Ethics

Week in Review, February 10, 2014

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A device maker settles kickback charges, the Serious Fraud Office looks to beef up the UK Bribery Act, and the FDA makes plans to release more guidance on social media.

The Super Bowl, National Signing Day and the Olympics all in one week; it was a sports fan’s trifecta! Hopefully your team won the game…signed that all important recruit…or took home the early gold! As the best of the best gather in Russia and you keep track of the medal count (Canada, Netherlands and Norway are tied for the early lead), we’ll keep tabs on the world of life sciences compliance. It’s time to light the torch on this week’s News in Review.

That big curling match is about to start in Sochi, and darn it, today is the day you left home without your smartphone. No worries. According to a new study, your healthcare provider  should have one you can borrow. The study finds that the vast majority of physicians are toting smartphones and about 70% have tablets. They’re putting the devices to use in their practice with the tablets being the tool of choice for content heavy tasks.

Device maker CareFusion recently spent some time in the penalty box. The company agreed to pay $40.1 million to settle charges it concealed kickbacks to a physician and marketed its surgical prep solution for off label uses.

Serious Fraud Office chief, David Green, wants to change the rules related to the Bribery Act. Green is proposing an amendment to the Act that would subject companies to fines and blacklisting if those companies fail to prevent financial crime by their employees. The law currently has a provision whereby companies are held liable for failing to prevent bribery. Green says the new power would only be used in “exceptional cases.”

Fortunately, we can look forward to more commentary on research and drug marketing during 2014. The FDA is expected to release more guidance on the use of social media in drug marketing, and guidance on the electronic submission of promotional labeling and advertising. The OIG plans to investigate issues around the price of drugs, including whether off-label uses should be reimbursable. For more in depth expert analysis of the OIG Work Plan, check out the video released by OIG, during which representatives discuss the agencies top priorities for the year and emerging trends in combating healthcare waste.

Speaking of the FDA, the agency may be ready to step up its enforcement of the regulations prohibiting off-label promotion. At a recent conference, an attorney for Pfizer, Emily Wright, noted that the industry should expect to see an increase in enforcement in the near future. Wright made note that the FDA issued two letters related to press releases in 2012 and she expects to see more.

And finally entering the stadium (cue the triumphant fanfare)…Open Payments registration! CMS has announced that beginning February 18th, registration and data submission will commence in two phases. During the first phase (February 18th – March 31st), users can register in CMS’ Enterprise Portal, and submit corporate profile information and 2013 aggregate data. Phase two will kick off in May.

Well that’s it for this edition of the News in Review. As you marvel at the accomplishments of the world’s greatest athletes this week, don’t forget to take the time to analyze your compliance curriculum for areas that need enhanced training. PharmaCertify™ off-the-shelf modules and mobile apps offer up-to-date content on topics like, on-label promotion, good promotional practices and the Sunshine Act, where your staff needs it most–in the field and at their fingertips.

Have a gold medal week everyone!

Week in Review, February 4, 2014

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Industry teams with HCPs to formulate a framework for ethical collaboration, medical device companies are advised to keep their compliance programs robust, and pharmaceutical companies disagree on the Sunshine Act as it relates to support for medical writing.

How about that Super Bowl Sunday! No doubt there were cheers, laughs and maybe even a few tears shed as you and your friends gathered to watch the best of the best compete. Of course, we’re talking about this year’s Super Bowl commercials! And, yes, there was a football game played (sort of) in between those delightful bits of entertainment. The array of commercials included some that were memorable and humorous (that bizarrely fun Audi “Doberhuahua” spot) and many that we found downright confusing (Axe “Kiss for Peace?”). While it might not be as memorable as that Radio Shack spot, we like to think that this week’s News in Review is a production worthy of your time and attention.

Huddle up! A group representing the pharmaceutical industry, healthcare providers and patient advocacy organizations recently published a framework for ethical collaboration. The framework is designed to foster collaborations that further patient care, and it is supported by four ethical principles: put patient’s first; support ethical research; ensure independence and ethical conduct; and promote transparency and accountability. The group says regular information sharing and communication between patients, practitioners and the industry is vital to improving health and advancing medical knowledge.

Biotech and small medical device companies need to be sure they stay aggressive on offense when addressing FCPA compliance. Since biotech and medical device products often require additional approvals that increase the level of interaction with government officials, the risk of FCPA violations also increase. With life sciences companies in the cross-hairs of enforcement agencies, companies need to make sure their compliance programs are robust and comprehensive.

