DOJ

“Dear Connie the Compliance Training Specialist” Debuts on the PharmaCertify Blog!

NXLevel Compliance Team , , , , , , , , , , , , , , ,

Welcome to the inaugural edition of “Dear Connie the Compliance Training Specialist,” where we answers questions about timely compliance topics and delve into the best training methods to reduce the risks.  

This week: managing the potential perils of speaker programs. 

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Dear Connie,

I am a compliance manager for a small pharmaceutical company in the Northeast. I am concerned that our new sales representatives may assume that they don’t need to worry about the details on speaker programs since an outside vendor manages them for us. We touch on speaker programs in the initial training all representatives take, but I am not sure we emphasized their responsibilities enough. Am I crazy to be concerned?

Signed,

Concerned in Connecticut

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Dear Concerned,

First, you are not crazy and I understand your concern. Speaker programs are a hotbed for potential compliance risks. It has been my experience that if you roll out additional training, like microlearning, assessments, and contests continuously to the reps, you’ll significantly reduce the risk around speaker programs.

Here are just a few topics to keep top-of-mind for the reps, and cover in the continuous training, even when an outside vendor is managing the program for you.

Attending to Attendees Concerns

On-going training needs to emphasize the finer details involving attendance. Representatives need to know that transparency laws require attendance to be documented, and it also helps the company evaluate the program. Whether a meal is offered or not, all attendees must sign-in. Reps need to remember no-shows and those who refuse a meal must be documented.

Speaker programs typically have a minimum required number of attendees. If the RSVPs fall short of that number, the program should be cancelled. Verbal commitments do not count.

Off-label Questions

Off-label questions asked during the presentation are another area of concern. If your company allows speakers to answer off-label questions (not all companies do), the speaker needs to make attendees aware that the question is in reference to an off-label use, and answer only the question that is asked. If that doesn’t happen, the sales representative must interrupt the speaker. Otherwise, the company can be accused of promoting the product for the off-label use. This is a great topic for role-playing during live training.

In addition, physician speakers represent the company. The programs are promotional in nature, so representatives must follow FDA regulations and speakers must follow the approved program. They may not proactively share their experience involving unapproved uses of products.

Speaker Requirements and Issues

I remember one case when a speaker unavoidably arrived late due to traffic and he suggested that he skip several slides to catch up on the time. Make sure the representative knows to stand firm on this. All slides must be delivered.

Another time, the representative realized, after the presentation started, that the speaker added his own slides to the deck. Representatives need to be trained to not panic and cause a disruption, but make note of the incident and notify a manager and the compliance department about the incident. Representatives should remind speakers that in the future, only the approved slides may be used.

Speakers sometimes ask if they can bring additional material about the topic being discussed, to hand out to the attendees. Representatives need to be trained to always let the speaker know that all materials must be approved by their company in advance of the program – whether the request occurs prior to the program or when the speaker arrives. Unapproved handouts are not permitted.

Thank you for a great question!

Connie the Compliance Training Specialist

Compliance Trends 2018: Our Point of View

NXLevel Compliance Team , , , , , , , , , , , , , , , , ,

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!

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , , , , , , , ,

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!

Open Payments Funding and Another Kickback Case in the News

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , ,

An Open Payments letter from two senators, a list of diabetes drugs from Nevada, near silence from the Office of Prescription Drug and Promotion (OPDP), and an unsealed kickback case…all in this edition of the Compliance News in Review.

Thanksgiving is just around the corner! There’s nothing like a day of food, family, friends, and parades (and of course, football!) to kick off the holiday season. Can’t you just smell the turkey and fixings permeating the hallways and your olfactory senses now? Before we go unpack our “Thanksgiving pants,” we’ll leave you with a different type of tasty morsel: a new edition of the Compliance News in Review. Bon appetit!

Senators Richard Blumenthal and Chuck Grassley don’t want to see CMS’s Center for Program Integrity (CPI) left at the kids’ table. They sent a letter to the acting Health and Human Services Secretary urging that funding for the CPI be made a priority. The CPI is responsible for managing the Open Payments database. The letter includes references to “recent reports that have raised concerns about the effect payments to health professionals may have on opioid prescribing practices, which in many ways has exacerbated this ongoing public health epidemic.”

