Ethics

The 2015 Pharmaceutical Compliance Congress: A Review and Recap

NXLevel Compliance Team , , , , , , , , , , , , , , , , ,

The 12th Annual Pharmaceutical Compliance Congress provided an overflow crowd of rapt attendees with two days of best practices and updates on critical compliance-related topics. While the usual array of content was covered, the focus often turned to two key topics – Speaker Programs and the FCPA.

Day 1

The conference kicked off with a keynote speech from Michael Shaw, Vice President and Chief Compliance Officer for GlaxoSmithKline. Shaw’s presentation was focused on the idea that instilling a culture of compliance is not enough in today’s regulatory environment. He emphasized the importance of ‘explaining the why’ behind the values, and the need to hold individuals accountable for compliance. As an example, at GSK, while Compliance is responsible for facilitating the process, Brand Directors are held accountable for managing the risk. As Shaw says, “compliance programs are important, but they’re not enough. The elements of the programs need to have traction.”

Otsuka ‘s Regina Gore Cavaliere and Brian Miller showcased their use of humor as a core tool for compliance training. Cavaliere and Miller have integrated a variety of creative elements, including a mock mini-series called The Pharm, comic books, and live talk shows, into their curriculum to keep the training fresh and appealing. Much of what was presented was indeed witty and engaging, and it showed that comedy can clearly be an effective tool when developed professionally and integrated carefully into a blended campaign.

In the Chief Compliance Officer Panel titled, Working with the Business – Ensure Compliance Adds Value to Operational Success, Jeffrey Rosenbaum from Vertex, Sujata Dayal from J&J, and Sumita Ray from Pharmacyclics, offered their perspectives on the keys to an effective program. With limited resources and time, Rosenbaum starts with his company’s business objectives while managing the issues with the highest risks. Ray agreed, saying she evaluates what risks she has to address on a daily basis, making training her first priority. As part of a large global company, Dayal begins with a formal risk assessment and conducts testing on a regular basis to ensure that mitigation is working. Rosenbaum also emphasized the importance of recruiting allies in the company when resources are stretched, as with Sunshine Act reporting, while Ray echoed Michael Shaw’s points about the importance of holding businesses accountable for their actions and results.

The presentations shifted to a governmental and regulator’s perspective with Doug Brown from CMS updating the audience on the state of Open Payments, a panel of US Attorneys addressing trends and top priorities in healthcare enforcement, and Andrew Ceresney, Director of Enforcement at the SEC covering disclosure issues relevant to the pharmaceutical industry.

What stood out during the enforcement panel was the increased amount of cases the regulators are seeing involving small to mid-size companies. Greg Shapiro, from the District of Massachusetts added that the audience should expect to see more criminal liability with those cases. Jacob Elberg, from the District of New Jersey encouraged those who identify a problem to self-report since “it sends the right message to employees and regulators.” More than one panel member delved into the risks of Speaker Programs, with Shapiro calling them “areas prone for abuse” and William Killian from Tennessee reminding the audience that Speaker Programs must not be tied to any promotion of business.

Ceresney covered the FCPA and the risks particular to the pharmaceutical industry. According to Ceresney, the SEC is focusing on three enforcement areas: pay to prescribe, pay to get on formularies, and charitable contributions. He emphasized the need for risk assessments and training, and the need to take measures when issues are identified.

After lunch, the sessions were divided into smaller groups, and I opted to stay with the FCPA theme in the session titled, Strengthen your FCPA Compliance through Smarter Training. David Nicoli, former VP, Corporate Affairs, AstraZeneca, and a panel of vendors walked through the steps they consider to be crucial when training on the FCPA. Collaboration is key, Nicoli claimed, and during his tenure at AZ he partnered on training initiatives with key allies, such as the Heads of Human Resources and Social Responsibility, who truly understand the work environment. The panel stressed the need for short, quick hits in FCPA training, and the fact that bad decisions make for good stories that stick in learners’ minds.

After the FCPA session, I jumped into the track dedicated to Product Promotional Compliance. Paul Silver from Huron presented statistics from a recent industry survey on company interactions with HCPs. For example, 86% of companies reimburse for HCP travel time and 1/3 of the companies surveyed have a limit on hotel expenses. Overall, the statistics presented a strong baseline for how the industry handles HCP travel time and I highly recommend the data for those interested in knowing what their peers are doing.

The session on overseeing the relationships between Sales, MSLs, and Managed Care Reps, was highlighted by one powerful statement from Kevin Stark, Director of GHH Compliance, at Merck, which could be considered a compelling theme for the entire conference, “build a culture where it’s okay for people to admit when they made a mistake.”

Day 2

The second day opened with Tom Abrams of the FDA and his annual update on enforcement trends at the Office of Prescription Drug Marketing. In the area of policy and guidance development, OPDP has released six draft documents since January 2014, and three draft guidance documents on social media.

