Compliance News in Review, August 25, 2016

Here’s the tune we’re whistling this week: a California state senator pulls his own proposed transparency bill; an analysis of the FDA user fee programs yields interesting information; former Insys employees in court; FCPA woes at Orthofix International; and a new way for New Jersey residents to learn how much their docs received from the industry.

Summer is coming to a close all too quickly, but you still have a few weeks to cruise the boulevard, roll down the windows and belt out that favorite song at the top of your lungs. Sadly, these anthems tend to disappear at the first hint of cool temperatures, so dance on whilst you can! While you pump up the volume on your music delivery apparatus of choice, we’ll fire up a jam of own, with this edition of the Compliance News in Review.

It’s been a Cruel Summer for a California state legislator. The state senator who proposed a drug pricing transparency bill for the state has pulled the bill from consideration, saying amendments to the bill “made it more difficult for us to accomplish our fundamental goal.”

Could a recent analysis of FDA user fees stir up some Bad Blood? The analysis of FDA user fees showed that the FDA has collected over seven billion dollars in fees since 1992. These fees account for a large percentage, in some cases the majority, of funding for FDA review programs, and there is nearly $300 million dollars in unused user fees being carried by the FDA.

An interactive map shows the Blurred Lines between New Jersey physicians and the pharmaceutical industry. A state news website created an interactive map that provides details of physician and hospital payments from the pharmaceutical industry. Users search by zip code, and see payment details for hospitals and physicians in the area. The site also has an alphabetical listing of physicians and hospitals receiving payments. Data for the site was sourced from the Open Payments website.

Orthofix International allegedly got in the Danger Zone regarding improper payments made by its Brazilian subsidiary. In a recent regulatory filing, Orthofix International registered a charge of $4.6 million to settle potential FCPA charges. The company reported the potential violation to the DOJ and SEC in 2013, and has been cooperating with both agencies to resolve the matter.

If Life is a Highway, a pair of former Insys employees may be about to head down a bumpy road. A former district sales manager and former sales representative recently pleaded not guilty to charges they provided kickbacks to doctors in exchange for prescribing the company’s fentanyl drug. The two are accused of paying speaker fees to doctors for events that were held at upscale Manhattan restaurants and were social, rather than educational, in nature.

With that, it’s time for us to boogie on out of here. We hope to see you back on the dance floor for the next edition of the Compliance News in Review. Until then, stay cool, keep the summertime jams going, and stay compliant.

Compliance News in Review, August 19, 2016

The Pfizer shareholder suit settlement, Open Payments Open Forum, Robert Callif addresses sharing truthful off-label information, a whistleblower suit, and it’s always Sunshiney in Germany in this edition of the Compliance News in Review.

Dum, dum, da, dum, dum, dum, dum. Dum dum da dum dum dum dum da dum dum dum dum. No doubt you recognized that familiar melody as “Bugler’s Dream” (a.k.a., the Olympic theme). The games in Rio are in full effect! If you’re like us, you’re suffering from sleep deprivation from all the hours of late night coverage. Fear not, we haven’t completely forgone compliance news in favor of sport. Take your mark, because we’re about to start this edition of the Compliance News in Review.

Pfizer is setting aside $486 million in “gold medals” to resolve the shareholder suit over concealing the safety risks of Bextra and Celebrex. The settlement is pending approval of the shareholders, and if approved, will end 11 years of litigation.

Open Payments is back on the track and poised for changes. In July, CMS posed several questions in the proposed 2017 Physician Fee schedule. The agency held an Open Door Forum for Open Payment stakeholders to provide responses to these questions. Much of the discussion focused on the reporting and reviewing of information related to teaching hospitals and whether to increase the number of payment categories. Other topics included pre-vetting data; the review and dispute process; and whether user accounts for physicians can be structured so they don’t expire after six months of inactivity.

