In Summer 2017, we wrote about Senator Claire McCaskill’s request to Teva Pharmaceutical Industries that they provide information about the distribution of opioids and its efforts to prevent drug diversion. In her original letter, McCaskill stated, ...

Off-Lable Regulatory Compliance Congress


Teva and McCaskill: A Game of Cat and Mouse and more...

Teva and McCaskill: A Game of Cat and Mouse


In Summer 2017, we wrote about Senator Claire McCaskill’s request to Teva Pharmaceutical Industries that they provide information about the distribution of opioids and its efforts to prevent drug diversion. In her original letter, McCaskill stated, “[t]his epidemic has reportedly arisen, in part, from the failure of opioid distributors to monitor the flow of hundreds of millions of painkillers to pharmacies across the United States and then on to the black market.”

In her initial letter, she requested several documents and pieces of information to “aid the Committee in understanding the role of manufacturers and distributors in overseeing opioid shipments and preventing diversion.” Included in that request were: descriptions of any suspicious order monitoring program Teva and its subsidiaries have implemented; copies of any questionnaires (and any responses to same) sent to distributors by Teva and its subsidiaries regarding their anti-diversion and compliance efforts; a list of all suspicious order notifications Teva and its subsidiaries provided to DEA regarding opioid orders originating from Missouri; and a list of all Missouri-based pharmacies, distributors, or other customers for which Teva and its subsidiaries have conducted an audit or investigation.

In response, Foley & Lardner, LLP, Teva’s attorneys, sent her a letter essentially telling McCaskill that they were not going to comply with any of her requests. The one response Teva provided through its attorneys were that it does maintain “robust anti-diversion systems and procedures,” and then described them in general detail.

McCaskill responded to the Teva response less than a month later, noting Teva’s lack of specific responses to her requests or requests for information issued by her Staff. In her letter, McCaskill also notes – interestingly – that Teva is the only company who received one of these letters from her office that has indicated “it will refuse to cooperate fully with this inquiry.” Other companies that received letters from McCaskill requesting information regarding their opioid prescribing practices or distribution of such products included Mallinckrodt, Endo, Allergan, McKesson Corporation, and Cardinal Health, Inc.

Then, on October 5, 2017, Foley & Lardner reiterated its recognition of “the pressing issue of prescription opioid abuse in the United States,” expressed its commitment to “working with leaders in government, the healthcare community, and the non-profit sector to address this crucial public health concern.” Throughout the letter, Teva references multiple discussion with McCaskill and/or her staff, which it often cites as reasons for not publicly disclosing the information McCaskill requests. Teva notes that it remains firm in its belief that its refusal to publicly release the documents, as a public disclosure of specific and sensitive proprietary information may “chill the willingness” of its customers to share information with the Committee and participate in larger efforts to address opioid abuse.

While it seemed for several months that Teva’s non-response was going to be the last in this investigation, on Tuesday, March 6, 2018, Senator McCaskill brought up the issue once again, noting,

“Teva’s refusal to cooperate with Congressional requests strongly suggests they have something to hide. I’d hope that everyone involved or associated with the company takes note that they’re dealing with an entity that’s stonewalling a Senate investigation examining a national public health crisis. Teva has been an outlier throughout our investigation, and they can rest assured that I’ll continue to pursue every possible avenue to get them to comply for as long as it takes.” 

This saga does not seem to be ending anytime soon, especially since several pharmacy benefit management firms are headquartered in McCaskill’s home state of Missouri. We will keep our eye on this continuing back-and-forth, and provide updates as they arise and change the course of the discussion.

In another act related to industry, there is talk that McCaskill is planning to introduce a bill that would toughen the Sunshine Act by requiring drug makers to report payments that are made to nonprofit organizations and patient advocacy groups. We will do our best to keep up with any developments in this as they arise.


Preparing for the 2018 Ethical MedTech, APACMed, and China Codes


The Healthcare Convention & Exhibitors Association (HCEA) presented a webinar, “Preparing for the 2018 Ethical MedTech, APACMed, and China Codes: Impact on International Attendee Participation at US Meetings.” Webinar attendees heard from several professionals on the new rules and the likely impact they will have in the coming years. Faculty included: Thomas Sullivan, President of Rockpointe and Editor of Policy & Medicine; Matthew Wetzel, JD, Vice President and Assistant General Counsel of AdvaMed; Aline Lautenberg, General Counsel and Director of Legal & Compliance, MedTech Europe; and Christine Wurster, Chief Revenue Officer of the Heart Rhythm Society.