Nevada’s Department of Health and Human Services published its list of three dozen diabetes drugs that are subject to the State’s new transparency law. Manufacturers with a drug on the list will have to report a variety of financial information, including costs associated with production the drug; rebates and coups offered; and profits earned from the drug. Regulations for reporting the information are still pending.

Will the OPDP pass on dessert at Thanksgiving Dinner? OPDP is on pace to issue a record low number of letters this year. So far, only two letters have been issued. In 2016, the agency issued five in the first six months, then in December, it issued six more. The letter count has steadily declined over the last sixteen years. Will 2017 will be a record low?

On the social media front, Twitter upped its character limit to 280, and according to social media manager, Andrew Grojean, pharmaceutical marketers should take advantage of the expanded word count. Grojean says the change does not solve all the issues related to use of the platform, but it provides more freedom and flexibility, as well as more space for the required fair balance.

Did Eli Lilly over stuff the turkey? A recently unsealed whistle blower case alleges that the company provided kickbacks to boost sales of its drugs. According to the suit, the company offered nursing services to HCPs through a third-party to induce doctors to prescribe three of its drugs. Allegedly, the nurses essentially acted as sales reps even though they were supposed to be providing independent medical advice and disease state education.

With that, we end this holiday edition of the Compliance News in Review. In the spirit of the season, we are thankful to all who take the time to read our tome on a regular basis, and as always, we invite you to contact our editor, Sean Murphy, with your feedback. He can be reached at smurphy@nxlevelsolutions.com.

Have a fun and festive Thanksgiving holiday!

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

NXLevel Compliance Team , , , , , , , , , , , , , , , , ,

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!

Friday the 13th Brings Multiple Settlements for One Unlucky Company

NXLevel Compliance Team , , , , , , , , , , , , ,

CMS posts new Open Payments thresholds, MedTech Europe revises its Code, California deals with two new pharmaceutical laws, and multiple settlements are announced for one “unlucky” pharmaceutical company…in this Friday the 13th edition of the Compliance News in Review.

Be careful what you wish for, Freaky Friday (a.k.a. Friday the 13th) has arrived. Steer clear of those sidewalk cracks, black cats, and broken mirrors! We prefer to focus more on the “Friday” part of the date stamp rather than the “13th.” Whether you’re working for the weekend, or just counting down the minutes until it officially begins, we offer the latest edition of the Compliance News in Review to help you whittle away the hours until the superstitions have subsided.

Change doesn’t have to always be scary. MedTech Europe, a joint venture of EucoMed and European Diagnostic Manufacturers Association, changed its Code of Ethical Business Practice. Changes include the phasing out of direct sponsorship for HCPs to attend medical conferences; enhanced transparency of educational grants; and new guidelines for demonstration products and samples. In addition, starting in 2018, members will only be able to provide educational grant support for meetings that have been vetted by the organization.

The “lucky” numbers for the Open Payments reporting thresholds for 2018 have been posted by CMS. The small payments, or de minimis threshold, was raised to $10.49, and the annual aggregate threshold was raised to $104.90.

California passed two new laws affecting the pharmaceutical industry. First, SB 17 requires health plans and insurers to report information about drug pricing. The information will be compiled into a report showing how drug pricing effects health insurance premiums. The law also requires drug manufacturers to notify purchasers 90 days in advance if a drug’s wholesale acquisition cost (WAC) is going to increase.

AB 265 prohibits prescription drug manufacturers from offering assistance to lower out of pocket costs, if a lower-cost generic equivalent drug is available. Exceptions include the discounts required under an FDA Risk Evaluation and Mitigation Strategy (REMS); single-tablet drug regimens for the treatment of HIV or AIDS that are as effective as a multi-tablet regimen; and completion of step therapy or prior authorization requirements for a branded drug, as mandated by the individual’s health coverage.

Time to start throwing copious amounts of salt over the shoulder at Aegerion. The company pled guilty and pay over $35 million to settle criminal and civil charges that it violated the FDCA, HIPAA, and the False Claims Act. According to the Department of Justice, Aegerion did not follow the proper Risk Evaluation and Mitigation Strategy when educating prescribers about the rare cholesterol condition its drug was approved to treat. The government also claimed the company filed a misleading REMS report and promoted the drug for the general treatment of high cholesterol, all in violation of the FDCA.

