18th Annual Pharmaceutical and Medical Device Compliance Congress: A Preview

PCF’s annual Pharmaceutical and Medical Device Compliance Congress kicks off next week. The conference offers attendees the rare opportunity to network with industry leaders and hear their thoughts and suggestions on the bevy of topics and regulations affecting those who work in the pharmaceutical or medical device compliance field. Narrowing the list of impressive panels and sessions down to a manageable schedule may seem overwhelming, but we’ve perused the agenda for what we are looking forward to the most:

Day 1, Monday November 6, 2017

Keynote: OIG Update
Hearing the list of topics that led to settlements and the OIG’s fiscal year 2017 workplan from Mary Riordan, Senior Counsel, Office of Inspector General, Department of Health and Human Services is always valuable for anyone responsible for rolling out compliance training. We are also looking forward to hearing how the agency expects to apply information from the Compliance Program Effectiveness Resource Guide released earlier this year as it conducts investigations.

U.S. Attorney’s Roundtable
While we expect to hear about topics such as off-label promotion, we look forward to hearing what the U.S. Attorneys say about the emerging trend of investigating manufacturer relationships with patient assistance charities. Several companies have been subpoenaed for information about these relationships. One company recently entered into a Deferred Prosecution Agreement, as well as a Corporate Integrity Agreement, after being accused of paying kickbacks to a patient assistance charity.

Chief Compliance Officer Roundtable
For those working in compliance for emerging companies, this session offers an opportunity to learn what risks their brethren from larger companies are facing so they know where to focus their priorities for the upcoming year. With Arjun Rajaratnam, from Smith & Nephew, joining the roundtable, medical device company representatives should also find the information worthwhile and relevant.

Day 2, Tuesday November 7, 2017

HCP Engagement: The Road to Proactive Risk Management

The title is intriguing and we’re curious to know what steps industry professionals like Tom Glavin of Olympus and Michelle Murphy of Regeneron utilize to change their corporate cultures and convince leadership to shift to a more proactive model for addressing risk.

Managed Market Considerations for Hub and Specialty Pharmacy Arrangements

Training and messaging for those who work with specialty pharmacies is a topic not often addressed in these forums, so hearing what industry professionals like Terra Buckley of Celgene and Greg Sherman of Gilead Sciences say should be of value.

Compliance Considerations for Small and Mid-Sized Pharma and Medical Device Companies

Here is a direct opportunity for attendees from emerging companies to evaluate their programs against companies of a comparable size and learn best practices for managing risks with less resources.

Brief Overview of the Policy and Politics of Pharma Pricing

Transparency around drug pricing is a hot topic with state and federal legislators. Learning more about the current laws, as well as what to expect from politicians in an election year, should prove to be valuable when evaluating risk, writing policy, and developing training.

The Exhibit Hall (Especially Booth #112!)

We’re looking forward to catching up with clients and friends (old and new) at the 18th Annual Pharmaceutical and Medical Device Compliance Congress. During the networking breaks, we invite you to stop by the PharmaCertify Booth to see demos of our newest compliance training solutions. Our mission is to help you build a stronger compliance culture and reduce risk, and we welcome the opportunity to show you how we’ve done just that for our clients. While you are there, don’t forget to enter the drawing to win a JBL Flip 4 Waterproof Portable Bluetooth Speaker!

See you in Washington!

The Do’s and Don’ts of Compliant Product Promotion

In keeping with our mission of helping you reduce risk and strengthen your compliance culture, we present our top do’s and don’ts for promoting products to healthcare professionals:

  1. Do…be balanced and accurate! Present the benefits and the risks of a product equally.
    Don’t…omit or minimize the risks associated with the use of a product, or exaggerate its effectiveness.
  2. Do…stay on-label! All promotional statements about a product must adhere to the product label.
    Don’t…promote any off-label uses of a product.
  3. Do…use approved promotional materials! Use promotional materials provided and approved by the company to promote a product.
    Don’t…Use retired promotional materials or create your own materials to promote a product. Do not add logos, names or other product information to candies, cookies, or other items, without prior approval.
  4. Do…be careful about comparisons! Only share competing product information that has been approved by the company.
    Don’t…Make unsubstantiated comparative claims about a competitor’s product.
  5. Do…spread the knowledge! Share approved scientific publications or journal reprints with healthcare professionals.
    Don’t…alter any approved publications before you share them with the approved audience.

Thanks for reading!

Life Sciences Compliance Congress West: A Preview

CBI’s 8th Annual Life Sciences Compliance Congress West kicks off in San Francisco in two short weeks. During the packed two-day conference, an esteemed lineup of industry professionals and government regulators will address the emerging risks facing life sciences companies. It’s a great opportunity to share notes and best practices with your peers and industry leaders. If you’re considering attending, we can help with a discount on the registration fee.

