Pharmaceutical Compliance Congress

News Week in Review, March 10, 2014

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Pharmaceutical companies cut spending on physician speakers,  the DOJ turns up the HEAT, China ups the stakes on the bribery front, and the value of a reprint under Sunshine is still unclear.

Hey, wake up! The transition to Daylight Saving Time is such a drag…on our energy that is. Soon enough, we’ll all be excited about the extra daylight hours, but right now, we’d settle for some extra caffeine. To help you find your set point and adjust your internal clock, we offer our regularly scheduled overview of all things compliance…with this week’s News in Review.

The amount pharmaceutical companies spend on physician speakers is not exactly spring forward, according to an analysis of Pro Publica data. In fact, several large companies have dramatically cut spending on physician speakers, which some attribute to the transparency requirements of Sunshine. The companies offer a different rationale though. A spokesperson for Lilly says educational programs are of most value when a product is launched, or new clinical data is released. Additionally, as web conferencing increases, the need for speakers declines. A spokesperson for Pfizer points out that as blockbuster drugs go off patent and face generic competition, the need for educational programs and speakers for those drugs wanes.

Spending on drug marketing is on the rise in Washington D.C., according to a report by the George Washington University School of Public Health and Health Services. In 2012, companies spent $97.5 million on drug marketing, which represented the first year-on-year increase since 2007.

As spring draws near, and the temperatures rise, the DOJ continues to provide some HEAT of its own with the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative. Using the False Claims Act as its primary tool, the agency has recovered $13.4 billion from individual providers, pharmaceutical companies, and medical device companies.

Takeda would like to turn back time after the company admitted using “inappropriate expressions” in an advertisement for its hypertension drug, Blopress, in Japan. A Japanese physician noticed that data presented in the advertisement was not consistent with the results of a head-to-head study with a competitor’s product. The company admitted that using a graph from a 2006 study in the advertisement could have caused confusion.

Speaking of losing sleep, life science executives may be lying in bed at night thinking about the increasing challenges of doing business in China. Officials in China announced that companies found to have committed bribery will be blacklisted and updated the country’s “Rules on the Establishment of Commercial Bribery Blacklists for Purchase and Distribution in the Health Care Industry.” Circular No. 50, which delineates the updates to the rules, states that a company may be blacklisted for several reasons, including minor instances of bribery that are not prosecuted by authorities. If blacklisted, hospitals and other facilities will be prohibited from purchasing goods in the province where the bribery occurred for two years. Companies blacklisted two or more times in five years will be prohibited from selling its products in the country all together.

A new study shows drug makers are not quite ready to crawl out from under the covers when it comes to using social media for clinical studies. The study conducted by the Tufts Center for the Study of Drug Development (CSDD) found that companies using social media in the clinical research process are doing so in a “siloed and experimental fashion.”  Lack of guidance from the FDA and concerns about the impact of social media on study integrity are cited as factors slowing the adoption of social media for clinical trials.

What’s a Daylight Saving Time theme without at least one reference to Sunshine. With little in the way of guidance from CMS, companies are taking various approaches to determining the value of journal reprints under the Sunshine Act. Some companies follow what CMS has stated, and value a reprint at the cost the company paid to acquire it from a publisher. Other companies use a blended average model and some hire a third party to determine the value of their reprints. Complicating the matter further, doctors are starting to refuse reprints because they see them as taxable form of income.

As the sun sets much later in the day, and on this week’s News in Review, we close with a reminder that the PharmaCertify™ online learning module, The Sunshine Act: The Federal Physician Spend Disclosure Law, covers the topics your learners need to understand, like disclosure requirements and excluded payments, to stay abreast of this industry-changing legislation.

Have a bright and sunny week everyone!

Week in Review, February 17, 2014

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A look back at 2013 FCPA enforcement reveals trends for the future, Brazil enacts an anti-bribery law of its own, at least one attorney wonders if Sunshine will hamper qui tam cases, and the FDA wants medical device adverse event reports submitted electronically.

Well, it’s President’s Day – certainly, one of the more interesting American holidays in terms of its evolution. From what we’re told by the folks at the history channel, the holiday was originally created to celebrate George Washington’s birthday. The shift to “President’s Day” is somewhat convoluted but suffice to say, it was part of the Uniform Monday Holiday, which was passed in 1971 and was intended to create more three day weekends for the nation’s workers, while fighting employee absenteeism by ensuring that holidays fell on the same weekday. Whew! Now that we are all clear on that, let’s focus on something a lot easier to understand, the compliance news of the week, in the News in Review.

Speaking of history, we begin this week with a look back at the DOJ’s enforcement of the FCPA for clues to future trends. Not surprisingly, the scope of FCPA enforcement widened in 2013, and the average cost of resolving increased to $80 million last year. New industries felt the brunt of the Act, with apparel manufacturer, Ralph Lauren, and ATM manufacturer, Diebold, entering into settlements with the government to settle charges. The agencies also expanded their investigatory search beyond written documents to business communication in general, with one representative of a mining company being charged with witness tampering based on a secretly recorded conversation.

