anti-bribery

Week in Review, July 22, 2014

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The Minnesota Board of Pharmacy confirms that payments to nurse practitioners and PAs must be reported, the FDA issues more Warning Letters, a grand jury indicts FedEx for shipping drugs for illegal pharmacies, and industry funding for CME continues to decline.

With summer in full swing, Major League Baseball took a break from the pennant races for its annual showcase of the best and brightest stars from both leagues…and the ratings were up. In what seems to be the trend lately, the American League came out on top and National League fans were left lamenting the fact that should their team make it to their World Series, they will once again be denied the coveted home field advantage (strange rule indeed). Now, as trade talks heat up and races tighten, we step up to the plate with this week’s News in Review.

First up, we have news from the state that hosted the All Star Game, Minnesota. The Minnesota Board of Pharmacy released a memo confirming that 2014 payments to nurse practitioners, physician assistants, veterinarians and dental technicians must be reported in May 2015. The Board advised manufacturers to begin tracking data for these professionals since it expected the legislature to require companies to report those payments.

Batting second this week is the always confusing topic of social media. The FDA recently issued an Untitled Letter to Gilead and a Warning Letter to Zarbee’s Naturals regarding the company’s use of social media for product promotion. In its letter to the company, the FDA cited an ad that used Google’s AdWords. The ad neglected to provide risk information, and the drug was misbranded. The ad also did not include the generic name of the product and only featured the brand name in a couple of URLs listed in the ad. Zarbee’s Warning Letter focused on the use of Facebook “likes.” The FDA equates “likes” top promotions and the company “liked” several customer testimonials on its page.

Companies that manufacture products for human use aren’t the only ones running afoul of the FDA’s promotion regulations. A Warning Letter was issued recently to the French pharmaceutical facturer, AB Science, for the off-label marketing of a veterinary drug. The letter cited several off-label statements on a product website. The FDA also noted that the company neglected to list important safety information on the product website and other promotional material.

The federal government took a swing at FedEx recently when a federal grand jury indicted FedEx for shipping drugs for illegal pharmacies. According to prosecutors, the company was warned for over a decade that they were shipping drugs for illegal pharmacies, but that those warnings went unheeded. Rather, the company “departed from its usual business practices” to continue shipping the drugs. According to prosecutors top managers at FedEx approved the continued shipping to known illegal pharmacies. A senior vice president for FedEx said the company was innocent of the charges levied against it, and would plead not guilty.

It’s a single for industry support of CME…a single digit decline in funding that is. According to the ACCME’s Annual Report, industry funding of accredited CME dropped by 1.9% in 2013. Support from industry represents 27% of all CME income. This is a far cry from 2008, when industry funding represented almost half of CME funding. Physician attendance at CME events was down in 2013 by just over 4%, but attendance by non-physicians was up by 5%.

As we wind down this week’s version of the Week in Review, we offer one last pitch about the importance of reviewing your Sunshine Act training needs – particularly in light of the ongoing activities around Open Payments registration and data review. The PharmaCertify™ eLearning module, The Sunshine Act: The Federal Physician Spend Disclosure Law, is designed to bring your team up to speed on reportable and excluded expenditures, and the information required for submission to CMS.

Have a great week everyone!

Week in Review, June 24, 2014

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New social media guidance from the FDA has arrived, a new survey points to the need for reps to be comfortable with the science of what they sell, and PhRMA asks CMS for an extension of the data submission deadline.

We have officially, or astronomically anyway, reached summer! The Summer Solstice occurred over the weekend, giving those of us who live in the northern hemisphere the “longest” day of the year. We hope you found a fun and worthwhile way to enjoyed those extra, precious minutes of daylight. While we may slowly be losing daylight from now until the Winter Solstice in December, that doesn’t the party needs to end. We’ll keep the celebration going as we take a look back at the compliance news of the week, with the News in Review.

