Compliance News in Review, September 8, 2017

Attention students! This week in the news: an opioid marketing Warning Letter; more state level transparency requirementss; and Novo Nordisk learns a tough lesson about product marketing.

The wheels on the bus are going ‘round and ‘round for children all over the country. School is back in session. Time to sharpen those pencils (do kids still use pencils?) and organize that Trapper Keeper. Sorry kids, but we kind of like this time of the year. After all, the deals on office supplies can’t be beat! Can one ever have enough index cards and three prong folders? While we go bask in the glow of our school supply haul, we’ll leave you with a little reading assignment: the latest edition of the Compliance News in Review.

Opioid manufacturer, Cipher Pharmaceuticals, didn’t have a letter sent home by the teacher, but it was issued a Warning Letter by the Office of Prescription Drug Promotion for misbranding its drug, ConZip. The company licenses the drug to Vertical Pharmaceuticals for sales. The letter references a sales aid that failed to disclose the risks associated with use of the product.

Don’t offer the teacher too many of those apples…at least in New Jersey. In the Garden State, Governor Christie wants to place restrictions on transfers of value to HCPs. The regulation limits compensation for “bona fide” arrangements up to $10,000 per year. It requires the arrangements to be in writing, with the HCP’s qualifications clearly stated in the agreement. The regulation also prohibits receipt of lavish meals, gift cards, and other items of a personal benefit to HCPs. Exclusions are made for payments for speaking at CME events and provision of items for patient education. The regulation will be published to the New Jersey Register in early October and a public hearing is scheduled for October 19.

Two industry trade associations are putting their civics education to work. PhRMA and BIO have filed suit against Nevada over the state’s transparency law. The groups claim the law is unconstitutional, and is preempted by federal law, and they have asked the court to put a halt to the implementation or enforcement of what they consider to be the problematic parts of the law. A representative from BIO said the law effectively establishes price controls on diabetes medication, which in turn will reduce private investment in biomedical innovation. A PhRMA representative said the law is unconstitutional because it conflicts with federal and state laws that protect intellectual property and trade secrets.

The city of Chicago is jumping onboard the drug pricing transparency bus. An ordinance has been proposed that will require manufacturers to report price increases 90 days in advance of sales. The ordinance also proposes the establishment of a Prescription Drug Price Review Board to monitor prices, and a hotline for the public to report information about price increases.

Novo Nordisk agreed to pay over $58 million to settle allegations it violated the Food, Drug, and Cosmetic Act (FDCA) and the False Claims Act. According to the DOJ, sales representatives downplayed or mislead HCPs about the risk of a rare cancer associated with the use of Victoza when detailing the drug to healthcare professionals. The company will pay $12.5 million in disgorgement for violating the FDCA, and $48.5 million for violating the False Claims Act.

With that, the final bell rings on this edition of the News in Review. We hope the return to the post-Summer school routine is a smooth and seamless one for all involved. We’ll see you around the schoolyard during recess with another edition of the Compliance News in Review.

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, 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!

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!

Compliance News in “Preview”

As we wistfully wish 2016 a fond farewell, we welcome 2017 and wonder what compliance surprises, developments, and news the year might hold. What will be the hot topics debated around the water cooler in your office? The team at the Compliance News in Review has dusted off its crystal ball once again and we offer a few suggestions on what we see as the hot topics for 2017.

Drug Pricing Transparency

Drug pricing was at the top of the list in 2016. CEOs were brought before Congressional panels to explain exorbitant price hikes, and in several states, laws were proposed that will companies to disclose factors related to drug pricing for certain drugs. Vermont was the only state to pass such legislation, but California has reintroduced the bill for this session. The federal government also got in on the act with a bipartisan bill introduced in the Senate. While some of the fervor has quieted, we don’t think we’ve heard the last of pricing transparency. The passage of Vermont’s law could be the catalyst other states need to get their own laws passed.

Off-label Guidance/Revised Regulations

We don’t expect to see new guidance or regulations in 2017, but the FDA did at least start a conversation with the industry in 2016. A two-day meeting with stakeholders in November resulted in a list of diverse statements and opinions from companies, the medical community, and patient groups. The meeting with stakeholders was a step in the right direction, but a few high-profile cases (Caronia, Amarin, and Pacira) that resulted in wins for the industry, only led to more confusion and questions. We are cautiously optimistic that the FDA will at least continue the conversation and somewhat clarify the regulations.

Warning Letters and Notice of Violation Letters

The FDA’s Office of Prescription Drug Promotion (OPDP) wasn’t very active in 2016…until December, that is. At the end of the year, the agency made up for lost time by sending six letters for non-compliance with drug promotion regulations, signaling (in our humble opinion) a more aggressive approach in 2017. Most of the letters that were sent in December were related to the use of digital media.

Bribery and Corruption Enforcement

In 2016, several companies settled with the Department of Justice over Foreign Corrupt Practices Act (FCPA) violations. Most notable was a $500 million plus settlement with Teva that occurred near the end of the year. We expect to see more settlements this year, with half a dozen life sciences companies already under investigation for FCPA violations, according to the most recent Corporate Investigations List on the FCPA Blog. One wonders if the Serious Fraud Office (SFO) will join the trend as well and pursue more UK Bribery Act cases now that the agency has dipped its feet into the pool of U.S.-style Deferred Prosecution Agreements. We wouldn’t be surprised to see SFO dive right into the deep end.

