off-label

News in Review, June 15, 2016

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Federal investigators subpoena information related to charitable organizations from three companies, Congress proposes an amendment to the FDCA, the head of the FDA speaks on off-label information, and New Hampshire’s Attorney General targets the manufacturer of a popular painkiller.

The temperatures are rising well past 70 degrees Fahrenheit and that can only mean one thing…time to hit the beach! Pack up the station wagon, minivan, or whatever mode of transportation best accommodates your gear and head to the sand and surf for some fun and relief from the heat! Of course, the standard precautions and warnings are in order: use plenty of sunscreen; mind the flags regarding ocean conditions; and above all, be wary of teens resembling Frankie Avalon and Annette Funicello bursting into fits of random dancing and singing (now there’s a dated reference for you). Of course, you’ll need plenty of reading material before you drift off into a coconut oil scented daydream. So after you finish the latest from Mary Higgins Clarke or that true crime tome, please enjoy the next best beach read…this edition of the Compliance New in Review.

The waves of compliance just got slightly chopping for a trio of drug manufacturers. Three companies, Gilead, Jazz and Biogen, received subpoenas from federal investigators for information related to their relationships with charitable organizations that help patients with medication costs. Charities receiving support from industry companies claim those companies have no say or influence on which patients they help or what drugs are covered. The government’s concern centers on whether the contributions are essentially illegal kickbacks.

Oh sunny day – a panel of the House of Representatives Energy and Commerce Committee proposed an amendment to the Food, Drug and Cosmetics Act that would allow companies more leeway in sharing truthful off-label information. The proposed amendment would limit the definition of intended use to the manufacturer’s “objective intent,” and allow for the dissemination of materials for scientific exchange, if the information in the materials is backed by scientific evidence. The panel expressed concern about the need for doctors to be kept abreast of the latest medical information, and frustration at the lack of movement by the FDA on guidance related to the dissemination of off-label information.

The head of the FDA also rode the off-label promotion wave when he spoke at the BIO International Convention. In his remarks, Robert Califf noted that supportable information worth sharing should be included on the product’s label, and he questioned why companies would not include useful information on the label or in the prescribing information. Califf also encouraged the industry to embrace social media, saying, “the best way to develop products in the future is likely going to involve a lot of people with diseases to have a handle on what their needs are, what their expectations are, and what their risk tolerance may be.”

As expected, Vermont was first in the water with a law requiring transparency of drug pricing. State officials will identify 15 drugs for which they want information about the reasons for price increases. The manufacturers of those drugs will have to submit information to justify the price increases.

New Hampshire Attorney General’s office has filed suit against Purdue over the company’s refusal to provide documents related to the marketing of OxyContin. The AG’s office claims the company is providing HCPs with misleading information regarding the product. The suit claims the company touts the drug lasts for 12 hours, and it also does not appropriately address end-of-dose failure. The AG also claims the company downplays the risks associated with addiction. Purdue says it is more than willing to cooperate with the investigation, provided the AG’s office does not share any documentation with private attorneys. The company believes a financial conflict of interest exists with the firm retained to assist in the investigation, and it should not be compelled to turn over information while a court case is pending.

A report from Reuters questions the independence of firms hired by companies under a CIA to serve as an Independent Review Organization (IRO). Unlike other agencies, the Department of Health and Human Services does not prohibit companies under a CIA from hiring an IRO with which they have an existing relationship. Critics claim those arrangements represent a conflict of interest. A representative of the HHS Office of Inspector General (OIG) said she has not witnessed any issues with these arrangements. Spokespersons for various industry companies said they disclose all their business relationships to the OIG in advance.

The seas have also been choppy for Salix Pharmaceuticals recently. The company agreed to pay $54 million to settle allegations it provided kickbacks to physicians for prescribing its products. According to the DOJ, the company admitted to paying doctors to be speakers for the company as an inducement for prescribing its products. The government claims the programs at which the doctors spoke were largely social in nature and provided little or no information related to a product. In addition to resolving the federal case, the settlement will resolve several related state fraud cases.

That’s all for this edition of the News in Review. Until next time, we wish you safe sailing and calm compliance waters!