A new bribery law  had its inauguration at the end of January. Brazil’s Clean Companies Act went into effect on January 29th. The law allows for the prosecution of  acts of bribery committed by Brazilian companies or foreign companies with a registered affiliate in Brazil. Unlike the FCPA and UK Bribery Act, the Clean Companies Act only carries civil penalties.

Holiday or not, Teva may not be a celebratory mood. The company announced it was under investigation by the government for the marketing practices related to two of its drugs. The government requested documents dating back to 2006 as it conducts the investigation.

From the land adjacent to the “land of Lincoln” comes an announcement of a program designed to educate medical students about the inner workings of the pharmaceutical industry. Eli Lilly is rolling out a four week rotational program where students will experience the various aspects of the drug development process and how physicians contribute to that process. The program will be conducted at Tulane University’s School of Medicine.

On the legal front, during a National Disclosure Summit, a qui tam attorney said Sunshine data could hamper qui tam cases more than it could help. The attorney said relators will have a harder time getting past the False Claims Act “public disclosure bar,” which requires relators to file their claims before information is in the public domain. On the other hand, the Sunshine data will add instant credibility to  a whistleblower’s claims, according to the same attorney. The data can also support an “inference of off-label marketing.”

The FDA announced that beginning in August of 2015, adverse event reports related to medical devices will need to be submitted electronically. The move, which is part of an initiative to improve operations, is expected to save the FDA $1.9 million each year. Companies will save too, but only after an estimated $38 – $42 million dollar investment to upgrade their own systems and procedures.

And so ends this week’s News in Review. With the end of another February in site, now is the time to launch updated product promotion training for 2014. The customizable PharmaCertify™ eLearning module, Good Promotional Practices offers the training your field staff needs on critical topics like gifts, meals and entertainment; advisory boards; and speaker programs.

Have a great week everyone!

 

The 2014 Pharmaceutical Compliance Congress: A Recap and Review

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The 2014 Pharmaceutical Compliance Congress featured many of the same speakers and topics as past conferences, but recent developments in the world of anti-bribery and compliance brought a new twist to the presentations.

Last year’s developments related to the Chinese government’s aggressive pursuit of corruptions was a recurring topic, with John Crisan, Chief Compliance Officer for Johnson & Johnson, stating at the start of the first session, “what happened in China is a major game changer,” and in a later session, Gary Giampetruzzi from Pfizer said, “The fact that China has put people to death for corruption-related offenses certainly gives pause for concern.”

After the opening remarks of Day 1, Tom Abrams from the Office of Prescription Drug Promotion at the FDA took the stage. Of course, Abrams’ presentation this year had the added bonus of the recently announced news regarding the agency’s guidance on social media. Before providing detail on the guidance, particularly in regard to the process for submitting promoting websites, he emphasized that the agency has more work to do in regard to social media and it “will continue to be a high priority.”   Abrams also told the audience that overall, the quality of promotional materials seems to be improving and the agency is very encouraged at the level of voluntary compliance by the industry.

Carmen Ortiz, US Attorney for the District of Massachusetts, followed with a keynote address regarding the trends in healthcare that have followed major settlements with pharmaceutical companies. Ortiz told the audience that there have been no shortage of qui tam referrals and “the publicity around the cases helps her office reach other whistleblowers and bring more issues to light.” She included the establishment of what she called “ethical compensation plans for reps” and on-going training (a topic close to our hearts and minds here at NXLevel Solutions) in her list of critical best practices for life sciences companies.

Anita Griner, from the CMS Center for Program Integrity followed with a review of the ever popular Open Payments program, a.k.a. the Sunshine Act. Griner offered a thorough review of what data needs to be reported under Sunshine and the process for submitting those reports. Her review included the three reporting categories: General Payments, Research Payments and Ownership and Investment Interests, as well as examples of both Direct and Indirect Payments. Griner’s presentation was comprehensive and she suggested anyone with questions contact the agency’s help desk at openpayments@cms.hhs.gov or sign up for the updates at http://go.cms.gov/openpayments.

The US Healthcare Fraud Enforcement Panel was next, with representatives from US attorney’s offices around the country. Ben Singer, from the Department of Justice, highlighted the focus on the healthcare industry by stating that the DOJ has 38 prosecutors fully dedicated to healthcare fraud prosecution.  Zane Memeger, from the Eastern District of Pennsylvania, discussed the cooperative nature of their work, saying the larger offices share resources with the smaller offices in order to boost their efforts throughout the country. Memeger stressed the critical behavior his office looks for when considering the settlements for violators. Key on his list is whether a company trains its employees regularly, since the rules change regularly, and whether the company self-discloses a violation. Bill Nettles, from South Carolina, agreed, saying he and his colleagues discuss whether each case was self-reported when they review. Of course, when the panel was asked whether they ever decided to not prosecute a case because the disclosure was voluntary, the members smiled and said no.

