Ethics

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.

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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!

Week in Review, March 17, 2014

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

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

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

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

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

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

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

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

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

Have a great week everyone!

News Week in Review, March 10, 2014

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Pharmaceutical companies cut spending on physician speakers,  the DOJ turns up the HEAT, China ups the stakes on the bribery front, and the value of a reprint under Sunshine is still unclear.

Hey, wake up! The transition to Daylight Saving Time is such a drag…on our energy that is. Soon enough, we’ll all be excited about the extra daylight hours, but right now, we’d settle for some extra caffeine. To help you find your set point and adjust your internal clock, we offer our regularly scheduled overview of all things compliance…with this week’s News in Review.

The amount pharmaceutical companies spend on physician speakers is not exactly spring forward, according to an analysis of Pro Publica data. In fact, several large companies have dramatically cut spending on physician speakers, which some attribute to the transparency requirements of Sunshine. The companies offer a different rationale though. A spokesperson for Lilly says educational programs are of most value when a product is launched, or new clinical data is released. Additionally, as web conferencing increases, the need for speakers declines. A spokesperson for Pfizer points out that as blockbuster drugs go off patent and face generic competition, the need for educational programs and speakers for those drugs wanes.

Spending on drug marketing is on the rise in Washington D.C., according to a report by the George Washington University School of Public Health and Health Services. In 2012, companies spent $97.5 million on drug marketing, which represented the first year-on-year increase since 2007.

As spring draws near, and the temperatures rise, the DOJ continues to provide some HEAT of its own with the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative. Using the False Claims Act as its primary tool, the agency has recovered $13.4 billion from individual providers, pharmaceutical companies, and medical device companies.

Takeda would like to turn back time after the company admitted using “inappropriate expressions” in an advertisement for its hypertension drug, Blopress, in Japan. A Japanese physician noticed that data presented in the advertisement was not consistent with the results of a head-to-head study with a competitor’s product. The company admitted that using a graph from a 2006 study in the advertisement could have caused confusion.

Speaking of losing sleep, life science executives may be lying in bed at night thinking about the increasing challenges of doing business in China. Officials in China announced that companies found to have committed bribery will be blacklisted and updated the country’s “Rules on the Establishment of Commercial Bribery Blacklists for Purchase and Distribution in the Health Care Industry.” Circular No. 50, which delineates the updates to the rules, states that a company may be blacklisted for several reasons, including minor instances of bribery that are not prosecuted by authorities. If blacklisted, hospitals and other facilities will be prohibited from purchasing goods in the province where the bribery occurred for two years. Companies blacklisted two or more times in five years will be prohibited from selling its products in the country all together.

A new study shows drug makers are not quite ready to crawl out from under the covers when it comes to using social media for clinical studies. The study conducted by the Tufts Center for the Study of Drug Development (CSDD) found that companies using social media in the clinical research process are doing so in a “siloed and experimental fashion.”  Lack of guidance from the FDA and concerns about the impact of social media on study integrity are cited as factors slowing the adoption of social media for clinical trials.

What’s a Daylight Saving Time theme without at least one reference to Sunshine. With little in the way of guidance from CMS, companies are taking various approaches to determining the value of journal reprints under the Sunshine Act. Some companies follow what CMS has stated, and value a reprint at the cost the company paid to acquire it from a publisher. Other companies use a blended average model and some hire a third party to determine the value of their reprints. Complicating the matter further, doctors are starting to refuse reprints because they see them as taxable form of income.

As the sun sets much later in the day, and on this week’s News in Review, we close with a reminder that the PharmaCertify™ online learning module, The Sunshine Act: The Federal Physician Spend Disclosure Law, covers the topics your learners need to understand, like disclosure requirements and excluded payments, to stay abreast of this industry-changing legislation.

Have a bright and sunny week everyone!

News Week in Review, March 4, 2014

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

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

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

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

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

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

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

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

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

Thanks for reading and have a great week!

Week in Review, February 17, 2014

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

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

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

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

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

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

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

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

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

Have a great week everyone!