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!

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!

Compliance News in Review, September 22, 2017

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

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!

Move Beyond the Basics to Make Compliance Training Stick

We’ve come a long way in life sciences compliance training in a relatively short time. Fifteen years ago, the common approach to compliance training often involved lawyers from the legal department, using PowerPoint slide decks to train large groups, once a year at POA sessions. Somewhere along the way, the industry recognized the importance of instructional design, and the power of technology, as the focus shifted to eLearning and the on-going search for ways to use it in an engaging and creative manner. That pursuit continues.

Instructionally-sound, creatively-scripted eLearning still represents an effective method for training large groups across a company, but to truly reduce risk, micro-learning concepts need to be strategically integrated to your curriculum. More targeted training, focused on specific subjects, and smaller audiences, is key. Let’s use anticorruption training as an example.

Anti-bribery legislation is on the rise around the world, and the increasing risks associated with the growing number of laws requires a comprehensive approach to your anti-bribery/anticorruption (ABAC) training. Core ABAC training, by nature, needs to address an expansive topic list, and it needs to be targeted to audiences as diverse as sales and marketing; medical affairs; regulatory; logistics; and manufacturing. Once that core training is launched though, the audiences that represent the highest risk (i.e., sales and marketing), and the topics that present the greatest risks to those audiences, (e.g., third-party red flags) need to be identified. As one example, deploying a smaller module on “recognizing and reducing third-party red flags,” to the sales and marketing audience after the broader ABAC module is completed, reduces risk for the one audience that has direct contact with third-party intermediaries.

Micro-learning doesn’t have to end with mini-modules. Employees are seeking information and training differently than they did back in those PowerPoint-driven years. Tools such as infographics and scenario-based video sequences offer more opportunity to make the focused learning stick, especially when spaced appropriately across a learner’s timeline and blended with other learning components. In addition, reinforcement doesn’t end with training. Apps offer an ideal method for delivering “just-in-time” reference content where the employees need it most – in the field and at their fingertips. In this case, offering access to a list of red flags, and tips for how to identify them, would drive down the risk for that sales and marketing audience.

The PharmaCertify team will be exhibiting at the 14th Annual Pharmaceutical Compliance Congress in Washington April 26-28. If you’re attending, stop by Booth 10 (it’s back there where CBI keeps all the good food!) to share your ideas for reinforcing compliance learning in your organization. After all, we’re compliance learning geeks – we want to hear them! And don’t miss Dan O’Connor, Senior Vice President for PharmaCertify™ at NXLevel Solutions, as he and his co-presenters offer a conference prelude session on healthcare compliance and policy applications.

See you in Washington!

Sean Murphy, Product and Marketing Manager

Compliance News in Review, March 27, 2017

Everything’s coming up roses, off-label speech, and corruption, in this edition of the News in Review.

We’ve got the fever…Spring fever! Spring has sprung, and we couldn’t be happier. Warmer weather, more daylight, budding trees and flowers, what’s not to love (besides the severe weather, commuting in the dark, and pollen)? This Spring, the flowers aren’t the only thing blooming, though. A new edition of the Compliance News in Review has appeared in our garden.

Arizona gets to claim the first “bloom” for sharing truthful off-label information with the governor signing the Free Speech in Medicine Act into law. The law protects the free speech rights of those in the medical community to discuss truthful off-label information about FDA approved drugs. It covers speech that is “not misleading, not contrary to fact, and consistent with generally accepted scientific principles,” and only deals with discussions between pharmaceutical companies and healthcare professionals. It does not cover off-label discussions or advertisements targeted to consumers.

The FDA has stemmed the implementation of a new off-label regulation. The agency announced in the Federal Register that it would delay the effective date of a final rule related to “intended use” regulations until March of 2018. It is delaying the effective date to consider public commentary. In February, industry trade groups petitioned the FDA to indefinitely stay and reconsider the rule.

Is a late season chill on the horizon for Novartis? According to a media report, the South Korean government is considering additional penalties against the company in relation to a kickback case. The government’s Ministry of Food and Drug Safety has already imposed a fine against the company and suspended the sale of some of the company’s products. A source at the Ministry of Health and Wellness said the government was considering lowering the price of the drugs involved in the kickback case. Novartis said the court case was on going, and it wasn’t aware of an “imminent” decision from the Health Ministry.

“New life” is being breathed into the FCPA Pilot Program. At the American Bar Association’s National Institute on White Collar Crime , Acting Assistant Attorney General, Kenneth Blanco said the DOJ will evaluate the Pilot Program and determine what, if any, changes should be made. Until the evaluation is complete, the Pilot Program will remain in force. The Pilot Program, the common name for the DOJ Fraud unit’s guidance on FCPA investigations and prosecutions, was due to expire on April 5. The Pilot Program is intended to encourage individuals and companies to voluntarily self-disclose instances of corruption, and establishes requirements for voluntary self-disclosure, cooperation with investigations, and the resolution of FCPA cases.

The growth in global anticorruption settlements and activity is sure to be a hot topic at the Pharmaceutical Compliance Congress, April 26-28 in Washington, DC. The PharmaCertify™ team will be providing demos our new Compliance Foundations™ module, Global Anticorruption Laws, along with all our new and updated compliance training products, at Booth 10 on the Exhibit Floor.

See you in Washington!