A panel of defense attorneys closed the morning with suggestions for mitigating risks and preparing for the future. Jennifer Romanski from Porzio reminded the audience that while compliance has to have authority, they have to have buy-in from the entire organization. “You can’t have compliance doing everything,” Romanski stated, “businesses need to play a role.” David Resnicoff of Miller & Chevalier focused on clinical research programs and the need for companies to focus on “what the conversations with the federal government will look sound like, even as they are building their compliance programs.”

For the early afternoon session, I selected the Product Promotional Compliance Track, which kicked off with Lessons Learned from Recent Enforcement Actions Related to Digital Marketing and Social Media. David Vance of Noven offered a comprehensive review of FDA’s position on Internet promotion, and emphasized the need for diligent self-regulation by the industry. During her presentation on Compliant Social Interactions and Engagement, Jennifer Chillas from Bristol-Myers Squibb made a point that those in the industry should not be telling their vendors about the compliance rules, the vendors should be telling them. Do your training vendors know the rules? We do.

During a lively question and answer session, Vance, Sheetal Patel from Johnson & Johnson, and Chillas delved into the challenges of “liking” pages on Facebook.  They agreed that the key is to be aware of what you are “liking” and be careful not to “like” off-label discussions or scientific discussions on sites such as Medscape.

To gain more of a perspective on the global front, I chose the 2:40 session titled FCPA – Key Insights and Enforcement Trends, during which Gary Giampetruzzi from Pfizer made the comment regarding China that I quoted earlier. Giampetruzzi was joined by Richard Konzelmann from Daiichi Sankyo, and the two presented what I considered to be one of the most informative and compelling sessions of the entire conference. After presenting an array of statistics and polls showing that a significant driver of business growth over the next three years will be customers outside the US, the two speakers made a case for the need for increased diligence over interactions, starting with more auditing and investigatory work. Giampetruzzi said he expects FCPA enforcement to accelerate even more quickly, with the 2013 institution of the whistleblower provision in the Dodd-Frank Act. Properly trained management is key to creating an environment in which employees feel comfortable discussing issues internally and feel their concerns are addressed without the need for outside reporting.

I closed Day 1 with the Effective Crisis Management Panel, which featured an impressive list of attorneys and consultants from King & Spalding and more. Wick Sollers, who not long ago represented Joe Paterno at Penn State, pointed out that due to the nature of its business, the pharmaceutical industry is one of the most crisis prone and the need for training on how to respond to a crisis is critical. Seth Lundy agreed, saying “too many of our clients are surprised when someone from the government shows up at the door.” The panel agreed that the Sunshine Act is a risk, particularly with the release of the data scheduled for September and their concern that companies are too focused on the details of the process instead of what the data will reveal.

Day 2

Day 2 started early and the FCPA was once again in focus, as Kathleen Hamann of the law firm, White & Case, again looked at the Act and reminded the bleary-eyed audience to not make their diligence just about the FCPA, but more about eliminating bribery worldwide.

Ilisa B.G. Bernstein, Deputy Director of the Office of Compliance at the FDA, covered the top oversight priorities for the agency. Bernstein focused on the manufacturing problems that occurred because so many facilities were old and out-of-date. But the FDA is encouraged to see the industry policing the problem itself, with firms building new plants, creating better methods and production redundancy.

As the second cup of coffee started to have its desired effect, Patrik Florencio and Samuele Butera, both of Sandoz, and Erik Ramanathan, of Harvard Law School, delivered their Making Compliance Part of Management 101 presentation, which was met with favorable comments throughout the rest of the day. The focus of their comments drilled down to “how often does your manager clearly and specifically reinforce that compliance must never be compromised in order to hit targets?” The three presenters offered a fresh take on the concept of a “culture of compliance” by presenting concrete examples of how internal communication, focused on sales targets, can be seamlessly enhanced with core compliance principles. Compliance targets and goals should not just be theoretical but should be intertwined with financial goals.

The Chief Compliance Officer Panel included the CCOs from AstraZeneca, Daiichi-Sankyo, Aegerion, and Sunovion. Following an introduction by the moderator, which ran a little too long for a number of attendees I later spoke to, the panel also discussed the rules-based vs. values-based approach to compliance. Balance seems to be the key, with Sarah Whipple from Aegerion noting that in “our business, you can’t get away from a rules-based approach. People are used to rules, but people need to be rewarded for doing the right thing.” Jeff Fleming from AstraZeneca pointed out that his company is evolving from a rules-based approach to a values-based one, which does present challenges. “If you’re not going to have rules, tremendous accountability is required,” said Fleming. Matthew D’Ambrosio from Sunovion touched on the handling of mistakes, “Mistakes can be addressed with training, except of course for catastrophic mistakes.” he said. The panelists also agreed that communications and effective awareness campaigns are critical.

The Compliance Program Structure and Effectiveness track was my next stop. Representatives from large and small pharma companies presented suggestions on topics from the challenges of multinational compliance programs to the importance of business in compliance decisions. Jessica Kwon of Forest Laboratories talked about the need to be aware of what is going on in a specific country, politically and culturally, when establishing a compliance program there. “That helps move the conversation along,” Kwon said, “bring yourself out of a US focus.”