Compliance News in Review – In Case You Missed It, April 2016

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Wow, we’re already a week into May 2016. Time flies when you’re staying compliant. If policy writing, auditing, monitoring, or compliance training development kept you too busy to keep up with all of the April compliance news, not to worry, we have a summary of all the compliance news that was fit to blog throughout the month…with the ICYMI, April 2016 edition of the Compliance News in Review.

A new study suggests drug ads aren’t particularly effective in prompting patients to discuss the advertised drug with their doctor. In fact, only 7% of people were moved to discuss a drug with their physician after seeing a televised ad. While they may not be motivated to speak to their physician, viewers do notice the ads. The survey found that 64% of the respondents said they believed they saw more drug ads over the past year.

Shionogi received a warning letter for omitting risk information on a co-pay coupon for a drug that treats lice. The FDA said the coupon touted the efficacy of the product without stating any of the risks.

The Department of Justice announced a pilot program for companies to self-report violations of the FCPA in exchange for reduced penalties. Under the program, companies that self-report and take steps to remediate identified problems will be eligible for the reduction in penalties.

Pfizer and the DOJ announced the settlement of the case involving Pfizer’s Wyeth unit. The company agreed to pay $784.4 million to resolve charges it had reported false and fraudulent price information to the government.

Ten of Canada’s top drug firms plan to voluntarily disclose aggregate physician and healthcare organization payment data. The movement was started by GSK Canada, and multinational firms like Abbvie, Purdue, BMS, and Lilly soon joined.

CMS held a webinar for Open Payments stakeholders. The agency’s remarks focused on program timelines, in particular, the review and dispute period. A question and answer session for participants was included.

The Massachusetts Medical Society is now requiring its members to disclose financial ties to industry when posting information or reviewing a medical procedure or service on the Internet.

With the review and dispute period for Open Payments in full swing, it is good time to make sure those in customer facing roles are up to date on the requirements of the Sunshine Act, and your company’s procedures for addressing questions from covered recipients. Sunshine Act and Open Payments, from the PharmaCertify Foundations™ curriculum of eLearning modules, provides an overview of data collection and reporting responsibilities, and is easily modified to include your company-specific policy on how to handle questions from covered recipients.

Stay compliant and here’s to a merry month of May!

News and Notes from the 13th Annual Pharmaceutical Compliance Congress

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CBI’s 13th Annual Pharmaceutical Compliance Congress, held last week at the Ritz-Carlton in Washington DC, offered an impressive lineup of industry luminaries and government regulators discussing a wide range of compliance-related topics. While some of the discussions didn’t offer much in the way of groundbreaking information (tone at the top, embed compliance in the businesses, relationships matter, etc.), the concepts presented were critical for any attendees new to their role or the world of life sciences compliance in general.

Embed Compliance into Business Practices

There was the expected emphasis on the concepts of embedding compliance into business practices and gaining buy-in from the C-suite. One panelist even mentioned that when asked to join her current company, she insisted that she be a member of the North American leadership team and therefore have direct access to the business leaders. As another speaker put it, “relationships matter, and you have to speak the language of the businesses in their terms.”

Tie Compliance to Incentives

One compliance officer from a small pharmaceutical company referenced the need to make sure sales incentive is tied to compliance, to make the concepts and policies more meaningful – a concept that was considered revolutionary in the industry just a few years ago. She added that sales management needs to own the compliance metrics in order for there to be lasting and real change. The same global officer touched on the challenges of doing business globally and the need to have tough conversations about spending caps. “You will get pushback,” she stressed, “but don’t compromise. There’s no need to take that kind of risk.”

Transparency: Think Globally, Act Locally

Continuing on the global front, presenters reviewed the merits and details of global transparency codes like EFPIA, while touching on upcoming movements toward laws and guidance. When dealing with global regulations and codes, the potential for confusion reigns. For example, when providing meals to HCPs from various countries, one panelist advised audience members to use the lowest common denominator for the meal limit, BUT, don’t forget to take Loi Bertrand into consideration if an HCP happens to be from France.