Two new social media guidance documents from the FDA have finally seen the light of day. One covers the topic of correcting misinformation posted by third parties on the Internet and social media. The document discusses the situations in which the guidance applies; the information that should be included in a response to misinformation; and the type of communication that is outside the scope of the guidance. The other document covers the presentation of risk and benefit information on social media platforms that restrict the number of character spaces. The guidance features examples of how companies can include risk and benefit information in these platforms.

While the limited character guidance was certainly welcomed, companies still need to proceed cautiously with platforms such as Twitter. The guidance does allow for the use of URL shortening services, as well as the use of common abbreviations to help address the character limitations. However, just providing a link to risk information, or posting a follow-up Tweet, is not sufficient for communicating risk.

A new season has dawned for pharmaceutical sales reps according to a recent survey of healthcare company leaders. More than half of the respondents said selling isn’t the most important skill for reps. Today’s products require sales reps be able to hold in-depth scientific conversations with doctors. Evolving technology was also referenced as being a key factor in the changing role of a sales rep.

A former president of the American Medical Association would like to see physicians and industry companies spending time together in the Sunshine. At a recent conference, former AMA president, Jeremy Lazarus, commented that manufacturers need to work with physicians to develop a mutually beneficial relationship when dealing with the requirements of the Sunshine Act. He said many physicians are still unaware of Sunshine, even though information about their relationships with industry companies will soon be publicly accessible.

PhRMA would like to see the Sunshine “extended.” Last week PhRMA sent a letter to CMS suggesting that the June 30 Phase 2 data submission deadline be extended. In the letter, PhRMA said its members are reporting technical problems with the registration process in Open Payments. Companies have also encountered numerous problems when uploading data. The problems are particularly troublesome for foreign entities, and those entities are having issues getting help because the CMS helpdesk does not accommodate European or Asian time zones. PhRMA would like CMS to extend the deadline 30 days once the agency confirms that the glitches have been corrected and the system is operating correctly.

The release of the latest social media guidance by the FDA is a timely reminder that promotional statements must meet certain requirements, regardless of the communication platform. That’s why we are updating the PharmaCertify™ Good Promotional Practices module to include the new information. The module is targeted to sales and marketing staff and topics include gifts, meals and entertainment; promotional statements; advisory boards; and the handling off-label inquiries.

Have a great week everyone!

Week in Review, June 09, 2014

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France publishes its first public reports related to physician payments, several companies pay out millions in settlement fines,  medical affairs professionals discuss their changing role in compliance, and Massachusetts releases a notice regarding the reporting of the same spend information required under the Sunshine Act.

Break out the mortarboard and fire up Pomp and Circumstance, it’s that time of year again. has arrived. There’s nothing quite like watching the graduates cross that stage, receive their diploma and bask in the achievement. Here’s hoping they enjoy the moment before they have to face the harsh realities of the next phase of life. (Remember that moment when we realized that “nap time” in first grade did not include a mat? Welcome to the real world!) With that in mind, we proudly present this week’s graduating class…and this week’s compliance News in Review.

A transfer story from France leads our parade of worthy stories. France has published the first public reports of industry transfers of value (TOVs) to healthcare professionals, as required by the French Sunshine Act. To manipulate this database you’ll need to dust off your old French text book, or quickly invest in a Rosetta Stone course, because there is no option to switch to an English (or any other language for that matter) translation. The company information is all .txt files that are practically impossible to read, but if you know some HCPs in France you’d like to search for, that information is slightly more reader friendly…except for the whole being in French thing. Oh well, the information is there for the linguistic and inquisitive among us. According to the folks at Policy and Medicine, there has been little press coverage of the release of the data.

Don’t get to comfortable with the French Sunshine Act though, it appears there may be a major change coming soon. Recently, the Ministry of Social Affairs of Healthcare issued a draft order that would modify some of the regulations. One modification will simplify the details reported about HCP arrangements. Another will lessen the level to which companies need to protect HCP information. Finally, a change to the schedule initially set up to declare the benefits and the conventions has been proposed.

Several industry companies are facing unexpected fees and fines. Medtronic will pay $9.9 million to settle allegations under the False Claims Act. According to the government, the company used a variety of payment schemes to induce physicians to use its pacemakers and defibrillators. The company is alleged to have paid physicians to speak at events to increase referral business, created marketing/business development plans for physicians at no cost, and provided sporting event tickets to physicians.

