off-label

News Week in Review, December 10, 2013

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Studies reveal non-clinician HCPs have a favorable view of industry relationship, AstraZeneca partners with Harvard to improve drug testing, and the focus on the FCPA intensifies.

Well, the year is almost over, and if you’re like us, you’re probably wondering how December got here so fast and what happened to the rest of 2013. Before we put another year in the books though, we at least have the usual list of holiday movies and specials to enjoy. While you search the listings and set your DVRs to record, we’ll deliver a little entertainment of our own, with this week’s News in Review.

In terms of their relationships with the industry, non-physician clinicians generally feel It’s a Wonderful Life, albeit one with the potential for risks and conflicts of interest. An analysis of multiple studies related to the industry and non-physician HCPs like registered nurses, nurse prescribers, and Physician Assistants, shows the providers typically have a favorable view of industry interactions and say they rely on industry representatives for important information. The authors of the review suggest institutions expand policies on industry interactions and the Sunshine Act to include non-clinician HCPs.

AstraZeneca researchers will Deck the Halls with researchers at Harvard. The company announced they will collaborate with the institution on an initiative to improve drug testing in humans. The technology, called Organs on Chips, uses human cells in a flexible polymer to imitate human organs. The two organizations will work to develop an animal version of the technology that will then be used to compare drug testing results between humans and animals.

Santa Claus is Comin’ to Town, with early gifts, by way of Vermont and CMS. The Vermont AG’s office released a memo announcing the 2013 disclosure forms and databases will be ready sometime this week, and that the draft guidance for 2014 will be released soon. A conference call to discuss the guidance will be held December 19. CMS posted several documents to the Open Payments website, including XML and CSD schema for reports and sample report examples.

Some in the industry might say the Department of Justice and Securities and Exchange Commission are acting more and more like Scrooge when it comes to FCPA investigations. According to the head of the DOJ’s FCPA Unit, the DOJ is investigating 150 cases and expects to bring “very significant cases” in 2014. The SEC has received over 3,000 whistleblower tips involving FCPA investigations and with cooperation increasing globally, regulators expect the prosecution of individuals for FCPA violations to continue.

Was that The Grinch Who Stole Christmas lurking about the offices of Reckitt Benckiser? Perhaps it was one of the agents from the OIG and IRS who removed boxes of documents from the company’s offices in Virginia. A company spokesperson confirmed that a warrant was served by the US Attorney’s Office for Western Virginia, and that the company was cooperating with the investigation. The purpose for the warrant was not disclosed.

Employees at Advance Sterilization Products haven’t been feeling merry lately. The FDA announced a $1.25 million settlement with the company and two of its executives for the selling of adulterated and misbranded product. The FDA claims the company knew it did not have sufficient data to support the expiration date on its sterilization monitoring product.

That brings us to the end of the News in Review for this week. As you close out 2013 and finalize your compliance curriculum for next year, remember the PharmaCertify™ suite of eLearning modules and mobile apps offer your staff the up-to-date content they need where and when they need it most – in the field and at their fingertips.

Have a great week everyone!

New Week in Review, November 18, 2013

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The APBI amends its Code of Practice, a doctor in Scotland looks for Sunshine, PhRMA sues the state of Maine over drug importation, and a congressman from New Jersey seeks clarification on how food provided to CME program speakers and attendees is reported.

The big day is almost here…if you have a tween or teenager, you are probably well aware that the long-awaited opening of the film, The Hunger Games: Catching Fire, is this Friday! With a number of theaters premiering the film a day early, we’re left with precious few hours to practice our skills for the archery tournament and best braid contest. But before we prepare for our time in the Arena, we pause to present you with a week’s worth of compliance news, with the News in Review.

Our first “tribute” comes courtesy of the ABPI, whose members have agreed to amend the Code of Practice to include greater transparency on payments made to HCPs and healthcare organizations. APBI’s chief executive views the changes to the Code as an important first step in correcting the public’s misconception of the relationship between the industry and HCPs. According to a recent British Medical Journal article, he may be onto something. The article reported the results of a recent survey, which found 90% of the nearly 1,055 respondents felt that payments to HCPs should be made public.

As the ABPI moves on with determining the details of its transparency program, a Scottish doctor is hoping a Sunshine Act style law will “catch fire” in his country. The physician has petitioned the government to create a Sunshine Act of Scotland, which would publicly disclose payments to NHS healthcare professionals.

A compliance uprising has been started in Maine as PhRMA and several Maine pharmacy associations are suing the state over its drug importation law. The law allows Maine’s citizens to obtain prescription drugs pharmacies in Canada and from licensed retail pharmacies in the U.K., Australia and New Zealand. PhRMA, and the other plaintiffs, say the law violates the U.S. Constitution and federal laws that control the sale of drugs.

If you’re looking for more information on Open Payments and data submission, CMS has announced a series of webinars, designed to introduce features of the Open Payments system, on November 19. While the webinars are targeted to manufacturers and individuals responsible for creating data submission files for manufacturers, anyone is welcome to attend. A follow up question and answer session will be held December 3.