Christine Fiore and Bob Doyle of Boehringer-Ingelheim centered their presentation on integrating the business into compliance and it proved to be one of the most dynamic sessions of the day. The pair explained how the compliance department at BI is made up of professionals from different backgrounds who bring a valuable range of experience to the table. Fiore stressed the need to make compliance training fun and engaging and shared tools and tips for doing so with the audience. She even demonstrated an internally-developed iPad app that features video clips and policy documents in a creative and organized framework. This was great material and certainly cutting-edge in terms of how critical compliance content is delivered.

For final session of the conference, I chose the discussion on Compliance Considerations for Small to Mid-Sized Companies, mostly because so many of my clients fit this description and I’m always looking for more knowledge to share with them. The session didn’t disappoint. The discussion began with the topic of resources and whether the participants utilize others, outside of compliance, to accomplish their objectives. “You have to,” said David Stollman from Incyte, “but you have to ask permission to do so. Don’t set yourself up for failure.” Jeff Rosenbaum from Vertex said he turns to his colleagues in accounting for help with auditing. He also pointed out that for small companies with a global presence, compliance can be difficult and again, a focus on the biggest areas of risk is necessary.

On the subject of budgets, the panel agreed that decisions have to be made on what is really needed and what is wanted. How much of that can be done in-house? A good risk assessment will lead to the budget and that assessment needs to be the first step. For Elizabeth Jobes from Auxilum, prioritization is critical. “The highest risk has to be addressed first.”

The session closed with a word of warning from a number of the panelist – no matter how limited your resources, don’t conduct investigations alone. One-on-one meetings in those situations present too many opportunities for facts to be recorded improperly and distorted later.

The 2014 Pharmaceutical Compliance Congress, along with PCF’s Pharmaceutical Regulatory and Compliance Congress both offer excellent opportunities for industry professionals to stay abreast of the best practices and strategies needed in a complex and evolving regulatory world. As a vendor partner, the conferences provide me the chance to not only network with clients and colleagues, but also distribute critical ideas through my social outlets, such as this blog.

If you attended the 2014 PCC, I welcome your comments and feedback. Thanks for reading!

Sean Murphy, NXLevel Solutions

Week in Review, February 10, 2014

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A device maker settles kickback charges, the Serious Fraud Office looks to beef up the UK Bribery Act, and the FDA makes plans to release more guidance on social media.

The Super Bowl, National Signing Day and the Olympics all in one week; it was a sports fan’s trifecta! Hopefully your team won the game…signed that all important recruit…or took home the early gold! As the best of the best gather in Russia and you keep track of the medal count (Canada, Netherlands and Norway are tied for the early lead), we’ll keep tabs on the world of life sciences compliance. It’s time to light the torch on this week’s News in Review.

That big curling match is about to start in Sochi, and darn it, today is the day you left home without your smartphone. No worries. According to a new study, your healthcare provider  should have one you can borrow. The study finds that the vast majority of physicians are toting smartphones and about 70% have tablets. They’re putting the devices to use in their practice with the tablets being the tool of choice for content heavy tasks.

Device maker CareFusion recently spent some time in the penalty box. The company agreed to pay $40.1 million to settle charges it concealed kickbacks to a physician and marketed its surgical prep solution for off label uses.

Serious Fraud Office chief, David Green, wants to change the rules related to the Bribery Act. Green is proposing an amendment to the Act that would subject companies to fines and blacklisting if those companies fail to prevent financial crime by their employees. The law currently has a provision whereby companies are held liable for failing to prevent bribery. Green says the new power would only be used in “exceptional cases.”

Fortunately, we can look forward to more commentary on research and drug marketing during 2014. The FDA is expected to release more guidance on the use of social media in drug marketing, and guidance on the electronic submission of promotional labeling and advertising. The OIG plans to investigate issues around the price of drugs, including whether off-label uses should be reimbursable. For more in depth expert analysis of the OIG Work Plan, check out the video released by OIG, during which representatives discuss the agencies top priorities for the year and emerging trends in combating healthcare waste.

Speaking of the FDA, the agency may be ready to step up its enforcement of the regulations prohibiting off-label promotion. At a recent conference, an attorney for Pfizer, Emily Wright, noted that the industry should expect to see an increase in enforcement in the near future. Wright made note that the FDA issued two letters related to press releases in 2012 and she expects to see more.

And finally entering the stadium (cue the triumphant fanfare)…Open Payments registration! CMS has announced that beginning February 18th, registration and data submission will commence in two phases. During the first phase (February 18th – March 31st), users can register in CMS’ Enterprise Portal, and submit corporate profile information and 2013 aggregate data. Phase two will kick off in May.

Well that’s it for this edition of the News in Review. As you marvel at the accomplishments of the world’s greatest athletes this week, don’t forget to take the time to analyze your compliance curriculum for areas that need enhanced training. PharmaCertify™ off-the-shelf modules and mobile apps offer up-to-date content on topics like, on-label promotion, good promotional practices and the Sunshine Act, where your staff needs it most–in the field and at their fingertips.

Have a gold medal week everyone!

