FDA

Week in Review, April 29, 2014

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Pakistan joins the transparency parade, Arkansas’ Supreme Court won’t reverse the Risperdal decision, one Google executive wonders why pharmaceutical companies aren’t using YouTube more, and the DOJ offers a reminder about the need for a proactive approach to compliance.

California Chrome. Vicar’s in Trouble. Wicked Strong. Titles to obscure B movies? Nope, they’re just some of the participants in the “greatest two minutes in sports.” The countdown is on to the Kentucky Derby! We have less than a week to polish up those mint julep cups and shop for that perfectly obnoxious large hat. In the meantime, sound the call to the post, it’s time for the News Week in Review.

First out of the gate is the news that Pakistan is considering physician-industry interaction transparency requirements. The Drug Regulatory Authority of Pakistan is driving the increased transparency initiative and Pharma Bureau, a trade group of multinational industry companies operating in Pakistan, welcomes the move. The Bureau sees consistent guidelines and enforcement as a step toward better patient care and an improvement in the industry’s image.

According to a new study, doctors who don’t accept drug samples are a long shot to prescribe branded drugs. The study, published in JAMA Dermatology, compared offices in an academic medical center, where samples are not permitted, to private practice offices that do accept samples. Only 17% of the prescriptions written for adult acne drugs in the academic centers were for branded drugs, compared to 79% of the scripts being written for branded drugs in the private offices.

No Big Bazinga from the Arkansas Supreme Court regarding its reversal of the Risperdal verdict. In a 4-3 decision, the court said it would not reconsider its March decision to overturn the verdict. The verdict was overturned when the court said the state’s Medical Fraud False Claims Act did not apply to the Risperdal manufacturer because the law was codified in way that conflicted with the intent of the law. Arkansas Attorney General Dustin McDaniel asked for the ruling to be reconsidered because the issue of how the law was codified was not raised but the state or the drug manufacturer.

The folks at Google think pharmaceutical companies could benefit from a little more Social Inclusion. The head of Google’s healthcare-focused digital marketing team, David Blair, says the industry could utilize YouTube more effectively. Online viewership has now eclipsed television, and according to Blair, one-third of You Tube users share what they watch. YouTube is also the second largest search engine behind Google and Blair believes pharmaceutical companies are missing an opportunity to make an emotional connection through a disease awareness video or wellness campaign.

According to experts speaking at the Dow Jones Global Compliance Symposium, companies should set an aggressive pace when scrutinizing their own compliance programs. A deputy attorney general from the DOJ told attendees at the Symposium that companies are too quick to claim the problem only involved a few employees and that’s one of the first signs of a weak compliance department. Attendees also learned that the U.K., Canada and Germany have all set up units similar to the DOJ’s FCPA unit.

That’s going to bring us to the finish line for this week’s News in Review. We’ll see you right back here next week with another summary of the news from the world of life sciences compliance. As always, thank you for reading and have a great week!

News Week in Review, April 15, 2014

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Wisconsin seeks to harmonize health records, a Vermont legislator wants an exemption for the medical device industry, and the pharmaceutical industry questions how much Sunshine has had an impact on relationships with physicians (so far).

The birds are signing, the grass is a vibrant green, the flowers are blooming…it must be time for the Super Bowl…of golf that is. The Masters, “a tradition unlike any other,” and the big daddy of all professional golf tournaments, was held in beautiful Augusta amid the standard back 9 meltdowns and whispers up and down the greens. With his usual breathtakingly long drives and birdies on 8 and 9, Bubba Watson fought off the young phenom, Jordan Spieth, to win his second green jacket. But enough about divots and drivers, tee time for this week’s News in Review is here.

In the words of the great Ty Webb, “be the ball.” It’s all about harmonization, right? Well, the governor of Wisconsin certainly thinks so. Governor Scott Walker signed a bill into law that will harmonize the state’s law regarding behavioral health records with the HIPAA Privacy Rule.