Speaking of “hunger games,” the language regarding meals at CME events continues to cause confusion. So much so that New Jersey Congressman Robert Andrews sent a letter to CMS requesting that the cost of food provided to speakers, faculty AND attendees of CME events be exempt from individual reporting requirements.

The rule already exempts the speakers and faculty as long as three requirements are met: the program is accredited by one of five designated organizations; payments or transfers of value are not made by the manufacturer directly to speakers or attendees; and the selection of faculty and speakers is not influenced by the manufacturer.

In his letter, Congressman Andrews points out that CMS has already acknowledged that accreditation bodies and industry standards create safeguards against sponsor involvement in educational content. He says the same logic should be applied to the meals provided to attendees.

Well, that’s the news for this week. We leave you this week with a recommendation for a different type of trilogy – one that weaves a compelling and engaging tale of compliance best practices and risk reduction across a broad array of topics. PharmaCertify’s Compliance Overview, Good Promotional Practices and On-label Promotion eLearning modules offer the regulatory and practical content your sales representatives and office staff need to understand the compliance rules and promotional policies that affect their daily activities. They’ve been met with rave reviews by learners of all ages!

Have a great week and, “may the odds be ever in your favor.”

2013 PCF Pharma Congress Review and Highlights

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Sean Murphy, NXLevel Solutions

Day 1

The first day of the Fourteenth Annual Regulatory and Compliance Congress and Best Practices Forum opened with a roundtable session featuring chief compliance officers from Eisai, Shire, Merck, Bristol- Myers Squibb and Purdue Pharma. Analytics and data were the primary themes and Anne Nielsen from BMS emphasized the need for companies to use data to spot the trends and the risk areas for compliance. Eve Costopoulos from Eisai agreed, noting that a coordinated effort addressing risks is crucial and web-based tools should be put into place to collect the data. Caroline West from Shire shifted the conversation to the importance of having a serious conversation with the sales force about what they can and can’t do and Eve suggested that the level of understanding among the sales team may not be what the audience of compliance officers believed it to be.

Mary Riordan, Senior Counsel to the Office of Inspector General was next with her annual OIG Update presentation. She began with an update on enforcement activity from the previous year and in particular, the large number of kickback cases, including the Sanofi Hyalgen case, the Boston Scientific/Guidant case and the Purdue Frederick case.

Riordan also stressed that promotional activities need continued scrutiny to be sure what messages are being conveyed and as in years past, she suggested the compliance officers look to recent CIAs for lessons. She specifically referenced the Par CIA and its recoupment program. And in agreement with the comments made by the chief compliance officers on the preceding panel, Riordan said the risk assessment process was a good way to bring businesses into compliance efforts and ensure an effective process.

Next on the docket was the Assistant US Attorney Roundtable with representatives from New York, Boston, Philadelphia and Los Angeles in attendance. Margaret Hutchinson of Los Angeles echoed earlier comments, saying that when investigations are conducted, her office focuses on the time period from when the company learns of a problem to when that company acts on the problem, while Paul Kaufman from New York urged the audience to consider their personnel, claiming that he has seen good compliance departments staffed by people who “really don’t know what they’re doing.” He also suggested that incentivizing employees on sales may lead to more compliance issues and offered the idea of taking away bonuses if employees violate compliance regulations.

Tom Abrams, Director of the Division of Drug Marketing, Advertising, and Communications for the FDA returned this year to speak to an audience anxious to hear his FDA-OPDP Update, especially the status of the agency’s guidance on social media. While Abrams did commit to providing guidance that will be high in quality and relevant, which was stated with a disclaimer that his office was limited in resources, he did not commit to meeting the deadline set forth in the Prescription Drug User Fee Act (PDUFA).

Abrams also updated the audience on the FDA’s Bad Ad program, and the most common violations found over the last year. Omissions of risk, misleading efficacy and misleading superiority claims led the pack in terms of those violations.

Mit Spears, Executive VP and General Counsel for PhRMA closed the first day with a keynote presentation that mostly amounted to a compelling argument in defense of promoting off-label. Spears’ points on the frequency of off-label use and the potential benefit to patients were not lost on an audience that was sure to agree with his thoughts. Unfortunately, the regulators who presented earlier in the day were most likely no longer in the room.

Day 2

The second day of the conference opened with a panel session of industry leaders and an interactive dialogue that included audience response questions designed to gauge compliance priorities and readiness.

When asked about their top priorities, 41% of attendees answered “improving compliance systems and processes,” and “aggregate spend and Sunshine” was the second most popular choice. On the subject of their top global issues, the audience cited “FCPA/Anti-corruption” as their primary concern. Kelly Freeman, Senior Director of Ethics and Compliance at Eli Lilly, took the opportunity to remind attendees that they can no longer just focus on the FCPA and the UK Bribery Act – anti-corruption in globally needs to be the focus of their training.

On the question of which area of aggregate spend they are most worried about implementing, 60% of the audience answered, “accuracy of data.” The panelists pointed this to the biggest benefit of the Sunshine Act – the data is critical and helpful. Kris Curry, formerly of Johnson & Johnson, issued a warning not to spend too much effort and too many resources on the smallest details.

