Compliance News in Review, June 13, 2017

States with new laws, lawsuits and more; HHS says drug pricing is a top issue; the AMA takes aim at DTC ads again; and transparency efforts and more from Europe…all in this edition of the Compliance News in Review.

The magic, mystery, and “monstering” of the summer movies season is in full swing! From super-heroes to lush gothic tales, there’s something for everyone this summer. There’s nothing like escaping to the theater on a rainy summer day. Can’t you just smell the popcorn and taste the Milk Duds? Before you head off to take in the latest blockbuster or art house feature, silence your cell phone and enjoy this screening of the latest edition of the Compliance News in Review.

We begin with a trilogy of compelling releases. The Nevada legislature passed a bill that would have required makers of diabetes drugs to report drug pricing information to the State. The bill was forwarded to the governor, who promptly vetoed it. Undaunted, State senators revised the bill; removing the requirements to which the governor objected and adding provisions that apply to all drug manufacturers. It was passed, and in an ending fit for Hollywood, the governor has said he is “proud to sign” the new bill. The law will require manufacturers to report pricing for diabetes drugs, and all manufacturers must now supply a list of sales representatives who work in the State. Additionally, all transfers of value from Nevada sales representative to HCPs must be reported each year, including those to mid-level practitioners and office staff.

It’s a wrap on a new law concerning generic drug pricing in Maryland. Generic drug makers will now be fined when a price increase causes a product’s wholesale acquisition price (WAC) to increase by more than 50% in one year, or if the drug’s WAC is greater than $80. Maryland’s expressed concern that the bill did not address the cost of patented drugs and devices, and that it may result in citizens not having access to some generic drugs. Concerns aside, the governor did not veto the bill. The law will go into effect October 1.

The Washington D.C. Department of Health has posted several FAQs related to AccessRx. The FAQs cover a variety of issues including reporting timelines, advertising expenses, and gift reporting.

HHS Secretary, Dr. Tom Price, says drug pricing is a coming attraction for the agency. In testimony before the senate budget committee, Price said the president has directed him to develop proposals to lower drug costs. He also said meetings with stakeholders have already taken place.

This attraction is rated “P” for pricing. At the AMA’s annual meeting, the group will consider a proposal urging drug manufacturers to list drug prices in DTC ads. The proposal was introduced by several New England medical societies, and advocates who have been pushing federal agencies, such as the Federal Trade Commission and the FDA, to compel drug companies to include retail pricing information in DTC ads. The proposal will need to be approved by the American Medical Association’s House of Delegates before being presented to the larger body.

From the foreign film division, a story of transparency. German doctors will be able to voluntarily disclose payments they receive from drug companies in a database managed by the non-profit journalism group, Correctiv. According to a study conducted by Correctiv, 71,000 German doctors received 575 million Euros worth of payments from the industry last year. The study also found that only 29% of doctors were willing to have their payment information published.

Two companies have been publicly reprimanded for breaches of the ABPI Code of Practice. In one case, a media agency published the work it did for the company to promote the agency’s creative capabilities. The work was out-of-date and no longer accurate. Even though the company did not give the agency permission to publish the work, and voluntarily reported the incident, it was found to have violated Clause 2 of the Code of Practice; bringing discredit upon and reducing confidence in the industry. In the other breach, another company was reprimanded for distributing a patient support leaflet with inaccurate and misleading information. The company was asked to issue a corrective statement to the healthcare providers who had already received the leaflet.

The last story is a good reminder of the importance of making sure your compliance training extends to vendors and other third parties. In bribery cases, we see the damage that can be caused when third parties run afoul of laws and regulations. Vendors and other third parties need to be evaluated for the risk associated with their services and targeted training should be provided based on that risk.

With that, we roll the closing credits on this edition of the Compliance News in the Review. Thanks for reading. We’ll see you at the movies!

Compliance News in Review, May 22, 2017

Insider trading baseball; PhRMA changes the rules; shorter FCPA investigations; praise for Medicines Australia transparency efforts; and a Chinese television drama all about anticorruption. The heat is on in this edition of the Compliance News in Review.

