Pharmaceutical Compliance Congress

Compliance News in Review, July 26, 2016

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Executives on trial, an FCA settlement, a “clarification” to a change in the District of Columbia detailer law, and an Open Payments open forum…all in this edition of the Compliance News in Review.

What do Teddy Roosevelt, Rob Lowe, and a chair have in common? They have all provided some rather famous, if not infamous, moments at the national conventions of the Democratic and Republican parties. Part pep rally, part three-ring circus, and part critical component in the fabric of this great democracy, the conventions are underway, and they have certainly provided entertaining television during the doldrums of summer. If your senses need a break from the constant barrage of politicking and speechmaking, let us gavel in all compliance news fit to blog, with this edition of the Compliance News in Review.

Guilty or not guilty? It was a little bit of both for two executives from Acclarent, who were on trial for selling misbranded and adulterated medical devices. The jury found the pair guilty of misdemeanor charges distributing misbranded and adulterated devices, but acquitted them of felony charges. Lawyers for both defendants said they felt confident that their clients would eventually be cleared on the misdemeanor counts.

Speaking of Acclarent, the company agreed to pay $18 million to settle allegations that it caused false claims to be submitted to government health programs. The government contended the Acclarent marketed one of its devices for a use that was rejected by the FDA.

The Washington D.C. Department of Health (DOH) released an FAQ sheet that was about as clear as most political speeches. The document is intended to provide guidance regarding a recent change to the D.C. detailer law. Unfortunately, it may have raised as many questions as it answered. The DOH recently made a change establishing that anyone engaged in detailing for less than 30 consecutive days did not have to obtain a license. Confusion seems to center on the Department’s definition of “consecutive.” The FAQ states that the exemption applies to those “individuals, such as speakers at a conference, who come to the District once a year, or other persons that come once a year for a short duration of time of less than 30 consecutive days.”” Makes sense right? But the FAQ also states the exemption is not meant to cover an individual who may come to the District for a few days, more than once during a calendar year. So how many visits to D.C. require registration as a licensed detailer? Stay tuned.

The Centers for Medicare and Medicaid Services (CMS) is conducting a “focus group,” of sorts. The agency is conducting a stakeholder forum on August 2 to solicit feedback on rulemaking and potential improvements to Open Payments. The forum is intended to give stakeholders an additional opportunity to comment on the recent questions posted by CMS about Open Payments in the proposed 2017 Physician Fee Schedule.

Well, that’s a wrap on this politically-charged edition of the Compliance News in Review. We now return you to your regularly scheduled convention coverage.

Stay compliant!

Excel for Tracking Training? Been There, Done That, and Sadly, I Have the T-Shirt.

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As someone who worked in compliance for a small life sciences company, I like to share the problems and pitfalls I experienced over the years, in the hope of saving others from the same fate. Today, we touch on the subject of Learning Management Systems and in particular, my hard-learned lesson about trying to use Microsoft Excel for some LMS functions. I like Excel as a software program overall. And, if you work in training, it may seem like a logical choice for measuring metrics. It’s not. If your company doesn’t have an enterprise-wide LMS in place, or if a particular group of learners (e.g., third-party vendors) doesn’t have access to your internal LMS, I strongly recommend using a hosted or cloud-based LMS  rather than relying on Excel to handle the tracking and reporting.

Is an LMS a Better Option?

The obvious and primary limitation of using Excel is you still need to find a way to host and deploy the training. Even when used solely for the purposes of tracking and reporting, it can be burdensome, error-prone, and time-consuming. At a minimum, you need to enter all of the learner-related data, as well as the list of courses assigned to each learner, and the dates the courses were deployed and completed. Then there’s the on-going need to keep your learners updated with reminders that training is due, and the work necessary to pull metrics from all the data. Using Excel is a manual process, which opens the door for mistakes and those mistakes, are hard to catch when you’re pouring over hundreds of lines of data.

Using a hosted or cloud-based LMS helps automate those processes, greatly improves accuracy, and lightens the burden of the on-going work. While some upfront work is necessary as an administrator, the LMS itself does most of the heavy lifting. Deployment of the training and management of the completion records are handled by the LMS, freeing you from developing formulas and creating your own reports. In fact, you’re likely to get far more insight from the reports and metrics that are standard with most hosted and cloud-based services than you’d ever be able to pull from Excel. And the best part – all of this comes with the ability to host and deploy the training.

Of course, a hosted LMS solution isn’t the panacea to all of your workload challenges. You may not be able to customize the functionality of the LMS, and depending on what service you choose, you may or may not be able to manage your classroom learning with the service. Then, of course, there’s the big elephant in the room, the cost. Reconciling the budget when you think you can manage with the software you already have in house may seem difficult, especially for small to mid-size companies. However, when you factor in the time spent by managing all the tasks manually, the cost may not seem so overwhelming.

What About the Budget?

A number of cost-effective options are available. For example, our PharmaCertify Access™ LMS offers an affordable way for small to mid-size (and even larger) clients to host and track online training, whether it’s developed by us, another vendor, or in-house by our client.

