Compliance Trends 2018: Our Point of View

The festivities have ended and a shiny new year is upon us, so we are switching hats – from party to prognostication – to delve into what we see as the hot compliance topics and trends for 2018. Based on our reading of the enforcement tea leaves, several 2017 topics should remain at the forefront, but our prediction on the level of activity emanating from the OPDP has changed from last year. So if you’ve resolved to stay up-to-date on all the compliance news fit to blog this year, what better way to start than with this look ahead.

We expect funding for patient assistance organizations, which are charities that provide financial assistance to patients to help cover the cost of medications, to be a trending topic in 2018. In 2016, federal agencies started to focus on the topic and issued subpoenas related to support provided to these charities. In 2017, two companies entered into settlements with the government over that funding. The government considers the practice to be a violation of the Anti-Kickback Statute because the funding offsets the co-pay of patients who participate in government healthcare programs.

Donations to charities that assist with medication costs are permitted, but assistance cannot be directed to patients who are prescribed the donating company’s medications. We would not be surprised to see the government take more of an interest in the financial relationship between the industry and charitable patient organizations this year. Training must emphasize the need to maintain appropriate independence between the company and the patient organizations it chooses to support.

In 2017, a small group of states passed laws related to price reporting, sales representative registration, and physician payment caps. That trend should continue in 2018 and the laws will most likely be focused on pricing transparency, as opposed to spend transparency, which was more common a few years ago. Expect more states to follow New Jersey’s lead and implement broader restrictions and caps on payments to healthcare professionals. The law is intended to combat the growing opioid addiction crisis.

2017 was a surprising year for the Office of Prescription Drug Promotion (OPDP). After a flurry of letters at the end of 2016, we expected the agency to continue that trend into 2017, but only four letters were issued the entire year. That is a record low. Don’t expect a dramatic increase this year.

The letters that were issued last year were focused on false and misleading statements related to risk and omission of risk. Two industry settlements in 2017 included charges of failure to disclose risk in violation of the Risk Evaluation and Mitigation Strategy, so emphasizing the importance of fair balance and truthful, accurate promotional statements when training sales representatives is critical.

On the global front, we would not be surprised to see an uptick in Foreign Corrupt Practices Act enforcement following the implementation of new processes that reward companies for self-disclosing potential violations and cooperating with investigations.

With that, we end this “preview” edition of the Compliance News in Review. To be automatically notified when we post new editions of the News in Review, conference highlights, or compliance training tips, just click the “follow” button on the right side of this page.

Have a safe and compliant 2018!

The 2017 Compliance Year in Review!

As the year winds to a close, we take a break from the hustle and bustle of holiday preparations to reflect on the 2017 trends, topics, and focal points from the world of life sciences compliance. It’s been a busy year, with some expected updates, along with a few surprises, filling our News in Review missives from month to month. So, grab a cup of egg nog, fire up the Yule Log on YouTube, and enjoy this “year in review” edition of the Compliance News in Review.

Drug pricing transparency was a hot topic at the end of 2016, and the trend carried through 2017. The rules for Chicago’s new sales representative licensure law, which is intended to help combat opioid addiction, went into effect. The law requires representatives to obtain a license to sell products in the city and to document their interactions with healthcare professionals. In California, drug manufacturers must now notify the State and other payers in advance when they intend to raise the wholesale acquisition cost of a drug over a certain percentage, and when new drugs are expected to have a wholesale acquisition cost that exceeds the Medicare Part D specialty drug threshold. Nevada passed similar legislation, but its law focuses on diabetes drugs. Nevada also requires sales representatives to be licensed and provide reports of their interactions with HCPs. Finally, Louisiana also jumped on the pricing transparency train.

In an effort to combat the opioid crisis,  Governor Christie in New Jersey issued rules that cap payments made to healthcare professionals by pharmaceutical companies.  Maine passed a gift ban law similar to the existing Minnesota law and, not surprisingly, we heard from Vermont in 2017. The attorney general there is reportedly investigating whether drug and device companies are adhering to the state’s HCP gift ban law.

Not all state-level action was successful. Missouri’s proposed price transparency law did not pass during the past legislative session, and a bill in California to restrict gifts and payments to HCPs passed the state Senate, but was rejected in the Assembly.

Pharmaceutical support for patient assistance charities was another 2016 hot topic that continued through 2017.  An IRS investigation into one of the charities focused on whether it provided an improper benefit to pharmaceutical donors by using the donations to purchase the drugs manufactured by those same companies. Support of patient assistance charities also figured into one company’s healthcare fraud criminal and civil settlement with the government.

2017 was a quiet year for the Office of Prescription Drug Promotion (OPDP). During December of 2016, the agency dropped a flurry of letters, but 2017 will likely see record low in activity with only three letters being issued so far for the entire year.

This was an interesting year in bribery and corruption enforcement. It began with a bang in January as the Serious Fraud Office entered into its first major Deferred Prosecution Agreement. With a changing of the guard in the U.S., FCPA actions were more subdued, but the diagnostic test company, Alere, settled with the Securities and Exchange Commission over improper payments to foreign officials allegedly made by its Colombian and Indian subsidiaries.

The Department of Justice (DOJ) published its Compliance Program Evaluation Guidance in 2017. The document offers details on what the agency considers to be an effective compliance program. Perhaps most notably, the DOJ made its Foreign Corrupt Practices Act Pilot Program permanent. The pilot program ended in early 2017, but it was effectively made permanent with the announcement of a new FCPA Enforcement Policy. Like the pilot program, the new policy encourages companies to self-report possible FCPA violations and rewards companies for their  cooperation during investigations.