The “official” start of summer is just around the corner and the sun, sand, and ‘squitos will be here before you can say “turn up the air conditioning.” Considering the late winter-like weather many have been experiencing around the U.S. (we feel your pain Colorado), a little heat and humidity sounds like a good idea. Before we restock the sunblock supply and head for the beach (or “down the shore” if you happen to reside in New Jersey), let’s review what has been heating up the newswires, with this issue of the Compliance News in Review.

A former “boy of summer” Doug DeCinces, was found guilty of insider trader for acting on non-public information related to the sale of a medical device company. Prosecutors claimed the former major league baseball player received information from his neighbor, the CEO of a medical device company, about the pending sale of the company to Abbott Laboratories. Prosecutors claimed DeCinces, who was found guilty on 14 felony counts, made stock trades based on the information and tipped others about the sale. His lawyer plans to file a motion for a new trial.

The heat is on at PhRMA. New rules regarding membership in the organization went into effect recently, and promptly led to the ouster of several companies. The new rules require member companies to spend at least 10% of sales on global research and development over three years. Companies must also spend at least $200 million a year on research. Seven companies were unable to meet the new requirements and lost their membership.

Some doctors felt the need to share their warm feelings for Medicines Australia’s transparency efforts. A pair of physicians, and the leader of the Greens party, who is also a doctor, penned a letter to the Australian Medical Journal, praising the organization’s move to increase transparency in industry/HCP relationships. The letter suggests that pharmaceutical and medical device companies follow Medicines Australia’s lead.

As the summer days grow longer, FCPA investigations could be getting shorter. During a conference, Trevor McFadden, acting principal deputy assistant attorney general, for the Department of Justice, expressed his hope that future FCPA investigations will “be measured in months, not years. FCPA thought leaders believe that narrowing the self-reporting window will help control the scope of investigations, but interviewing witnesses in foreign countries can be time consuming.

A television program focused on anti-corruption in government is heating up the Chinese airwaves. The Chinese government usually bans artistic endeavors related to anti-corruption, but the drama, In the Name of the People, has the support and “green-backing” of the government. The show follows the story of an upstanding detective who investigates government corruption in a fictional Chinese province. The program is the top show on Chinese television, and nearly a dozen similar programs are in production.

The focus on anticorruption efforts around the world continues to grow. Does your training extend beyond the FCPA to cover countries like China, Mexico, and Brazil? The newly update Compliance Foundations™ eLearning module, Global Anticorruption Laws introduces learners to the regulations, and the affect they have on their daily work lives and the pharmaceutical and medical device industries in general. Contact us to see a content outline or demo.

Thanks for reading!

Notes from A Busy Day at CBI’s 14th Annual Pharmaceutical Compliance Congress

The 14th Annual Pharmaceutical Compliance Congress featured an array of industry leaders, regulators, and legal consultants offering best practices, tips, and first-hand experiences related to reducing risk and strengthening compliance programs. This summary is focused on Day 1 of the conference, which featured a robust array of general sessions and breakout panels.

Pre-conference sessions were held the day before, and included Accelerated Learning — Healthcare Compliance and Policy Applications, which featured a panel of industry subject matter experts, including Dan O’Connor, Senior Vice President for PharmaCertify™, covering the topics those new to life science compliance need to understand in order to establish and maintain an effective program.

Luminary Session

The first presentation, Ignite and Infuse — Integrating a Compliant Culture within the Company’s DNA, featured three senior industry leaders, Beth Levine from Regeneron, Jim Massey of AstraZeneca, and Michael Shaw from GlaxoSmithKline offering compelling lessons on establishing successful compliance programs and the value of understanding “why they do what they do.”

Beth Levine shared the value principles she prioritized as she started building the department in 2008 when she was hired as the company’s first chief compliance officer. From the beginning, she emphasized the importance not having a “prosecutorial culture,” but one that was more “human, helpful, and empathetic.”

Jim Massey began his comments by recounting the recent United Airlines story related to the passenger being forcefully removed from a flight and the company’s public relations missteps in the immediate follow up. The core of the problem, as Massey saw it, was that United employees were strictly following rules and not making decisions for themselves.

At AstraZeneca, Massey and his team have instituted a true rules-based in which they “trust their people and not just the policies.” His goal was to simplify the policies as much as possible, so much so that the company now has a one-page Code of Conduct.

Michael Shaw followed in agreement, stating his belief that “complexity creates more risk rather than mitigating risk.” He used the example of speaker programs and the value of narrowing the policy down to kickback risks and communication risks.