Boehringer Ingleheim has agreed to pay $650 million to settle 4,000 lawsuits involving the drug, Pradaxa. According to a BI spokesperson, the average payout per settlement will be $162,500. Plaintiffs claim the company didn’t adequately warn patients of the risks associated with use of the blood thinner. The company says the drug’s safety has been repeatedly demonstrated, and the settlement does not change the drug plays in patients’ lives.

GSK has agreed to pay $105 million to 44 states and the District of Columbia to settle claims they illegally promoted two antidepressants and an asthma drug. In the agreement with the states, the company agreed to changes in its incentives to sales people, not use paid physicians to promote products, and to refrain from making deceptive or misleading statements in its advertising.

Chicago is throwing its cap in the ring and has filed suit against five manufacturers of highly addictive painkillers. In a suit similar to one filed by several California counties, Chicago is claiming the companies overstated the benefits and downplayed the risks associated with the use of the pain drugs. The suit says the companies violated laws related to consumer fraud, misleading advertising and false claims. In addition to the civil penalties and punitive damages, the city is seeking to reclaim profits associated with the illegal marketing activity.

As the regulatory landscape changes, medical affairs personnel are becoming more important in conversations with HCPs and more involved with health economic and outcomes research (HEOR). Within these two areas, concerns regarding off-label use of products are becoming a hot issue. Speakers at last week’s World Congress said their companies have evolved their policies on responding to unsolicited requests for off-label information. Compliance issues related to HEOR include the nature of the studies used and whether or not the company is providing payers with balanced information regarding the safety and efficacy of products.

Massachusetts has finally moved the tassel on some of its HCP spend reporting requirements. The state recently released a Notice of Federal Preemption, which stated that the Department of Public Health could not require pharmaceutical and med device companies to report the same spend information that is required by the Sunshine Act.

And with that, we bring this week’s ceremony to a resounding close. We wish all of the graduates out there good luck with whatever life holds for them next. Toss those caps in the air everyone and have a great week! We’ll see you right back here next week.

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, May 20, 2014

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A new survey shows that calls to company hotlines are on the rise and a U.S. Appellate Court looks to clarify the meaning of a key term in FCPA cases.

It’s time to dust off that picnic blanket and dig the stadium chair out of the back of the closet…summer concert season is about to kick off. From county festivals to stadium shows, acts ranging from big bands to Buffet will soon be filling the warm air with the sounds of summer. Whether your tastes tend toward rock or Rachmaninoff, you’re bound to find a sound that soothes your soul again this year. While you ponder your live summer playlist, we’ll strike up the band with the compliance news you need to know for this week, with the Week in Review.

Are whistleblowers turning it up to eleven? A recent survey conducted by the Society of Corporate Compliance and Ethics (SCCE) and the Heath Care Compliance Association (HCCA) found that reports to company hotlines are on the rise. According to the survey, 37% of compliance officers say they have seen a rise in reports to hotlines and another 51% say the rate of reports remains steady. In publicly traded companies, the rise is more pronounced, with 56% of compliance officers reporting an increase in hotline calls. The CEO of SCCE and HCCA says the rise is good news, and points to employees’ willingness to come forward as evidence that their concerns will be heard objectively.

GSK, the first industry company called out in last summer’s bribery accusation parade, faced the music during a press conference this past week. The Chinese police accused the former head of GSK’s operations in China, Mark Reilly, of telling employees to pay bribes to doctors and hospitals in order increase sales. According to the police, the bribery led to higher drug prices and illegal revenue in excess of $150 million. Two other GSK executives were also accused of being involved in orchestrating the bribery scheme. The company said it was continuing to cooperate with the investigation and legal experts say the accusations against Mr. Reilly may cause some companies to rethink their investment in China.