In addition, panelists stressed that companies can’t fall into the trap of thinking that because they are familiar with the rules around the Sunshine Act and Open Payments, they can roll right into global reporting. As one speaker from a large pharmaceutical company suggested, you have to look at it differently. “If you approach it like you approach Open Payments, your credibility will be challenged.”

Yates Memo and Individual Culpability

Among the regulators and defense attorneys who spoke during the conference, one common theme was the Yates Memo, and the affect it has (or is some cases, doesn’t have) on how investigations are conducted and cases prosecuted. The Memo, which is named for Department of Justice Deputy Sally Quillian Yates, was released in September of 2015. It generally states that the DOJ will increasingly target individuals in corporate crimes. A number of the regulators stressed that while the Memo is significant in its scope, it will not necessarily change how their offices pursue pharmaceutical and medical device cases. During the U.S. Healthcare Fraud Enforcement Panel, one US Attorney said it “codifies what they have already been doing in her office” and another commented that he asks his prosecutors to always look at individual culpability in each case.

Innovations in Training

As a compliance-focused learning company, we at PharmaCertify™ pay close attention to presentations and commentary with a slant toward training. It’s been a slow process, but based on the information and concepts presented in this and other recent conferences, it’s clear to us that companies are integrating exciting and novel techniques into their curriculums. Innovative compliance departments are adding micro-learning solutions and app-based tools in an effort to raise the level of engagement among their learners, which is music to our ears.

One company representative detailed the planning process and upfront analysis she and her colleagues conduct to ensure that training concepts meet the needs of the business as well as the compliance department. Once those needs are identified, they look for unique ways, including a healthy dose of humor, to make their messages stick. She and her co-presenter reviewed the details of the compliance app recently launched across the company, which uses self-produced video sequences, with compliance department employees as actors, to communicate the concepts. While we agree that technique can help to “humanize” compliance, as we warned in a recent post, you need to be careful that bad acting doesn’t distract from the important messages.

While this year’s Pharmaceutical Compliance Congress featured much of the same themes as recent conferences, the ever-evolving world of life sciences compliance always offers new twists and turns for those tasked with ensuring their individual companies remain in alignment with the latest rules and regulations. These conferences offer attendees the invaluable opportunity to learn best practices, tips, and updates directly from their peers and government regulators from around the world. They shouldn’t be missed.

See you at the next conference!

Compliance Edutrainment: Too Much of a Good Thing?

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These days, the standard airline safety presentation is delivered via video on most aircraft. Somewhere along the way, airlines decided this approach was an opportunity to express their creative spirit, and a bit of a competition developed, with the imagined spoils going to the company that produces the most entertaining safety video. That competition reached a new level when Virgin America rolled out its Safety Dance video. It boasts talented singers and dancers (and one Olympian) delivering the FAA- required safety information. If the objective is simply to entertain, then mission accomplished. However, if the objective is to educate passengers about safety protocol, we’re not sure it hits the mark.

The world of compliance training has thankfully evolved beyond the “death by PowerPoint” approach that dominated the life sciences landscape years ago. Those charged with developing compliance training now look to create programs that are more engaging and entertaining. In the case of eLearning, a number of tools and techniques can be applied to deepen engagement and learning, but if overused, or misused, the same tools have the opposite effect and distract from the learning. We call this the Edutrainment Trap.

All good adult learning starts with objectives, answering the question, “What do I want the learner to know and be able to do by the end of this training?” Enamored with the latest tools and ideas, losing sight of objectives once we start to design and develop the learning is easy. Here are five tips to help keep your compliance organization from falling into the Edutrainment Trap:

  1. Use Interactivity Intelligently: The interactivity itself is often overused in online compliance training. Of course, a well thought-out level of interactivity is important, but overloading the interaction on every screen only serves to distract the learner from the salient points. When covering critical topics like off-label marketing and privacy, interactive exercises and games need to be integrated intelligently, and in a manner that doesn’t cloud the learning with unnecessary messages. Interactive elements should serve a purpose, and not just be included for the sake of entertainment.
  2. Include Targeted Imagery: Images and graphics are sometimes misused or overused in a way that distracts from the core objectives. There is truth to the phrase, “a picture is worth a thousand words” and well-placed imagery is certainly more engaging than an overabundance of text on screen. But when the objective is to ensure the learner can “demonstrate an understanding of the payments that need to be reported under the Sunshine Act,” pretty pictures only go so far. Relevant images and graphics that reinforce key concepts and support learning objectives are needed.
  3. Mind the Bandwidth: Video and animation offer exciting opportunities for compliance training, but like any new tools, they need to be utilized judiciously and with the objectives in mind. In this time of high-speed corporate networks, we can forget that bandwidth is sometimes an issue for third-party vendors. An overabundance of video or complex animations may cause problems. Think carefully about geography and access when developing that global transparency module for deployment around the world.
  4. Remember that Acting Counts: If live actors are being used, make sure the subject matter remains the star of the training. Oscar-quality acting isn’t necessary for the training to be effective, but there is a fine line between amusing amateur acting and just plain bad acting. When the goal is to communicate the seriousness of a topic like the Anti-kickback Statute and its implications, amateur acting will derail any hope for effectiveness, as the learners start to pay more attention to the acting, and not the learning. Similarly, the more conversational the dialogue, the better. If the narration sounds like someone is reading a law journal or compliance policy, learners will tune out.
  5. Be Mindful of Cultural Differences: Making cultural references or using humor can be a fun way to interject life into training, but it has to be included carefully. Jokes can lessen the importance of the message. Cultural references that the audience may not understand can frustrate and ultimately distract the learner, leaving them saying “huh?” instead of “I got it.” This safety video by Delta is a great example. The video is entertaining, funny, and clearly communicates the required safety information – all good things. However, if the learners are not familiar with the nature of viral videos and Internet stars, the humor is lost, and the random assortment of characters only leads to confusion.

Avoid the Edutrainment Trap of loading training with every bell and whistle imaginable in the effort to make the learning fun and engaging. A good balance of imagery, text, and interactivity keeps training interesting and flowing and is a necessity in today’s complex regulatory landscape. Understanding which techniques are most effective and appropriate for the learners and the subject matter is the key to developing effective and highly-engaging training.

Thanks for reading and stay compliant!

Compliance News in Review, April 13, 2016

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Industry companies in Canada announce plans to voluntarily disclose payment data. Massachusetts institutes new disclosure requirements, the DOJ offers smaller penalties in exchange for self-reporting, an administrative court in France recommends the provision for allowing DPAs be removed from bribery legislation, and Shionogi receives a warning letter for a co-pay coupon.

April showers bring May flowers, and outside the News in Review offices, we’re already feeling the brunt of that whimsical rhyme. But, the bright colors and fragrant blooms are just around the bend, so we’ll tolerate a bit of turbulent transitional weather for the opportunity to soon enjoy nature’s bountiful beauty. In the meantime, after you dry out the umbrellas and shake off the cold rain, we offer the latest in the compliance news fit to blog, with this edition of the Compliance News in Review.

There’s only Sunshine on the horizon in Canada. Ten of the country’s top drug firms plan to voluntarily disclose aggregate physician and healthcare organization payment data. The movement was started by GSK Canada, and they were joined by other multinational firms including, Abbvie, Purdue, BMS and Lilly. Canada’s industry trade organization praises the initiative. Critics claim the plan will yield no meaningful information, and are pressuring Canadian lawmakers to pass a U.S.-style Sunshine Act.

New disclosure requirements are blooming for physicians in Massachusetts. The state’s Medical Society is now requiring its members to disclose financial ties to industry, including the receipt of free goods or services from companies, when they post information or review a medical procedure or service on the Internet. The requirement comes as a result of growing concern about physicians promoting treatments on social media platforms.

Could a respite from the bribery enforcement storm be on the horizon? The Department of Justice announced a one year pilot program for companies to self-report violations of the FCPA, in exchange for reduced penalties. Under the program, companies that self-report and take steps to remediate identified problems will be eligible for significantly lower fines. The head of the agency’s fraud unit says the program draws a line between companies that self-report and those that cooperate once violations are identified by the DOJ.

There’s a light rain falling on France’s new anti-bribery efforts. The country’s highest administrative court has recommended removal of the provision for Deferred Prosecution Agreements in foreign bribery legislation. The recommendation did not come as a surprise, considering the calls from numerous organizations to remove the provision.