The concept of a values-based approach to compliance has been discussed at length over the last ten years of the Pharmaceutical Compliance Congress, but this was the first time I heard the presenters offer such concrete and compelling examples and case studies of how their companies put the idea into practice. So much so that, throughout the day, other industry professionals and government regulators repeatedly referenced their comments to emphasize and highlight their own points. It was an illuminating presentation.

Elite Chief Compliance Officer Exchange and Fireside Chat

Next, compliance officers from Alexion Pharmaceuticals, Johnson & Johnson and Merck focused on data privacy and shared their thoughts on the proverbial question of “what keeps them awake at night.” For one presenter, that answer was tied to global risks (another common theme throughout the conference) and for another, it is more about the risks that “have not yet been identified” and that’s why regular risk assessments are so important. In a nod to representatives from smaller companies in the audience, that same presenter warned them not to over-engineer the risk assessments too much and to, “follow the money, and focus on the company’s business plan” to help identify the risks.

More than one presenter during the Fireside Chat stressed that while the data can be useful and powerful, “at the end of the day, it’s about respecting people’s privacy,” which relates to the values approached espoused in the first session. In the words of that CCO, “you need to think about what’s important, not just the process.” As another echoed, “don’t sit back and wait for laws and regulations, put in protections for providers and patients.”

U.S. Healthcare Fraud Enforcement Panel/Former Prosecutor’s Panel

The presentations shifted to the point of view of the industry as a panel of U.S. Attorneys took the stage for the Top Enforcement Trends and Focal Points for 2017 and Beyond session, which was blended with the former prosecutor’s panel, New Developments on High-Profile Cases and Settlements Uncovering Healthcare Fraud.

Unexpectedly, the discussion began with a sobering discussion about the opioid crisis in America, with disturbing statistics on the alarm growth of addiction rates and overdose deaths. It’s not a topic the audience necessarily expected, but it’s one that needs to be discussed, as regulators and the healthcare community seek answers to this frightening scourge that crosses all socioeconomic borders. The numbers are disturbing, and the panelists emphasized that “everyone is working together to figure out where the over-prescribing is coming from,” and “anyone involved in the distribution chain must have a program in place to help detect misuse and abuse.” They’re comments were punctuated by a reference to the recent McKesson case, in which the company paid $150 million to settle claims that it failed to put a system in place to detect suspicious orders.

A former US attorney offered a powerful suggestion when he called for the audience members to immediately and safely remove unused medications from their home, when they return from the conference, because “70% of people who start abusing opioids get them from someone they know, not a doctor.”

The two panels covered more traditional topics as well, and discussed the need for an active and strong compliance program. One presenter focused on smaller companies and warned of the risk of being too focused on being acquired to spent sufficient time on compliance. Not only is that a risk for the company itself, it should be a huge concern for any company interested in acquiring it. Another presenter touched on the familiar theme of “embedding yourself in the business,” as a method for ensuring the program is predictive and “risk-intelligent.”

The session closed with an important and hopeful comment from one panelist when he said, “what you don’t hear about are cases we decide not to prosecute because the companies have such robust compliance programs. That happens in all of our offices.”

Promotional Compliance

After the lunch break, I joined the Promotional Compliance content stream, which began with Tom Abrams of the Office of Office of Prescription Drug Promotion, and his annual Hot Topics, Guidance, Enforcement Trends, and Warning Letter Review session.

Tom detailed the recent Tuxarin ER warning, which focused on a series of troublesome product claims, including the suggestion that the product is safer than its competitors based on differences in dosing formulation and safety profiles of individual ingredients. He also provided a review of the recent Draft Guidance of Medical Product Communications That Are Consistent With the FDA-Required Labeling. The guidance explains the FDA’s current thinking on common questions about the topic and explains that the agency does not consider communications that are consistent with the FDA-required labeling to alone be evidence of a new intended use. A full list of recent warning letters and guidance documents are available on the FDA’s website.

During the First Amendment and Off-label – Caronia and Beyond presentation, Elizabeth Kim of Loeb and Loeb briefly touched on the history of the key cases over the years, and left the audience with key takeaways in terms of where we are now with off-label promotion as it relates to the First Amendment, including:

  • FDA will continue regulate promotion, and there is no green light to promote off-label;
  • Information can be truthful but still misleading in context, and;
  • Transparency and full disclosure are key and includes the good and the bad in terms of how you promote.