And just when GSK thought the news in China couldn’t get worse, here comes an encore. The company is now accused of tax evasion in a Chinese legal newspaper. According to the publication, which is run by the government, the company failed to pay import duties and taxes for an HIV product between 2005 and 2008. GSK has not issued a comment.

Could an Appellate Court’s decision in an FCPA case be music to the ears of prosecutors, defense teams and companies alike? In a closely followed case, the court provided a definition of the word “instrumentality” as it pertains to who qualifies as a foreign official under the FCPA. The case hinged on that definition. The court wrote that an instrumentality is, “an entity controlled by the government of a foreign country that performs a function the controlling government treats as its own.” The court went on to say that the facts of a case will determine what constitutes “control” and a “function the government treats as its own,” but did suggest there are certain factors for judges and juries to consider, such as whether the government has a controlling interest in the entity, or the ability to hire and fire the principals.

Well, that just about brings us to the end of this week’s performance. Obviously, the sound of settlements and investigations continues to fill the airwaves. Now, more than ever, the PharmaCertify™ eLearning modules, Commercial Compliance Overview and Good Promotional Practices offer a perfectly harmonized solution to compliance training challenges. Compliance Overview presents a comprehensive introduction to the critical commercial topics all employees need to understand, while Good Promotional Practices targets those in the field, highlighting the policies and best practices related to product promotion and HCP interactions.

Have a great week everyone and rock on!

Week in Review, May 13, 2014

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CMS posts help for applicable manufacturers to prepare for Phase 2, Maine’s Pharmacy Board questions the validity of an Internet pharmacy, the OIG asks Boston Scientific about two of its products, and Brazil fines Eli Lilly for manufacturing violations.

We’re not sure how it happened, but somehow, nearly half the month of May has passed with us not realizing that this is Barbeque (or Barbecue if you prefer) Month. And if you thought (insert your favorite sports rivalry here) was a topic that could fire up a heated conversation, just mention proper barbecuing techniques. Pork versus beef, sauce versus no sauce (we won’t even open up the type of sauce can of worms), dry rub versus wet rub…it’s all a point of contention and fierce debate. So break out the brisket and make your plans to celebrate Barbecue/Barbeque Month while we fire up this week’s Compliance News in Review.

CMS is getting the coals all nice and hot for Phase 2 of the Open Payments data submission process. The agency announced that it will post a series of tutorials to help applicable manufacturers and GPOs prepare for Phase 2. The first of three tutorials is available now on the Open Payments website. CMS also announced that physicians and teaching hospitals will be able to register in CMS’ Enterprise Portal beginning June 1. Registration is not necessarily required for physicians or teaching hospitals, but it is needed if anyone from those institutions wants to see their Open Payments data.

The Maine Pharmacy Board is asking the Attorney General to apply some direct heat to an Internet pharmacy that has been advertising inexpensive drugs in the state. The president of Maine Pharmacy Association filed a complaint with the Board, saying the online drug seller wasn’t a licensed pharmacy. He says he ordered three medications from the company and all were made outside of Canada.

Is there a secret sauce for determining fair market value (FMV) rates in emerging markets? It certainly can get complicated in a constantly changing global economy. In an article for Policy and Medicine, Mario Prohasky, of Polaris, suggests companies should update their FMV rates when macroeconomic changes occur. For example, when an annual inflation rate exceeds 10% to 15%, or a local currency experiences a devaluation of 20% or more, a company should re-evaluate its FMV rates.

HHS is asking Boston Scientific to carve out a little information related to one of its products. In a regulatory filing, the company revealed that the OIG has asked for information regarding the 2008 launch of two of its defibrillators.

On the physician spend front, the total cost of payments to physicians and hospitals in Massachusetts dropped between 2011 and 2012. While recently released data shows a 12% drop in the total amount of payments, the number of payments actually increased. This can be credited to the change in the Massachusetts law that allows companies to provide modest meals. Spending on food (barbecue and otherwise) was up 65%.

Eli Lilly is disputing the ingredients it’s been accused of using at one of its manufacturing plants. The company was fined $450 million by a Brazilian court for allegedly exposing employees to hazardous materials at the plant. Lilly is appealing the decision, saying the chemicals to which the plaintiffs claim they were exposed were not used in manufacturing. Lilly also claims the court’s ruling is based on bad math and “inaccurate scientific claims.”