Looking back on that Excel experience, I regret not giving more than a fleeting thought to using a hosted LMS, even though I only had a few hundred learners to manage. I’m sure an LMS would have provided better insight into the impact the training had on the audience, and would have allowed me to dedicate more time and resources to building an even better compliance training curriculum.

Thanks for reading, and stay compliant!

Lauren Barnett
Compliance Content Specialist
PharmaCertify™ by NXLevel Solution

 

 

 

The Right Stuff: Compliance Training in Preparation for Your Company’s First Product Launch

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A first product launch is an exciting and overwhelming time for any life sciences company. So much to do, and what seems like so little time to do it – especially if you are a compliance department of one or two people. As employees are brought on board in support of the launch, planning and implementing an initial compliance training curriculum is a critical task. You need to cover all the essential bases and topics, and direct the training to the appropriate audiences so individuals aren’t burdened and distracted by messages and information that may not be applicable to their job duties.

With that in mind, the team at PharmaCertify™ has compiled a list of suggested topics and audiences for any company working toward an initial product launch.

Topic 1: Code of Conduct
Audience: All Employees

Good code of conduct training introduces employees and external contractors to the behavioral expectations your company has established. It also provides a foundation for understanding the requirements of working in such a heavily-regulated environment. We could fill an entire blog entry with instructional tips for building effective code training, but for now, we’ll make this one suggestion – make it more meaningful with scenarios that demonstrate how the concepts are manifested in their daily activities. Learners need to relate to the information being presented in order for it to stick.

If your company has not yet developed a code of conduct, see topic two.

Topic 2: Overview of Healthcare Compliance
Audience: All Employees

All employees must be aware of the laws, regulations, and guidance documents related to working for a pharmaceutical or medical device company. If your company doesn’t have a code of conduct, or the code doesn’t include basic information about the laws affecting the industry, a compliance overview course is especially necessary to communicate the concepts they need to know. If you do have a code of conduct, consider the idea of narrowing the audience to the commercial, medical affairs, regulatory, and communications groups.

Topic 3: Interactions with Healthcare Professionals
Audience: Sales, Marketing, Medical Affairs, and Customer-Facing Regulatory

Employees whose job responsibilities involve interacting with healthcare professionals (HCPs) on some level need training to ensure those interactions are in compliance with laws, regulations, and company policy. The training should include topics such as the rules associated with providing gifts and meals; the use of HCP consultants; proper conduct during speaker programs and advisory boards, and interactions at medical congresses or other scientific meetings.

Topic 4: Good Product Promotion
Audience: Sales and Marketing

Sales and marketing teams need detailed training regarding the regulations that govern prescription drug and device promotion. Focus your promotional training on how the regulations affect both verbal and written promotional statements. It should include topics such as what constitutes promotional statements versus medical information; what is a proper promotional statement (i.e., accurate, balanced, and truthful); FDA guidance on dissemination of reprints; and the use of social media.

Topic 5: PDMA and Drug Sample Management
Audience: Field Sales

If samples are going to be a component of the product program, training regarding the requirements of the Prescription Drug Marketing Act (PDMA) is needed before the sales representatives receive any of the samples for distribution. The training should be twofold though and include information about inventory management, and your company’s sample documentation processes – a topic just as important for medical device companies as well.

Topic 6: HIPAA
Audience: Sales, Medical Affairs, and Any Group Interacting with Patients or Handling Patient Information

The protection of patients’ personal information is a hot button issue, so you need to ensure those who handle, or who may be exposed to that information, are aware of their responsibilities regarding confidentiality. In addition, credentialing requirements at hospitals and other facilities now require anyone doing business in those facilities to be trained on the requirements of HIPAA and the protection of personal health information. In fact, if your sales representatives are going to be selling in a hospital environment, you will want to add Bloodborne Pathogens and Aseptic Technique training to their curriculum as well, but we will save that for our blog entry on the rise of credentialing and its requirements.

More Information

While the above list of topics constitutes a strong compliance training foundation for any company moving toward its first product launch, the topics and audiences may need to be tweaked based on your particular product and product indication.

The PharmaCertify™ team of compliance subject matter experts and instructional designers are here to help and we are making information available to you. To see an expanded list of the suggested content for each of the topics listed above, contact Sean Murphy, Product and Marking Manager at smurphy@nxlevelsolutions.com, or 609-483-6876.

Thanks for reading and stay compliant!

Lauren Barnett, Compliance Content Specialist, PharmaCertify™ by NXLevel Solutions

Compliance News in Review, July 5, 2016

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Another organization calls for a ban on Direct to Consumer advertising, two former industry sales reps are arrested for kickbacks, a former executive is acquitted on kickback charges, and CMS releases update TOV data.

Strike up the band and light up the fireworks! The American Experiment marked its 240th year this weekend. So, it’s fitting that the hottest ticket on Broadway these days is the story of one our nation’s founders. Since most of us won’t be lucky enough (or rich enough) to score tickets to Hamilton in celebration , we had to stick with the old standbys of parades, barbecues, fireworks. To cap the holiday weekend, we offer a new tradition to add to the list, the Independence Day edition of the Compliance News in Review.