The 2017 year in life sciences compliance looks to be an interesting one, and we’ll be tracking the news and headlines through our Compliance News in Review updates. Don’t forget to “follow” our blog so you don’t miss any news or our tips and best practices for building and deploying the compliance training you need to reduce risk and strengthen your compliance culture.

Thanks for reading and best wishes for a compliant and successful 2017!

Compliance News in Review, October 14, 2016

Ghouls, goblins and ghosts galore…the haunting season is here! Enjoy it while you can, before you know it, reindeer, snowmen, and gingerbread men will be scattered across the landscapes. (Poor Thanksgiving…it gets no respect!) No tricks from us though, just treats. And by treats we mean delicious bites of news! So before you head out to wait for the Great Pumpkin, join us for this not-so-scary edition of the Compliance News in Review.

The FDA has carved out time for a public hearing on November 9th and 10th to discuss the subject of communicating off-label uses of drugs and devices. The agency hopes to hear from a variety of stakeholders, including industry representatives, healthcare professionals, patients, and research institutions. Approximately 30 topics will be discussed, ranging from the effect that increased communications will have on patient enrollment in clinical trials to how patients should be made aware that they are receiving information about an off-label use.

GSK is feeling a bit of a chill in the air. The company reached an agreement with the SEC to pay $20 million to resolve FCPA-related charges its Chinese subsidiary paid bribes to increase sales. As part of the settlement, GSK is also required to provide the SEC with reports regarding its implementation of anticorruption measures for the next two years.

Dermatologists are receiving lots of treats from the industry. A study of 2014 Open Payments data reveals that nearly three-quarters of the country’s dermatologists received payments in 2014. Most were under $50.00, but a few of the doctors received payments totaling more than $90,000.00. The study appears in JAMA Dermatology.

These are frightful times at Mylan as the company agrees to pay $465 million to settle claims it overcharged Medicaid for EpiPen. The company has come under intense fire for its pricing practices related to the product. In agreeing to the settlement, Mylan did not admit to wrongdoing.

The news of the FDA’s public hearing on communication related to the unapproved uses of drugs and devices is encouraging. Hopefully, after the forum, the agency will move quickly on the release of new guidance. As court decisions are discussed in the media and more public hearings are announced, now is a great time to reinforce appropriate promotional communication through the release of updated training.

With that, we close our autumnal edition of the Compliance News in Review. One final note – if you’re attending the Pharmaceutical and Medical Device Compliance Congress next week, stop by Booth 404 in the exhibit hall and say “boo!”

Thanks for reading and stay compliant!

The Pharmaceutical and Medical Device Compliance Congress: A Preview

The Seventeenth Annual Pharmaceutical and Medical Device Compliance Congress gets underway in just a few short weeks. The annual gathering provides an opportunity for industry professionals and experts to learn from one another and hear from representatives of enforcement agencies. Whether your focus is international compliance, U.S. compliance, transparency, or risk assessment, the conference has something for everyone. We’ve reviewed the agenda and compiled a list of what we see as some the most compelling presentations.

Several sessions focus on compliance issues in managed markets. The preconference Managed Markets 101 review covers private payer systems, market access programs, and government payer systems. The session should provide helpful content and practical examples for those needing to train managed market personnel and salespeople.

If you’re not able to attend the preconference, there are also two managed markets mini summits on Day 2. The morning session covers compliance issues affecting managed markets in general and the afternoon one is focused on audit and monitoring issues. We expect both to spark worthwhile discussions among panel and audience members.

The Pharmaceutical Compliance Forum planners always do a great job of scheduling a variety of sessions dealing with compliance issues in markets outside of the U.S. This year is no exception, with preconference, plenary, and breakout sessions addressing global issues. Since the first transparency reports were filed by EFPIA members over the summer, unpacking what has been learned from the data, and discussing the challenges faced by companies thus far, will be of interest to anyone involved in global transparency.

We are also interested in the keynote address on Day 1 by Sophie Peresson, LLM, MA, Director of Pharmaceuticals & Healthcare Programme for Transparency International. (FYI – the printed brochure has this listed as the keynote for Day 2, but the website has it scheduled as the second keynote on Day 1.) The organization, well-known for its work addressing corruption, recently focused its attention on the pharmaceutical industry, so Ms. Peresson’s presentation should be valuable for companies mapping their future transparency training plans.

Finally the day two mini-summit titled, “Reimbursement Support, Patient Assistance Programs, Coupons, and Charitable Foundations” is another one on our radar. Enforcement agencies have sharpened their focus on these programs, and the area could be the next target for investigators. The panel includes both industry and legal professionals.

Now, we’re interested in your opinion. If you’re attending the conference, stop by the PharmaCertify™ booth in the exhibit hall between sessions and let us know what you think of the sessions and speakers. While you’re there, don’t forget to enter our drawing for a Bose® Soundlink® Bluetooth® speaker.

See you in Washington and stay compliant!