Aegerion also resolved civil charges it violated the False Claims Act. The company allegedly shared misleading information about its drug, altered or falsified statements of medical necessity or prior authorization to federal healthcare programs, and defrayed the copay obligations of patients in federal healthcare programs, which is a violation of the Anti-Kickback Statute.

Following the settlement, the patient assistance organization involved, Patient Services, Inc. (PSI), acknowledged it received a subpoena from the DOJ. PSI said it had cooperated with the government in the case. The organization said it operates “under guidelines set by the U.S. Health and Human Services Office of the Inspector General and does not funnel funds for manufacturers.”

Some “strange magic” leads to a $13 million FCPA settlement for Alere to resolve charges it violated the FCPA. The company allegedly paid bribes to meet its revenue targets. According to the SEC, company subsidiaries in India and Colombia used distributors or consultants to make improper payments to foreign officials. The agency said the company failed to maintain adequate internal controls to prevent the payments and recorded the payments incorrectly.

With that, we close out this superstitious edition of the Compliance News in Review. Thanks for reading! Stay safe out there as you navigate the potholes and pitfalls that allegedly lurk in shadows, and no matter what, don’t walk under that ladder!

Life Sciences Compliance Congress West: A Preview

NXLevel Compliance Team , , , , , , , , , , , , , , ,

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

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

Day 1

Session: Industry’s Guide to GDPR

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

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

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

Session: Small to Mid-Sized Boot Camp

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

Day 2

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

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

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

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

Summary

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

See you in San Francisco!

Compliance News in Review, September 22, 2017

NXLevel Compliance Team , , , , , , , , , , ,

Reprimands in the UK, opioid manufacturers face another investigatory group, and registration processes for Nevada representatives, all in this week’s Compliance News in Review.

Ready or not, Fall is here! Leaves are turning, football is back, the oppressive heat of Summer is fading, and pumpkin spice everything is available. We are certainly fans of Autumn here in the offices of the News in Review and we’re ready to break out the flannel shirts, boots, and maybe a knit cap to enjoy the cooler evenings ahead. We are also fans of compliance! So, grab a pumpkin spice latte and settle in to this edition of the Compliance News in Review.

A nip in the air, and a nip at the marketing practices of several companies by the ABPI. The industry organization reprimanded Pfizer, Novartis, Astellas UK, Astellas Europe, and TOR Generics for breaches of its Code. Pfizer and Novartis were both cited for misleading promotion, and unclear materials used by representatives. Astellas UK and Astellas Europe voluntarily admitted that prescribing information for several of their products omitted references to adverse events. Lastly, TOR Generics was accused of promoting an unlicensed product, which was expected to be a prescription-only product, in a public magazine.

A new team is investigating opioid marketing. 41 state attorneys general formed a coalition to investigate opioid manufacturers and distributors. The group subpoenaed several top manufacturers, and wholesale distributors Amerisource, Cardinal, and McKesson. The AGs want to know if manufacturers deceived healthcare professionals about product efficacy and addictiveness.

Time to turn over a new leaf in Nevada. The state published draft procedures for the registration of pharmaceutical representatives. Individuals who work in Nevada for at least five days a year and communicate with healthcare professionals, or participate in the activities listed below, must register with the state’s Department of Health and Human Services (DHHS):

  • Marketing of prescription drugs to healthcare providers, pharmacists or pharmacy employees, and employees of medical facilities
  • Meeting with healthcare providers to answer questions about product use and benefits, or to provide discussion and product information and resources to those providers or other decision makers while representing the manufacturer or supporting promotional efforts of the manufacturer
  • Distributing FDA regulated product samples and product information

These activities are excluded under the law:

  • Attending a conference in Nevada that is not exclusively marketed to Nevada healthcare professionals
  • Activities related to clinical trials, investigational drugs, or Risk Evaluation and Mitigation Strategies
  • Activities performed by wholesale distributors who do not represent a single manufacturer

Companies are required to notify DHHS as employees are hired and terminated, and employees must be registered with DHHS within 30 days of hire.

With that, we wrap up this edition of the Compliance News in Review and head outback to roast marshmallows and make smores! If you can’t join us by the fire pit, we’ll catch you back here for our next issue.

Thanks for reading!

Compliance News in Review, September 8, 2017

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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, August 21, 2017

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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.