A Vermont physician and legislator, George Till, would like to take a mulligan (of sorts) on the state’s physician gift ban law. He has introduced a bill in to the state’s legislature for an exemption to allow medical device companies to provide food and drink to doctors at seminars and other events sponsored by medical device companies. According to Till, physicians really need to have a “hands on” experience to familiarize themselves with a medical device. Till is a supporter of the state’s gift ban, and he doesn’t believe that his bill is in opposition to the principle of the law.

Are conflicts of interest the sand trap of the CME world? At a meeting of the American College of Cardiology, ACCME president, Murray Kopelow, spoke about the ACCME’s conflict of interest requirements. Kopelow said the ACCME is “very precise” about determining when a conflict of interest exists. The organization evaluates whether the individual: a) has a financial relationship with a defined commercial interest and b) has the ability to control the content of CME relevant to that relationship. The content of accredited CME must be valid and free of commercial interest as defined by the ACCME. Kopelow is concerned about criticisms that ACCME’s standards are hindering innovation. He says this was not the intention and special guidance has been created for those working in discovery.

Takeda and Lilly were recently assessed one heck of a penalty stroke. The two companies were ordered to pay $9 billion by a federal jury for failure to disclose the cancer risks associated with use of the drug Actos.

The FDA is not quite sure what approach to take to the proposed safety prediction and mining tool intended to help assess drug adverse event safety signals. The project was initially announced in April of 2013, but by September it was put on hold due to funding concerns. On March 31 of this year, the FDA again announced it was again looking for an outside partner for the project, but just three days later they changed their minds. The agency provided no reasoning for the latest cancellation, only saying that it would “re-advertise the contract solicitation at a later date.”

What would a Week in Review be without one story about the Sunshine Act? During PhRMA’s annual meeting, leaders from various companies said the Act was having no effect on how their companies interact with physicians. While doctors have not shut the door on the industry, Bob Hugin, PhRMA’s board chair, is concerned that once published, the Sunshine data could be mischaracterized by the public and cause the physicians to reconsider how they do business with the industry. Hugin says companies must take a proactive approach to ensure the data is presented in the correct context.

As we approach the 18th green for this issue of the Week in Review, we’ll finish with a brief word about the expanding curriculum of PharmaCertify™ compliance training solutions. If global transparency is on your radar, we are adding Understanding Global Physician Spend to our lineup of customizable off-the-shelf eLearning modules. The module covers the EFPIA Code of Transfers of Value, as well as specific country laws, like the French Sunshine Act. Contact Sean Murphy at smurphy@nxlevelsolutions.com for more information and to see a content outline.

Have a great week everyone!

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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

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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!

Week in Review, March 17, 2014

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In this issue…a look back on Caronia and its impact (if any), China cracks down on medical device websites, Teva settles improper allegations involving one of its subsidiaries and the FDA chastises one company for its product claims on Facebook.

Top o’ the morning, afternoon and evening to you! This may be the Ides of March, but we’ll put that aside and focus on the fun of St. Patrick’s Day instead. If this is March 17th, spring must be right around the corner and this must be Lá Fhéile Pádraig! Hopefully, you wore enough green today to avoid the pinch of those dastardly leprechauns. Pass the corned beef and cabbage, cue the bagpipes and straighten your kilts…it’s time for this week’s O’News in Review!

More than a year has passed since the Caronia decision, but it hasn’t exactly been the lucky charm some thought it would be for the industry. The decision supported the argument that truthful, non-misleading statements regarding off-label uses were protected by the First Amendment. However, the government distinguishes the application of the decision as it applies to the Food, Drug, and Cosmetics Act from how it applies to the False Claims Act (FCA). The government has argued that Caronia has no bearing on cases brought under the FCA because the Act applies to any conduct, including off-label promotion, that results in the submission of a false claim being submitted. For the foreseeable future at least, the government is as committed as always to pursue cases involving off-label promotion.

