DOJ

Week in Review, April 21, 2014

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , ,

The European Federation of Pharmaceutical Industries and Associations increases its education efforts, GSK conducts internal bribery investigations, FCPA experts warn of increasing scrutiny and some restaurants look for creative solutions to changing pharmaceutical company requirements.

May is almost upon us, and you know what that means…so is the summer movie season! It’s a time marked by seemingly endless blockbusters and family movies, released on a weekly basis. Captain America: The Winter Soldier “sort of” represented the unofficial start of the season, and in a matter of weeks, the parade of superhero, wacky comedies, sci-fi thrillers and animated family films will begin in earnest. Hollywood’s big blockbuster may be still be a week or two away, but we have a little entertainment of our own to share, with this week’s News in Review.

Coming soon to a global theater near you: physician payment disclosure. The European Federation of Pharmaceutical Industries and Associations (EFPIA) is rolling out an education program to help companies prepare for its financial disclosure requirements. In January, companies will have to collect, and subsequently disclose, payments made to healthcare professionals and healthcare organizations. The education program, which will include webinars, leaflets and videos, will focus on current best practices and highlight how companies across Europe are preparing for the disclosures.

Look for sequels to be a popular choice for audiences this summer (How to Train Your Dragon 2, 22 Jump Street), but don’t expect GSK to be excited about another sequel on the anti-bribery front. Polish authorities are accusing the company of bribery, and the company has launched an investigation into bribery allegations in Jordan and Lebanon. In Poland, the company is accused of paying doctors for prescriptions, and disguising the payments as speaker fees. According to Polish authorities, a dozen doctors were paid fees for presentations they never delivered. GSK conducted its own investigation, saying the payments seem to be linked to one employee and that employee has been disciplined.

In Jordan and Lebanon, GSK began investigating allegations of bribery after a whistleblower contacted the company. The investigation is focused on allegations that bogus speaker fees were paid to physicians; free product was offered for the physicians to sell to patients; and a physician was allowed to exchange a business class plane ticket economy class tickets so his family could accompany him to a medical conference.

Corporations should expect even more focus on FCPA enforcement this summer and in coming years, especially now that global agencies are pooling enforcement resources. Speaking at a conference of the New York City Bar Association, two former government fraud officials, one formerly with the SEC and one formerly with the DOJ, warned that the two agencies are adding to the penalties if companies don’t cooperate with the investigations or try to obstruct the process.

Senator Grassley is planning a new whistleblower production and he is turning to his colleagues for help. The Senator announced he intends to form a Senate Whistleblower Protection Caucus to help ensure whistleblower protection laws are enforced. The plan is to recruit colleagues for the caucus throughout the year, with the goal of launching the new production at the start of the new Congress.

The rules on providing food for pharmaceutical and medical device company meetings have changed, but rather than walk away from the business, some restaurants, like Fogo de Chao, are taking a more creative approach. Leo Jakobson, editor for Successful Meetings, says the Brazilian steakhouse keeps the menus modest and informal by focusing on meals served on skewers, and all of the locations offer private dining rooms for up to 120 participants.

And that’s almost a wrap…at least for this version of the News in Review. The summer season is a great time to reconsider the impact your compliance training has had on your audience. Compliance rules, guidance and best practices are evolving, and we’re expanding the PharmaCertify™ list of mobile training solutions to keep pace with those changes. Through the release of new titles, like Understanding Global Physician Spend Transparency, and updates to existing modules like The Sunshine Act: The Federal Physician Spend Disclosure Law, PharmaCeritfy™ offers the training where your reps need it most – in the field and at their fingertips.

Have a great week everyone! We’ll see you at the movies.

News Week in Review, April 8, 2014

NXLevel Compliance Team , , , , , , , , , , , , , , , , , ,

China shifts its focus to medical device, the Arkansas Attorney General petitions the state’s Supreme Court to reconsider its reversal of the Risperdal verdict, GSK dismisses employees for violating expense rules, and a new study raises questions about conflicts of interests for medical school leaders sitting on the boards of pharmaceutical companies.

Ah yes, the glittering dresses, the suave tuxes, the perfectly coifed hair. No, we’re not talking about the Academy Awards or the Golden Globes, this is much more important than all that. It’s almost prom season!

If your Facebook, Twitter or Instagram isn’t littered with pictures of your kids and their cronies in their formal finery yet, it’s just a matter of weeks. You can take some small amount of solace knowing all those happy smiling faces will one day be questioning their choice of fashion or hairstyle. C’mon, you know you did. (Let’s just say there were some very unfortunate prom fashion choices made in the 70’s and 80’s by members of the News Week in Review staff.) As we wax poetic about proms of yore, let’s also look back at the compliance week that was, in this week’s News Week in Review.