In the meantime, we’ve perused the agenda to note the sessions that hold the most interest:

Day 1

Session: Industry’s Guide to GDPR

The General Data Protection Regulation of the European Union, or GDPR, applies to companies that control or process the personal data of EU citizens, regardless of geographic location. That’s a wide reach, and your employees need to understand how their role helps ensure compliance with this new and potentially confusing regulation.

Session: Navigate the Complexities of Patient Assistant Programs (PAPs), Reimbursement Support and Patient Services Compliance in an Era of Ambiguity

Industry assistance for patients is an emerging enforcement area in the U.S. and abroad. Several U.S. companies have received subpoenas from the DOJ centered on their relationship with patients assistance organizations. This session covers the compliance issues related to patient support and the strategies for reducing risk.

Session: Small to Mid-Sized Boot Camp

We may be a little biased on this one, since our own Dan O’Connor, Senior Vice President of PharmaCertify, will join Jim Schneider of Seattle Genetics and Jane Wright-Mitchell of AcelRx to cover compliance governance considerations and key elements of compliance program development. It’s a must-attend for anyone building out a curriculum for an emerging company.

Day 2

Keynote Session: A Journey to the Dark Side of International Business and Steps to Protect Your Organization

Presented by a former FCPA Violator turned FBI/UK Cooperator, the session covers a range of international business practices and pitfalls. We expect topics to include privacy; patient interactions; bribery; and compliance risks when conducting business internationally, all critical information whether you’re updating an existing compliance training curriculum, or building one from scratch.

Session: Operations Management — Align Compliance Strategy with Emerging Risks on the Horizon for 2018

As new life sciences compliance risks emerge, training content, and the methods by which those risks are addressed, need to evolve. This session may offer tips for identifying curriculum gaps as well as the overall program adjustments needed to strengthen your curriculum and reduce risk.

Summary

We’re looking forward to catching up with our friends and clients at the 8th Annual Life Sciences Compliance Congress West. If you’re attending, don’t forget to stop by our booth to say hi and see demos of our newest Compliance Foundations™ eLearning modules, QuickTakes™ reinforcement tools, and compliance workshops. While there, don’t forget to enter our drawing to win a JBL Flip 4 Waterproof Portable Bluetooth Speaker.

See you in San Francisco!

Compliance News in Review, August 21, 2017

Opioid investigations expand; the FDA plans drug advertising studies; DOJ units team up for healthcare sector FCPA investigations; the Sunshine Act is out in South Korea; and a big settlement could signal a new enforcement avenue; all casting a shadow in this edition of the Compliance News in Review.

Here comes the sun, and the moon, and a shadow. It’s eclipse fever! The total eclipse over the continental U.S. was one for the record books, and had people flocking to places like Alliance, NE, Hopkinsville, KY, and Red Bank, SC. If you couldn’t make it to the path of totality this time, you have seven years to plan for the next event.

The shadow of the investigation into the business practices opioid makers use continues to spread. In an SEC filing, Mylan revealed it has received a subpoena from the Department of Justice (DOJ) for information about its opioid business practices. The company, a relatively small player in the opioid market, said it is cooperating with the request.

The FDA, hoping to shed some light on disclosures in drug advertising, has proposed two studies that will focus on how safety information is perceived. The first study will involve patient recall of important safety information presented in print, direct to consumer ads. The second will include oncologists, primary care physicians, and non-oncology mid-level practitioners. It will focus on the effectiveness of disclosures related to preliminary or descriptive clinical and scientific data.

The DOJ’s Criminal Fraud Section announced a partnership between its Healthcare Fraud Unit’s Corporate Strike Force and Foreign Corrupt Practices Act (FCPA) prosecutors. Speaking at an anticorruption conference, the acting chief of the Criminal Fraud Unit said, “This increased coordination will ensure that companies, their executives, employees, and agents are held to account for the payment of bribes and kickbacks to foreign and domestic officials and actors regardless of the market.” He also urged companies to empower compliance teams to take steps to make their anticorruption programs better.

South Korea is the latest nation to bring sunshine to industry-physician relationships. The country has enacted a transparency law like the U.S. Sunshine Act. The law applies to pharmaceutical and medical device companies, and covers a wide range of recipients including pharmacists, herbalists, and acupuncturists, in addition to physicians. Transfers of value covered by the new law include product samples, academic conference sponsorships, food, beverage, and other items (e.g. pens, notepads). Transfers of value must be reported on one of seven reporting templates, and companies must begin collecting data on January 31, 2018.

Is a bad moon rising over industry relationships with patient assistance charities? Recently, United Therapeutics announced it had reserved $210 million in anticipation of a settlement with the government over activities involving a copay assistance charity. Other companies have disclosed that they are subject to investigations as well. Charities do not face the same restrictions as pharmaceutical companies when offering co-pay assistance and the contributions companies make to charities can be considered kickbacks. According to an attorney with Morgan and Morgan, the United Therapeutics announcement is likely to send “shock waves” through the industry.

With that, we end this shadowy edition of the Compliance News in Review. Until next time, we leave you with a total eclipse of the sun, er…Total Eclipse of the Heart.

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!

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!