Author: NXLevel Compliance Team

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!

News Week in Review, March 4, 2014

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The FDA updates its good reprint practices guidance, ACCME modifies the accreditation process, one attorney feels the abundance of qui tam cases are slowing the system, and the Solicitor General offers a suggestion to the Supreme Court on a qui tam case.

Laissez les bons temps rouler everyone! It’s the last day of the Carnival season and Mardi Gras is upon us. This is a crazy time of year in the Big Easy for sure, but even if you can’t make it to Bourbon Street, you just need to grab yourself some King Cake, organize an office krewe, and let the good times roll. As you contemplate all of the thematic possibilities for your floats, we’ll kick off our celebration of the week in compliance with this week’s News in Review.

Extravagant designs may work when designing Mardi Gras masques, but not so much for CME accreditation rules. The ACCME’s board of directors has adopted changes to simplify the accreditation process and requirements. Changes include a simplification of the process for first-time applications and the removal of some of the accreditation criteria and policy requirements. The changes apply to all CME providers in the ACCME accreditation system, and are effective immediately.

According to one expert, there are way too many attendees lining up for the qui tam ball. Peter Hutt, a defense lawyer in False Claims cases, points out that nearly 75 percent of cases brought by qui tam plaintiffs don’t result in government intervention or a recovery for the U.S. Treasury. According to Hutt, the cases are a drag on the system and he believes there should be changes to the qui tam provisions of the False Claims Act. Qui tam litigation should be a second line of defense in fighting fraud, says Hutt, and he would like to see incentives in place for companies to self-disclose fraudulent activity.

The U.S. Solicitor General is suggesting that the U.S. Supreme Court not review a qui tam case involving Takeda. The case raises the question of whether a relator has to provide specific instances of false claims in order to meet satisfy rule 9(b) of the Federal Rule of Civil Procedure. Although the circuit courts are split on the case, the Solicitor General believes the split among the circuit courts is not as pronounced as it initially appeared, and as the law evolves, the courts may resolve the issue.

Merck has good reason to celebrate this week. In a securities filing, the company noted the DOJ has closed its FCPA investigation of the company, and no action will be taken.

Any celebrating at the  French train manufacturer, Alstom, will have to wait. The company is expected to face charges of violating the U.K. Bribery Act. The charges are the result of a five year investigation. In 2010, the Serious Fraud Office raided the Alstom offices and the homes of several executives in the U.K., who were arrested under suspicion of paying bribes to win foreign contracts.

The FDA updated its good reprint practices guidance to address the topic of “distributing scientific and medical publications on unapproved new uses.” In the section referencing scientific or medical reference texts, the agency offers guidance on two fronts; providing chapters from a text and providing an entire textbook. Overall, the guidance for medical reference texts and CPGs are largely the same as medical journals.

That about does it for this week’s parade of compliance news. We wish you a joyous Fat Tuesday, and we look forward to bringing you all the compliance news you need to know right back her next week.

Thanks for reading and have a great week!

News Week in Review, February 24, 2014

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A survey shows anti-bribery policies may not be working in Asian-Pacific companies, businesses are again reminded to keep an eye on third party intermediaries in regard to the FCPA, two pharmaceutical companies settle anti-competition charges and West Virginia institutes its own false claims act.

Well, did you set aside any time to indulge in one of the great spectacles in sports over the weekend? We’re not referring to the closing ceremonies of the Olympics, but the 55th running of the Daytona 500…the Super Bowl of racing! While it does seem a little odd to have the big “game” at the beginning of the season, we’ll roll with it anyway. (See what we did there? Roll with it.) Just like in the Olympics, the weather added some stress, but eventually, the race was completed and Dale Earnhart Jr. celebrated his win not by announcing he was going to Disneyworld, but by launching a Twitter account. So with the “Great American Race” as our inspiration, we start our engines on this week’s News in Review.

Sitting in the pole position is an article that raises the question of whether strong anti-corruption policies are actually having an impact on behavior. A recent Ernst & Young survey of employees at Asia-Pacific companies shows that nearly half of those employees believe that corruption is a real problem in their organizations, despite the presence of policies intended to prevent it. Nearly 25% of those surveyed say that the provision of gifts to win business is still commonplace. While 81% of the respondents say they would use an anonymous hotline to report concerns only 32% say their companies had created procedures to do so.

Businesses hoping to avoid the black flag for FCPA violations need to keep tabs on their third party intermediaries and resellers. The 2012 FCPA Resource Guide offered clarity on the question of whether companies are responsible for the actions of third parties. In addition, recent cases have reinforced the notion that the government holds companies responsible for the actions of third parties. One case from 2013 involved a company that used a freight forwarder to avoid paying customs duties and tariffs in Nigeria. In another, a company entered into a Non-Prosecution Agreement after the manager of a foreign subsidiary was found to have paid bribes to customs agents.

PhRMA is not happy with the Federal Trade Commission (FTC) over the transfer of patent rights and the organization is headed to court to do something about it. In November, the FTC made a change to the Hart-Scott-Rondino Act over premerger notification rules that applies only to the pharmaceutical industry. PhRMA filed suit to have the change declared unlawful, saying the costs of compliance with the rule will be significant.

On the settlement front, Ranbaxy and Teva have been assigned a couple of penalty laps for restricting competition. The two companies settled charges with the state of New York over an arrangement that would allow Teva to sell the generic form of Lipitor in the U.S. should Ranbaxy’s generic not be approved. Each company agreed to pay $150,000 as a part of the settlement.

The West Virginia House Judiciary Committee has approved a bill that would create a state version of the False Claims Act. The bill provides for whistleblower awards, and if passed, will give the state a larger percentage of federal settlements.

And so ends this week’s race through the world of the compliance news you need to know. Have a great week everyone and we’ll see you back here next week!

 

Week in Review, February 17, 2014

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

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

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

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

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

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

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

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

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

Have a great week everyone!

 

The 2014 Pharmaceutical Compliance Congress: A Recap and Review

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

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

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

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

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

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

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

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

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

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

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

Day 2

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

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

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

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

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

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

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

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

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

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

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

Sean Murphy, NXLevel Solutions

Week in Review, February 10, 2014

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

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

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

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

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

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

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

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

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

Have a gold medal week everyone!

Week in Review, February 4, 2014

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

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

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

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

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

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

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

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

Have a great week everyone!

Week in Review, January 28, 2014

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

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

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

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

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

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

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

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

Stay warm everyone!