While many of us may get frustrated at these Codes and regulations that continue to pop up, there are several reasons for them, as discussed by Thomas Sullivan. The reasons include: ensuring ethical interaction with healthcare professionals; helping independent decision making and public confidence in the medical industry; aligning compliance with international standards; and ensuring proper documentation of the interactions with professionals.

Asia – APACMed Code of Conduct

APACMed, the medical device association in Asia, has adopted a code for their members. Starting in 2018, APACMed will begin to review educational meetings for independent content, promotion of science, educational merit and an appropriate venue; and that there will be no inducements to use, recommend, purchase, or prescribe any product in return for payments. Payments will be made in the form of grants to defray the costs of the event and support the attendance of HCPs. Grants will be given to healthcare institutions and professional associations, moving away from direct sponsorship. Such direct sponsorships are prohibited as of January 1, 2018.

China – AdvaMed China Code

Matt Wetzel discussed the AdvaMed Code, largely as it relates to China, created to help guide member companies when it comes to customer interaction. AdvaMed has been in China for roughly ten years as it is an enforcement hot stop for US authorities and settlements continue to show that there is a need for adequate internal controls and a timely disclosure of misconduct. Therefore, working in China means that you have a need for strong standards and strong guidance for compliance efforts. 

The AdvaMed China Code was adopted in March 2015 and became effective on January 1, 2016. The Code – based on best practices and global compliance trends – allows for a self-regulatory approach to proactively address potential anti-bribery and anti-corruption concerns in the Chinese marketplace. It establishes baseline compliance guidelines for companies to incorporate into their policies on customer and HCP interactions and serves as a foundational document for the medical device industry operating in China.

While Mr. Wetzel encouraged everyone to spend some time with the Code to see what truly is and is not permitted, the status of sponsorships in China is unclear. The AdvaMed Code helps to clarify requirements for participating companies in China, as phasing out direct sponsorship seems to be the direction China is heading.

In that vein, the AdvaMed Code has phased out direct sponsorships of HCPs to attend third-party educational events, beginning January 1, 2018. As of the first of this year, there is no grant or donation allowed for direct travel, lodging, meals, or registration fees for individual HCPs to attend third-party educational conferences. Instead, companies can provide educational grants or donations to conference organizers to support the conference. The conference organizer or other allowable recipient can then use the grant funds to defray or underwrite HCP costs of attendance.  

Europe – MedTech Europe

Aline Lautenberg noted that much of what was covered in China is true for Europe, with slight differences. One of the newest changes is that companies will have to disclose the grant or donation they are giving to societies or conference organizers on a European platform for any countries where there is no such legislation in place. Further, there is an independent enforcement mechanism throughout Europe to help enforce legislation and regulations.

The rules to phase out direct sponsorships are similar to others found around the world, requiring that grants can only be provided to legal entities (never individuals) and require a written contract and other related documentation. Companies are also able to define the type of recipients that are eligible for the grant but can never name individual recipients that are eligible. Further, companies must have an internal and independent process based on objective criteria to assess any grant requests it receives.

Ms. Lautenberg provided several helpful visual maps to “demystify” the code, including when direct support is permitted as of January 1, 2018.

Heart Rhythm Society Approach

Christina Wurster of the Heart Rhythm Society (HRS) helps to put on frequent educational events for the Society, and was able to speak to the way HRS hosts their events with the help of industry while steering clear of any legal wrongdoings. HRS started the process to understand the regulations by meeting with their global counterparts and surveying event attendees to learn the broad impact the regulations have and to understand the impact the regulations will have on their events.

Ms. Wurster also provided some tips on how to craft your key message, including reviewing the highlights from the new regulations, considering all potential impacts to your organization and meetings, and reviewing and discussing proposed solutions. Once the message has been created, seek buy-in and provide resources to your target audiences, including exhibitors, international ambassadors, and delegates. You’ll also want to have a tactical plan in place, including mapped out communication channels and a customized level of frequency based on the audience.


As of January 1, 2018, these new rules have gone into effect throughout Europe, Asia and China. If you have any additional questions or concerns, a recording of the webinar can be viewed here.   

