pharmaceutical compliance

Compliance Week in Review, June 18, 2014

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Comments to CMS show physicians and the pharmaceutical industry are wary about the Sunshine dispute resolution process, the American Medical Association passes a resolution to modify the Act, and Minnesota makes changes to its aggregate spend law.

Well, that was a big weekend. First we had a Friday the 13th to escape and/or celebrate (your choice), and then the big day, Father’s Day. Hopefully, you avoided any unfortunate incidents or questionable neckties. So now here we are on just another plain ol’ day in June. We’ll keep the “party” rolling by taking a look back at some of the big news stories of the past week. Time to for this week’s Compliance News in Review.

Comments received by CMS regarding the Sunshine dispute resolution process show physicians and the industry alike are feeling a bit wary about the future. Physician groups commented that the 60 days to resolution period is too short. It was pointed out that even if a physician submitted a dispute to CMS when the window opens, there is no guarantee CMS will forward the dispute in a timely manner to the manufacturer. In addition, teaching hospitals will need more time to complete their review of the data than an individual physician. The CME Coalition suggested that data publication be delayed until March of 2015. The group said physicians should be allowed more time to deal with discrepancies. On the industry side, PhRMA noted that CMS was correct in allowing manufacturers the ability to determine what disputes will be investigated and resolved.

The “lucky” number for the AMA House of Delegates is 100. During a recent meeting, the House of Delegates passed a resolution to lobby Congress to enact two significant changes to the Sunshine Act. First, the Medical Society of New Jersey (MSNJ) suggested the minimum threshold for reportable transfers of value be raised to $100. The MSNJ said the current threshold is too difficult for the industry and physicians to track. The second change involved the inclusion of medical textbooks and journal articles in the educational items exclusion. The change was suggested by the American Medical Group Association. The passage of the resolution is considered to be a message to the Washington D.C. office of the AMA to work with Congress to institute the changes to the Act.

A new article disputes the argument that conflicts of interest between the industry and physicians result in decisions that are harmful to patients. The authors of the article say the “conflict of interest campaign” has directed resources away from worthwhile medical care and research issues. The authors claim the huge settlements in off-label cases give the impression that patients were in harm’s way, however there is very little evidence that was actually the case. Where publication biases are concerned, the article’s authors say the conflict of interest detractors are asking the wrong question. Detractors focus on whether there are differences in industry-funded studies and studies conducted by non-profits, rather than focusing on whether the studies are scientifically unsound. Removing the assumption that positive results from industry studies are the result of misconduct, no reason exists to assume the studies are scientifically flawed.

Changes have been made to the granddaddy of aggregate spend laws. The Minnesota legislature passed a bill that expands the definition of a practitioner to include APRNs, Medical Assistants and Dental Assistants who are authorized to prescribe, dispense or administer medication. The expansion means these professionals now fall under the state’s gift ban and reporting laws. The Board of Pharmacy suggested companies begin tracking spend related to these professionals since reporting would likely be required in 2015.

To no one’s surprise, the Sunshine Act is still dominating the news. During a recent webinar aimed at physicians and teaching hospitals, CMS said that the dispute resolution period would be in the August/September time frame, but the agency did not offer specific dates. CMS still appears committed to a public release of the data by September 30. However, one of the callers on the webinar pointed out that the September 30th date was not included in the Final Rule and the Rule only states that 2013 data reports will be published in 2014. If CMS pushes the public release back, this would address one of the issues raised in the comments about the dispute resolution process. CMS also said it would not be expanding covered recipients to include mid-level practitioners. That sort of change would have to come from Congress.

There sure was plenty of Sunshine in this week’s news and there are bound to be plenty of Sunshine-related questions from healthcare professionals. The PharmaCertify™ eLearning module, The Sunshine Act: The Federal Physician Spend Disclosure Law, provides your sales representatives to up-to-date training on the Act, and includes a comprehensive list of the disclosure requirements included in the law.

Have a great week everyone!

Week in Review, May 27, 2014

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CMS prepares for Phase 2 of Open Payments registration, data submission, and attestation; Washington D.C.’s Department of Health announces it will not require the reporting of gift expenses; Roche gets a visit from the State Authority for Industry and Commerce in China; and the FDA evaluates its off-label promotion policies in light of First Amendment cases.

Summer has arrived! Well, not really, but Memorial Day certainly marks the unofficial start of the season. And nothing says summer more than a trip to the beach. Or as our New Jersey staffers like to say, “down the shore.” If you’re struggling to shake the sand off of a memorable weekend at the beach, and refocus on all things compliance, we’ve got just the remedy…this Week’s News in Review.

Break out those beach towels and SPF 70, it’s time to bask in the Sunshine. Phase 2 of Open Payments registration, data submission and attestation will begin on June 1. This phase will occur in two parts, with the first beginning June 1. Applicable manufacturers and GPOs will be able to register in Open Payments; confirm the reporting entity profile; assign roles within the system; and upload test files. Then, beginning June 9, manufacturers will be able to submit final reports and attest to the accuracy of those reports. Companies have until the end of June to complete both parts of Phase 2.

The Sunshine is a little less intense in Washington D.C. The District’s Department of Health will not require pharmaceutical companies to submit gift expenses for physicians and teaching hospitals. For the 2013 reporting year, manufacturers and labelers do need to report physician and teaching hospital gifts provided prior to July 31, 2013. Also, expenses for all other recipients must be reported. Reporting requirements for advertising and aggregate expenses remains the same.

Roche may have found themselves caught up in the wave of bribery investigations in China. The company revealed that China’s State Authority for Industry and Commerce (SAIC) paid a visit to one of its facilities in China. The SAIC is generally the lead agency in bribery cases. Roche said the reasons for the visit were not immediately clear.

Could the FDA be rearranging the beach chairs when it comes to off-label promotion? Recent court decisions have raised issues around the First Amendment and drug promotion, and FDA chief counsel says the agency is taking the “First Amendment concerns very seriously.” The Center for Drug Evaluation and Research chief, Janet Woodcock said, “We are currently carefully evaluating our policies in light of court decisions on First Amendment issues.” While the agency may be revaluating its stance, the DOJ still intends to aggressively pursue off-label cases.

Speaking of the FDA, the agency is planning a study to determine if bargain-hunting consumers weigh price more heavily than other attributes of a drug. The study will show three versions of an ad for a diabetes drug to patients and HCPs. One ad will feature a price comparison between the advertised drug and a competitor, another will feature pricing information only for the advertised drug, and the third version will state the drug’s safety and efficacy profile, and one that will inform the viewers that actual prices may vary. The FDA currently allows manufacturers to include pricing in advertising but very few do.

June 1 not only marks the beginning of Open Payments Phase 2 for manufacturers, it’s also the start date for physicians to register with CMS to access the reported data. This is a critical time for the industry, and keeping your team up to speed on requirements of the Sunshine Act is more important than ever. The PharmaCertify™ module, The Sunshine Act: The Federal Physician Payments Disclosure Law, includes a comprehensive list of the disclosure requirements included in the law and the physician spend information that will be shared with the public.

Have a great week everyone.

Week in Review, April 21, 2014

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

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

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

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

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

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

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

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

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

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

News Week in Review, April 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!

News Week in Review, April 8, 2014

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

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

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

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

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

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

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

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

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

Have a great week everyone.

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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 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!

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!