A co-pay coupon brought out the dreary side of the FDA for Shionogi. The company received a warning letter for omitting risk information on a co-pay coupon for a drug approved to treat lice. The FDA says the coupon touted the efficacy of the product without stating any of the risks. The coupon did provide the website addresses where consumers could read the full prescribing information but the letter claims that is not enough to address the full risk information requirement.

The FDA’s position on truthful off-label statements has been the focus of recent headlines. Ensuring that colleagues are trained on the requirements related to promotional statements is critical. According to a study, the FDA cited omission of risk in 60% of the untitled and warning letters that were issued between 2013 and 2015. You can read about our observations on those letters here. Everything from press releases to statements made by hired speakers is subject to FDA oversight, providing training to all who are in a position to make promotional statements is important.

Well, that’s the news for now. We look forward to seeing you, rain or shine, for the next edition of the Compliance News in Review.

The 2016 Pharmaceutical Compliance Congress: a Preview

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On April 26 and 27, compliance professionals and government representatives will gather in Washington, D.C. for the 13th Annual Pharmaceutical Compliance Congress. As usual, the conference offers a cornucopia of sessions and workshops focused on important compliance topics. There is plenty to see and learn, but here are the topics that have piqued our interests:

Day One General Session: FMV Considerations and Emerging Compliance Risk – In this age of transparency, FMV is a hot topic for life science companies and healthcare providers alike. This session, along with the breakout sessions on the same topic, offer a great opportunity to identify emerging risks related to FMV, and learn best practices from industry colleagues.

Day One General Session: EFPIA Initiatives for 2016 and Beyond — Charting the Course for Global Transparency – EFPIA members have completed their first year of data collection to comply with the Disclosure Code. We’re hoping to hear about the early challenges companies are facing and EFPIA’s plans for the future of its transparency initiative.

Day One Track: Product Promotional Compliance – In particular, we are interested in two sessions:

Social Media — New Challenges and Opportunities: While social media presents a unique set of challenges, its affect on life sciences marketing and compliance has to be taken into consideration.

Speaker Programs and Medical Roundtables — Environment and Areas of Risk: In this era of increasing scrutiny, we’re specifically interested in hearing about the emerging risks surrounding roundtables and the strategies for mitigating those risks.

Day One Workshop: Analyze FCPA Updates and Identify Areas of High-Risk to Mitigate Non-Compliance, paired with the Day Two General Session FBI address, International Corruption Squads – the FCPA and Beyond – At the end of 2015, the DOJ announced that it planned to hire 10 additional attorneys for its Fraud Division FCPA Unit. Also, the Serious Fraud Office entered into its first corporate Deferred Prosecution Agreement for violation of the U.K. Bribery Act last year. Enforcement of anti-corruption laws continues to be a priority for the U.S. and governments abroad. Learning about the emerging risk areas, and how various agencies cooperate in enforcement, is key to ensuring that your anti-corruption program is covering all the right bases.

Day Two Track: Fraud, Abuse and Kickback Prevention – The scrutiny of payments to physicians is only going to increase as more entities comb through transparency data. Concern from investigators and enforcement agencies about the potential for kickbacks is growing. The discussion on anti-kickback enforcement trends, and the establishment of compensation limits will be helpful when addressing your organizational kickback risks.

Day Two Discussion Group: Focus on Pricing – Considerations for Compliance as Scrutiny Heats Up – Last year, we saw the largest settlement ($12.4M) under the OIG’s Civil Monetary Penalties Authority. The settlement was over price misreporting, and enforcement in this area isn’t about to let up. This session presents a great opportunity to learn about best practices and the challenges compliance professionals are facing regarding government pricing.

Day Two Track: Compliance Program Structure and Effectiveness – Engage the Organization to Promote Ethics within Compliance

Okay, we may be a bit biased on this one, since Peter Sandford from NXLevel Solutions is one of the presenters, but as your training audience evolves, so should your compliance training. As millennials bring a new sense of energy and expectations to the industry, implementing modern and innovative learning strategies is more important than ever. Peter and his co-presenter, Jim Massey – Vice President, Global Compliance, Enablement & Assurance, AstraZeneca, will share five key principles for integrating creative and engaging compliance training into your organization.