A whistleblower claims Celgene isn’t playing the game fairly. A suit filed by a former company sales rep claims the company made donations in order to drive product sales. The suit claims the company made donations and then worked with the charities to assure that the majority of the funds were directed to patients who were using Celgene drugs. Celgene says the claims are baseless and the federal rules regarding donations were followed.

FDA chief Robert Califf spent time hurdling the issue of sharing of truthful off-label information at the recent BIO conference. In his remarks, Mr. Califf said scientifically supported information worth sharing should be on the product’s label, and that there is a responsibility to share use information gleaned through the clinical trial process and it’s reasonable to expect that information to be part of the product’s label. He noted that publicly available information that is not part of the label is trickier, and that the agency was “working on it.”

The score from the German judge is…575 million. According to the German news magazine Spiegel, payments made to German HCPs and HCOs totaled 575 million euro in 2015. The country made the data public in a searchable database following a suggestion by EFPIA. The magazine noted problems with the data being incomplete and inaccurate, and only 75% of pharmaceutical companies were represented. It called for the German government to consider legislation similar to the Sunshine Act in order to implement true transparency.

Well, we need to get back to the thousands of hours of streaming coverage – bring on the table tennis – so we’ll end this edition of the Compliance News in Review here. Enjoy the rest of the Games everyone, and stay compliant.

To Use Employees as Actors for Compliance Training or Not: That is the Question

Shakespeare said, “All the world’s a stage,” but when that stage is your training video, should your colleagues be the players? Before taking the leap and giving employees their “fifteen minutes,” you need to weigh the advantages and disadvantages and determine how each approach could help or hurt the effectiveness of your compliance curriculum. At PharmaCertify™, we have differing opinions based on first-hand experiences developing compliance training and corporate video programs. Here’s where two of us landed.

The Case for Using Employees as Actors
Lauren Barnett, Compliance Content Specialist

One obvious reason to use employees in your compliance training is the cost. Actors, even non-union ones, are expensive. Depending on the level of the skill the actor brings to the table, the cost of talent can be one of the top expenses in your video. A video shoot can last anywhere from a few hours to a few days, depending on the requirements of your project, so using the “free labor” you have at your fingertips can have a significant impact on the overall cost of the project.

Businesses and industries often have their own jargon. Add the medical or product-specific lingo that may need to be included in the training, and understanding the script for your compliance video could be like learning a new language. Your colleagues will be more authentic when delivering jargon-laden lines on camera. Actors won’t have the contextual experience with the language to deliver lines naturally or with confidence. Your learners do have familiarity with the language and they’ll notice when the actors aren’t comfortable and the learning will suffer.

Finally, using employees from the compliance department, or other departments the learners only interact with on a remote level, humanizes those departments and has the potential to build a stronger rapport between compliance and the rest of the company. Too often, the compliance department is seen in a negative light, or as the “police,” who are just waiting for employees to do something wrong. A truly effective compliance training curriculum addresses that concern, and includes components designed to portray those responsible for policy and training as partners who are there to support, encourage and inform. Using team members as actors in the compliance training is one major step toward that goal.

The Case Against Using Employees as Actors
Sean Murphy, Product and Marketing Manager

You may see your coworkers as free talent, but they aren’t professional talent. Acting is an art and a skill, and the fact an employee “was in a play in high school,” doesn’t necessarily mean that colleague is a trained actor. Good actors, even those working in local theater, have typically trained for years in their craft. You might get lucky and have a gem or two in your free talent pool, but when you use someone who is not comfortable or experienced, you run the risk of the key messages being lost behind the bad acting.

You also have to consider the cost to the business in lost productivity when employees are spending their time trying to convincingly read lines. Video shoots are time-consuming (especially when multiple takes are required because the actors are not professionals) and often require the actors to be “on set” for a number of hours. When your colleagues are pulled away from their jobs for that extended period of time, others may have to do their work, or they will at least have to book extra hours to make up the work they missed.