On the question of whether their companies regularly assess employee perception about compliance culture, 62% of the audience answered yes, which was definitely considered a positive trend by the panelists.

Speaking of trends, when asked about the background of their compliance staff, audience members said 40% had a legal background, 16% came from the sales and marketing function, and the remaining staff was spread across a number of disciplines.

During the session covering the View from the C-Suite, panelists Jean-Luc Fleurial of Bristol-Myers Squibb, Adrienne R. Takacs of Takeda and Michael Goolsby of Fresenius Vascular Care, agreed that compliance has to start in the hiring process. Goolsby advised those in a hiring role to look for employees who bring integrity coupled with coachability. He also touched on the training process, stressing that training needs to extend beyond the check-the-box approach recognizable to real-world scenarios.

The second half of Day 2 featured a series of “mini summits” in topics as diverse as third party relationships, government pricing, data sharing and cGMPs. I was anxious for an update on the FCPA and UK Bribery Act so I started with the Anti-corruption Update session with a panel of experts, including Nathaniel Edmonds, Former Assistant Chief, FCPA Unit of the DOJ and Vivian Robinson, Former General Counsel of the UK Serious Fraud Office. In noting that while there have been no significant UK Bribery Act cases to date, Robinson reminded the audience that the law had not been in place long and he was aware of “a number of cases on the books that were likely to come into the public domain in a short time.”

Edmonds focused on recent trends in FCPA enforcement and in particular, Fair Market Value and the importance of proper methods for reimbursing CROs and other third parties. Robinson agreed that third party due diligence is essential but warned that the focus on gifts and entertainment can be a distraction from that third party focus.

China was of course a topic of discussion with so much anti-corruption news emanating from the country in recent months. Edmonds called China “one of the most important recent developments for the pharmaceutical industry” and Robinson emphasized the need for clearly recorded due diligence, “you can say what you did and back it up.”

After a disappointing start to one of the late afternoon sessions, which started more as an advertising opportunity for the companies presenting, I joined a number of other attendees in moving to the Interplay between Company Culture and Compliance, where the key message seemed to be the importance of emphasizing the positive when evaluating employees. Or, as Gina Dunsmuir from Ortho Clinical Diagnostics said, “give the employees examples of what they are doing right.” Tom Costa from Bristol-Myers Squibb believes employees “want to be proud of their corporation,” and that’s even more reason why compliance officers need to be out in the field listening to employee feedback.

I decided a dose of medical device compliance would be a good way to close Day 2, and took in the Medical Device Compliance Issues Update session with Paul Kalb of Sidley Austin, Seth Whitelaw of Deloitte & Touche, and Sandy Kalter, Chief Regulatory Counsel for Medtronic. The panel pointed to the trend toward more med device CIAs and the increased focus on executive management and directors in those CIAs. For example, in 2012, of the $260 million dollars collected in anti-corruption fines, $50 million was from three device companies.

For Kalter, the biggest priority is managing off-label risks by first studying recent CIAs and developing a policy around the results. The different areas where off-label arises are key, according to Kalter, including areas like consultative meetings and MSL interactions.

Day 3

Day 3 opened with a keynote presentation from Bret Saunders, the new CEO of Forest Laboratories who was once a compliance officer for Schering-Plough. Saunders offered a unique view on how he perceives compliance from the CEO role. He believes “integrity includes compliance, yet goes beyond to include following your moral compass.” It took three days, but I knew I’d hear a reference to “tone at the top” and Saunders didn’t disappoint. But he used the oft-quoted phrase effectively, stressing the need for that tone to be communicated from the Board.

Understanding the background of his audience, Saunders included tips for presenting compliance concepts to directors. For example, keep concepts clear and in perspective. These are often people who don’t know the industry, so the information has to be right and it has to be organized. He advised the CCOs to approach their role as in a way in which they understand what the organization is trying to accomplish and which risks have the most impact on business. The best way to measure compliance readiness is to repeatedly survey internal and external stakeholders, according to Saunders, and conduct focus groups with employees to reveal how they feel about compliance and the related issues.

After an intriguing presentation on the role of unconscious biases in everyday life by Shankar Vedantam, NPR Correspondent and author of The Hidden Brain, and two panel discussions covering topics as diverse as Sunshine, state laws and lessons learned by attorneys who formerly worked in public service, Arun Sharma, from the University of Miami closed the conference with his take on the future of compliance. PCF planners may have made a mistake in scheduling Sharma for the last session because his comments were some of the most compelling and certainly controversial ones made during the conference. Leave it to academia to think outside the box and challenge the audience to approach compliance as a strategic opportunity to enhance marketing opportunities. The audience that hadn’t left for an early train or flight stirred uncomfortably as Sharma emphasized that “compliance 2.0” should be viewed as a chance to enhance a brand and grow that brand within the letter of the law. He challenged those audience members to be “more creative within the rules.” During a follow up question and answer session, one remaining audience was grateful for Sharma’s unique ideas but lamented the fact that government regulators hadn’t stayed to hear the presentation because he was sure they would disagree with the approach.