We invite you to stop by the NXLevel booth to see demos of our compliance-focused training solutions and to share your thoughts on the sessions. And while you’re there, don’t forget to enter our drawing to win a Bose® SoundLink® Bluetooth speaker.

Stay compliant and we’ll see you in Washington!

Compliance News in Review, March 29, 2016

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New anti-corruption measures are introduced in Australia, the FDA announces a new requirement for opioid labels, PhRMA is sending researchers to Capitol Hill, and Respironics settles False Claims allegations.

Everything’s coming up roses…and daffodils and tulips. Spring fever is here! Of course, with that beauty comes all that not so lovely pollen, but for now at least, we prefer to stay positive. To help pass the time as you wait for old man winter to release his final desperate grip, we offer the Compliance News in Review, blooming with all the recent compliance fit to blog.

Seeds of change have been planted in Australia. Following criticism from the Organisation for Economic Co-operation and Development, the Australian government is taking steps to strengthen anti-corruption measures in the country. Several new anti-corruption measure have been introduced in the last several months by the government. New laws went into effect that clarified that proving intent to influence a foreign official was not necessary to establish a bribery claim, and that strengthened accounting fraud laws. The government also shared a discussion paper regarding the possibility of implementing DPAs in corporate law cases.

The Food and Drug Administration announced it will now require labels on short-acting opioids to include a “black box” warning about the risk of addiction, abuse, overdose, and death associated with use of the products. The warning must include a statement indicating that the chronic use of the drugs by pregnant women may result in a painful withdrawal process for the newborn. The warning applies to over 200 products. The change comes as part of a larger government strategy to combat opioid abuse.

PhRMA is making plans to sprout up on Capitol Hill. The trade association plans to send top scientists and researchers to meet with lawmakers to discuss drug pricing. PhRMA CEO, Steve Ubl, says the organization is going to take a more proactive tact in addressing issues around drug pricing. Mr. Ubl said, “I think it’s fair to say this represents a bit of a pivot for the organization. We’re going to develop a proactive policy agenda, and we’re going to drive it.” In the past, PhRMA has reacted to negativity about extreme drug price increases at companies like Turing and Valeant, by explaining the complexities of drug pricing, or by distancing itself from the companies by pointing out they are not PhRMA member. Moving forward, the organization plans to push for policy that will limit price increases.

The bloom is off the rose at sleep apnea mask manufacturer, Respironics. The company agreed to pay almost $35 million to settle False Claims Act allegations. Respironics was accused of providing kickbacks, in the form of free call center services, to durable medical equipment (DME) suppliers that bought its sleep apnea mask. DME suppliers that did not use the Respironics product had to pay a monthly fee for using the call center. The illegal activity allegedly occurred between April of 2012 and November of 2015.

Well, that’s all the news springing up around here for this edition. Have a great week everyone and may hope spring eternal!

Compliance News in Review, Ides of March Edition

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BMS makes changes to its promotional spend policy in China, a physician is sentenced to prison for accepting kickbacks, and the FDA agrees to allow Amarin to promote its fish oil drug for off-label purposes.

“Beware the Ides of March,” and with good reason. Not only was Julius Caesar assassinated during the Ides, but Czar Nicholas II abdicated his throne, the Nazi’s occupied Czechoslovakia, and the issuance of global health alert concerning the SARS virus all occurred on that infamous date. While plenty of good things probably happened as well, we’re stocking up on horseshoes and four leaf clovers here at the News in Review headquarters, just in case. As we wait for the clock to tick down on March 15th, let’s look at the fortunes of those who made news in the world of compliance, with this edition of the News in Review (fingers crossed it isn’t all bad).

Advice from a soothsayer isn’t necessary for BMS to make changes to its promotional spending policy in China. The company will no longer pay speaker fees to doctors, and will be cutting is spending on entertainment and donations to medical associations due to red flags identified in its Chinese operations. This is second wave of changes for BMS in China, following the company’s settlement with the SEC over violations of the FCPA.

Misfortune has certainly followed one Chicago doctor into March. Dr. Michael Reinstein was sentenced to nine months in prison for accepting kickbacks when issuing prescriptions for clozapine. The doctor admitted to accepting close to $600,000 in kickbacks for prescribing the drug. The defense requested probation, but the judge rejected the request, saying Dr. Reinstein’s patients were among the most vulnerable in society and he violated the trust of those patients when he accepted the kickbacks.

The news isn’t all bad in the Ides, though. The FDA has agreed to allow Amarin to promote its fish oil drug for off-label purposes. Amarin filed suit against the FDA claiming the agency was violating its free speech rights by trying to restrict the company from sharing truthful off-label information in its promotion of the drug. The FDA agreed to be bound by the decision issued in US District Court, which allowed the truthful off-label promotion of the drug. The agency says “the settlement is specific to this particular case and situation, and does not signify a position on the First Amendment and commercial speech.”

As witnessed by the FDA’s statement on the Amarin settlement, a definitive stance regarding the use of off-label information when promoting a product seems to still be a moving target. While companies and legal-types debate how this decision, and other free-speech cases, should be interpreted and applied, we see it as another opportunity to highlight all the legal requirements around product promotion. Providing fair-balance, making accurate, truthful and not-misleading statements are just as important when promoting a prescription drug or device. As an example, notice of violation letters sent by OPDP in recent years typically site inaccurate and misleading statements as the reason for the notice.

With that, we put a green ribbon on this “pre” Saint Patrick’s Day edition of the Compliance News in Review. Here’s hoping the Ides treat you well. Have a great week everyone and stay compliant!

Compliance Buzz March 14, 2016 – Three Good Reasons to Pre-Disclose HCP Spend

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To pre-disclose, or not to pre-disclose. That is the question.

Life science staffs are juggling multiple HCP spend transparency disclosure requirements these days. Managing those requirements can be a complex process, involving multiple systems and personnel dedicated to collecting and reporting the data. Teams charged with the management of spend transparency have to consider whether pre-disclosing the data, outside of what may be required by law, is a good idea.

Here are three reasons why we think the answer is yes:

1: It keeps HCP’s from being blindsided. Under most global transparency initiatives, data sent to regulatory bodies is made public, so it must be accurate. Pre-disclosure is one tool that can be used to facilitate that effort. Since the release of Open Payments data (and even before with ProPublica’s Dollars for Docs), local media outlets have featured stories about which doctors in their state or locality are receiving the most money from the industry. Pre-disclosure is one way to help HCPs be prepared for the information that will be released about them.

In addition, HCPs that have relationships with public medical institutions are required to disclose their relationships with industry companies. Discrepancies between what an HCP reports to a medical institution and what is disclosed through Open Payments or other transparency initiatives can be problematic for these HCPs. Pre-disclosure gives HCPs the opportunity to ensure that what they’ve reported, or will report, to these institutions aligns with what is disclosed to the public. Pre-disclosure demonstrates a true partnership between the company and the HCP.

2: It helps a company proactively address discrepancies . Pre-disclosing spend information throughout a reporting year allows for queries and disputed transactions to be addressed prior to any review period required by regulators. In fact, under Open Payments and the Medicines Australia’s Code of Conduct, the required review period is relatively short considering the volume of transactions open to dispute. Granted, wholesale  disputes of data are highly unlikely, however, just one or two disputes, multiplied  over an HCP universe of hundreds of practitioners, add up quickly. Spreading those disputes over time is a more effective approach.

3: It’s good customer service. During CBI’s 9th Annual Aggregate Spend and Transparency Forum, two panelists from the American Medical Association Board of Trustees noted that physicians were most concerned about accurate data being released to the public. The panelists emphasized that providing a website for physicians to review spend data prior to the Open Payments review period would help in alleviate those concerns.

For a reportable recipient, spend transparency initiatives are akin to consumer credit reporting. Information is being shared about their business relationships, yet they aren’t really part of the collection and data release process. Some transparency initiatives require a review period for reportable recipients, but reportable recipients then need to review a large amount of data at once, potentially from multiple sources. Pre-disclosure allows reportable recipients to review smaller chunks of spend data over time, rather than during a single short window. This helps customers better manage what they can control . That’s good customer service.

The bottom line: pre-disclosure is a good idea because it benefits the company responsible for reporting and the HCPs about whom information is being reported. When spend data is pre-disclosed,  HCPs have the opportunity to review that data for accuracy before it is submitted to regulatory agencies and the company is presented with a valuable opportunity to engage in a critical and proactive conversation with its HCP partners.

Compliance News in Review, March 8, 2016

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A bill is introduced in the Senate to end DTC advertising, Endo settles with New York over alleged marketing violations, and Olympus settles multiple False Claims Act, Anti0kickback, and FCPA charges.

March has certainly roared in like a lion, but will it go out like a lamb? Or will it go out more like a Blue Devil, a Jayhawk, a Cardinal, or a Wolverine? March Madness is almost here, so rise up bracketologists! Whether you employ a highly-scientific method for filling out your brackets, or you make your picks based on which team colors, it’s time to put pen to paper (or fingers to keyboard) and make you selections official. Before you get completely engrossed in what sixteen seed might have a shot at the huge upset in the first round, let’s take a look at what has dribbled through the newswires lately, as we tip off on this edition of the Compliance News in Review.

Senator Al Franken is the latest to join the “Ban DTC Advertising” team. The Senator has introduced a bill that would end the DTC advertising tax break for drug companies. Franken argues the costs of the ads are increasing the costs of drugs, and they encourage consumers to seek new, expensive medications, over cheaper alternatives. A spokesperson for PhRMA said the legislation “ignores the value of information patients about their health care and treatment options,” and it may have the unintended consequence of a patient not seeking medical attention for chronic conditions that can be managed more cost effectively when treatment begins early.

Endo has resolved a marketing foul with the state of New York. The company reached a settlement with the State over its marketing of an opioid pain medication. According to the state’s Attorney General, Endo claimed its painkiller, Opana ER, was crush resistant and it underplayed the addictive nature of the drug. The AG said the misleading marketing led to increased sales of the drug because it created a “false sense of security.” The company agreed to pay $200,000 and to cease marketing the drug as crush resistant. Additionally, Endo must create a program to keep its sales team from promoting the drug to healthcare providers who may be prescribing it in an abusive manner.

Olympus Corporation of the Americas (OCA), has agreed to pay $646 million to settle criminal and civil charges related to violations of the False Claims Act, the federal Anti-kickback Statue and the FCPA. The endoscope maker was accused of paying kickbacks in the form of consulting payments; free endoscopes; travel; meals; and grants. The company will pay $312 million to settle charges of paying kickbacks and $310 million to resolve the False Claims Act charges. The company’s Latin American subsidiary is accused of making payments to healthcare providers working in government-owned hospitals in Central and South America in order to secure business. The company will pay $22.4 million to resolve charges it violated the FCPA and it has entered into a three year Deferred Prosecution Agreement (DPA) and a Corporate Integrity Agreement (CIA). The DPA requires the establishment of a confidential hotline, improvements to the compliance training and the establishment of a program to recoup executive performance pay for those who participate in misconduct or fail to promote compliance. The CIA requirements include the implementation of a healthcare code of conduct; specific training and education; and requirements around grants and charitable contributions, consulting arrangements, and travel expenses.

The DOJ noted in its press release about the Olympus settlement that “the criminal complaint alleges that the improper payments happened while Olympus lacked training and compliance programs.” A “subpar compliance program,” was also noted by prosecutors in the recent SciClone FCPA case and the Sweett Group UK Bribery Act case. Regular and effective training is a key element of any effective compliance program, and helps reduce the risk of violations. While laws such as the False Claims Act of the FCPA may not change often, training on these laws cannot be conducted in a “one and done” manner. It should be reviewed and refreshed regularly, and highlight real-world examples applicable to the industry to keep it relevant and fresh.

With that, the buzzer has sounded on this edition of the Compliance News in Review. If you have a rooting interest, good luck to your team(s) in the upcoming tournament.

Stay compliant and we’ll see you right back here for the next edition