Week in Review, February 4, 2014

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Industry teams with HCPs to formulate a framework for ethical collaboration, medical device companies are advised to keep their compliance programs robust, and pharmaceutical companies disagree on the Sunshine Act as it relates to support for medical writing.

How about that Super Bowl Sunday! No doubt there were cheers, laughs and maybe even a few tears shed as you and your friends gathered to watch the best of the best compete. Of course, we’re talking about this year’s Super Bowl commercials! And, yes, there was a football game played (sort of) in between those delightful bits of entertainment. The array of commercials included some that were memorable and humorous (that bizarrely fun Audi “Doberhuahua” spot) and many that we found downright confusing (Axe “Kiss for Peace?”). While it might not be as memorable as that Radio Shack spot, we like to think that this week’s News in Review is a production worthy of your time and attention.

Huddle up! A group representing the pharmaceutical industry, healthcare providers and patient advocacy organizations recently published a framework for ethical collaboration. The framework is designed to foster collaborations that further patient care, and it is supported by four ethical principles: put patient’s first; support ethical research; ensure independence and ethical conduct; and promote transparency and accountability. The group says regular information sharing and communication between patients, practitioners and the industry is vital to improving health and advancing medical knowledge.

Biotech and small medical device companies need to be sure they stay aggressive on offense when addressing FCPA compliance. Since biotech and medical device products often require additional approvals that increase the level of interaction with government officials, the risk of FCPA violations also increase. With life sciences companies in the cross-hairs of enforcement agencies, companies need to make sure their compliance programs are robust and comprehensive.

Share clinical trial results you will. Janssen announced it will share some of its clinical trial data through the Yale School of Medicine’s Open Data Access Project (otherwise known as YODA). YODA will serve as the vetting agent for clinical trial data requests from researchers and physicians. Some requests for the data will still be handled by Janssen R&D directly.

A federal judge is allowing a whistleblower case against Abbott to continue. A former sales rep filed the suit, alleging the company paid kickbacks and promoted its drug TriCor for off-label uses. Abbott moved to dismiss the case because the whistleblower failed to provide specific evidence of a false claim being submitted. The judge rejected those allegations.

Pharma companies are not reading the signals from the Sunshine Act the same when it comes to medical writing support. During the International Society for Medical Publication Professionals’ European meeting, representatives from several pharmaceutical companies revealed how their companies were handling medical writing support provided to authors of clinical studies, and not all companies agreed that there was any real transfer of value to physicians. AstraZeneca and Pfizer representatives said there was value to the author. Shire, on the other hand, saw the only value was to the company, and there was no need to report medical writing support. The Shire representative said they were collecting the information in case it ultimately has to be reported, but that the company was confident in its approach.

And with that, the clock has run out on this week’s News in Review. If you attended last week’s Pharmaceutical Compliance Congress, you heard industry peers and government regulators emphasize the need for an up-to-date compliance program that extends training beyond the check-the-box approach. The PharmaCertify™ suite of off-the-shelf compliance solutions offers the eLearning modules and mobile apps you need to extend critical compliance policies to where your team needs it most – in the field and at their fingertips.

Have a great week everyone!

Week in Review, January 28, 2014

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Sunshine and state-accredited CME are clarified at a conference, the Supreme Court weighs in on medical device patent infringement, China institutes a new program to monitor healthcare and a new study shows the industry is still wary of social media.

Go west, young man…if you want to escape this arctic cold that is. It was another week of super cold weather, snow showing up in unlikely locales (you saw all the memes about Austin, TX, right?), frozen pipes and below zero wind chills. When Anchorage, Alaska is warmer than Atlanta, GA, you know we’re having cold weather here in the east. To make matters worse, another blast of arctic cold is on the way. The only escape seems to be the western part of the country, where temperatures in the 80’s and sunshine are thriving. The rest of us will just have to huddle around the fireplace and catch up on all things compliance, with this week’s News in Review.

The topic of Sunshine and state-accredited CME programs heated things up at a recent continuing education conference. A CMS representative speaking at the conference mistakenly indicated that state accredited CME programs were not exempt under Sunshine. The final rule actually refers to both certified and accredited CME and does not draw any clear lines between the two distinctions. After hearing how the process actually works, the CMS representative realized that the state-accredited CME would qualify for exemption.

The U.S. Supreme Court iced out patent holders in a recent decision. The Court unanimously ruled that patent holders bear the burden of proof in patent infringement cases, even if they received a declaratory judgment. The case at the center of the ruling involved Medtronic and Mirowski Family Ventures,LLC. Mirowski holds patents for implantable heart stimulators, and Medtronic had a license agreement to use those patents. The company claimed Medtronic infringed its patents, but a federal court ruled Mirowski  had not met the burden of proving infringement. The case was appealed and a U.S. Court of Appeals reversed the ruling, saying Mirowski set the events in motion and that there was “no convincing reason why burden of proof law should favor the patentee.”

The FDA has discovered a new way to submit nominations for its advisory committees. The agency announced the launch of an interactive online portal for the submission of advisory committee nominations. Applicants can submit their entire application through the new portal. The FDA says the system will eliminate confusion and accelerate timelines for submission and acceptance.

