FCPA

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, 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, 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.

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News Week in Review, April 1, 2014

Signs of sunshine in Canada, the DOJ issues its first FCPA advisory opinion of 2014, and the Serious Fraud office faces growing challenges in the enforcement of the UK Bribery Act.

April showers bring May flowers…and we are certainly ready for some flowers! Really, any sign that spring is here to stay would be appreciated. We’re even looking forward to a little spring cleaning as long as the spring part comes along with the cleaning part. So with visions of daffodils dancing in our heads, and the chill of winter fading from our memories, we bring you the compliance news of the week, with the News in Review.

Those May flowers may even have a little Sunshine added to the mix in Canada. Two Canadian physicians think the Ontario Minister of Health should require pharma companies with drugs on public formulary to disclose their financial relationships with physicians. As justification, the physicians claim other transparency initiatives in the country have proven to be both beneficial and popular and studies have shown that even small tokens, such as pens and note pads, influence decision making.

The DOJ’s first FCPA advisory opinion of 2014 has sprouted. The FCPA opinion procedure allows entities to seek an opinion from the Attorney General on whether a specific situation is in line with the DOJ’s current enforcement of the anti-bribery provisions of the law. This particular opinion was in response to a financial services provider and investor bank asking if a payment due to an individual when the individual was a private citizen could be considered illegal if the individual now is a foreign official.

The Serious Fraud Office continues to face stormy weather following the disintegration of the high-profile bribery case against Victor Dahdahel. In addition to the negative publicity around the failed prosecution, the agency has faced significant cuts in funding; increasing pressure to secure convictions under the Bribery Act; and growing questions about how it expects to obtain evidence from jurisdictions outside the U.K.

The seeds of clinical trial transparency are taking root, according to the European Federation of Pharmaceutical Industries and Associations (EFPIA). EFPIA recently provided an update on the adoption of the joint EFPIA-PhRMA principle on clinical trial transparency. According to the announcement, several companies, including Pfizer, UCB and Sanofi, have all taken steps to make the results of their clinical trials publicly available. Pfizer has expanded its policies on data sharing and Sanofi will be participating in a multi-company web portal designed to share clinical trial data. UCB revealed its plans for adoption of the principles in a publicly accessible webinar.

The Ontario College of Physicians and Surgeons is looking to eliminate the need for Sunshine. Proposed guidelines from the influential regulator will put a stop to the practice of physicians accepting gifts or items of value from the industry and will prohibit doctors from having articles ghostwritten by pharmaceutical companies. The guidelines will allow doctors to accept lunches, patient education items, drug samples, and funds for educational programs. Physicians will also be permitted to serve as speakers or consultants. Critics say the proposed guidelines offer nothing in the way of true reform.

Not only does the end of March signal the start of spring, it brings us the deadline for submitting Phase I Sunshine reports. Now that you’ve cleared that hurdle and you have time to stop and smell the roses, have you considered sprucing up your Sunshine training? The Sunshine Act: The Federal Physician Spend Disclosure Law from the PharmaCertify™ suite of compliance training modules, offers the updated training your staff needs to understand the law’s disclosure requirements.

Have a great week everyone!

News Week in Review, March 24, 2014

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GSK plans to hire physician speakers as employees, the Arkansas Supreme Court reverses the Risperdal verdict, SciClone sets money aside for an FCPA settlement, and Canada strengthens its Food and Drug Act.

Are your brackets ruined? You’re not alone. They don’t call it March Madness for nothing! Take heart though, most NCAA fans are in the same boat, and that one billion dollars from Warren Buffet for a perfect bracket can still be yours…next year. As you work through the carnage of your tournament picks, we offer the solace of a week’s worth of compliance news, with this week’s News in Review.

Outside physician speakers have suddenly been delegated to the bench at GSK. The company announced it plans to hire physicians and scientists to conduct product-focused educational programs rather than pay external speakers. Bringing the speakers in house should lighten the company’s Sunshine Act reporting load, but some experts question whether the move is worth the risk of having the speakers’ credibility and qualifications questioned.

Upon video review, the ruling in the courtroom has been overturned. The Arkansas Supreme Court has reversed the $1.2 billion Risperdal verdict against J&J and Ortho-McNeil-Janssen. The companies were sued and ultimately fined for violations of the state’s Medicaid Fraud False Claims Act (MFFCA) and Deceptive Trade Practices Act (DTPA). In an appeal, the companies argued appeal that the court erred when it ruled on the MFFCA and DTPA claims. The justices agreed on the MFFCA since the law is written to apply to a healthcare facility and not a pharmaceutical company and a majority of them agreed that the DTPA fines were not warranted.

No cash, no foul? A recent ruling in a case involving GSK and Teva seems to suggest so. A U.S. District Court judge ruled that since a settlement between the two companies did not involve a cash payout, the arrangement did not violate antitrust laws. As part of the settlement, GSK agreed to allow Teva to sell a chewable form of one of its drugs prior to the patent expiring while agreeing not to sell its own authorized generic of the drug. The Federal Trade Commission had argued that those types of arrangements have their own value.

SciClone is keeping some key resources on the bench and ready to be utilized when needed. The company announced it is reserving $2 million for penalties related to an ongoing FCPA investigation. In its annual report, the company said a settlement was probable.

A full-court press to strengthen Canada’s Food and Drug Act is in effect. The Canadian Parliament will debate a bill that would give the country greater ability to regulate drugs even after they are approved. The bill will give the Health Minister the power to recall unsafe products and require changes to labels.

If you thought NCAA rules were confusing, try figuring out the international physician spend transparency requirements. At the recent Disclosure Summit, an expert discussed the EFPIA’s Code of Disclosure on Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organizations (hence forth know as the Code). The EFPIA Code must be integrated into its member organizations’ code by the end of the year. That’s 33 different organizations! Further complicating the situation for the manufacturer are conflicts between the Code and existing laws in countries like France and Portugal. EFPIA is expected to release more guidance on addressing these conflicts at the end of March.

As the final buzzer sounds on this week’s Review, we offer a reminder that the PharmaCertify™ suite of customizable off-the-shelf eLearning modules and mobile apps provide the touch point learning opportunities your reps need to stay up-to-date with the latest commercial compliance information and good promotional practices.

Have a great week everyone!

Week in Review, March 17, 2014

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

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

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

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

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

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

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

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

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

Have a great week everyone!