Abrams’ agency continues to allocate resources and priorities based on potential threats to public health. The most common violations over the past year were related to omission and minimization of risks, and unsubstantiated superiority claims.

Day 2’s enforcement panel, titled, A View from the Outside —Mitigate Risk and Prepare for the Future featured a panel of defense attorneys well-versed in the areas of risk for small and large pharmaceutical companies. Scott Lieberman of Loeb and Loeb stressed the need for sales representatives to know exactly how to handle off-label questions when dealing with HCPs. Matthew O’Connor, of Covington & Burling warned smaller companies to allocate enough resources to monitoring, an area often neglected. When asked about the relationship between Compliance and Legal, Allison Shuren from Arnold & Porter said Compliance should be the “boots on the ground, moving issues up the food chain,” and John Richter, from King & Spalding, noted that Compliance should be ‘setting the policy and evaluating the balance between costs and risks.’

I was particularly interested in the Life After a CIA — Impact on Internal Team Structures and Resource Allocation panel, so I attended the breakout session: Compliance Program Structure and Effectiveness.

Sujata Dayal, from J&J, stressed the need to continue the conversation between the businesses and Compliance but that dialogue needs to change as the role of the business shifts from one in which the businesses mandates company priorities to one in which they influence actions and decisions. Gregory Beeman, from Eli Lilly, said the first step was to see what can be streamlined and continued post-CIA. In other words, what was under OIG oversight that could be eliminated now that the CIA has expired?

In Successful Promotional Programs — How to Use Data Analysis & Market Research to Drive Compliant, Effective Results, Mark Dizon from Actelion, and David Gilman from Huron led a spirited discussion on the use of data and analytics to assess risks and results of Speaker Programs. The idea of whether Speaker Programs should be evaluated against Return on Investment was of particular interest as audience members and the panel members debated the merits and risks associated with acknowledgement of the ROI.

The final session I attended was focused on the challenges faced by small to mid-size businesses as they struggle to allocate compliance resources. The panel, consisting of Timothy Ayers of Porzio, Bromberg & Newman, Katrina Church of Merz North America, Jeff Rosenbaum from Vertex, Sarah Whipple from Aegerion, and Greg Moss from Kadmon, offered a diverse set of best practices based on their experiences with limited resources and time. The perspective offered by those who are literally ‘departments of one,’ and those, like Church from Merz, whose departments are growing rapidly, had enough content, suggestions, and tips to fill a conference unto itself. As one example, the panel and audience debated the benefits and challenges of live training versus eLearning. While live training offers the opportunity to work face-to-face with each trainee, which is easily achieved in very small companies, Church was quick to point out that as Merz grew, a shift to more eLearning, with its streamlined tracking, became a necessity. And, like their colleagues from larger companies, these participants emphasized the need to include the Board of Directors and the C-Suite in the importance of compliance training; and in getting buy-in at all levels of the company.

To sum up, the details brought forth over two days by many well thought out presentations and panel sessions in this year’s Pharmaceutical Compliance Congress offered veteran attendees and new comers alike a wealth of practical and impactful information, making attendance not only a good idea, but crucially important to staying abreast of new developments and best practices in life sciences compliance.

Compliance Week in Review, March 15, 2015

NXLevel Compliance Team , , , , , , , , , , , , , , , ,

A French court overturns the fee for service exclusion from Loi Bertrand, a dental company settles with the Vermont AG’s office over failure to report charges, an internal investigation at Teva reveals potential FCPA violations, and a representative from the SEC discusses the FCPA with a group of life sciences compliance professionals.

Well, we’ve survived another shift to Daylight Saving Time and we’ve had a few days to adjust and reset our internal clocks…yeah right. There isn’t enough caffeine in the world, is there? That spring forward thing certainly leaves us here at the Week in Review offices feeling anything but springy! As it is, we’re in Daylight Saving Time now, like it or not (unless of course you live in AZ, or a handful of U.S. Territories that have the good sense not to jump on this bandwagon), and while the clock may shift, the news waits for no one. So sit back, relax, but not too much, as we spring into this week’s News Week in Review.

The times they are a changing, and so is the French Sunshine Act. The top French administrative court reversed the decision by the Ministry of Social and Health Affairs to exclude the amount paid to healthcare professionals and organizations for fee for service contracts from manufacturer reports. Currently, manufacturers only need to report the existence of the contract. The court said that Ministry overstepped its bounds with the decision. The Ministry is evaluating the implications of court’s decision, and will issue new regulations at some point in the future.

Better make time to send in those disclosure reports to Vermont! A dental company settled a case with the Vermont Attorney General’s office for $45,000 over its alleged failure to submit disclosure reports. This is the second settlement in a month involving the disclosure law.

Through a securities filing, TEVA revealed it had uncovered information that some of its actions may have violated the FCPA. The company’s investigation began after it received subpoenas from the DOJ and SEC. The investigation centered on business practices is in Russia, Eastern Europe and Latin America.

A representative from the Securities and Exchange Commission (SEC) shed some light on the subject of FCPA risks for life sciences companies at the recent Pharmaceutical Compliance Congress. Andrew Ceresney, Director of Enforcement athem nt the SEC, focused on three key areas of risks, pay-to-prescribe arrangements, (rewarding doctors for writing prescriptions), payment of bribes in exchange for being placed on a formulary, and the payments of bribes disguised as charitable donations.

Ceresney also pointed out the importance of establishing internal controls specific to the business, and updating the internal controls when the business changes or grows. He referred to dealings with the FDA as the “lifeblood” of the industry, and emphasized the importance of investors having accurate information when making critical decisions.

And that brings us to the end of this Daylight Saving Time edition of the Compliance Week in Review. Remember, if you’re compliance training curriculum is in need of a wakeup call, the PharmaCertify™ suite of solutions offers up-to-date compliance training and reference content where your team needs its most – in the field and at their fingertips.

Have a great week everyone, and don’t forget that extra cup of coffee.

Week in Review, March 6, 2015

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A potential new law in California calls for greater drug pricing transparency, consumer advocacy groups and industry trade groups in Europe argue over clinical trial data transparency, a Maine law allowing the purchase of pharmaceuticals from foreign pharmacies is overruled, and the issue of off-label speech and free speech is back in the news.

In like a lion and out like a lamb; it’s hard to believe March is here. The really good news…spring is almost here as well (although looking at the seven inches of fresh snow outside the Week in Review windows, we find that hard to believe). Whether you subscribe to the meteorological or astronomical start of spring, one way or another it is/will be here this month, and that alone is reason to celebrate! We are on the downward slope of winter, folks and we couldn’t be happier. Another thing that makes us happing is sharing the news of the week with all of you, so let’s spring in to action and get this week’s Week in Review underway!

Nothing says spring like some sunshine, and nothing says sunshine like transparency laws. A California assemblyman has proposed a law that would require the disclosure of information related to the pricing of drugs. The law would apply to drugs costing $10,000 or more for a course of treatment, and companies would have to report information such as production costs, sales and marketing costs, and financial assistance provided through prescription assistance programs. If the law is passed, companies would submit annual reports to the state, and the information would be made available to the public.

Speaking of transparency and disclosure, there seems to be a kerfuffle blooming in Europe over clinical trial data transparency. Proposed rules by the European Medicines Authority (EMA) have prompted comments from industry trade groups and others regarding the confidentiality of commercial information. Industry groups have said certain data related to clinical trials could reveal trade secrets and compromise patient privacy. Consumer advocacy groups insist the more transparency the better in the name of protecting patients. In a press release, a Germany-based advocacy group accused the EMA of writing such a broad definition of commercial confidential information that the determination of what is confidential is left up the study sponsor. Two bio industry trade groups released a statement saying there should be a “deferral” for the disclosing information from Phase I trials due to the “commercial sensitivity” of the information.

Medical device manufacturer, ev3, had to spring for some past promotional issues allegedly committed by one of its recent acquisitions. The company agreed to pay $1.25 million to settle allegations that it violated the False Claims Act. The government claimed Fox Hollow Technologies, which was acquired by ev3, caused hospitals to improperly bill Medicare and Medicaid for medically unnecessary inpatient stays for patients undergoing atherectomies using a Fox Hollow device. The government alleged the company suggested the inpatient procedures in order to drive sales of the device to hospitals, thereby causing hospitals to be reimbursed more than they were entitled.

There’s been a late freeze on the Maine law that allows individuals to purchase prescription drugs from select foreign pharmacies. A federal judge has ruled the Maine law is overruled by federal law, which prohibits importing drugs from foreign countries. The decision nullifies the Maine law. The state can appeal if it chooses.

The seeds are being planted for another free speech case involving off-label statements. A federal district court in California is considering a whistleblower False Claims Act case against Millennium Pharmaceuticals in which the whistleblower claims that Millennium and Schering-Plough (now Merck) promoted a heart drug for off-label uses. In a motion to dismiss, Merck argued that the False Claims Act cannot be interpreted to prohibit the truthful, non-misleading exchange of scientific information. In making the argument, Merck sited both the Sorrell v. IMS Health and U.S. v. Caronia cases. The DOJ filed a brief with the court saying that truthful speech could be used as a basis for the False Claims Act. PhRMA filed a friend of the court brief in support of Merck’s argument.

With that, we end this “almost spring, we hope” edition of the Week in Review. Have a great week everyone!

 

News Week in Review, February 18, 2015

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Several companies announce settlements of charges related to the False Claims Act, CMS releases new information to help with system registration and data submissions, and the National Coalition on Healthcare holds a lively panel session on the Sunshine Act.

Laissez les bons temps rouler, y’all! The end of the Carnival season is here and yesterday was the big send off…Fat Tuesday! Or as you may know it, Mardi Gras. Yes, a time of frolic, frivolity, and according to Turbo Tax, a number of incidents that can affect the filing of your taxes for the next year. Whether you partied until the wee hours in NOLA, or just enjoyed the simple fun of a pancake dinner at home, we hope it was a great celebration. Now it’s time for our regular look back at some of the “celebrated” compliance news of the week, with this edition of the Compliance News in Review.

We start today’s parade with settlement news for several industry companies. Medtronic agreed to pay $2.9 million to settle allegations it violated the False Claims Act. The government alleges the company caused claims to be submitted to Medicare and Medicaid for an investigational procedure. Next, AstraZeneca paid $7.9 million to settle charges it violated the False Claims Act. The company is alleged to have paid kickbacks to PBM Medco in exchange for Nexium’s “solely and exclusively” being maintained on Medco’s formulary. The government claims the kickbacks were provided as prices concessions on other AstraZeneca drugs. Finally, a physician has pled guilty to accepting kickbacks from two pharmaceutical companies in exchange for prescribing the drug, Clozapine. The physician received nearly $600,000 in kickbacks and benefits from IVAX and later, Teva. He also agreed to pay over $3 million to settle a parallel civil case.

The Centers for Medicare & Medicaid Services has been busy tossing beads and doubloons to the industry in the form of advice and consultation. Another Open Payments Q&A session was held just this past week, and in advance of the Q&A session, CMS released several new resources covering system registration and data submissions. The agency has also posted the audio from the January Q&A session.

Speaking of the Q&A session, the February session covered a couple of important topics for industry stakeholders. First, it was announced that a fix would occur over the Valentine’s Day/Presidents Day weekend that should resolve most of the problems that companies are having with submission of the 2013 data. On the downside, attendees were notified that the release of the Validated Physician List has been delayed. CMS is hoping to have the list ready by February 20. Those on the call were reminded that this list is only comprised of physicians for whom a 2013 record was submitted. CMS is scheduling a full day to take stakeholder questions. As soon as a date is nailed down, it will be announced on the Open Payments website and via a listserv email.

It wasn’t exactly cause for great celebration, but a recent briefing held by the National Coalition on Healthcare led to the call for expanded requirements under the Sunshine Act. The panel was comprised of individuals from the government, physician groups and the Pew Charitable Trust. A representative from Senator Grassley’s office explained that ultimate goal of the Sunshine Act was to spur an open discussion between patients and their doctors. The founder of PharmedOut, an organization that advocates against pharmaceutical marketing influence in medicine, took the harshest stance, saying the law wasn’t strict enough. She accused companies of seeking out the family and friends of physicians as an avenue for delivering marketing messages, and expressed grave concern about the industry engaging in disease state awareness. Drug samples were a hot topic. A representative from the AMA says there is a gap in transparency where the provision of samples is concerned and he believes providing samples is “misdirected and unsafe.” The founder of PharmedOut agreed, stating that patients should refuse samples and ask for older drugs that have stood the test of time.

That’s about it for the edition of our weekly look back on all the news fit to blog. As we get closer to spring (albeit, slowly for those of us in the Northeast), and the annual POAs are in the rear view mirror, this is as good as time as any to clean up your commercial compliance training. With transparency extending beyond the U.S., shouldn’t your training do the same? The newest addition to our PharmaCertify™ suite of off-the-shelf eLearning modules, Global Transparency: Reporting HCP and HCO Transfers of Value covers the key provisions of the EFPIA Disclosure Code, French Sunshine Act (Loi Bertrand) and the Medicines Australia Code of Conduct. Contact Sean Murphy at smurphy@nxlevelsolutions.com to learn more and see a content outline.

Have a great week everyone!

2014 Year in Review

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , , , , , , ,

2015 is upon us! It seems like only yesterday we were posting our 2014 Compliance Year in Review. Time sure does fly! We here at the Compliance News in Review wish you and yours the best for a happy and healthy 2015. But don’t toss out that warm glass of sparkling cider or noisemaker yet. It’s time to take a look back at a year’s worth of news, with the Compliance News Year in Review – 2014 Edition.

Our countdown begins with what had to be the big story of 2014 – the never ending saga of Open Payments and the Sunshine Act. The year began with a two-phase registration and data submission process for Applicable Manufacturers and GPOs. Phase 1 opened in February and Phase 2 was supposed to start in May. As it turned out, Phase 2 was delayed until June and was deployed in two phases itself, and not without some technical difficulty. So much so that PhRMA petitioned CMS to extend Phase 2 by as much as 30 days.

The registration of physicians and the opening of the review and dispute period represented the next big milestones. That’s when the fireworks really started. Physicians had problems registering, and when they could finally view the data, there were significant problems – confusing “error” messages, missing payments, payments attributed incorrectly. CMS took the system down to correct the problems, and extended the review and dispute period to accommodate for the time the system was down. When Open Payments opened back up for physicians, almost one-third of manufacturer records were “missing.” Eventually, CMS said the records were withheld due to data matching problems. A number of issues were identified that caused the data to disappear. The primary offenders appeared to be state license numbers and NPI numbers submitted by manufacturers and GPOs that did not exactly match what CMS had in its database for those identifiers. Despite all the delays and problems, CMS said the September 30th date for making payment records public would stand, minus the withheld records. Those records would be published by June 30 of the next year.

September 30th came, data was published, and all was right with the world, right? Onward to 2015! Not so fast there dear readers. As we all spent time regretting those unfortunate photos taken at the office Christmas party, CMS elves were busy at work. The agency released 68,000 records that were previously withheld, notified users that Open Payments would be unavailable for most of January to allow time for system maintenance, and announced it will be hosting an Open Payments Q&A in early 2015.

Yes, it was a full year of Open Payments fun, but the news surrounding the data was not all CMS had up its transparency sleeve. The agency notified stakeholders that changes were on the way for Sunshine’s Final Rule. The one change that sparked the most debate was the removal of the exemption for payments to physicians speaking at accredited CME events. Medical societies, physician groups and CME providers were staunchly opposed to the change, but it was still made official in October. The change will take effect in 2016 but it may not be the end of the road for the exemption. A bipartisan bill was proposed to exempt indirect CME payments, as well as the value of medical textbooks and reprints.

Other news of note on the transparency front for 2014 included the passage of a law in Connecticut that requires the reporting of industry payments to nurse practitioners; Minnesota making good on the Board of Pharmacy’s notification that payments to nurse practitioners and others would be required in 2015 reports; and the changes in transparency requirements to the Medicines Australia Code of Conduct.

The cork popped on GSK’s bribery woes in 2014. The company was one of several pharmaceutical companies under investigation by the Chinese government for allegations of bribery. The company announced it was investigating potential bribery in Iraq, Jordan, Lebanon, Poland, and Syria. GSK enhanced its compliance efforts in China and fired several employees over failure to adhere to expenses rules. In the fall, it was able to close the book on the Chinese investigation with a fine of close to $500 million dollars. The head of China operations and four other executives were sentenced in the matter, but all had their jail sentences suspended and avoided actual jail time. The head of China operations, a British national, was deported. The company could still face legal action from the U.S. Department of Justice and the U.K.’s Serious Fraud Office for violating bribery laws.

The FDA resolved it would make the July 2014 deadline for social media guidance, and it actually did! Three draft guidance documents related to social media were published. One document is related to the submission of advertising content, and the other two dealt with actual postings on social media platforms. The guidance on correcting misinformation on social media platforms applies to correcting independent user-generated content, and not content generated by a company, its employees or agents.

The more anticipated document, and the one that drew the most criticism, deals with the posting of information on character-limited platforms, such as Twitter. Some companies feel the FDA has basically restricted them from using character-limited platforms to promote their products due to strict requirements around presenting risk and benefit. The Washington Legal Foundation and the Medical Information Working Group said the guidance infringes upon manufacturers First Amendment rights.

And there you have it, our choices for top stories of 2014. What will be the “big news” of 2015? If we were betting people, we’d put money on Open Payments and Sunshine being the stories that generate the most headlines. With a full year’s worth of spend data hitting the system for the first time, expect more hiccups. Also, a full year’s worth of data is likely to reveal even more issues and have the pundits buzzing. Transparency overseas will likely make news in 2015, as EFPIA member associations and Medicines Australia members begin collecting data for disclosure in 2016.

There was a noticeable lack of big dollar enforcement cases in healthcare fraud and FCPA cases last year. While the DOJ could boast upwards to $2 billion in healthcare fraud recoveries for the 2014 fiscal year, there were no billion or multibillion dollar settlements with life sciences companies. The crystal ball is a little cloudy on that front. Was 2014 the calm before the next storm, or has the season of the multimillion to billion dollar settlements with pharma and med device companies come to an end?

FCPA enforcement actions were in a bit of a lull through at least the first half of 2014 compared to years past. The DOJ ended the year on a big note though, with its Alstom settlement. As far as we’re concerned, it’s been a little too quiet lately where FCPA enforcement is concerned, so we wouldn’t be surprised to see more activity in 2015. Don’t be surprised if we see actions against the handful of pharma companies that were accused of passing bribes in China in 2013.

Whatever 2015 brings, we’ll be writing about it through our weekly Compliance News in Review. Have a great year everyone and as always, thanks for reading!

Week in Review, December 16, 2014

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , ,

Otismed pleads guilty to selling knee replacement cutting guides that had been rejected by the FDA, Senators Hatch and Bennett introduce bill to exempt low risk software from the definition of a medical device, and the oversight group for the APBI Code of Conduct chastises Galderma over the requirements for attending a presentation.

They litter the landscape of the Christmas season, and have become so iconic that an entire day is dedicated to celebrating the infamous ugly Christmas sweater. It’s as much a fixture of the season as Santa hats and reindeer antler headbands. In fact, a number of on-line retail outlets have jumped on the bandwagon for this haute mess couture. Before we get dive into a debate over the categorization of light-up sweaters as “ugly” or just a “whole separate item,” we’ll dive into something a little less controversial, this week’s Compliance News in Review.

This isn’t a warm and cozy situation for Otismed and its former CEO. The company pleaded guilty to criminal and civil charges that it sold knee replacement surgery cutting guides despite it being rejected by the FDA. According to prosecutors, the former executive directed that over 200 of units be shipped despite the product not receiving FDA clearance and the company’s board voting to cease shipments of the product. Otismed was purchased by Stryker, which was unaware of the incident at the time of purchase. The company will pay $80 million to resolve the charges and the former CEO will be sentenced in March of 2015.

There are no ugly feelings from med tech innovators about a bill recently introduced in the U.S. Senate. Senators Orin Hatch and Michael Bennett have introduced a bill that will exempt low-risk medical software and apps from the definition of a medical device under the FDCA. The senators say the bill will provide clarity over which devices should be regulated. The bill, called the MEDTECH Act, removes five categories of innovation from the definition of a covered device.

Could the Prescriptions Medicines Code of Practice Authority (PMCPA) be unraveling its ties with Galderma? PMCPA, the oversight group for the Association of the British Pharmaceutical Industry’s Code of Practice, and Galderma are at an impasse over a public reprimand issued against the company by the organization. The reprimand stems from a complaint lodged by a nurse attending an educational meeting sponsored by Galderma. The complaint alleges that attendees had to prove they had purchased the company’s filler in order to attend the presentation. In addition, the PMCPA says attendees received financial incentive to attend in the form of free product. Galderma says it was not uncommon to require attendees to purchase product in order to attend, and the filler is a medical devices so any related activities do not fall under the Code. Galderma appealed the decision, and the PMCPA has removed the company from its list of companies agreeing to abide by the Code.

With that, we put a wrap on this week’s edition of the News in Review. Good luck with those ugly sweater contests this weekend everyone, and remember, light-up reindeer noses always seem to catch the judge’s eyes.

Have a great week!

Week in Review, December 10, 2014

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The Serious Fraud Office gains its first conviction under the U.K. Bribery Act, Sanofi is charged with kickback violations, and CMS unveils new tools and user guides in the Open Payments system.

Well, we’re smack dab in the middle of it now. There’s no escaping the mire, so just give in and go with the flow. The Christmas shopping season is in full swing. Daily Doorbuster specials, circling the mall parking lot repeatedly looking for a space to park…yes, the joys of the season are upon us. As you lick your wounds from another weekend of retail madness and mayhem, we offer a brief respite, with this week’s Compliance News in Review.

Gift giving is certainly a joy of this season, but you don’t want it to land you on the naughty list during an FCPA investigation. This list of ten tips to consider when giving business gifts can help keep a company on the nice list. Tips include making sure the gift is permitted under the local law where the recipients is based and recording gifts routinely in company books and records.

The Serious Fraud Office (SFO) has tied a bow around its first conviction under the U.K. Bribery Act. Two individuals were found guilty in a case that involved the sale of biofuel investment interests to U.K. investors. The defendants were found to have created fake invoices that allowed them to collect large commissions from the investors. Legal experts say the case makes it clear that the SFO will pursue individuals for private sector bribery.

Sanofi, its former CEO, and several other executives have been accused of overfilling the stockings of doctors, pharmacists and hospitals. A whistleblower suit, filed by a former Sanofi paralegal, claims she was fired when she raised concerns over several contracts that paid consultants to pass along kickbacks to doctors, pharmacies and hospitals. The kickbacks were allegedly offered in return for prescribing or purchasing the company’s diabetes drug. Former CEO, Chris Viehbacher said the accusations are “entirely baseless and are categorically false.” The company says it will vigorously defend the suit.

AstraZeneca and Ranbaxy won’t need to return the present they received in a pay-for-delay case. A jury decided that a deal between the two companies, which delayed a generic version of Nexium, was large and unjustified, but was not anticompetitive. A Ranbaxy spokesperson stated “the jury understood the facts of the case and was not swayed by wishful thinking on the part of the plaintiffs.”

CMS donned the Santa cap as it handed out several “gifts” last week for Open Payments users. The agency released an improved physician and manufacturer search tool, updated physician lists and revised user guides. CMS also announced it would soon provide reference information for the 2014 program year, including an overview of the timeline and updates on system enhancements.

If new commercial compliance training is on your holiday wish list, PharmaCertify™ from NXLevel Solutions, offers updated training on critical topics like global transparency, the Anti-kickback Statute, on-label promotion, and the False Claims Act. To see a demo of our eLearning modules and mobile apps, contact Sean Murphy at smurphy@nxlevelsolutions.com

That’s all for this week folks. Stay safe out there, and we’ll see you back here next week!

Week in Review, November 26, 2014

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Time to head over the river and through the woods to grandmother’s, or somebody’s house, for turkey, gravy, stuffing and pumpkin pie! Thanksgiving is almost here! The Week in Review staff is excitedly looking forward to a day of family, football (Go Eagles!) and tryptophan. Before we start the food prep and festivities though, we need to take care of a little business first; this week’s Compliance News in Review.

Doctors in Michigan aren’t just talking turkey when it comes to the context that surrounds public disclosure of physician payments under Sunshine. A Michigan news outlet gave the physicians that received the most in payments a chance to provide that context. The five doctors received payments in the hundreds of thousands of dollars. For most, the payments represented royalties for devices they had invented. One physician received in excess of $500K for clinical research. The money did not go to the doctor, but to the clinic for which he works, and he is strictly a research physician. Another received almost $350K in payments for consulting and speaking. This physician is a plastic surgeon who runs a training center to teach other physicians. He says consulting pays 1/10th of what he would receive if he were working in his practice, and therefore is not financially beneficial. All of the doctors profiled said they believed physicians should be upfront with patients about their financial relationships with life sciences companies.

A jury in West Virginia found Takeda destroyed documents related to the drug Actos and ordered the company to pay $155,000. The case was brought by an individual who claimed the destruction of the files prevented him from proving his case that the company failed to provide adequate warnings about the cancer risks associated with the drug. A Takeda spokesperson said the company is considering an appeal.

Recoveries from False Claims Act cases are stuffing the federal treasury. The Department of Justice announced that nearly $6 billion was recovered through the False Claims Act in fiscal year 2014. Housing and mortgage fraud represented the largest amount of recoveries at $3.1 billion. Healthcare fraud recoveries were not too far behind at $2.3 billion. Whistleblower cases resulted in nearly $3 billion in recoveries and the government paid out $435 million in whistleblower awards.

The OIG has released a report of the top challenges and issues facing HHS during fiscal year 2014. The report lists several issues related to Medicare, Medicaid and the federal healthcare exchanges. Number ten on the list, ensuring the safety of food, drugs, and medical devices, should be of particular note for the industry. This challenge primarily addresses problems associated with drug compounding and importation of drugs from foreign countries, but the OIG also cites drug marketing; specifically off-label marketing. According to the report, illegal off-label marketing undermines the system intended to ensure that drugs are safe and effective, and may lead to fraudulent claims for reimbursement being submitted to Medicare and Medicaid.

With that final serving of off-label news, we’ve come to the end of this holiday edition of the Compliance News in Review. Have a wonderful Thanksgiving everyone, and remember, it’s all about that baste.

Week in Review, November 5, 2014

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The OECD questions Japan’s bribery law, OIG releases its 2015 Work Plan, CMS hopes to clarify the issues with data mingling, and Biomet settles False Claims Act charges against one of its subsidiaries.

Well, it certainly was a spooktacular weekend full of ghosts, goblins, and sugary goodies. November is upon us and Thanksgiving is just around the corner. But before we start the annual debates over canned or real cranberry sauce, or apple pie vs. coconut custard (a particular favorite at the Week in Review home offices), we have one more treat; this week’s News in Review.

The Organization for Economic Cooperation and Development (OECD) is taking issue with Japan’s ghost-like anti-bribery enforcement efforts. Japan does have a law prohibiting bribery of foreign officials, but it has done little in the way of enforcing that law. Under pressure from the OECD, the Japanese government developed a plan to increase enforcement, but the organization claims the law doesn’t address key issues, such as facilitation payment. The government plans to make more changes, but businesses are not waiting. According to Transparency International, a number of businesses are seeking guidance on how to develop effective anticorruption programs.

If you’re looking for a little something to help you take advantage of that extra hour of sleep we picked up over the weekend, the OIG has released its 2015 Work Plan. Sweet dreams.

CMS provided a few treats for applicable manufacturers and GPOs caught up in the data mingling issue that occurred during the inaugural submission of physician payments records. The agency has returned the report records to those affected and has given manufacturers and GPOs until March 31, 2015 to re-submit corrected records. A webinar for organizations with a returned record report is scheduled for November 13th and CMS is also providing a Validated Physician List in the Open Payments portal.

It wouldn’t be Halloween without a few surprises and CMS was happy to oblige. The agency announced several changes to the Sunshine Act Final Rule. The changes include the removal of the CME exemption; the deletion of the “covered device” definition; a requirement to report the marketed name and therapeutic area of a covered drug, device or biologic; and a requirement that stocks, stock options and any other ownership interest be reported as separate categories. The changes are effective immediately, but due to comments from industry CMS and the time needed to make changes to manufacturer systems, the changes will be implemented in the 2016 collection year.

On the settlement front, Biomet agreed to pay $6 million to settle charges it violated the False Claims Act. According to prosecutors, EBI, Inc., a Biomet subsidiary, provided kickbacks to encourage physician office staffers to use its bone growth stimulating product. The lawsuit was filed under the False Claims Act by a former product manager.

We close this week’s Review with a reminder that as you look to expand, supplement, or revamp your compliance curriculum, PharmaCertify™, from NXLevel Solutions, offers the off-the-shelf and custom training solutions you need to continually deliver critical compliance content where your staff needs it most – in the field and at their fingertips.

Have a great weekend everyone.

Week in Review, September 17, 2014

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A new study reveals surprising information about FDA panelists and their ties to manufacturers seeking regulatory approval, the DOJ files a False Claims suit against a neurosurgeon and a spinal implant company, the FTC accuses two companies of trying to stymie generic competition for Androgel, and a collection of advocacy groups ask CMS for an indirect payments exemption.

Ahoy there mateys! Stand fast, secure the rigging, and let us hear your best “arrr.” Yes, “Talk Like a Pirate Day” is on the horizon. As you prepare to weigh anchor and hoist the mizzen, we strongly recommend you avoid the parrot on the shoulder idea – that didn’t end well for one of the old salts here at the Week in Review offices last year. The big day isn’t until Friday, so we’ll fill the time with this week’s Compliance News in Review.

It’s not the amount of treasure involved, but rather the type of treasure, that may be more influential in the decisions made by FDA panel members when they decide which drugs to recommend for regulatory approval. A recent study found that panelists who have financial ties only to the drug manufacturer seeking approval are 1.5 times more likely to vote favorably for the company than members with no ties. However panelists who have ties to the company seeking approval and its competitors are no more likely to recommend for approval than those panelists who have no ties. Panelists with multiple relationship may not have a sense of loyalty to any one particular manufacturer. In addition, panelists who serve on advisory boards are more likely to approve a drug than panelists who have research or consulting relationships with the manufacturer.

A physician and spinal implant company have found themselves on the wrong end of a hornswaggle claim by the Department of Justice. The agency has filed a False Claims Act suit against a Michigan neurosurgeon, as well as spinal implant company, Reliance Medical Systems, and two of its distributorships. The company is accused of paying kickbacks through physician-owned distributorships (PODs). The government alleges that the company set up the PODs to induce physicians to use its spinal implants. The physician involved received payments through a POD in which he had an ownership stake. He is also accused of performing unnecessary procedures on patients who did not need spinal implants.

The Federal Trade Commission (FTC) is suing Abbvie and Besins Healthcare for running a rig and trying to prevent generic competition for the product Androgel. The agency claims the companies filed baseless patent infringement lawsuits in an effort to prevent potential generic competitors from entering the market. While the lawsuits were pending, Abbvie then entered into a pay-for-delay deal with Teva in order to postpone the launch of its generic version of the product. The FTC is asking the court to declare that Abbvie and Besins Healthcare violated the Federal Trade Act, and is seeking disgorgement of profits.

The mutiny against indirect payment disclosures under Sunshine continues to grow. A collection of 64 patient advocacy groups sent a letter to CMS requesting an exemption for indirect payments to the groups. The letter claims drug and device manufacturers have no discretion on how funds provided to patient advocacy groups are directed. It also suggests that the process of determining how a manufacturer’s funds are allocated places an unnecessary administrative burden on the groups.

As we heave to on this week’s journey into the world of compliance, we end with a question: arrr your sales representatives prepared with the up-to-date content on topics like the Sunshine Act, HIPAA, and Good Promotional Practices? The PharmaCertify™ suite of solutions offers your team compliance-focused information where and when they need it most – in the field and at their fingertips.

Have a great rest of the week everyone.