The fireworks continue regarding DTC advertising. The American Society of Health-System Pharmacists is the latest group to express a desire to see DTC advertising of prescription drugs banned. In the past, the organization has been supportive of the advertising, as long as it meets certain criteria. Since it now believes the industry is ignoring the criteria, the group has withdrawn its support. A spokesperson says a complete ban is not possible, but he hopes this action will lead to a discussion between industry and healthcare providers about DTC ads. The current model of DTC advertising is outdated according to the spokesperson, and pharmacists and providers are spending too much time explaining to patients why drugs they see in ads are not appropriate for them.

A pair of former Insys sales representatives could be losing their independence in the near future. The two were arrested for allegedly paying over $250,000 in kickbacks to doctors who wrote prescriptions for the painkiller fentanyl. The complaint alleges that most of the money was paid for serving as speakers at programs that were essentially social functions. Very little, if any, educational information was shared, according to the complaint, and following the programs, the sales reps would often take the doctors out for drinks and other entertainment. In a statement, the company says the sales reps were no longer employed and company policy prohibits the giving of cash or other items of value as inducements for writing prescriptions.

It was no tea party in Boston for the feds in a case against a former Warner-Chilcott executive. W. Carl Reichel was acquitted of charges that he paid kickbacks to doctors. Prosecutors charged that the former executive created a strategy of paying kickbacks to doctors in the form of sham speaking fees, money, and free meals in exchange for writing prescriptions of Warner-Chilcott drugs. US Attorney Carmen Ortiz said the charges against Mr. Reichel were warranted, and while cases against executives are difficult to prove, they’re necessary to deter improper conduct.

CMS sent out its annual declaration about Open Payments data. The payment and transfer of value data has been published, and is now publicly accessible. This year’s data represents nearly 12 million records covering $7.52 billion paid to physicians and teaching hospitals. As usual, research payments account for the largest share of the total amount.

This edition of the News in Review reminds us that the consequences of non-compliant behavior can be quite personal. When the big headlines tend to be about the multi-million and multi-billion dollar settlements paid to settle charges of fraud and non-compliance, convincing individuals that there is also a price to pay can be challenging. Citing cases like these in your training is one way to inform commercial staff and executives of those consequences.

While we don’t advocate turning compliance training into something akin to “Scared Straight,” sharing the full landscape of government enforcement actions is important. This is especially true following last year’s memo from Deputy Attorney General Sally Yates about the DOJ’s emphasis on holding individuals accountable in cases of corporate wrongdoing.

That’s it for this edition of the Compliance News in Review. Stay compliant!

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, 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 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 Buzz™ February 29, 2016: Three observations from OPDP Notice of Violation Letters

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Welcome to the first issue of PharmaCertify Compliance Buzz™!

From Corporate Integrity Agreements to FDA guidance documents, the material published by government enforcement entities offers valuable insight into the enforcement of healthcare laws and regulations. This holds true for Notice of Violation (NOV) and Warning letters issued by the FDA’s Office of Prescription Drug Marketing (OPDP). Regularly reviewing these letters as they are released is one way to ensure training about compliant product promotion is up-to-date and relevant.

So for this inaugural edition of Compliance Buzz™, we have reviewed the NOV and Warning letters OPDP issued over the last several years, and identified three trends to keep top of mind as you evaluate your compliance training program.

Focus on smaller companies. In recent years, the focus of OPDP letters has been small and medium-sized companies, rather than larger companies. In 2015, only three of the ten letters were issued to companies listed in the Scrip100 top 50 pharmaceutical companies. In 2014, only one letter was issued to a top 50 company, and in 2013, only five. Compare this to 2010, when 2/3 of the letters were to top 50 companies. While this doesn’t necessarily mean that OPDP is targeting smaller companies, it is a compelling trend to keep in mind, especially if your company falls into the small to medium-sized category.

Rise of Social Media. The OPDP is taking note of the industry’s Internet presence. Almost half the letters issued in 2014 and 2015 involved promotional information found on the Net, including posts on Facebook, Instagram, and Google Ads. The only letter issued thus far this year involves a YouTube post. The information required for promotional material doesn’t always align with the untamed spirit of social media, and it’s easy to assume that using links or other shortcuts to the required information is sufficient. As we all know, it’s not. As the industry continues to embrace social media as a promotional tool, training programs need to include content regarding the use of these platforms.

No risk, no reward. Omission of risk is one of the most often cited issues in letters sent by the OPDP over the last couple of years. Discussing the negative aspects of a product is not always comfortable for those responsible for promoting a product. However, for the pharmaceutical industry, it’s a requirement. Disclosure of product risks and benefits is a critical topic for training.

While the ODPD has issued significantly fewer letters in the last several years, there’s still much to be gleaned from the comments found in those letters. They are valuable touchstones for evaluating the content of your compliance training and offer important real-word examples to share with your learners.

Thanks for reading and stay compliant!