She also touched on the recent Arizona off-label law knows as the Free Speech in Medicine Act. At least one institution, the Goldwater Institute, wants to encourage other state legislatures to consider similar legislation, but the law is federally pre-empted, so at this point, it is a symbolic step.

Conclusion

The panel sessions and presentations covered above represent only a portion of the guidance and valuable information offered throughout this year’s Pharmaceutical Compliance Congress. The conference is always chock full of content applicable to those new to the field of life sciences compliance, as well as experienced professionals seeking the latest in best practices, suggestions, and guidance from their peers, consultants, and regulators. This year’s agenda and presenters did not disappoint.

Thanks for reading.

Sean Murphy, Product and Marketing Manager

Pharmaceutical Compliance Congress 2017 Preview

The 14th Annual Pharmaceutical Compliance Congress (PCC 2017) is just around the corner. Whether you work in Compliance, R&D, or Medical Affairs, this year’s conference has sessions for you. We’ll be there as well, catching up with friends and colleagues and learning the latest trends and best practices from industry and government professionals. Here are just a few of the sessions and content streams we have on our to-do list.

Preconference

If you’re there for the preconference sessions on Wednesday, we humbly suggest the session titled Accelerated Learning – Healthcare Compliance and Policy Applications. Dan O’Connor, Senior Vice President for PharmaCertify™, will join a panel of industry leaders and legal consultants in what promises to be a valuable primer for those new to the compliance function or those not in the compliance department who need to understand the responsibilities of their compliance colleagues. We’ve seen the previews!

Day One

Plan to arrive early on Day One, since the opening session, Ignite and Infuse – Integrating a Compliant Culture within Company DNA features an impressive panel of leaders from the industry, including Beth Levine from Regeneron, Jim Massey from AstraZeneca, and Michael Shaw from GlaxoSmithKline.

Following the lunch break, we’re interested in the First Amendment and Off-label Promotion – Caronia and Beyond session occurring in the Promotional Compliance content stream. Considering the recent news around the final rule for off-label promotion and the introduction of a bill in Congress on the topic, it promises to be a timely discussion. We’re also interested the HEOR, Real World Evidence and Comparative Research Effectiveness session in the Clinical Research and R&D Compliance content stream to learn more about how health economic and outcomes research affects the compliance space.

The Small to Mid-Sized Bio/Pharma Boot Camp offers sessions dedicated to issues of concern to a significant portion of the attendees. Compliance professionals working in smaller companies face the same issues as their counterparts in large companies, but are challenged to do more with less as they strive to build or expand their compliance programs. We’re looking forward to hearing how they deal with the challenges of training with such limited resources.

The late afternoon Global Compliance content stream includes several sessions covering anticorruption laws around the globe. (And by the way, when you can work a nod to Walt Disney World in your session title, you’ve got our attention.) Anticorruption efforts are increasing rapidly around the world. The Department of Justice has indicated it doesn’t intend to end the FCPA Pilot Program anytime soon, signaling its intention to continue the aggressive pursuit of corruption cases. Also, the Serious Fraud office in the UK recently entered into its first corporate Deferred Prosecution Agreement, adding even more muscle to the UK Bribery Act.

Since training around speaker programs is a consistent concern and need for our clients, we’ll also be listening carefully and taking copious notes in the Compliance Concerns Regarding Speaker Programs session in the Medical Affairs content stream.

Day Two

On Day Two, we’ll be in our seats bright and early again, and we don’t expect to need extra coffee for a session titled, Cardiac Arrest – Surviving Five Years as a Medical Device CEO on the DOJ’s Hit List. We are particularly interested to hear how prosecutors use the Yates Memo to focus on individuals during an investigation. If that isn’t enough to wake you up, the Data Protection, Privacy Risks and Cyber Crime session should do the trick, considering the vast amounts of data those in the industry are required to manage and protect.

The use of third parties and other intermediaries is one of the top bribery risks facing life sciences companies, so as Day Two wraps up, we’ll be sure to catch the Third-Party Due Diligence in the U.S. and Abroad workshop.