First on the dance floor is news that China intends to toughen penalties for corporate malpractice against medical device companies. The country will segment devices into three categories based on their potential risk to consumers. The new rules are set to take effect in June, and the top fine for selling illegal medical devices will increase to 20 times the value of the device.

Not wanting to feel like a wallflower, the Attorney General of Arkansas is asking the state’s Supreme Court to reconsider its reversal of the $1.2 billion verdict in the Risperdal case. The court ruled the state had misapplied the state Medicaid fraud law when it tossed the verdict, and even said the law was codified incorrectly. The Arkansas Code Revision Commission voted to provide the AG with an analysis comparing the law as written to how it was written into Code. The AG says the analysis may be helpful in obtaining a new hearing.

The chaperones seem to be working hard at GSK. The company has dismissed several individuals for violating company expense rules. The company did not comment on the number of individuals involved, but did say monitoring efforts in China have increased, and that irregularities are always investigated. Emails reviewed by the Wall Street Journal indicate the company is also investigating allegations of bribery in the Middle East. The emails focus on activities occurring in Iraq, including the hiring of state employed doctors as medical representatives while those doctors were still working for the government.

A former GSK sales representative in China tells the Financial Times that kickbacks to doctors there were widespread. According to the former rep, domestic and foreign firms routinely paid kickbacks to doctors to achieve their sales targets, and the sales model at GSK was no different than those of its competitors. GSK called the behavior “completely unacceptable,” but as AstraZeneca’s CEO pointed out, even a tough compliance program can’t stop an employee determined to stray.

A new study finds that the leaders of medical schools and hospitals are being paid handsomely for sitting on the boards of pharmaceutical companies. The study found that of the 50 largest companies, 40% had at least one board member who was in a position of leadership at an academic medical facility. The average total compensation for these individuals was over $300k per year. The study raises the potential for a conflict of interest. For example, the president of Yale’s medical school receives nearly $300k from Abbott, but a spokesperson from Yale says the doctor would not make decisions about formularies, clinical trials, or drug samples, when Abbott is involved. Several other medical schools made similar comments regarding leaders of their medical facilities who receive compensation from pharmaceutical companies.

As we cue the last song on this week’s playlist, we’ll take this opportunity to let you know the PharmaCertify™ list of compliance modules and mobile apps is expanding. If global transparency, including the EFPIA Code and French Sunshine Act, is on your radar, we’ve added Understanding Global Physician Spend Transparency to our curriculum of customizable eLearning modules. To learn more about the module, or any of topics, contact Sean Murphy at (609) 466-2828, ext. 25.

Have a great week everyone.

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , ,

News Week in Review, April 1, 2014

Signs of sunshine in Canada, the DOJ issues its first FCPA advisory opinion of 2014, and the Serious Fraud office faces growing challenges in the enforcement of the UK Bribery Act.

April showers bring May flowers…and we are certainly ready for some flowers! Really, any sign that spring is here to stay would be appreciated. We’re even looking forward to a little spring cleaning as long as the spring part comes along with the cleaning part. So with visions of daffodils dancing in our heads, and the chill of winter fading from our memories, we bring you the compliance news of the week, with the News in Review.

Those May flowers may even have a little Sunshine added to the mix in Canada. Two Canadian physicians think the Ontario Minister of Health should require pharma companies with drugs on public formulary to disclose their financial relationships with physicians. As justification, the physicians claim other transparency initiatives in the country have proven to be both beneficial and popular and studies have shown that even small tokens, such as pens and note pads, influence decision making.

The DOJ’s first FCPA advisory opinion of 2014 has sprouted. The FCPA opinion procedure allows entities to seek an opinion from the Attorney General on whether a specific situation is in line with the DOJ’s current enforcement of the anti-bribery provisions of the law. This particular opinion was in response to a financial services provider and investor bank asking if a payment due to an individual when the individual was a private citizen could be considered illegal if the individual now is a foreign official.

The Serious Fraud Office continues to face stormy weather following the disintegration of the high-profile bribery case against Victor Dahdahel. In addition to the negative publicity around the failed prosecution, the agency has faced significant cuts in funding; increasing pressure to secure convictions under the Bribery Act; and growing questions about how it expects to obtain evidence from jurisdictions outside the U.K.

The seeds of clinical trial transparency are taking root, according to the European Federation of Pharmaceutical Industries and Associations (EFPIA). EFPIA recently provided an update on the adoption of the joint EFPIA-PhRMA principle on clinical trial transparency. According to the announcement, several companies, including Pfizer, UCB and Sanofi, have all taken steps to make the results of their clinical trials publicly available. Pfizer has expanded its policies on data sharing and Sanofi will be participating in a multi-company web portal designed to share clinical trial data. UCB revealed its plans for adoption of the principles in a publicly accessible webinar.