Share clinical trial results you will. Janssen announced it will share some of its clinical trial data through the Yale School of Medicine’s Open Data Access Project (otherwise known as YODA). YODA will serve as the vetting agent for clinical trial data requests from researchers and physicians. Some requests for the data will still be handled by Janssen R&D directly.

A federal judge is allowing a whistleblower case against Abbott to continue. A former sales rep filed the suit, alleging the company paid kickbacks and promoted its drug TriCor for off-label uses. Abbott moved to dismiss the case because the whistleblower failed to provide specific evidence of a false claim being submitted. The judge rejected those allegations.

Pharma companies are not reading the signals from the Sunshine Act the same when it comes to medical writing support. During the International Society for Medical Publication Professionals’ European meeting, representatives from several pharmaceutical companies revealed how their companies were handling medical writing support provided to authors of clinical studies, and not all companies agreed that there was any real transfer of value to physicians. AstraZeneca and Pfizer representatives said there was value to the author. Shire, on the other hand, saw the only value was to the company, and there was no need to report medical writing support. The Shire representative said they were collecting the information in case it ultimately has to be reported, but that the company was confident in its approach.

And with that, the clock has run out on this week’s News in Review. If you attended last week’s Pharmaceutical Compliance Congress, you heard industry peers and government regulators emphasize the need for an up-to-date compliance program that extends training beyond the check-the-box approach. The PharmaCertify™ suite of off-the-shelf compliance solutions offers the eLearning modules and mobile apps you need to extend critical compliance policies to where your team needs it most – in the field and at their fingertips.

Have a great week everyone!

Week in Review, January 28, 2014

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Sunshine and state-accredited CME are clarified at a conference, the Supreme Court weighs in on medical device patent infringement, China institutes a new program to monitor healthcare and a new study shows the industry is still wary of social media.

Go west, young man…if you want to escape this arctic cold that is. It was another week of super cold weather, snow showing up in unlikely locales (you saw all the memes about Austin, TX, right?), frozen pipes and below zero wind chills. When Anchorage, Alaska is warmer than Atlanta, GA, you know we’re having cold weather here in the east. To make matters worse, another blast of arctic cold is on the way. The only escape seems to be the western part of the country, where temperatures in the 80’s and sunshine are thriving. The rest of us will just have to huddle around the fireplace and catch up on all things compliance, with this week’s News in Review.

The topic of Sunshine and state-accredited CME programs heated things up at a recent continuing education conference. A CMS representative speaking at the conference mistakenly indicated that state accredited CME programs were not exempt under Sunshine. The final rule actually refers to both certified and accredited CME and does not draw any clear lines between the two distinctions. After hearing how the process actually works, the CMS representative realized that the state-accredited CME would qualify for exemption.

The U.S. Supreme Court iced out patent holders in a recent decision. The Court unanimously ruled that patent holders bear the burden of proof in patent infringement cases, even if they received a declaratory judgment. The case at the center of the ruling involved Medtronic and Mirowski Family Ventures,LLC. Mirowski holds patents for implantable heart stimulators, and Medtronic had a license agreement to use those patents. The company claimed Medtronic infringed its patents, but a federal court ruled Mirowski  had not met the burden of proving infringement. The case was appealed and a U.S. Court of Appeals reversed the ruling, saying Mirowski set the events in motion and that there was “no convincing reason why burden of proof law should favor the patentee.”

The FDA has discovered a new way to submit nominations for its advisory committees. The agency announced the launch of an interactive online portal for the submission of advisory committee nominations. Applicants can submit their entire application through the new portal. The FDA says the system will eliminate confusion and accelerate timelines for submission and acceptance.

China is cranking up the thermostat with a campaign to deal with bad manufacturing and marketing practices in healthcare. The inter-departmental campaign involves eight different departments in the Chinese government. Officials hope to also use the program to deepen reform efforts in medical services.

A new report shows much of the industry still feels chilly about social media. The report from IMS Health indicated that 23 of the top 50 companies worldwide are using Facebook, Twitter and YouTube. However, only 10 of the companies are using all three, and very few are using social media to engage patients. Most are using social media as a way to deliver messages intended for providers and patients alike. Companies with a small therapeutic focus tend to use social media more to engage the patient. In an interesting twist, the study also found that regulators are quite active on social media. The FDA and EMA post high index reach scores, and the FDA scored higher than any pharmaceutical company on IMS’ relationship scale.