If you’re attending the conference, we want to know what you think. Stop by Booth 10 in the Exhibit Hall and let us know what sessions you found to be most intriguing and useful. If you can’t make it this year, watch for updates on the PharmaCertify™ Twitter feed and our annual post conference highlights and notes here on our blog.

We hope to see you in Washington!

Compliance News in Review, April 19, 2017

The city of Chicago releases sales representative licensure rules; review and dispute time is here again; opioid manufacturers receive letters and negotiate settlements; and Australia proposes changes to its bribery law, in this edition of the Compliance News in Review.

April showers may bring may flowers, but they also bring something else…the Boys of Summer. Major League baseball is back! Much of the buzz seems to center around a former Heisman Trophy winning quarterback and his homerun prowess. Whether your team is off to a hot start (we’re looking at you Yankees fans) or surprisingly struggling (are the Blue Jays already too far out?), there’s plenty of time for the standings to change as the temperatures warm. For now, buy me some peanuts and Cracker Jack and settle in for this edition of the Compliance News in Review.

Our first story comes from Chicago, home of the 2016 World Series champion Cubs. The City has released draft rules for its pharmaceutical sales representative licensure ordinance. The initial license is $750.00. Like the rules in place for detailers in Washington DC, Chicago’s ordinance has a continuing professional education provision. Education provided by the rep’s company will not suffice in meeting the requirement unless the company applies for and receives approval from the city. The draft rules also require sales representatives to track their interactions with healthcare professionals.

April 1st was opening day for the Open Payment’s review and dispute period. Physicians and teaching hospitals are free to review recent submissions to the system and dispute items they believe are incorrect. The review and dispute period for the 2016 Program Year ends on May 15th.

Senator Claire McCaskill sent letters to a lineup of opioid manufacturers requesting that they provide information related to sales, marketing and education strategies used to promote their products. from which she wants some information. McCaskill acknowledged that most of the players in the opioid market act responsibly and she said the purpose of her investigation is to learn if any of the practices

Mallinckrodt has agreed to settle a DEA probe for $35 million. The settlement involved the company’s suspicious order monitoring program for controlled substances. The settlement is under review by the DOJ and DEA. In a statement, Mallinckrodt said it had not violated the law, and the settlement does not include an admission of liability.

Australia appears to be poised to move its bribery law up to the major leagues. Government officials there announced that several reforms were being considered to deal with bribery of foreign public officials. The reforms include the addition of a “corporate failure to prevent bribery” offence and use of deferred prosecution agreements to encourage self-reporting. Among the changes proposed, the definition of a foreign public official would include political candidates and bribery offences would extend to those that offer a “personal advantage,” not just a “business advantage.”

The anticorruption landscape continues to evolve. The PharmaCertify Compliance Foundations™ eLearning module, Global Anticorruption Laws, covers the concepts common to most anticorruption/anti-bribery laws, as well as the specifics related to laws such as the FCPA and the UK Bribery Act. In addition, our new Compliance QuickTake™, Recognizing and Reducing Third-Party Risks, covers the risks associated with working with third parties, in a targeted microlearning format.

The PharmaCertify™ team will be offering demos of our compliance training products at the Pharmaceutical Compliance Congress in Washington next week. Stop by Booth 10 in the Exhibit Hall to say hi, and while you’re there, enter our drawing to win a JBL SPLASHPROOF PORTABLE SPEAKER.

See you in Washington!

Move Beyond the Basics to Make Compliance Training Stick

We’ve come a long way in life sciences compliance training in a relatively short time. Fifteen years ago, the common approach to compliance training often involved lawyers from the legal department, using PowerPoint slide decks to train large groups, once a year at POA sessions. Somewhere along the way, the industry recognized the importance of instructional design, and the power of technology, as the focus shifted to eLearning and the on-going search for ways to use it in an engaging and creative manner. That pursuit continues.

Instructionally-sound, creatively-scripted eLearning still represents an effective method for training large groups across a company, but to truly reduce risk, micro-learning concepts need to be strategically integrated to your curriculum. More targeted training, focused on specific subjects, and smaller audiences, is key. Let’s use anticorruption training as an example.

