One company seeks to negotiate a settlement with the several states over opioid marketing, while Vermont investigates violations of its gift ban regulation…in this edition of Compliance News in Review.

Will Purdue Pharma go for the Hail Mary? Is Vermont about to throw a flag for gift ban violations? Is there a new way to offset bribery penalties? Will there be a third down push from the OPDP? We address these questions and more, in this edition of the Compliance News in Review.

In the words of Max from Where the Wild Things Are, “let the wild rumpus start.” No, not the holiday shopping frenzy (although that certainly applies), but the college football conference championships! Championship weekend is upon us and with it, the fight for a position in the playoffs. So far, the season has had its share of twists and turns, and the conference championships should provide additional drama. It all ends with the selection of the four playoff teams on December 3rd. To help fill the time to kickoff, we offer “X’s” and “O’s” of our own, in this edition of the Compliance News in Review.

Has Purdue Pharma huddled up with several state attorneys general? According to people familiar with the situation, the company has reached out to the states to gauge their interest in a global settlement related to its opioid drug. Currently, a consortium of 41 state attorneys general are investigating several opioid manufacturers’ marketing and sales practices. While Purdue is not authorized to represent other opioid makers, those familiar with the situation say the company is seeking an agreement that would cover all states’ lawsuits against all opioid manufacturers.

Vermont is calling for a review. The Vermont attorney general is investigating possible violations of the state’s gift to healthcare professionals ban according to a source familiar with the matter. The state law bans the provision of most items of value to healthcare providers. However, Open Payment data shows that physicians are receiving gifts, travel, and other banned transfers of value.

Companies that cooperate in FCPA investigations will now score big points with the Department of Justice. The agency will now consider foregoing criminal charges when a company self-reports. If a company cooperates with prosecutors, fixes the issue that led to the investigation, and helps investigators find the individuals responsible for the misconduct, the DOJ will presume the issue can be resolved without criminal charges. Any profits received from the misconduct will still need to be forfeited. Companies that do not voluntarily report possible FCPA violations may still be eligible for some leniency if they cooperate with investigators.

The Office of Prescription Drug Promotion has issued its third violation letter for 2017. A warning letter was issued to Amherst Pharmaceuticals and Magna Pharmaceuticals over promotional statements related to an insomnia drug. The OPDP cited false or misleading information about the risks and efficacy of the drug found on a product webpage and an exhibit panel. The letter also stated that the companies failed to submit the webpage and exhibit panels to the FDA prior to them being first used, as is required. Magna Pharmaceuticals says it will correct the exhibit panels and make sure all materials in the marketplace are correct. Amherst Pharmaceuticals was cited for information on the product webpage, but sold the insomnia drug to Magna in May.

With that news from the OPDP, the clock is winding down on this conference championship edition of the Compliance News in Review. If you’ve got a Dawg (how’s that for a hint as to who we will be pulling for?) in the fight in this weekend’s conference championships, we wish you luck (unless of course, your “Dawg” is a Tiger). Good luck to your favorite team or alma mater and we’ll see you here for the next edition.

Thanks for reading!

Open Payments Funding and Another Kickback Case in the News

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!

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

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

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

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

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

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

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

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

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

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

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

See you in Washington!

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

PCF’s annual Pharmaceutical and Medical Device Compliance Congress kicks off next week. The conference offers attendees the rare opportunity to network with industry leaders and hear their thoughts and suggestions on the bevy of topics and regulations affecting those who work in the pharmaceutical or medical device compliance field. Narrowing the list of impressive panels and sessions down to a manageable schedule may seem overwhelming, but we’ve perused the agenda for what we are looking forward to the most:

Day 1, Monday November 6, 2017

Keynote: OIG Update
Hearing the list of topics that led to settlements and the OIG’s fiscal year 2017 workplan from Mary Riordan, Senior Counsel, Office of Inspector General, Department of Health and Human Services is always valuable for anyone responsible for rolling out compliance training. We are also looking forward to hearing how the agency expects to apply information from the Compliance Program Effectiveness Resource Guide released earlier this year as it conducts investigations.