The Chinese government thinks that some medical device websites have taken the gift of gab a bit too far. The country’s State Food and Drug Authority has reported ten websites to the authorities for publishing false information about medical devices. The discovery is particularly concerning to the global med tech industry since several of the sites have allegedly forged the names of medical device manufacturers and posted fake equipment.

Teva Pharmaceuticals, Ltd. has agreed to part with a wee bit o’ green ($27.6 million) to settle allegations that one of their subsidiaries made improper payments to a physician.  According to the government, the Teva subsidiary, IVAX, funded vacations to Miami for the doctor, his family, friends and staff. The doctor is facing civil charges in Illinois federal court.

Closing the discrepancy between what medical device manufacturers report for physician spend and what those physicians disclosed may take more than just a little luck, according to a new study by Yale. The study compared the spend disclosures posted on the Medtronic and DePuy websites against what the physicians had disclosed. More than half of the information on Medtronic’s website was not in line with what the physicians reported and the discrepancy rate at DePuy was 30%. The study’s director says the errors go both ways, and he is concerned the public will assume that physicians are trying to hide something when that is not the case.

The International Society of Medical Publication Professionals has reevaluated its recommendations regarding support for medical publications and Sunshine reporting. In its previous recommendation, the organization suggested that all support from an applicable manufacturer was reportable. Now it recommends members consider who would benefit from the publication. For example, if the support provided by the manufacturer helps an author publish a study that the manufacturer would have an ethical obligation to publish anyway, then that support is not reportable.

The FDA has issued an Untitled Letter to a pharmaceutical manufacturer over content on the company’s Facebook page. According to the letter, statements on the page touted the benefits of the drug without revealing any of the risks. In addition to failing to report potential risks, the company omitted important “approved use” information from the product label.

With that, we end this emerald edition of the News in Review. While the celebration of St. Patrick may be filled with talk of good luck and the proverbial pot of gold, compliance training is not something you want to leave to chance. That’s why our PharmaCertify™ suite of off-the-shelf modules cover the critical topics, like on-label promotion and the Sunshine Act, your colleagues need to integrate good promotional practices into their daily activities.

Have a great week everyone!

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!

 

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, 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!

2013 PCF Pharma Congress Review and Highlights

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Sean Murphy, NXLevel Solutions

Day 1

The first day of the Fourteenth Annual Regulatory and Compliance Congress and Best Practices Forum opened with a roundtable session featuring chief compliance officers from Eisai, Shire, Merck, Bristol- Myers Squibb and Purdue Pharma. Analytics and data were the primary themes and Anne Nielsen from BMS emphasized the need for companies to use data to spot the trends and the risk areas for compliance. Eve Costopoulos from Eisai agreed, noting that a coordinated effort addressing risks is crucial and web-based tools should be put into place to collect the data. Caroline West from Shire shifted the conversation to the importance of having a serious conversation with the sales force about what they can and can’t do and Eve suggested that the level of understanding among the sales team may not be what the audience of compliance officers believed it to be.

Mary Riordan, Senior Counsel to the Office of Inspector General was next with her annual OIG Update presentation. She began with an update on enforcement activity from the previous year and in particular, the large number of kickback cases, including the Sanofi Hyalgen case, the Boston Scientific/Guidant case and the Purdue Frederick case.

Riordan also stressed that promotional activities need continued scrutiny to be sure what messages are being conveyed and as in years past, she suggested the compliance officers look to recent CIAs for lessons. She specifically referenced the Par CIA and its recoupment program. And in agreement with the comments made by the chief compliance officers on the preceding panel, Riordan said the risk assessment process was a good way to bring businesses into compliance efforts and ensure an effective process.

Next on the docket was the Assistant US Attorney Roundtable with representatives from New York, Boston, Philadelphia and Los Angeles in attendance. Margaret Hutchinson of Los Angeles echoed earlier comments, saying that when investigations are conducted, her office focuses on the time period from when the company learns of a problem to when that company acts on the problem, while Paul Kaufman from New York urged the audience to consider their personnel, claiming that he has seen good compliance departments staffed by people who “really don’t know what they’re doing.” He also suggested that incentivizing employees on sales may lead to more compliance issues and offered the idea of taking away bonuses if employees violate compliance regulations.

Tom Abrams, Director of the Division of Drug Marketing, Advertising, and Communications for the FDA returned this year to speak to an audience anxious to hear his FDA-OPDP Update, especially the status of the agency’s guidance on social media. While Abrams did commit to providing guidance that will be high in quality and relevant, which was stated with a disclaimer that his office was limited in resources, he did not commit to meeting the deadline set forth in the Prescription Drug User Fee Act (PDUFA).

Abrams also updated the audience on the FDA’s Bad Ad program, and the most common violations found over the last year. Omissions of risk, misleading efficacy and misleading superiority claims led the pack in terms of those violations.

Mit Spears, Executive VP and General Counsel for PhRMA closed the first day with a keynote presentation that mostly amounted to a compelling argument in defense of promoting off-label. Spears’ points on the frequency of off-label use and the potential benefit to patients were not lost on an audience that was sure to agree with his thoughts. Unfortunately, the regulators who presented earlier in the day were most likely no longer in the room.

Day 2

The second day of the conference opened with a panel session of industry leaders and an interactive dialogue that included audience response questions designed to gauge compliance priorities and readiness.

When asked about their top priorities, 41% of attendees answered “improving compliance systems and processes,” and “aggregate spend and Sunshine” was the second most popular choice. On the subject of their top global issues, the audience cited “FCPA/Anti-corruption” as their primary concern. Kelly Freeman, Senior Director of Ethics and Compliance at Eli Lilly, took the opportunity to remind attendees that they can no longer just focus on the FCPA and the UK Bribery Act – anti-corruption in globally needs to be the focus of their training.

On the question of which area of aggregate spend they are most worried about implementing, 60% of the audience answered, “accuracy of data.” The panelists pointed this to the biggest benefit of the Sunshine Act – the data is critical and helpful. Kris Curry, formerly of Johnson & Johnson, issued a warning not to spend too much effort and too many resources on the smallest details.

On the question of whether their companies regularly assess employee perception about compliance culture, 62% of the audience answered yes, which was definitely considered a positive trend by the panelists.

Speaking of trends, when asked about the background of their compliance staff, audience members said 40% had a legal background, 16% came from the sales and marketing function, and the remaining staff was spread across a number of disciplines.

During the session covering the View from the C-Suite, panelists Jean-Luc Fleurial of Bristol-Myers Squibb, Adrienne R. Takacs of Takeda and Michael Goolsby of Fresenius Vascular Care, agreed that compliance has to start in the hiring process. Goolsby advised those in a hiring role to look for employees who bring integrity coupled with coachability. He also touched on the training process, stressing that training needs to extend beyond the check-the-box approach recognizable to real-world scenarios.

The second half of Day 2 featured a series of “mini summits” in topics as diverse as third party relationships, government pricing, data sharing and cGMPs. I was anxious for an update on the FCPA and UK Bribery Act so I started with the Anti-corruption Update session with a panel of experts, including Nathaniel Edmonds, Former Assistant Chief, FCPA Unit of the DOJ and Vivian Robinson, Former General Counsel of the UK Serious Fraud Office. In noting that while there have been no significant UK Bribery Act cases to date, Robinson reminded the audience that the law had not been in place long and he was aware of “a number of cases on the books that were likely to come into the public domain in a short time.”

Edmonds focused on recent trends in FCPA enforcement and in particular, Fair Market Value and the importance of proper methods for reimbursing CROs and other third parties. Robinson agreed that third party due diligence is essential but warned that the focus on gifts and entertainment can be a distraction from that third party focus.