Anti-bribery legislation is on the rise around the world, and the increasing risks associated with the growing number of laws requires a comprehensive approach to your anti-bribery/anticorruption (ABAC) training. Core ABAC training, by nature, needs to address an expansive topic list, and it needs to be targeted to audiences as diverse as sales and marketing; medical affairs; regulatory; logistics; and manufacturing. Once that core training is launched though, the audiences that represent the highest risk (i.e., sales and marketing), and the topics that present the greatest risks to those audiences, (e.g., third-party red flags) need to be identified. As one example, deploying a smaller module on “recognizing and reducing third-party red flags,” to the sales and marketing audience after the broader ABAC module is completed, reduces risk for the one audience that has direct contact with third-party intermediaries.

Micro-learning doesn’t have to end with mini-modules. Employees are seeking information and training differently than they did back in those PowerPoint-driven years. Tools such as infographics and scenario-based video sequences offer more opportunity to make the focused learning stick, especially when spaced appropriately across a learner’s timeline and blended with other learning components. In addition, reinforcement doesn’t end with training. Apps offer an ideal method for delivering “just-in-time” reference content where the employees need it most – in the field and at their fingertips. In this case, offering access to a list of red flags, and tips for how to identify them, would drive down the risk for that sales and marketing audience.

The PharmaCertify team will be exhibiting at the 14th Annual Pharmaceutical Compliance Congress in Washington April 26-28. If you’re attending, stop by Booth 10 (it’s back there where CBI keeps all the good food!) to share your ideas for reinforcing compliance learning in your organization. After all, we’re compliance learning geeks – we want to hear them! And don’t miss Dan O’Connor, Senior Vice President for PharmaCertify™ at NXLevel Solutions, as he and his co-presenters offer a conference prelude session on healthcare compliance and policy applications.

See you in Washington!

Sean Murphy, Product and Marketing Manager

Compliance News in Review, March 27, 2017

Everything’s coming up roses, off-label speech, and corruption, in this edition of the News in Review.

We’ve got the fever…Spring fever! Spring has sprung, and we couldn’t be happier. Warmer weather, more daylight, budding trees and flowers, what’s not to love (besides the severe weather, commuting in the dark, and pollen)? This Spring, the flowers aren’t the only thing blooming, though. A new edition of the Compliance News in Review has appeared in our garden.

Arizona gets to claim the first “bloom” for sharing truthful off-label information with the governor signing the Free Speech in Medicine Act into law. The law protects the free speech rights of those in the medical community to discuss truthful off-label information about FDA approved drugs. It covers speech that is “not misleading, not contrary to fact, and consistent with generally accepted scientific principles,” and only deals with discussions between pharmaceutical companies and healthcare professionals. It does not cover off-label discussions or advertisements targeted to consumers.

The FDA has stemmed the implementation of a new off-label regulation. The agency announced in the Federal Register that it would delay the effective date of a final rule related to “intended use” regulations until March of 2018. It is delaying the effective date to consider public commentary. In February, industry trade groups petitioned the FDA to indefinitely stay and reconsider the rule.

Is a late season chill on the horizon for Novartis? According to a media report, the South Korean government is considering additional penalties against the company in relation to a kickback case. The government’s Ministry of Food and Drug Safety has already imposed a fine against the company and suspended the sale of some of the company’s products. A source at the Ministry of Health and Wellness said the government was considering lowering the price of the drugs involved in the kickback case. Novartis said the court case was on going, and it wasn’t aware of an “imminent” decision from the Health Ministry.

“New life” is being breathed into the FCPA Pilot Program. At the American Bar Association’s National Institute on White Collar Crime , Acting Assistant Attorney General, Kenneth Blanco said the DOJ will evaluate the Pilot Program and determine what, if any, changes should be made. Until the evaluation is complete, the Pilot Program will remain in force. The Pilot Program, the common name for the DOJ Fraud unit’s guidance on FCPA investigations and prosecutions, was due to expire on April 5. The Pilot Program is intended to encourage individuals and companies to voluntarily self-disclose instances of corruption, and establishes requirements for voluntary self-disclosure, cooperation with investigations, and the resolution of FCPA cases.

The growth in global anticorruption settlements and activity is sure to be a hot topic at the Pharmaceutical Compliance Congress, April 26-28 in Washington, DC. The PharmaCertify™ team will be providing demos our new Compliance Foundations™ module, Global Anticorruption Laws, along with all our new and updated compliance training products, at Booth 10 on the Exhibit Floor.

See you in Washington!

%d bloggers like this: