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!

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!

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

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!