Additional Resources can be found here:

Chart Comparing the Ethical Codes

China Code


MedTech Europe Code

Ethical Medtech - Conferences


Prime Therapeutics Proves PBMs’ Value


On February 20, 2018, Prime Therapeutics issued a press release that highlighted the way it – as a leading pharmacy benefit manager – has helped save its clients billions of dollars. The 2017 drug trend reports noted that its clients saw overall expenditure reductions (per member, per month) across all three lines of business (commercial, Medicare, Medicaid) as compared to 2016. Additionally, corresponding annual savings delivered to clients in 2017 exceeded $3 billion across all three lines of business.

“Our outstanding 2017 drug trend results are hard won, especially as we continue to see ongoing and significant price increases for medicines in some of the most expensive disease categories,” said Jim DuCharme, Prime’s president and CEO. “These outcomes require many dedicated employees working tirelessly on behalf of our clients and their members to deliver optimal care and prescription drugs at the lowest net cost. Our close alignment with 22 Blue plan clients – 18 of whom are owners – allows us to see the complete pharmacy and medical drug picture to help us drive total cost of care outcomes.”

While specialty medicines continue to exert upward pressure across commercial and Medicare part D clients, Prime was able to offset those spending pressures by delivering substantial savings in other areas, including:

  • Negotiated discounts – In 2017, Prime secured substantial discounts including competitive rebates and more than $1 billion from pharmacy MAC pricing, illustrating the important role generics play in controlling drug costs. Client adoption of Walgreens-anchored networks also exerted downward pressure on trend. Incremental negotiated savings exceeded $1.9 billion.
  • Utilization management – Prime’s efforts to promote appropriate use of medicines approached $2.3 billion in total savings across all three lines of business.
  • Pain medication management – Prime is particularly proud of our efforts in managing controlled substances such as opioids. Not only has Prime decreased pain medicine expenditures across all three lines of business (-14.6 percent in commercial, -12.2 percent in Medicare and -9.8 percent in Medicaid), but these results build on Prime’s controlled substance successes over the past five years. These successes include decreasing by 71 percent the number of commercial members who were at high-risk for misuse* and reducing their health care costs by $1,500 PMPY.  

“While we’re thrilled drug expenditures for our clients declined in 2017, this doesn’t mean drug costs no longer present a challenge,” said David Lassen, chief clinical officer at Prime. “Low trend is not synonymous with low cost. Prescription drugs still represent 20 to 30 percent of costs for our health plans and employers. And out of the 46 drugs the FDA approved in 2017, eight of them drove commercial trend by about 1 percent, at an average price tag of $96,000 annually.”

“PBMs play a crucial role in counterbalancing upward forces in drug spending,” DuCharme concluded. “Without our active and assertive efforts to help drive clinically appropriate use and lowest net cost, spending on prescription drugs would be much higher. We’re proud to stand alongside our clients in this important work, helping people get the medicine they need to feel better and live well.”


ACCME Announces New Collaboration with ABPath


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).


FDA announces Public Meeting on Evaluating Inclusion and Exclusion Criteria in Clinical Trials on April 16


On April 16 from 8:30am to 5pm, the FDA will be holding a public meeting entitled “Evaluating Inclusion and Exclusion Criteria in Clinical Trials.” The event is convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA. The purpose of the public meeting is to bring the stakeholder community together to discuss a variety of topics related to eligibility criteria in clinical trials and their potential impact on patient access to investigational drugs, and how to facilitate the enrollment of a diverse patient population.


The public meeting will be held at the National Press Club, 529 14th St. NW, Washington, DC 20045. For additional travel and hotel information, please refer to the following website. There will also be a live webcast for those unable to attend the meeting in person. For further information, contact Dianne Paraoan at the FDA’s Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3326, Silver Spring, MD 20993, 301-796-2500,

Topics for discussion during this meeting include:

  • The risks and benefits of participation in clinical trials as well as potential regulatory, geographical, and socioeconomic barriers to participation.
  • The rationale for eligibility criteria in clinical trials, as well as the impact of exclusion criteria on the enrollment of populations, such as infants, children, pregnant and lactating women, elderly, individuals with advanced disease, and individuals with co-morbid conditions.
  • Alternative clinical trial designs that may increase enrollment of more diverse patient populations, while facilitating the collection of data to establish safety and effectiveness.
  • How appropriate patient populations can benefit from the results of trials that employ alternative designs.
  • How changes to eligibility criteria may impact the complexity and length of clinical trials, as well as the strength of data necessary to demonstrate safety and effectiveness.
  • Opportunities for using data from expanded access trials.




Safely Unsubscribe ArchivesPreferencesContactSubscribePrivacy