China was of course a topic of discussion with so much anti-corruption news emanating from the country in recent months. Edmonds called China “one of the most important recent developments for the pharmaceutical industry” and Robinson emphasized the need for clearly recorded due diligence, “you can say what you did and back it up.”

After a disappointing start to one of the late afternoon sessions, which started more as an advertising opportunity for the companies presenting, I joined a number of other attendees in moving to the Interplay between Company Culture and Compliance, where the key message seemed to be the importance of emphasizing the positive when evaluating employees. Or, as Gina Dunsmuir from Ortho Clinical Diagnostics said, “give the employees examples of what they are doing right.” Tom Costa from Bristol-Myers Squibb believes employees “want to be proud of their corporation,” and that’s even more reason why compliance officers need to be out in the field listening to employee feedback.

I decided a dose of medical device compliance would be a good way to close Day 2, and took in the Medical Device Compliance Issues Update session with Paul Kalb of Sidley Austin, Seth Whitelaw of Deloitte & Touche, and Sandy Kalter, Chief Regulatory Counsel for Medtronic. The panel pointed to the trend toward more med device CIAs and the increased focus on executive management and directors in those CIAs. For example, in 2012, of the $260 million dollars collected in anti-corruption fines, $50 million was from three device companies.

For Kalter, the biggest priority is managing off-label risks by first studying recent CIAs and developing a policy around the results. The different areas where off-label arises are key, according to Kalter, including areas like consultative meetings and MSL interactions.

Day 3

Day 3 opened with a keynote presentation from Bret Saunders, the new CEO of Forest Laboratories who was once a compliance officer for Schering-Plough. Saunders offered a unique view on how he perceives compliance from the CEO role. He believes “integrity includes compliance, yet goes beyond to include following your moral compass.” It took three days, but I knew I’d hear a reference to “tone at the top” and Saunders didn’t disappoint. But he used the oft-quoted phrase effectively, stressing the need for that tone to be communicated from the Board.

Understanding the background of his audience, Saunders included tips for presenting compliance concepts to directors. For example, keep concepts clear and in perspective. These are often people who don’t know the industry, so the information has to be right and it has to be organized. He advised the CCOs to approach their role as in a way in which they understand what the organization is trying to accomplish and which risks have the most impact on business. The best way to measure compliance readiness is to repeatedly survey internal and external stakeholders, according to Saunders, and conduct focus groups with employees to reveal how they feel about compliance and the related issues.

After an intriguing presentation on the role of unconscious biases in everyday life by Shankar Vedantam, NPR Correspondent and author of The Hidden Brain, and two panel discussions covering topics as diverse as Sunshine, state laws and lessons learned by attorneys who formerly worked in public service, Arun Sharma, from the University of Miami closed the conference with his take on the future of compliance. PCF planners may have made a mistake in scheduling Sharma for the last session because his comments were some of the most compelling and certainly controversial ones made during the conference. Leave it to academia to think outside the box and challenge the audience to approach compliance as a strategic opportunity to enhance marketing opportunities. The audience that hadn’t left for an early train or flight stirred uncomfortably as Sharma emphasized that “compliance 2.0” should be viewed as a chance to enhance a brand and grow that brand within the letter of the law. He challenged those audience members to be “more creative within the rules.” During a follow up question and answer session, one remaining audience was grateful for Sharma’s unique ideas but lamented the fact that government regulators hadn’t stayed to hear the presentation because he was sure they would disagree with the approach.

While some attendees anecdotally expressed frustration over the lack of new information presented at the Fourteenth Annual Regulatory and Compliance Congress and Best Practices Forum, conference organizers continue to seek new and innovative methods, e.g., mini summits, to present an ever-evolving stockpile of information to an eager audience. The conference, along with CBI’s Pharmaceutical Compliance Congress, remains the premiere opportunity for the industry to share the latest best practices and concepts.

See you at PCC in January!