The Ontario College of Physicians and Surgeons is looking to eliminate the need for Sunshine. Proposed guidelines from the influential regulator will put a stop to the practice of physicians accepting gifts or items of value from the industry and will prohibit doctors from having articles ghostwritten by pharmaceutical companies. The guidelines will allow doctors to accept lunches, patient education items, drug samples, and funds for educational programs. Physicians will also be permitted to serve as speakers or consultants. Critics say the proposed guidelines offer nothing in the way of true reform.

Not only does the end of March signal the start of spring, it brings us the deadline for submitting Phase I Sunshine reports. Now that you’ve cleared that hurdle and you have time to stop and smell the roses, have you considered sprucing up your Sunshine training? The Sunshine Act: The Federal Physician Spend Disclosure Law from the PharmaCertify™ suite of compliance training modules, offers the updated training your staff needs to understand the law’s disclosure requirements.

Have a great week everyone!

News Week in Review, March 24, 2014

NXLevel Compliance Team , , , , , , , , , , , , , , , , , ,

GSK plans to hire physician speakers as employees, the Arkansas Supreme Court reverses the Risperdal verdict, SciClone sets money aside for an FCPA settlement, and Canada strengthens its Food and Drug Act.

Are your brackets ruined? You’re not alone. They don’t call it March Madness for nothing! Take heart though, most NCAA fans are in the same boat, and that one billion dollars from Warren Buffet for a perfect bracket can still be yours…next year. As you work through the carnage of your tournament picks, we offer the solace of a week’s worth of compliance news, with this week’s News in Review.

Outside physician speakers have suddenly been delegated to the bench at GSK. The company announced it plans to hire physicians and scientists to conduct product-focused educational programs rather than pay external speakers. Bringing the speakers in house should lighten the company’s Sunshine Act reporting load, but some experts question whether the move is worth the risk of having the speakers’ credibility and qualifications questioned.

Upon video review, the ruling in the courtroom has been overturned. The Arkansas Supreme Court has reversed the $1.2 billion Risperdal verdict against J&J and Ortho-McNeil-Janssen. The companies were sued and ultimately fined for violations of the state’s Medicaid Fraud False Claims Act (MFFCA) and Deceptive Trade Practices Act (DTPA). In an appeal, the companies argued appeal that the court erred when it ruled on the MFFCA and DTPA claims. The justices agreed on the MFFCA since the law is written to apply to a healthcare facility and not a pharmaceutical company and a majority of them agreed that the DTPA fines were not warranted.

No cash, no foul? A recent ruling in a case involving GSK and Teva seems to suggest so. A U.S. District Court judge ruled that since a settlement between the two companies did not involve a cash payout, the arrangement did not violate antitrust laws. As part of the settlement, GSK agreed to allow Teva to sell a chewable form of one of its drugs prior to the patent expiring while agreeing not to sell its own authorized generic of the drug. The Federal Trade Commission had argued that those types of arrangements have their own value.

SciClone is keeping some key resources on the bench and ready to be utilized when needed. The company announced it is reserving $2 million for penalties related to an ongoing FCPA investigation. In its annual report, the company said a settlement was probable.

A full-court press to strengthen Canada’s Food and Drug Act is in effect. The Canadian Parliament will debate a bill that would give the country greater ability to regulate drugs even after they are approved. The bill will give the Health Minister the power to recall unsafe products and require changes to labels.

If you thought NCAA rules were confusing, try figuring out the international physician spend transparency requirements. At the recent Disclosure Summit, an expert discussed the EFPIA’s Code of Disclosure on Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organizations (hence forth know as the Code). The EFPIA Code must be integrated into its member organizations’ code by the end of the year. That’s 33 different organizations! Further complicating the situation for the manufacturer are conflicts between the Code and existing laws in countries like France and Portugal. EFPIA is expected to release more guidance on addressing these conflicts at the end of March.

As the final buzzer sounds on this week’s Review, we offer a reminder that the PharmaCertify™ suite of customizable off-the-shelf eLearning modules and mobile apps provide the touch point learning opportunities your reps need to stay up-to-date with the latest commercial compliance information and good promotional practices.

Have a great week everyone!

News Week in Review, March 10, 2014

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , ,

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

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , , , ,

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

NXLevel Compliance Team , , , , , , , , , , , , , , , , ,

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

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , ,

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

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , ,

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

NXLevel Compliance Team , , , , , , , , , , , , , , , , ,

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!