China is cranking up the thermostat with a campaign to deal with bad manufacturing and marketing practices in healthcare. The inter-departmental campaign involves eight different departments in the Chinese government. Officials hope to also use the program to deepen reform efforts in medical services.

A new report shows much of the industry still feels chilly about social media. The report from IMS Health indicated that 23 of the top 50 companies worldwide are using Facebook, Twitter and YouTube. However, only 10 of the companies are using all three, and very few are using social media to engage patients. Most are using social media as a way to deliver messages intended for providers and patients alike. Companies with a small therapeutic focus tend to use social media more to engage the patient. In an interesting twist, the study also found that regulators are quite active on social media. The FDA and EMA post high index reach scores, and the FDA scored higher than any pharmaceutical company on IMS’ relationship scale.

We certainly hope everyone stays warm and safe as the next arctic express heads east. We’ll be venturing out into it ourselves for CBI’S 11th Annual Pharmaceutical Compliance Congress. If you’re there, stop by our booth in the exhibit hall to say  hi and see a demo of our new Compliance Curriculum Refresher Training series.

Stay warm everyone!

Week in Review, January 14, 2014

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The University of Minnesota adds a medical device degree to its curriculum, Microsoft requires its partners to take anti-corruption training, Aegerion receives a subpoena from the Department of Justice and CMS clarifies its stance on textbooks and journal reprints under Sunshine.

If you weren’t watching television Sunday, you missed a night of glittering stars, flowing wine and cutting one-liners. Even with Meryl Streep pronouncing awards season as ridiculous, millions tuned into the Golden Globes to see if their favorite movie, TV show, or actor took home the trophy. Okay…let’s face it, some of us watch just to marvel at the ridiculousness of the fashion choices, which is often far more interesting than the acceptance speeches (with the exception this year of Jacqueline Bisset’s confused rambling – what was that!?). We have winners and losers of our own (of the compliance kind) to cover in this week’s News Week in Review.

The University of Minnesota plans to award individuals a medical device master’s degree in the near future. The University is currently recruiting students for a master’s level program in medical device innovation. The program will be part of the school’s College of Science and Engineering and the first class is expected to be enrolled this June.

The question at Microsoft isn’t “who are you wearing?” it’s “who has taken anti-corruption training?” The company launched a global initiative requiring all its partners to provide anti-corruption training to “all employees who resell, distribute, or market Microsoft products or services.” Media reports claim the DOJ and SEC are investigating allegations of bribery involving Microsoft partners in several countries.

In a settlement that almost rivals the value of the jewels on the stars walking the red carpet Sunday night, Alcoa has agreed to pay $348 million to settle charges it violated the FCPA. The settlement is a joint effort between the SEC and DOJ. SEC officials said Alcoa subsidiaries repeatedly bribed officials in Bahrain and Alba in order to obtain government contracts. The company agreed to plead guilty to one count of violating the FCPA.

Here’s one envelope you don’t want to see your name on: a DOJ subpoena. Aegerion confirms it has received a subpoena from the DOJ for information related to the sale and marketing of its cholesterol drug, Juxtapid. The company’s CEO recently received a warning letter for misleading statements he made about the drug during a television interview. Aegerion says it is fully cooperating with the investigation.

As far as two clinical research professionals are concerned, the Sunshine Act should be nominated for the “Law Having the Most Negative Impact on Clinical Research” award. Gary A. Shangold, M.D., chairman of the Association of Clinical Research Professionals Board of Trustees, and Michael J. Koren, M.D., former president of the Academy of Physicians in Clinical Research, authored an article outlining how the Sunshine Act will negatively impact clinical research and medical innovation. They are concerned that the reports on payments related to research are not reflective of what the physicians are actually paid; the cost of complying with the law will divert money from research; and overall quality of care will ultimately be affected by the diminished investment in research. The two also call on lawmakers to change the legislation in order to provide a more accurate picture of the financial transactions between research physicians and the industry.

CMS Administrator Marilyn Tavenner recently responded to an inquiry from Congress about textbooks and journal reprints not being considered educational items under the Sunshine Act. Educational items are described as those that are intended for patient use or have a direct benefit for the patient and are therefore excluded from reporting. In her letter, Ms. Tavenner said textbooks or journal reprints do not have a direct benefit for patients the way an anatomical model does. Rather, the textbooks and reprints provide a “downstream benefit” for patients so CMS believes the items should be reported as gifts or education.

With that, the band is signaling us that it’s time to wrap up the News in Review for this week, so we’ll leave you with one last note. If you’re looking for additions to your 2014 compliance training cast, PharmaCertify™ offers up-to-date modules and apps on critical topics like Adverse Events, On-label Promotion and Good Promotional Practices.

Have a great week everyone!

Week in Review, January 7, 2014

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Industry associations implement new principles on clinical study data, Abbott settles a False Claims case, the SEC suggests that the FCPA could cover commercial bribery, and the FDA wants to know if its messages are being heard on social media.