Finally, yes, employees can add an air of authenticity to your video, but it comes with the risk of your learners focusing on the fact they are watching “Bill from Marketing” in a video. Your key training messages may be lost because the learner’s attention is focused on the fact that is “Bill from Marketing,” instead of the subject matter. Additionally, if the audience includes vendors, they won’t know Bill, so he’s just another actor for them, so any authenticity is lost, and if Bill isn’t a good actor, he’s now a distraction as well.

What’s Your Verdict?

Using colleagues as actors can add an element of authenticity and fun to your training videos and can certainly help with the budget department. Before moving ahead in casting colleagues, it is important to consider the training goals of the video and determine if using colleagues will serve those goals or will simply be a distraction.

Now, we want to know what you think. Have you tried using your coworkers as actors in your compliance training? Did it work well? What were the pitfalls? Do you agree with Lauren or Sean? Who gets the bragging rights this time? Contact Sean at smurphy@nxlevelsolutions.com to let us know.

Compliance News in Review, July 26, 2016

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.

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

 

 

 

Compliance News in Review, July 14, 2016

The Serious Fraud Office has its second application for a DPA approved, CMS solicits feedback, and experts are dismissed from an advisory panel due to perceived conflicts.

It’s hot, it’s humid, and the editorial staff at the New Jersey AND Georgia offices of the Compliance News in Review is already desperately seeking safety from the sun’s intense rays. The dog days of summer have arrived with gusto. If you’re looking for a good reason to spend a few more minutes in the comfortable confines of an air conditioned office or home, we suggest a deep dive into the cool waters of this edition of the CNIR, and all of the compliance news fit to blog.

Deferred Prosecution Agreements (DPAs) seem to be no sweat for the Serious Fraud Office (SFO). The agency has had its second application for a DPA approved in a case that involves violations of the UK Bribery Act. The company involved agreed to pay $8.48 million in fines and disgorgement. It must also report annually on its third-party intermediary transactions and compliance programs, and continue to cooperate with the SFO. The DPA remains in effect until 2020, but it may be terminated in 2018 if the company meets its financial obligations by then.

The Centers for Medicare and Medicaid Services (CMS) is basking in the Sunshine these days. In the proposed 2017 Physician Fee schedule, the agency solicited feedback for a number of questions related to the Open Payments program. The questions cover record retention, issues related to teaching hospitals, and the nature of payment categorization. Of particular note, the agency is seeking feedback about the benefits of pre-vetting payments with covered recipients and issues related to uploading data to Open Payments.

In an indication that their relationships with industry were a little too hot to handle, several experts have been removed from a panel that is responsible for advising the FDA about painkillers. The panel was created by the National Academies of Science, Engineering and Medicine, a larger advisory group to the FDA. The removal of the panel members appears to have been spurred by a letter Senator Ron Wyden sent to the Academy of Medicine complaining that some panelists had received support (in the form of grants) from pharmaceutical companies. One panelist, Dr. Mary Lynn McPherson, says the support in question did not go to her directly, it went to the university where she is on staff, and was in the form of unrestricted grants so the pharmaceutical companies never had input on how the money was used. Another of the dismissed panelists, Dr. Gregory Terman, says he was removed because the nonprofit group he heads received funding from several pharmaceutical companies. Terman says his association with the nonprofit was well known, and he has gone out of his way to avoid conflicts of interest.

The last story serves as a reminder that much of the data regarding the relationship between healthcare professionals and the industry is presented with little context as to the nature and reasons for the payments. HCPs are understandably sensitive about receiving certain transfers of value, and they have questions about how those TOVs are disclosed. Your transparency training should remind learners that they need to be sensitive about these concerns, and educate them on the proper protocol for addressing HCP questions about data.

With that, we close this mid-summer edition of the Compliance News in Review. Stay compliant and stay cool.

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

A first product launch is an exciting and overwhelming 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

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