With that, we close out another issue of the Compliance News in Review, and another year in the wonderful world of life sciences compliance. We look forward to keeping you up-to-date on all compliance news fit to blog in 2017 and continuing to provide you with an ever-expanding suite of PharmaCertify compliance training products and services.

Thank you for reading. Have a warm and wonderful holiday season and a happy New Year!

The Los Angeles City Attorney opens an investigation against one pharmaceutical company, while the founder of another is indicted on federal racketeering charges.

This year’s World Series brought record-setting excitement and late nights (more like wee hours of the morning for those of us in the East) for fans of America’s game. Congratulations to the Houston Astros, who outlasted the Los Angeles Dodgers, in a seven-game extravaganza, just as Sports Illustrated predicted…three years in advance!

If you’re searching for a new pastime to fill the void left by passing of another season, we have just the ticket. Step into the batter’s box as we present all the life sciences compliance news fit to blog, with this edition of the Compliance News in Review.

Leading off this week, a Wisconsin state legislator introduced a bill that will require drug manufacturers to notify the state in advance if they plans to increase the price of a drug by more than 25%. The lawmaker cited the costs to Medicaid budgets and a lack of transparency with consumers as the justification for the bill.

There’s no “Dodging” the Los Angeles City Attorney for Avanir Pharmaceuticals. On the heels of a CNN report, the City Attorney announced that he intends to open an investigation into the company’s prescribing practices for elderly patients in nursing homes. The report pointed to a rise in prescriptions for the drug in question, even though the studies supporting use with elderly patients are lacking. Top prescribers allegedly received speaking and consulting payments from the company.

Canada is pulling facilitation payments from the mound. The Canadian government announced it will repeal the exception for facilitation payments from its Corruption of Foreign Public Officials Act. The repeal was effective October 31. The law had previously permitted payment to expedite routine services, such as obtaining permits and scheduling inspections.

In news from overseas, the Prescription Medicines Code of Practice Authority (PMCPA), the group responsible for overseeing adherence to the Association of the British Pharmaceutical Industry’s Code of Practice (APBI), saw a rise of more than 40% in the number of complaints it received in 2016 about marketing and promotional practices. The complaints led to 100 new cases, with more than half of those resulting in the determination that the Code was breached.

Insys is on the losing end of a doubleheader, with the founder being indicted on federal charges and a New Jersey doctor potentially losing his license for allegedly accepting kickbacks from the company. The founder was indicted on charges of racketeering, conspiracy to violate the Anti-Kickback Statute, and conspiracy to commit mail and wire fraud. The company has been accused of promoting its opioid product for off-label uses and paying kickbacks to healthcare professionals.

The attorney for the New Jersey doctor says his client has never been the subject of a disciplinary hearing, or had a patient complaint in 25 years of practice, and he welcomes the chance to present his case to the medical board.

Speaking of New Jersey, a public hearing was held to receive feedback on the state’s pending regulation, “Limitations on Obligations Associated with Acceptance of Compensation from Pharmaceutical Manufacturers by Prescribers.” The regulation, which was announced by Governor Christie in late summer, includes restrictions related to transfers of value to prescribers of prescription drugs.  Many of the groups in attendance have expressed concern that the regulation’s $10,000 per year cap on bona fide services payments would have unintended consequences on clinical research. The New Jersey Attorney General stated that while some revision is possible, the State is committed to moving forward with the regulation. Public comments will be accepted through December 1.

With that, we end this “boys of summer (and well into fall)” edition of the Compliance News in Review. One final note: if you’re attending the 18th Annual Pharmaceutical and Medical Device Compliance Congress in Washington DC, November 6-8, stop by Booth 112 (back by all the good food!) to see demos of our newest compliance training solutions and the Compliance 365 Continuous Learning System.

See you in Washington!

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!

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!

Top Ten Compliance Training Mistakes

With apologies to the recently unretired (and bearded) David Letterman, welcome to the first edition of the PharmaCertify Compliance Training Top Ten List. We’ve witnessed a range of missteps and mishaps in individual eLearning modules and curricula over the years and here is a list of the more common ones:

  1. Not refreshing the content regularly. Even if most of the content hasn’t changed, the way in which it is presented, as well as the delivery method, should be updated.
  2. Topic overload. Focus on the most important content for training and use other tools to supplement the training.
  3. Reliance on one type of training. Blended is best.
  4. Training is overloaded with legalese. Use plain English as much as possible to avoid confusion.
  5. Too much content in one course. People retain information better when it is presented in smaller chunks. Break down those 45-60 minute courses into more digestible bites of 25 – 30 minutes.
  6. Too many words on the screen. A screen packed with text leads to cognitive overload. Only use your main points on screen with engaging graphics, and leave the rest to the narrator.
  7. All substance, no style. Content is important, but so are engaging graphics and interactivity. Learners want to be active participants in their training.
  8. All sizzle, no steak. An overabundance of graphics, videos, and music also leads to cognitive overload. If the bells and whistles don’t help the learning, your message is lost.
  9. Not considering the goals for the training. “Checking a box” isn’t a goal. Determine and define the learning objectives before you begin to write the content.
  10. One size does not fit all. Include examples, scenarios, and case studies that are relevant and applicable to the targeted audience.

Thanks for reading!

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.