Welcome to a new year of compliance news! As the calendar turns, our thoughts turn to the yearly rite of passage otherwise known as New Years’ resolutions. Whether your goals are personal in nature (eat right, save more money, exercise more, etc.) or more focused on your professional life, we wish you the best of luck and as we say in the training field, we hope it sticks! At the Compliance News in Review, we resolve to keep you updated every week on the news from the world of life sciences compliance. With that, we welcome you to the inaugural 2014 edition of the News Week in Review.

The  European Federation of Pharmaceutical Industries and Associations (EFPIA) and PhRMA are starting the year by changing how clinical trial study data is handled. The joint principles on clinical trial data created by the two organizations in 2013 went into effect January 1 and the new principles provide healthcare professionals, qualified researchers and others with the ability to request patient-level data, study-level data, and full clinical study reports and protocols. Some member companies, like GSK and Pfizer, have already provided directions on how to request the data.

Transparency International wants businesses to resolve not to make facilitation payments. In the latest version of the organization’s Business Principles for Countering Bribery, provision of facilitation payments is now considered bribery. Other changes to the principles include the addition of a section addressing conflicts of interest and the addition of a section on the need to complete a business-specific risk assessment when developing an anti-bribery policy.

Abbott is starting the year $5.475 million lighter following a settlement with the DOJ over charges the company violated the False Claims Act. The government alleged Abbott paid doctors to implant several of the company’s vascular products into patients. The suit was originally filed by two former Abbott employees who will receive over one million dollars of the settlement.

The commitment hasn’t quite risen to the level of a resolution yet, but the SEC seems to be indicating it may expand how it enforces the FCPA. At a recent conference, FCPA Unit Chief Kara Brockmeyer told participants that the books and records provision of the Act makes the prosecution of corporate bribery fair game. If corporate bribery is discovered during the course of an investigation, a company’s books and records will be scrutinized and action can be brought against the company.

China is starting 2014 with a renewed focused on bribery involving pharmaceutical, medical device and nutritional products companies. The country is planning to blacklist companies that pay bribes to doctors or healthcare authorities. The first offense will result in a regional ban, and the second in a full country ban.

The FDA is taking new steps to make sure its messages are being heard. The agency will monitor online chatter to see if its social media messages are reaching an audience and if that audience is paying attention.

That’s all for this week folks. Remember, if you’re 2014 compliance training curriculum could use a refresher, the PharmaCertify™ suite of off-the-shelf modules and mobile apps bring up-to-date compliance content on topics like the Sunshine Act and on-label promotion to your staff where they need it most – in the field and at their fingertips.

Have a great week and Happy New Year!

Week in Review, October 21, 2013

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A U.S Senator calls for an investigation into the relationship between pharmaceutical companies and the FDA, the definition of “foreign official” under the FCPA is debated in Florida, the Baycol False Claims Act case moves forward and 25 manufacturers settle with Vermont over charges of failing to file required reports.

The World Series gets underway this Wednesday with the Cardinals returning after a one year hiatus to face a scraggly, scrappy Red Sox squad. With the team from Boston representing the American League, no doubt the boys from St. Louis have gained a new legion of fans in New York. So, do you have a side in the battle, or will you just be glad when it’s over, and you can get back to The New Girl and Sleepy Hollow? Whether you’re looking forward to the first pitch or the last, we’re here to help fill the time with the current version of the News in Review.

U.S. Senator, Joe Manchin, has put a call into a different type of commissioner to investigate an alleged pay-for-play scheme between the FDA and pharmaceutical companies. In the letter to FDA commissioner Margaret Hamburg, Senator Manchin expresses concern about reports of pharmaceutical companies paying thousands of dollars to attend FDA advisory meetings about the safety of pain medication. He would like to see a full senate investigation into the allegations to shed light on whether the relationship between pharma companies and the FDA caused any delay in the rescheduling of addictive pain killers.

A meeting on the mound is needed to settle an FCPA case in Florida. The case is now in the hands of three judges, and at the crux of the discussion is everyone’s favorite topic – the definition of a foreign official. More specifically, the case focuses on the definition of an “instrumentality.” Two telecom executives are accused of bribing the government-owned Haiti Teleco and defense lawyers have argued that an instrumentality has to be a direct part of the government under the FCPA, which is not the case with Haiti Teleco.

Internal controls charges are on the rise in FCPA cases, leading the Cadwalader law firm to wonder if the DOJ and SEC are poised to begin charging independent directors for failing to assure or maintain proper controls. Several companies have faced such charges recently, and as was demonstrated in the Orthofix case, companies can be charged with a violation for not having financial controls or an adequate compliance program in place. The FCPA guidance states that compliance begins with board members and senior executives, so the idea of independent directors being charged for the lack of proper controls isn’t far-fetched.

Upon further review, a whistleblower case against Bayer will move forward, but only on the grounds that the Department of Defense was defrauded, not federal healthcare programs. The False Claims Act case, which alleges that Bayer was deceptive in its marketing of Baycol, was dismissed last year because the court said the whistleblower failed to meet the specificity threshold related to false claims. The appeals court reversed the lower court’s decision.

