French Sunshine Act

Compliance Week in Review, June 18, 2014

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

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

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

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

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

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

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

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

Have a great week everyone!

Week in Review, 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 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 15, 2014

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Wisconsin seeks to harmonize health records, a Vermont legislator wants an exemption for the medical device industry, and the pharmaceutical industry questions how much Sunshine has had an impact on relationships with physicians (so far).

The birds are signing, the grass is a vibrant green, the flowers are blooming…it must be time for the Super Bowl…of golf that is. The Masters, “a tradition unlike any other,” and the big daddy of all professional golf tournaments, was held in beautiful Augusta amid the standard back 9 meltdowns and whispers up and down the greens. With his usual breathtakingly long drives and birdies on 8 and 9, Bubba Watson fought off the young phenom, Jordan Spieth, to win his second green jacket. But enough about divots and drivers, tee time for this week’s News in Review is here.

In the words of the great Ty Webb, “be the ball.” It’s all about harmonization, right? Well, the governor of Wisconsin certainly thinks so. Governor Scott Walker signed a bill into law that will harmonize the state’s law regarding behavioral health records with the HIPAA Privacy Rule.

A Vermont physician and legislator, George Till, would like to take a mulligan (of sorts) on the state’s physician gift ban law. He has introduced a bill in to the state’s legislature for an exemption to allow medical device companies to provide food and drink to doctors at seminars and other events sponsored by medical device companies. According to Till, physicians really need to have a “hands on” experience to familiarize themselves with a medical device. Till is a supporter of the state’s gift ban, and he doesn’t believe that his bill is in opposition to the principle of the law.

Are conflicts of interest the sand trap of the CME world? At a meeting of the American College of Cardiology, ACCME president, Murray Kopelow, spoke about the ACCME’s conflict of interest requirements. Kopelow said the ACCME is “very precise” about determining when a conflict of interest exists. The organization evaluates whether the individual: a) has a financial relationship with a defined commercial interest and b) has the ability to control the content of CME relevant to that relationship. The content of accredited CME must be valid and free of commercial interest as defined by the ACCME. Kopelow is concerned about criticisms that ACCME’s standards are hindering innovation. He says this was not the intention and special guidance has been created for those working in discovery.

Takeda and Lilly were recently assessed one heck of a penalty stroke. The two companies were ordered to pay $9 billion by a federal jury for failure to disclose the cancer risks associated with use of the drug Actos.

The FDA is not quite sure what approach to take to the proposed safety prediction and mining tool intended to help assess drug adverse event safety signals. The project was initially announced in April of 2013, but by September it was put on hold due to funding concerns. On March 31 of this year, the FDA again announced it was again looking for an outside partner for the project, but just three days later they changed their minds. The agency provided no reasoning for the latest cancellation, only saying that it would “re-advertise the contract solicitation at a later date.”

What would a Week in Review be without one story about the Sunshine Act? During PhRMA’s annual meeting, leaders from various companies said the Act was having no effect on how their companies interact with physicians. While doctors have not shut the door on the industry, Bob Hugin, PhRMA’s board chair, is concerned that once published, the Sunshine data could be mischaracterized by the public and cause the physicians to reconsider how they do business with the industry. Hugin says companies must take a proactive approach to ensure the data is presented in the correct context.

As we approach the 18th green for this issue of the Week in Review, we’ll finish with a brief word about the expanding curriculum of PharmaCertify™ compliance training solutions. If global transparency is on your radar, we are adding Understanding Global Physician Spend to our lineup of customizable off-the-shelf eLearning modules. The module covers the EFPIA Code of Transfers of Value, as well as specific country laws, like the French Sunshine Act. Contact Sean Murphy at smurphy@nxlevelsolutions.com for more information and to see a content outline.

Have a great week everyone!

News Week in Review, April 8, 2014

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

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

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

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

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

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

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

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

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

Have a great week everyone.

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News Week in Review, April 1, 2014

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

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

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

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

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

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

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

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

Have a great week everyone!

News Week in Review, March 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!