority was extended, but also stated that FDA’s REMS is optional for prescribers. He went so far as to suggest that it may be time to consider making it mandatory, “given the scale of the epidemic.” One potential approach that he suggested would be to require the training of the prescribers at the time they register with the DEA and again at registration renewal.

Commissioner Gottlieb continued, noting, “This training could also include information about the appropriate dose and duration of opioid analgesic use for the most common outpatient indications. To reinforce this training, this information could be made easily available at the point of care so practitioners could incorporate more of it into their prescribing decisions.”

Evidence-Based Prescribing

He also expressed a desire to collaborate with professional societies to develop evidence-based guidelines on the appropriate dose and duration for some common procedures. He suggested that this new data and evidence would not be relied upon for primary evidence of effectiveness, but instead, on how providers can better use the drugs when there are significant safety concerns present about abuse.

He also stated, that the Agency and the public need to seek better information that we could more easily incorporate into the labels of opioid alternatives; like when an NSAID and acetaminophen combination is a suitable, if not better alternative to an immediate release opioid. He also mentioned a proposal the FDA is pursuing to streamline the monograph process that currently governs Over-the counter (OTC) labeling could allow this kind of information to be more easily incorporated into the labels of common OTC pain relievers.

E-Prescribing

Gottlieb offered support for improving prescribing platforms that make it easier for doctors to adopt evidence-based guidelines. He believes a “robust e-prescribing system could streamline access for patients with chronic pain who are appropriately managed on an opioid therapy as the history of safe-use could be documented in the system, allowing greater ease for both patients and their providers,” which would allow clinicians and pharmacists to focus their attention on new opioid prescriptions instead of appropriately-managed patients who suffer from chronic pain. 

Commissioner Gottlieb further mentioned his support for Congress’ efforts to pass legislation that would create a uniform system of electronic prescriptions for controlled substances and integration of Electronic Health Records (HER) and Prescription Drug Monitoring Program (PDMP), as well as data sharing across PDMPs.

Enforcement

Gottlieb also called on social media companies, internet service providers and others to collaborate with the FDA to stop illegal efforts to distribute opioids in their tracks. According to Gottlieb, FDA will host a summit meeting with CEOs and other senior representatives of the internet stakeholders, academics, and advocacy groups to identify technology gaps and new solutions.

He referenced a report by the U.S. Senate Permanent Subcommittee on Investigations, which found that online sellers offered to sell fentanyl and ship any purchases through the “international arm of the U.S. Postal Service,” and accepted a variety of payment options, including Bitcoin. The sellers would even offer “flash sales” on their products to entice buyers. The investigators used payment information to identify more than 500 financial transactions totaling $230,000 linked to 300 individuals in 43 states. 

In a hearing on January 25, Senator Rob Portman, the Subcommittee Chair, said that their investigation found that: “…online sellers were quick to respond, unafraid of getting caught, and ready to make a deal. They offered discounts for bulk purchases and even tried to up-sell us to carfentanil – a powerful synthetic opioid that is so strong it’s used as an elephant tranquilizer. Ordering these drugs was as easy as buying any other product online.”   

FDA has investigators conducting some dark web operations, resulting in some notable take-downs. He is asking for the help of internet firms to help the FDA continue to crack down on these violations.

Conclusion

Commissioner Gottlieb ended his speech by recognizing that “we haven’t seen meaningful, voluntary actions,” when it comes to opioids and to that end, the FDA is planning to host a summit with CEOs and other senior representatives of internet stakeholders, academics, and various advocacy groups to identify technology gaps and possible solutions.

Both the House and the Senate are working on a variety of bipartisan proposals that could be included in the next legislative package addressing the opioid epidemic. The House Energy and Commerce Committee has the third in its hearing series on this topic scheduled for April 11th, during which the Committee will consider more than two dozen bipartisan bills. The Senate Finance committee and the Senate HELP committee are both involved in finding a resolution as well and are still working on solidifying hearing dates.

March 19, 2018

ACCME Announces New Collaboration with ABPath

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The Accreditation Council for Continuing Medical Education (ACCME) and the American Board of Pathology (ABPath) are pleased to announce a new collaboration to simplify the integration of accredited continuing medical education (CME) and Continuous Certification (formerly referred to as Maintenance of Certification).

The ACCME and ABPath share a commitment to supporting pathologists’ continuing professional development and to improving pathologists’ performance and their care of patients. The collaboration is designed to expand the number and diversity of accredited CME activities that meet the ABPath’s Continuous Certification requirements and to streamline the process for accredited CME providers and ABPath diplomates. The ACCME and ABPath pursued this collaboration in response to the needs and requests of diplomates and of accredited CME providers that support pathologists’ lifelong learning and improvement.

The collaboration with ABPath continues the ACCME’s commitment to supporting the goals of Continuous Certification and Maintenance of Certification. The ACCME has also developed collaborations with the American Board of Anesthesiology (ABA), the American Board of Internal Medicine (ABIM), and the American Board of Pediatrics (ABP).

Under this collaboration, all accredited providers must clearly indicate to learners that the activity has been registered to offer credit in the ABPath Continuous Certification materials and brochures (not applicable to initial, save-the-date type activity announcements). The language shall note what type of credit is available (i.e., Lifelong Learning (Part II), Self-Assessment Module (SAM), and/or Improvement in Medical Practice (Part IV))and the number of credits.

All accredited CME providers in the ACCME System already use the Program and Activity Reporting System (PARS) to enter data about each of their CME activities. CME providers now have the option to also use PARS to register activities that began on or after January 1, 2018 for ABPath Continuous Certification. CME providers that choose to participate will use PARS to attest their activities’ compliance with ABPath Continuous Certification requirements. 

Comments from Leadership

“The ABPath is committed to a meaningful and relevant Continuous Certification program that demonstrates to the public and the profession that our diplomates are current in their medical knowledge and are continually striving to improve their practice and provide excellent patient care. Our partnership with ACCME and CME providers is another initiative to strengthen our Continuous Certification program and provide a service to our diplomates that facilitates their participation in the program, “ said Rebecca L. Johnson, MD, CEO, American Board of Pathology (ABPath). 

“We share a common mission with our colleagues at ABPath to facilitate the continuing professional development of physicians. We celebrate our collaboration because it will generate more opportunities for accredited CME providers to deliver relevant, effective, independent, practice-based education that counts for ABPath Continuous Certification. I look forward to working with ABPath, our community of accredited CME providers, and our community of diplomates to leverage the power of education to drive quality in our medical profession and improve care for the patients we all serve, said Graham McMahon, MD, MMSc, President and CEO, Accreditation Council for Continuing Medical Education (ACCME).

March 15, 2018

Benchmarking Insights 2017 Report Released

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Recently, the Industry Alliance for Continuing Education (IACE) Benchmarking Working Group of the Alliance for Continuing Education in the Health Professions (ACEHP) issued its annual report, Benchmarking Insights 2017. This annual report is developed by surveying the medical education professionals of the pharmaceutical, biotechnology, and medical device industries to gain insights into standards and trends that are applied in commercial support of Independent Medical Education (IME).

Since 2009, the survey and subsequent report have been used as a way to learn and educate others about commercial supporters’ best practices related to the support of IME, advocacy efforts, and ongoing evaluations of supported educational programs.

The surveys for the annual reports have typically focused on benchmark practices and processes that are related to the industry funding of education grants, intended primarily for dissemination within supporter organizations to help facilitate benchmarking. In addition to standard benchmarking on budget, grants volumes and monitoring, this year, the survey also assessed role of industry in distributing invitations, what has improved, what remains as areas for improvement, and supporting repeat series activities.

This year, sixty organizations with US IME offices were identified and a survey with sixty questions on key IME areas of interest was developed, pilot tested, and sent to one key individual per organization from April to May 2017. Twenty-three organizations responded, with the bulk of respondents coming from the pharmaceutical industry.

One of the topics in the survey was budget. Previously data were reported based on IME budget ranges, which did not correlate to company annual revenue. This year, two-thirds of the respondents noted that their budgets were either similar or were increased compared to their 2016 budgets. As much as one-third of respondents also anticipated an increase in budget for 2017, which roughly one-third reported a decrease in budget. Half of the respondents predict that budgets will either remain stable or increase for 2018.

ACEHP has also invested significant resources addressing the importance of Quality Improvement (QI) as a means to integrate IME more centrally into the healthcare system; as such, multiple questions on QI were included in the survey to understand the level of support respondents have for QI goals. More than two-thirds of respondents have supported QI education in the past, with three-quarters of respondents having received QI proposals. Just under half of respondents who have supported QI programs in the past reported receiving the level of outcomes expected, while an additional 13% are awaiting outcomes yet to be reported.

With respect to grant details, the number of grants submitted has more or less remained similar over recent years. In 2017, one fourth of supporters reported having received less than 250 grant requests per year, while only one company reported receiving more than 2,500 grant applications per year. Interestingly, the volume of grants received is not dependent on the number of therapeutic areas supported.

When it comes to collaboration, sixty-one percent of respondents reported that they are open to communicating in some way with their industry peers in the same disease state. Additionally, of those who indicated that they do not currently communicate with others in their disease state, more than half were open to the idea. Further along the lines of collaboration, 14.3% of respondents believe that having a society partner has a positive impact on the grant review decision process, while less than half of respondents were unsure, or thought it had low to no impact at all.

A hot topic for the coming months is likely to be patient education. The benchmarking survey asked commercial supporters what kind of IME have been supported that are likely to have an impact on the patients, including education intended for patients as well as education intended for health care practitioners that integrate tools or concepts to increase patient engagement. The vast majority of respondents reported that topics related to patient engagement are part of their educational strategy.

For more information, you can find the benchmarking report here.

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