And with that, we bring this week’s feast of compliance news to a close. If you’re wondering if your compliance training curriculum offers the right list of ingredients, the PharmaCertify™ suite of eLearning modules and mobile apps offers comprehensive and up-to-date training on the regulations and policies your learners need to understand as they interact with healthcare professionals.

Have a great week everyone!

Week in Review, May 5, 2014

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UCLA settles with a surgeon over conflicts of interest, CMS announces a timeframe for Phase 2 of Open Payments data submission, qui tam lawyers pour through the recently released Medicare payment data and PhRMA weighs in on simplifying product warning information.

Not so long ago in a galaxy…well, right here…the greatest achievement in cinema was celebrated (yes, we’ll admit it, we’re often given to hyperbole). With all due respect to Bogie and Bacall and Orson Welles, we’re of course referring to this past weekend when the Fourth of May was with us, and we celebrated Star Wars Day. Then, on Monday we had to deal with the Revenge of the Fifth. Rather fitting don’t you think? If Star Wars isn’t your particular cup of blue milk, feel free to jump right to the earthly compliance news of the week with this issue of the News in Review.

10,000 credits in advance may get you a ride on the Millennium Falcon, but it took 10 million dollars to settle a retaliation suit between a UCLA surgeon and the University of California Board of Regents. The surgeon, who was head of the orthopedic surgery department, raised concerns about physicians’ financial relationships with medical device companies. He claims his complaints were ignored and he was then denied patient referrals and prevented from participating in grants. In settling, UCLA claims it chose “to end a prolonged conflict and permit UCLA Health Sciences to refocus on its primary missions of teaching, research, patient care and community engagement.”

Open Payments: Episode 2, coming soon to an industry company near you. CMS has announced that applicable manufacturers can expect Phase 2 of Open Payments data submission to be open late May or early June. During Phase 2, applicable manufacturers and GPOs should:

  • Register any authorized officials not registered during Phase 1
  • Complete the registration for entity and the authorized official (supplemental information is required)
  • Verify entity profile information is correct
  • Upload, verify and attest to accuracy of payment data

Additional roles within the Open Payments system may also be assigned during Phase 2. CMS is preparing tutorial videos to assist applicable manufacturers and GPOs with implementation.

Qui tam lawyers have been mining the recently released Medicare payment data almost as aggressively as the Empire mined the Tibanna gas mines at Bespin (wow, we went full out geek there). The organization known as Taxpayers Against Fraud has lawyers pouring through the data looking for physicians who prescribe high numbers of a particular product. Obtaining this type of data previously required a subpoena. Is this a foreshadowing of what to expect once Sunshine data is released? Sunshine data might be used to demonstrate alleged instances of kickbacks, or infer that a company is involved in off-label marketing when a physician’s specialty doesn’t align with the approved use of a product.

They may not be well-liked by the hard core fans, but the Ewoks certainly proved the power of “keeping it simple.” Seriously, a bunch of teddy bears held off the Empire with rocks and logs! PhRMA appears to share this simplicity sentiment when it comes to the warnings in DTC ads. When the FDA asked for comments regarding a study focused on whether simplified warning information would help patients better understand the risks, PhRMA didn’t hesitate to voice its opinion. The organization believes shorter or less-complex warnings would help patients understanding the risks and motivate patients and healthcare providers to seek additional information about the drug.

With Phase 2 of Open Payments registration and data submission about to begin and the data publication expected not too far in the distant future, the Sunshine Act is burning brighter than the two suns of Tatooine. Make sure your team understands the nuances of the law The Sunshine Act: The Federal Physician Spend and Disclosure Law from the PharmaCertify™ suite of off-the-shelf eLearning modules.

Well folks that brings us to the end of this episode. Have a great week, and may the Force be with you!

Week in Review, April 29, 2014

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

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

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

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

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

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

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

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

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 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.