U.S. Attorney’s Roundtable
While we expect to hear about topics such as off-label promotion, we look forward to hearing what the U.S. Attorneys say about the emerging trend of investigating manufacturer relationships with patient assistance charities. Several companies have been subpoenaed for information about these relationships. One company recently entered into a Deferred Prosecution Agreement, as well as a Corporate Integrity Agreement, after being accused of paying kickbacks to a patient assistance charity.

Chief Compliance Officer Roundtable
For those working in compliance for emerging companies, this session offers an opportunity to learn what risks their brethren from larger companies are facing so they know where to focus their priorities for the upcoming year. With Arjun Rajaratnam, from Smith & Nephew, joining the roundtable, medical device company representatives should also find the information worthwhile and relevant.

Day 2, Tuesday November 7, 2017

HCP Engagement: The Road to Proactive Risk Management

The title is intriguing and we’re curious to know what steps industry professionals like Tom Glavin of Olympus and Michelle Murphy of Regeneron utilize to change their corporate cultures and convince leadership to shift to a more proactive model for addressing risk.

Managed Market Considerations for Hub and Specialty Pharmacy Arrangements

Training and messaging for those who work with specialty pharmacies is a topic not often addressed in these forums, so hearing what industry professionals like Terra Buckley of Celgene and Greg Sherman of Gilead Sciences say should be of value.

Compliance Considerations for Small and Mid-Sized Pharma and Medical Device Companies

Here is a direct opportunity for attendees from emerging companies to evaluate their programs against companies of a comparable size and learn best practices for managing risks with less resources.

Brief Overview of the Policy and Politics of Pharma Pricing

Transparency around drug pricing is a hot topic with state and federal legislators. Learning more about the current laws, as well as what to expect from politicians in an election year, should prove to be valuable when evaluating risk, writing policy, and developing training.

The Exhibit Hall (Especially Booth #112!)

We’re looking forward to catching up with clients and friends (old and new) at the 18th Annual Pharmaceutical and Medical Device Compliance Congress. During the networking breaks, we invite you to stop by the PharmaCertify Booth to see demos of our newest compliance training solutions. Our mission is to help you build a stronger compliance culture and reduce risk, and we welcome the opportunity to show you how we’ve done just that for our clients. While you are there, don’t forget to enter the drawing to win a JBL Flip 4 Waterproof Portable Bluetooth Speaker!

See you in Washington!

Friday the 13th Brings Multiple Settlements for One Unlucky Company

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!

The Do’s and Don’ts of Compliant Product Promotion

In keeping with our mission of helping you reduce risk and strengthen your compliance culture, we present our top do’s and don’ts for promoting products to healthcare professionals:

  1. Do…be balanced and accurate! Present the benefits and the risks of a product equally.
    Don’t…omit or minimize the risks associated with the use of a product, or exaggerate its effectiveness.
  2. Do…stay on-label! All promotional statements about a product must adhere to the product label.
    Don’t…promote any off-label uses of a product.
  3. Do…use approved promotional materials! Use promotional materials provided and approved by the company to promote a product.
    Don’t…Use retired promotional materials or create your own materials to promote a product. Do not add logos, names or other product information to candies, cookies, or other items, without prior approval.
  4. Do…be careful about comparisons! Only share competing product information that has been approved by the company.
    Don’t…Make unsubstantiated comparative claims about a competitor’s product.
  5. Do…spread the knowledge! Share approved scientific publications or journal reprints with healthcare professionals.
    Don’t…alter any approved publications before you share them with the approved audience.

Thanks for reading!

Life Sciences Compliance Congress West: A Preview

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

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

Day 1

Session: Industry’s Guide to GDPR

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

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

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

Session: Small to Mid-Sized Boot Camp

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

Day 2

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

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

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

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

Summary

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

See you in San Francisco!