While some attendees anecdotally expressed frustration over the lack of new information presented at the Fourteenth Annual Regulatory and Compliance Congress and Best Practices Forum, conference organizers continue to seek new and innovative methods, e.g., mini summits, to present an ever-evolving stockpile of information to an eager audience. The conference, along with CBI’s Pharmaceutical Compliance Congress, remains the premiere opportunity for the industry to share the latest best practices and concepts.

See you at PCC in January!

Week in Review, November 4, 2013

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Week in Review, November 4, 2013
The FDA explores the Bad Ad program, targeting misleading drug ads for younger audiences; whistleblower cases shed light on Cephalon kickbacks and the government steps up corruption investigations.

It’s the most wonderful time of the year! When we’re nestled all snug in our beds with visions of sugarplums (or dew drops) dancing in our heads. Finally, Daylight Savings Time came to end over the weekend! Oh, the joy of receiving that precious hour back. We hope you made the most of that “free” hour over the weekend. We sure did! The back of eyelids never looked so good. It’s back to the grind now, so let’s get rolling with this week’s News Week in Review.

The FDA has decided it’s about time to study how teens perceive direct drug advertising. The study will gauge how teens respond to ads for fictitious acne and ADHD drugs. Studies have shown that the part of the brain that helps in discerning risk in decision making is not fully developed until the mid-twenties. The FDA wants to understand how teenagers judge the risk and benefits associated with the drugs in the ads to determine if changes should be made in the way certain drugs are advertised online.

The FDA has sprung forward with a new CME program as a part of the Bad Ad program. The agency will launch a web-based CME program to teach HCPs how to identify misleading drug ads. The course will focus on various types of advertising, and is open to anyone, even though it’s directed to HCPs.

The government will fall back from a pair of whistleblower cases against Cephalon. The first whistleblower case focuses on the off-label promotion of four drugs Cephalon co-promoted with Takeda. This is the second case brought by this group of whistleblowers against the company. The first case resulted in a settlement. In the second, the relator alleges Cephalon promoted three drugs for off-label purposes and paid kickbacks to doctors. The relator also alleges Cephalon and WebMD conspired to locate certain patient populations and promote drugs for off-label use to those patients.

A study by Taxpayers Against Fraud found that for every dollar the federal government spends on investigating and prosecuting healthcare fraud, it recovers $16. The study showed that between 2008 and 2012 civil, criminal and state recoveries were just over $18 billion. The study also showed that since 1987, recoveries totaled nearly $40 billion. China, the U.K. and U.S. are not dilly-dallying when it comes to corruption investigations. Speakers at a conference in Beijing said the countries are stepping up corruption investigations in the food and drug industry. This year, the U.S. government initiated 11 FCPA investigations of drug and medical device companies. According to a former DOJ official speaking at the conference, the agency believes there is considerable corruption occurring in drug firms overseas, and addressing it is a priority with the DOJ. John Tan, counsel with international law firm Reed Smith, said the Serious Fraud Office has six Bribery Act investigations under consideration.

Don’t overlook the importance of having administrative assistants spend time on anti-corruption training. Addressing the question of who should be included in FCPA training, the FCPA Professor points out that while administrative assistants may not interact with “foreign officials” directly, they can be a valuable asset in identifying FCPA risks if they receive training. The article references a recent article in the WSJ about the influence and power admins hold, and points out this should not be overlooked when determining your FCPA training audience.

Well, the clock has run out on another issue of the Week in Review. If all of this news surrounding product promotion has you wondering if your field force is up-to-date on the latest compliance practices, Good Promotional Practices from the PharmaCertify™ suite of customizable off-the-shelf eLearning modules, covers topics ranging from gifts and meals to speaker programs and the handling of off-label inquiries.

Have a great week everyone!

Week in Review, October 21, 2013

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A U.S Senator calls for an investigation into the relationship between pharmaceutical companies and the FDA, the definition of “foreign official” under the FCPA is debated in Florida, the Baycol False Claims Act case moves forward and 25 manufacturers settle with Vermont over charges of failing to file required reports.

The World Series gets underway this Wednesday with the Cardinals returning after a one year hiatus to face a scraggly, scrappy Red Sox squad. With the team from Boston representing the American League, no doubt the boys from St. Louis have gained a new legion of fans in New York. So, do you have a side in the battle, or will you just be glad when it’s over, and you can get back to The New Girl and Sleepy Hollow? Whether you’re looking forward to the first pitch or the last, we’re here to help fill the time with the current version of the News in Review.

U.S. Senator, Joe Manchin, has put a call into a different type of commissioner to investigate an alleged pay-for-play scheme between the FDA and pharmaceutical companies. In the letter to FDA commissioner Margaret Hamburg, Senator Manchin expresses concern about reports of pharmaceutical companies paying thousands of dollars to attend FDA advisory meetings about the safety of pain medication. He would like to see a full senate investigation into the allegations to shed light on whether the relationship between pharma companies and the FDA caused any delay in the rescheduling of addictive pain killers.

A meeting on the mound is needed to settle an FCPA case in Florida. The case is now in the hands of three judges, and at the crux of the discussion is everyone’s favorite topic – the definition of a foreign official. More specifically, the case focuses on the definition of an “instrumentality.” Two telecom executives are accused of bribing the government-owned Haiti Teleco and defense lawyers have argued that an instrumentality has to be a direct part of the government under the FCPA, which is not the case with Haiti Teleco.

Internal controls charges are on the rise in FCPA cases, leading the Cadwalader law firm to wonder if the DOJ and SEC are poised to begin charging independent directors for failing to assure or maintain proper controls. Several companies have faced such charges recently, and as was demonstrated in the Orthofix case, companies can be charged with a violation for not having financial controls or an adequate compliance program in place. The FCPA guidance states that compliance begins with board members and senior executives, so the idea of independent directors being charged for the lack of proper controls isn’t far-fetched.

Upon further review, a whistleblower case against Bayer will move forward, but only on the grounds that the Department of Defense was defrauded, not federal healthcare programs. The False Claims Act case, which alleges that Bayer was deceptive in its marketing of Baycol, was dismissed last year because the court said the whistleblower failed to meet the specificity threshold related to false claims. The appeals court reversed the lower court’s decision.

Boston Scientific and its Guidant division have agreed to pay $30 million to settle charges of knowingly selling defective heart devices to facilities that treat Medicare patients. The government alleged that despite being aware of the problem, Guidant continued to sell defective stock and sent misleading communications to doctors in attempt to hide the true nature of the defect. The government also alleged that Guidant attempted to hide the defect from the FDA.

Vermont racked up 25 strikes against manufacturers under its Prescribed Products Gift Ban and Reporting law. The state’s Attorney General recently announced settlements with 25 manufacturers for alleged violations of the law. Most of the companies involved were small manufacturers and most of the charges levied were for failure to file the required reports. One manufacturer faced six charges of violating the gift ban.

We close with a reminder that the PharmaCertify team will be on-site at the Fourteenth Annual Pharmaceutical Regulatory and Compliance Congress next week. So if you’re attending, don’t forget to stop by the booth, say hi, and ask about our suite of compliance training modules and apps.

Have a great week everyone.

News Week in Review, October 14, 2013

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An industry watchdog group raises concerns about pay-for-play, the Supreme Court considers medical devices, one company claims its trade secrets were sent overseas and a critique of off-label promotion is, well, criticized.

“In fourteen-hundred and ninety-two, Columbus sailed the ocean blue”…certainly one of the more effective pneumonic devices from our younger days. So it is that today we celebrate the journey that would lead Mr. Columbus to “discover” the Americas. Unless of course you’re Canadian, in which case…Happy Thanksgiving! There is much to celebrate in North America today, but before you dig into the turkey and stuffing or take advantage of the Columbus Day sales at the local mattress emporium (nothing says “woo hoo, America was discovered!” like a new mattress), we set sail with this week’s News Week in Review.

The discovery of emails about meetings between government regulators and industry executives has raised concerns about the relationship between the two groups. The emails reveal that since 2002, pharmaceutical companies paid their way into the IMMPACT (an organization dedicated to improving clinical trials for new pain treatments) meeting, where they were able to discuss clinical trial procedures with regulators. The industry watchdog group, Public Citizen, says this raises concerns of a pay-for-play arrangement, in which drug companies could buy access to regulators, other health officials and academics. One of the founders of IMMPACT acknowledged that the email messages could appear problematic on the surface, but no one has complained about pharmaceutical companies paying for representatives to attend the meetings.

The U.S. Supreme Court could be exploring a case of a patient’s ability to sue a device maker under state laws when a problem with an FDA-approved device occurs. The case involves an Arizona man who has sued Medtronic over a pain medication pump which he claims left him paralyzed. At the time the man was using the pump, the device was approved by the FDA. The device was eventually removed from the market following a warning from the FDA about Medtronic’s failure to disclose all the risks. The Court has turned to the Obama Administration for an opinion on the matter.

A semi-retired Harvard doctor is suggesting that the Massachusetts legislature define a modest meal as one comparable to what one would receive at a hospital cafeteria. The doctor testified before the Committee of Public Health about a bill that would set a standard for a modest meal. He lamented the repeal of the existing meal ban and lectured about the so-called evils of pharmaceutical marketing.

Three former Lilly employees may be forced to walk the plank after they were indicted for handing over company trade secrets to a Chinese pharmaceutical company. According to the indictment, two of the employees emailed information about nine early-stage research projects to a third employee, who was also employed by the Chinese drug company. Lilly claims the company has a value of $55 million.

Fresenius, the maker of Propofol, ceased shipments of an anesthetic drug to Morrison-Dickson for several months, after the wholesaler accidently sent 20 vials of the drug to a Missouri prison for use in lethal injections. Fresenius will sell the drug to U.S. wholesalers only under the condition that they not sell it to prisons or jails. When company officials originally tried to reclaim the drug from the prison, they were told that decision would have to come from the state’s director of corrections or the governor. The state has agreed to return the vials.

In a case of the old world borrowing an idea from the new world, the U.K.’s Home Office is considering U.S. style whistleblowers awards in fraud, corruption and bribery cases. Currently, the U.K offers limited legal protections for employees who blow the whistle and the move is seen as one way to incentivize them. Some are concerned that the financial rewards will lead to bogus claims and raise questions about the credibility of a whistleblower as a witness.

A rehabilitation physician is trying to take the wind out of the sails of critics of prescribing drugs off label. Ford Vox, a physician at the Shepherd Center, responded to a recent article in the Washington Post about the number of off-label prescriptions written for patients covered by Medicare and Medicaid. Vox poked holes in the article’s assertions that off-label prescribing is inherently suspect, and that CMS has a responsibility to police physicians engaged in the practice. He notes that while focusing on one specific physician and drug, the article does not mention that the particular use is backed by research from 2006.

And so we end our exploration of all things compliance for this week. Fall has definitely arrived and as you map your compliance training curriculum for 2014, keep in mind that PharmaCertify™ offers the custom and off-the-shelf training solutions you need to help your crew navigate today’s murky compliance waters.

Have a great week everyone!

Week in Review, October 1, 2013

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The False Claims Act goes global, the FDA chimes in on mobile apps, and we hear from the OPDP on social media guidance…sort of.

Have you seen them yet? They’re small in number now, but if you look carefully, you’ll see them. October has only just begun, and yet, they’ve emerged…Christmas decorations. For now, it may just be a small display of collector ornaments off in a corner, or an inflatable lawn ornament, or two, slyly mixed in with the Halloween bunch. And we haven’t even started raking the leaves yet! We’re nowhere near ready to even think about the mad rush of the holiday season, but we are ready to bring you the compliance news you need to know, with this week’s News in Review.

Not rushing the holiday season might be good for the nerves, but putting off the implementation of a good due diligence program is never a good idea. The actions of intermediaries continue to be a key risk area for companies doing business overseas. FCPA investigations are on the rise and the Serious Fraud Office has levied its first charges for violations of the UK Bribery. Prosecutors are not likely to take a kind view of companies that have a “check the box” mentality when it comes to assuring their intermediaries are operating in a compliant manner. Pre-contract vetting of agents and suppliers, on-going monitoring, and compliance clauses in third-party contracts, are critical steps in demonstrating you company takes the risks posed by the use of intermediaries seriously.

Federal regulators certainly seem to be in a hurry to utilize the False Claim Act globally. With a large percentage of finished pharmaceutical products and the vast majority of active ingredients coming from outside the U.S., the FCA was bound to be applied to misdeeds occurring in other countries. The recent Ranbaxy case, involving the company’s manufacturing facilities in India, is one example. The FDA has regulatory authority over manufacturing facilities making products for the U.S. market, and the Ranbaxy case demonstrates prosecutors’ willingness to apply the FCA to actions occurring outside our borders.

Bayer found itself in the news after the company allegedly breached the APBI’s Code of Practice when a high-ranking employee provided late night drinks to healthcare professionals attending a medical congress. An anonymous healthcare professional provided the information, and said a good deal of alcohol had apparently been consumed by those present. Bayer did not dispute that the employee bought drinks for the physicians, but the company took exception with the characterization that a good deal of alcohol had been consumed, and said that only £28.15 was spent.

The Australian Medical Association (AMA) wants to slow down the physician spend reporting requirements that the pharmaceutical industry is proposing. The group supports increased transparency, but feels reporting “tea and biscuit” payments would be administratively cumbersome and weaken the transparency system. The Association sent a letter to the group working on the requirements, asking for certain limits on transparency. The limits requested include a $500 starting point for payments to be reported; a two year window for the reports to be available; and a requirement for patients to supply an e-mail address when they want to access the registry of spend data.

The FDA delivered an early gift for medical mobile app developers. The agency announced it will regulate medical mobile apps that turn smartphones into a medical device or ones that allow an attachment, like a blood pressure cuff, to be plugged into a smartphone.

It’s been a long time coming, but at the Food and Drug Law Institute’s recent Advertising and Promotion Conference, OPDP chief, Tom Abrams, said he expects the OPDP to meet the July deadline set by Congress for the release of guidance on the use of social media. So, until the guidance is released, how does the industry handle product promotion in the social media world? One panel of experts at the conference suggested a review of OPDP Warning and Untitled Letters involving web based advertising could provide some clues as to FDA’s current thinking. Panel members noted that the FDA was focusing on claims in testimonials and case studies, as well as fair balance and accuracy.

And so ends the News in Review for this week. If your end of year plans (we know, we’re rushing things) include the distribution of mobile devices to field and home office staff, the PharmaCertify™ suite of commercial compliance modules are accessible on PCs or iPads and offer the up-to-date content your learners need where they need it most – in the field and at their fingetips.

Have a great week everyone.

News Week in Review, September 23, 2013

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

The PharmaCertify™ Team

The sun, the moon, and the stars have all given their approval for the change of season, so we can make the official call…it’s FALL! Cool, crisp days and changing leaves can’t be far behind. And if that isn’t enough to make you happy, the advent of fall means that “delightful” chore of cutting the lawn will be ending soon. Gee, what a shame. Whether your favorite fall activities include pumpkin carving, apple picking, or getting lost in corn mazes, there will be plenty of time for all of that later. Now it’s time to take a look at the news from the last week of summer, with this week’s News Week in Review.

The Massachusetts legislature is kicking off fall with a number of bills aimed at the relationship between physicians and industry companies. A joint senate and house committee will discuss the bills on October 1st. The bills under consideration include a ban on drug advertising; a ban, with a few exceptions, on gifts to healthcare professionals and their family members, which will also require annual reporting on the value of permitted gifts (um…isn’t there a law in place for this?); and one that will define what constitutes a modest meal at an educational/informational presentation. The last bill prohibits the provision of alcoholic beverages at the presentations, and prohibits educational or informational meetings from being held at “resorts, sporting clubs, casinos or other vacation destinations.”

While you’re watching those fall television premieres, watch out for those drug advertisements…they’re deceptive! Or so says a new study in the Journal of General Internal Medicine. According to the study, 8 of 10 ads for OTC drugs and 6 of 10 ads for prescription drugs contained exaggerated or misleading formation, left out vital information, or made meaningless lifestyle associations. The ads aired from 2008 to 2010 during the evening news timeslot (30 minutes) on the three major networks and CNN.

Two industry trade groups are looking for companies to turn over a new leaf when doing business in China. PhRMA and RDPAC (a trade group for foreign companies in China) prepared a joint memo to address industry corruption issues in China. The memo calls on companies to employ the highest ethical standards while conducting business in China, and to react swiftly if something occurs outside the parameters of a company’s code of conduct. The memo also calls on trade organizations to enhance their efforts to ensure physicians are better paid by the Chinese healthcare system, and to encourage the introduction of ethical standards for the entire healthcare sector.

The corruption scandals and investigations in China have put a chill on the relationship between physicians and the industry. Pharmaceutical sales representatives are making fewer visits to hospitals simply because physicians are refusing to see them, and because companies have been cutting back or eliminating the visits out of caution. Sales are also down in the country as a result of scandals and the lower sales have lead companies to cut back on their marketing and promotional activities. The CEO of Sanofi says there is “a lot of confusion out there” and he expects there to still be “turbulence” in the marketplace over the next few months.

Prosecutors in the U.K. have harvested new laws and guidelines to help them pursue Bribery Act cases. A law that will allow the use of Deferred Prosecution Agreements to settle Bribery Act cases should become effective in February. The use of DPAs is expected to reduce the number of lengthy investigations, and provide companies a way to avoid the stricter penalties. The U.K. Sentencing Council has also released draft sentencing guidelines for violations of the Bribery Act. The guidelines include a tiered rating for determining a violator’s level of guilt under the law (e.g., a violator was an instigator vs. being coerced or intimated in to violating the law). The guidelines also state that fines against a company must be significant enough to have a real financial impact.

Google’s leaf pile just keeps getting bigger! The company announced it’s going to step into the bio-pharmaceutical industry, and form a research company dedicated to “health and well-being, in particular the challenge of aging and associated diseases.” The company will be called Calico, and the CEO will be Arthur Levinson from Genentech.

Now that fall is here and the daylight hours are waning, this is a good time to shift back to Sunshine. With Sunshine Act data collection in full swing, PharmaCertify’s, The Sunshine Act: The Federal Physician Spend Disclosure Law, will help you ensure customer-facing colleagues are well-versed on what information needs to be collected and reported.

Have a great week everyone!

Week in Review, September 16, 2013

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

The PharmaCertify Team

If you are reading this, we’ll assume you survived another Friday the 13th. How did you spend the day? Did you stay at home and not take any chances or was it business as usual? We of course stayed abreast of the compliance news of the week, albeit while keeping our lucky rabbit’s foot at the ready and digging out the usual four leaf clover. After all, Friday “December” 13th will be here in a flash. So, now that you’ve thrown a dash of salt over your shoulder and safely navigated the cracked sidewalks of your daily commute, we invite you to check out the News Week in Review.

Accepting drug samples could prove to be bad luck for Australian physicians if new ethical guidelines are accepted. The Royal Australasian College of Physicians is proposing a ban on drug samples in its draft guidelines on interactions with the industry. The RACP says samples are largely a “marketing exercise,” and access to samples is in the best interest of patients.

Not long ago, representatives from the European Union Chamber of Commerce were talking about how no Chinese pharma companies were being investigated for bribery. Well those words must have had brought some bad voodoo with them. No sooner was the ink dry on that announcement then news came that Chinese insulin maker, Gan & Lee, and a division of Sino Biopharmaceutical, were both accused of paying bribes to doctors to increase sales. In the case of Gan & Lee, a whistleblower says the company gave away overseas trips to doctors in order to boost sales in advance of an initial public offering. The revelations about Sino were made via a report on China’s state run television network. Sino was also accused of providing vacations to physicians in order to increase its sales.

Executives at Quest Diagnostics and LabCorp should have avoided ladders and black cats since they now find themselves the subjects of a false claims whistleblower suit in Virginia. The case, which was unsealed in August, alleges the two companies overcharged Virginia’s Medicaid system for diagnostic tests. In one instance, Quest is accused of charging Medicaid $10.42 for a test it charged others as little as $1.42. The complaint, which was filed by Hunter Laboratories and its CEO, Chris Reidel, is asking for $11,000 in civil penalties for each false claim.

PhRMA and the Maine Pharmacy Association are two of the groups looking for all the luck they can get as the group challenges Maine’s drug importation law in court. The new law allows consumers to purchase drugs from mail order pharmacies in Canada, Australia, New Zealand and the UK. The lawsuit claims drugs from the other countries are not subject to the same safety controls as those produced in the U.S. and the FDA has already warned states about their residents purchasing drugs from other countries.

The International Society of Medical Publication Professionals (ISMPP) has created a task force to help clarify the impact of Sunshine on medical publications. While publishers have no direct reporting responsibility, the activities publishers perform in conjunction with researchers could fall under the definition of indirect payments. The task force identified a variety of activities that should be tracked, including statistical support provided specifically for the publication. In addition, applicable manufacturers should track all transfers of value associated with publication costs and keep the data available for reporting and the dispute process.

CME providers have been making good use of their good luck charms recently. According to a report from the ACCME, the number of providers receiving accreditation with commendation has risen from just 3% in the November 2008 cohort to 28% in the July 2013 cohort. The total number of accredited CME providers of CME is down, suggesting that the tough ACCME standards may be thinning the herd.

With that, we’ve reached the end of another Review. While you may have been lucky enough to navigate another Friday the 13th, leaving your compliance training to chance in this age of increased regulatory focus is not such a good idea. More than ever, your sales and marketing teams need to integrate solid compliance practices into their daily activities. That’s why our Good Promotional Practices module includes topics like Gifts, Meals and Entertainment, Meetings and HCP Consultants and On-Label Promotion. Contact Sean Murphy at smurphy@nxlevelsolutions.com to see a content outline.

Best wishes for a great week everyone!

News Week in Review, September 9, 2013

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

The PharmaCertify Team

That plaintive wail you heard in the distance last week may have actually been the low groan of children across the country as they boarded buses, or trudged their way back to school last week. With the passing of Labor Day, summer came to an unofficial end, and schools welcomed al (those eager and those less enthusiastic) back to reality. And for those of us who have aged beyond the school years, a heavier rush hour commute was our welcome back to reality. Good times all around. Enough waxing poetic, it’s time to swing open our own school doors and ring the first bell on this week’s News Week in Review.

A new survey shows that physicians need more education about the Sunshine Actor. The survey shows a ten percent increase in physicians who say they are “somewhat aware” to “very aware” of the law’s requirements. However, almost half of the respondents stated that they are unaware of the law. The survey also delves into the impact of the law on industry-physician relationships. Almost 40 percent of the physicians say they believe the law will negatively impact their relationships with the industry, and 21% said they would end their relationship with a company if inaccurate payment information is made public.

A federal Circuit Court has offered a whistleblower an eighth opportunity take what some would consider to be a generous makeup test. The court asked for yet another amended complaint from the whistleblower, who had filed a False Claims Act case against Bayer. The whistleblower alleges Bayer hid the dangers of two if its drugs and provided kickbacks when promoting those drugs. She claims that when she objected to the marketing tactics, she was fired. The seventh complaint alleged violations of the false claims acts of twenty one states, Washington D.C. and New York City. The Circuit Court judge tossed the state claims, along with her emotional distress and misbranding claims, but gave her thirty days to file an amended complaint.

Major Pharmaceuticals found itself in detention as a result of its settlement with Texas. The company agreed to pay $5 million to settle claims it misreported prices of generic drugs, which resulted in the state overpaying for the drugs. The case was initially brought by whistleblower, Ven-A-Care Pharmacy, and the state recently decided to join the case.

In China, foreign pharma companies haven’t exactly been the teacher’s pet lately. But, the chair of the European Union Chamber of Commerce in China’s pharmaceutical work group, Bruno Gensburger, said China is unfairly targeting foreign pharmaceutical firms in its bribery and price fixing investigations. Gensburger said the targeted firms have global SOPs in place and have generally been operating in a responsible manner. He went on to say that no Chinese company has been targeted for investigation.

In its recent analysis of the global reach of the Sunshine Act, the law firm of Fulbright & Jaworksi LLP explained that Sunshine has applicability to foreign firms that have a business presence in the U.S. CMS has established an applicable manufacturer as one having a physical location in the U.S. or conducting business in the U.S., either directly or through a legal representative. Manufacturers need to consider payments made to U.S. physicians who practice abroad, but are actively licensed in the U.S.

Well, the dismissal bell is ringing on this edition of the News Week in Review. The start of a new school year reminds us that 2014 isn’t far away and this is a great opportunity to review your compliance curriculum and see where a fresh take might be needed or a new topic could be added. From Commercial Compliance Overview, to Good Promotional Practices to the Sunshine Act, PharmaCertify offers the up-to-date training your learners need to help integrate critical compliance awareness into their daily activities.

Have a great week everyone!