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.

Compliance News in Review, July 31, 2017

A whistleblower settlement, the effect of a recent cyberattack on one company’s drug supply, transparency in Ontario, and the growth of CME, all served for your approval in this edition of the Compliance News in Review.

It is the quintessential American food, even if it didn’t originate here; it’s the hamburger. Nothing beats a good burger, even during the hot dog days of summer (see what we did there?). The tasty entrée even inspired the bard of gulf and western music, Jimmy Buffet, to write a song extoling its virtues. So, how do you like your burger? With slaw? Kraut? Chili? Our mouths are watering just pondering the possibilities! Before we fire up the grill here at the News in Review World Headquarters, we’ll serve a tasty treat of a different flavor – the latest edition of the Compliance News in Review.

This is hardly minced meat. Celgene has agreed to pay $280 million to settle claims in a whistleblower suit that accused the company of promoting two of its cancer products for off-label purposes. The whistleblower, a former employee, claims the company directly marketed the drugs for the off-label uses and hid risks of blood clots from physicians. Celgene did not admit to wrongdoing in the settlement.

Still in a bit of pickle following the Petya cyberattack, Merck has warned that some drug supplies may be disrupted as it continues to rebound from the attack. The company’s R&D and manufacturing operations have not yet fully recovered and there may be temporary delays in filling orders for some products.

Ontario doctors may be flipping over a recent judicial decision that will allow the payments they receive from the government insurance program to be published. The Toronto Star filed a Freedom of Information Act request to obtain the names of the top 100 billers. The Ontario Health Ministry refused to provide the names, saying it would be an invasion of privacy. Two doctor groups and the Ontario Medical Association also fought the release of names, arguing that doing so “accomplishes nothing other than naming and shaming.” The judges disagreed, saying the “public is entitled to information in the possession of their governments so that the public may, among other things, hold their governments accountable.”

The Accreditation Council of Continuing Medical Education (ACCME) 2016 report on the growth of CME finds an increase in the number of events (7%), as well as an increase in the number of instructional hours (9%). The study also shows the number of activities and interactions has increased steadily since 2010. ACCME President and CEO, Dr. Graham McMahon, noted that there are currently more than 3,000 hours of CME available to healthcare providers.

That brings us to the end of another “well done” edition of the Compliance News in Review. We’ll see you right back here for the next summertime treatise, and in the meantime, we leave you with a few tips for barbecuing the perfect burger (olive oil…who knew?).

Have a great week!

Compliance News in Review, July 7, 2017

Canadians, Californians, and Mainers are all on the hunt for transparency. Will they find “gold” they seek? Find out in this week’s News in Review.

There’s gold in them thar hills! Seriously. A number of years ago, a man hid an estimated $2 million treasure of gold and jewels somewhere in the Rocky Mountains, leaving only a cryptic poem to guide treasure hunters to the stash. At the time, he said he hoped it would inspire folk to get up off their couches and explore nature. Many have, and unfortunately, a couple of them met an untimely end during that search. As far as anyone knows, the treasure is still out there for the taking, but before we break out our atlases and sharpen our pickaxes, let’s dig into the news of the day in this edition of the Compliance News in Review.

Pharma companies will be able to hold on to their doubloons if an amendment to the California bill prohibiting gifts and restricting payments to doctors stands. Legislators eliminated the penalties associated with the bill, but added a provision that prohibits doctors from receiving payments for speaking or serving as faculty at events that are not accredited by the ACCME or a similar organization.

A pair of Canadian doctors are on the hunt for transparency with a program intended to gain support for more industry/physician transparency. According to one of the doctors, “interaction with industry is everywhere and a lot of progress has come from collaborating,” but he worries that trust will be eroded if they continue to “keep relationships in the dark.”

Providing some clues to the transparency hunt, ten of the largest pharmaceutical companies in Canada released information on transfers of value they provided to healthcare professionals and organizations. The effort was headed by GSK, and included AbbVie, Merck, and Eli Lilly. Total payments for all the companies came in just under $50 million and covered the 2016 calendar year. Critics complained the data provided little real transparency because the figures represented the companies’ aggregate payments to all doctors or healthcare organizations, rather than individual practitioners or organizations.

The release of this data prompted one treasure hunter, Ontario’s health minister, to announce he will investigate the concept of requiring pharmaceutical companies to disclose physician payment data (a la the U.S. Sunshine Act). He said the voluntary release of recent spend data by certain pharmaceutical companies was a good start, and that the government is “committed to strengthening transparency across the healthcare sector.” Consultations into the matter are scheduled for this summer.

Trekking across the Canadian border to Maine, we discover the legislature has passed a bill that will curtail payments from pharmaceutical companies to doctors. The bill prohibits the provision of “cash gifts” but allows non-monetary gifts of “minimal value.” It also allows doctors to receive payments for speaking about research at “legitimate educational conferences.”

For those wishing to do a little prospecting, the Open Payments data for the 2016 is now available. Nearly 1,500 companies reported transactions totaling $8.1 billion. Just over half of the $8 billion went toward research. A billion dollars was paid in ownership interest, and just under $3 billion fell in the general payments categories. Nearly 12 million records were published this year, covering 631,000 physicians and 1,146 teaching hospitals.

There’s a certain theme running through this week’s news bites. Transparency. Governments, academia, and special interest groups, all extol the need for transparency in the relationships between life science companies and healthcare professionals. Although most of the heavy lifting regarding data is typically handled by a small group of dedicated data hounds, others in the organization need to be aware of the laws and their restrictions.

Those who interact with healthcare professionals need to know the types of information that is reported and understand their role in assuring the accurate and timely collection of the data. As the saying goes, “garbage in: garbage out,” and considering that many of these laws carry financial penalties for reporting errant data, companies certainly want to take steps to reduce the “garbage.”

Well, we’ve reached the end of the trail on this edition of the Compliance News in Review. We’ll see you right back here for the next edition.

Thanks for reading!