Boston Scientific and its Guidant division have agreed to pay $30 million to settle charges of knowingly selling defective heart devices to facilities that treat Medicare patients. The government alleged that despite being aware of the problem, Guidant continued to sell defective stock and sent misleading communications to doctors in attempt to hide the true nature of the defect. The government also alleged that Guidant attempted to hide the defect from the FDA.

Vermont racked up 25 strikes against manufacturers under its Prescribed Products Gift Ban and Reporting law. The state’s Attorney General recently announced settlements with 25 manufacturers for alleged violations of the law. Most of the companies involved were small manufacturers and most of the charges levied were for failure to file the required reports. One manufacturer faced six charges of violating the gift ban.

We close with a reminder that the PharmaCertify team will be on-site at the Fourteenth Annual Pharmaceutical Regulatory and Compliance Congress next week. So if you’re attending, don’t forget to stop by the booth, say hi, and ask about our suite of compliance training modules and apps.

Have a great week everyone.

News Week in Review, October 14, 2013

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An industry watchdog group raises concerns about pay-for-play, the Supreme Court considers medical devices, one company claims its trade secrets were sent overseas and a critique of off-label promotion is, well, criticized.

“In fourteen-hundred and ninety-two, Columbus sailed the ocean blue”…certainly one of the more effective pneumonic devices from our younger days. So it is that today we celebrate the journey that would lead Mr. Columbus to “discover” the Americas. Unless of course you’re Canadian, in which case…Happy Thanksgiving! There is much to celebrate in North America today, but before you dig into the turkey and stuffing or take advantage of the Columbus Day sales at the local mattress emporium (nothing says “woo hoo, America was discovered!” like a new mattress), we set sail with this week’s News Week in Review.

The discovery of emails about meetings between government regulators and industry executives has raised concerns about the relationship between the two groups. The emails reveal that since 2002, pharmaceutical companies paid their way into the IMMPACT (an organization dedicated to improving clinical trials for new pain treatments) meeting, where they were able to discuss clinical trial procedures with regulators. The industry watchdog group, Public Citizen, says this raises concerns of a pay-for-play arrangement, in which drug companies could buy access to regulators, other health officials and academics. One of the founders of IMMPACT acknowledged that the email messages could appear problematic on the surface, but no one has complained about pharmaceutical companies paying for representatives to attend the meetings.

The U.S. Supreme Court could be exploring a case of a patient’s ability to sue a device maker under state laws when a problem with an FDA-approved device occurs. The case involves an Arizona man who has sued Medtronic over a pain medication pump which he claims left him paralyzed. At the time the man was using the pump, the device was approved by the FDA. The device was eventually removed from the market following a warning from the FDA about Medtronic’s failure to disclose all the risks. The Court has turned to the Obama Administration for an opinion on the matter.

A semi-retired Harvard doctor is suggesting that the Massachusetts legislature define a modest meal as one comparable to what one would receive at a hospital cafeteria. The doctor testified before the Committee of Public Health about a bill that would set a standard for a modest meal. He lamented the repeal of the existing meal ban and lectured about the so-called evils of pharmaceutical marketing.

Three former Lilly employees may be forced to walk the plank after they were indicted for handing over company trade secrets to a Chinese pharmaceutical company. According to the indictment, two of the employees emailed information about nine early-stage research projects to a third employee, who was also employed by the Chinese drug company. Lilly claims the company has a value of $55 million.

Fresenius, the maker of Propofol, ceased shipments of an anesthetic drug to Morrison-Dickson for several months, after the wholesaler accidently sent 20 vials of the drug to a Missouri prison for use in lethal injections. Fresenius will sell the drug to U.S. wholesalers only under the condition that they not sell it to prisons or jails. When company officials originally tried to reclaim the drug from the prison, they were told that decision would have to come from the state’s director of corrections or the governor. The state has agreed to return the vials.

In a case of the old world borrowing an idea from the new world, the U.K.’s Home Office is considering U.S. style whistleblowers awards in fraud, corruption and bribery cases. Currently, the U.K offers limited legal protections for employees who blow the whistle and the move is seen as one way to incentivize them. Some are concerned that the financial rewards will lead to bogus claims and raise questions about the credibility of a whistleblower as a witness.

A rehabilitation physician is trying to take the wind out of the sails of critics of prescribing drugs off label. Ford Vox, a physician at the Shepherd Center, responded to a recent article in the Washington Post about the number of off-label prescriptions written for patients covered by Medicare and Medicaid. Vox poked holes in the article’s assertions that off-label prescribing is inherently suspect, and that CMS has a responsibility to police physicians engaged in the practice. He notes that while focusing on one specific physician and drug, the article does not mention that the particular use is backed by research from 2006.

And so we end our exploration of all things compliance for this week. Fall has definitely arrived and as you map your compliance training curriculum for 2014, keep in mind that PharmaCertify™ offers the custom and off-the-shelf training solutions you need to help your crew navigate today’s murky compliance waters.

Have a great week everyone!