We certainly hope everyone stays warm and safe as the next arctic express heads east. We’ll be venturing out into it ourselves for CBI’S 11th Annual Pharmaceutical Compliance Congress. If you’re there, stop by our booth in the exhibit hall to say  hi and see a demo of our new Compliance Curriculum Refresher Training series.

Stay warm everyone!

2013 Year in Review

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With a blink of an eye, 2013 comes to an end. Didn’t it just start? As the dust settles on another year and we pack away the party hats and noisemakers, we pause to look back at some of the big stories that shaped the world of life sciences compliance over the last year, with our second annual Year in Review.

The big story of the year was transparency, transparency, and transparency. After closing 2012 with the draft of the final rule for the Sunshine Act (now known as Open Payments), CMS fielded comments from various stakeholders, and in February the final rule was released. Data collection began on August 1 and report templates, FAQs, and webinars followed throughout the year.

The stakeholders involved didn’t hesitate to weigh in about the rule. For example, the AMA (along with other physician groups) wrote to HHS, saying the value of journal reprints and text should not be reportable because items like these benefit patient care. Payments related to CME events are still a bit blurry and the process for handling payments related to unaccredited CME also remains a hot button issue.

Transparency in the financial relationships between physicians and the industry wasn’t just a U.S. story, it was global. In May, France issued the final decree on its law requiring the disclosure of payments to physicians. The requirements of the law are similar to those of the Sunshine Act, and payment reports are made public on a website.

Several industry groups around the world announced payment transparency initiatives. Medicines Australia added transparency requirements similar to the Sunshine Act to its Code of Conduct. Medicine Australia’s Transparency Working Group has been working on the requirements, and the current edition of the Code is under review until the middle of 2014. Upon approval, the Code of Conduct will go into effect in January 2015.

The Association of the British Pharmaceutical Industry (APBI) announced it would require member companies to provide information on payments made to physicians. The organization is changing its Code of Practice to include the transparency requirements, and the changes should be in the 2015 Code.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) amended its Code to include a requirement that member associations implement payment transparency requirements by 2015. In addition, the EFPIA and PhRMA joined together to release principles on clinical trial data transparency. The principles provide for the release of patient level and full study data to qualified researchers.

Enforcement of anti-corruption laws has been a hot topic in recent years; most notably the DOJ’s and SEC’s stepped-up enforcement of the FCPA and the passage of the UK Bribery Act. In 2013, China clamped down on bribery and began enforcement of its own laws, with a bulls-eye on the pharmaceutical industry. Starting with the detainment of several GSK executives in China, reports emerged regularly of investigations into pharmaceutical companies for alleged bribes paid to doctors and hospitals.

In recent years, the federal courts handed the industry significant “victories” in decisions regarding the Vermont data mining law and the Caronia case. This year, the U.S. Supreme Court ruled against the industry and sided with the Federal Trade Commission when it decided that pay for delay deals violated antitrust laws. While the decision does not make the deals illegal, it does open the door for lawsuits to be filed by wholesalers, distributors and enforcement agencies.

We end our review of 2013 with a story that could very well shape the dialogue in 2014. In the last weeks of 2013, GSK announced it would no longer pay doctors to promote its drugs or to attend medical conferences. The company will continue to pay for advisory and consulting services. GSK also announced a global expansion of the program by which sales reps are compensated on parameters other than the number of scripts written. The program is already in place in the U.S.

And with that, we close our look back on the big stories of 2013. This year promises to be as eventful, particularly with the first Sunshine-related reports due and the eagerly-awaited social media guidance scheduled for release by the FDA. Through it all and throughout the year, we’ll be here to keep you up-to-date on all the compliance news you need to know.

Happy New Year 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.”

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 7, 2013

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PhRMA’s assistant general counsel tells physicians the industry is spending millions to avoid reporting mistakes, Canada takes steps to limit access to physicians, and two different whistleblower cases are dismissed.

The PharmaCertify™ Team
In case you missed it, last Thursday was National Techie’s Day. So, if you find yourself lining up extra early outside the Apple store on the day of a new product release, or you can’t help but play armchair engineer while watching The Big Bang Theory, or you have a room in your house with enough computer equipment to launch a space shuttle…you probably had a good week. Rather then regale you with the celebratory details of our parking lot robot battles, we’ll stick with this week’s News in Review.

Garbage in, garbage out, or GIGO, in techie nomenclature, is what PhRMA says its members are working hard to avoid in their forthcoming Sunshine reports. Speaking to a gathering of family physicians, PhRMA’s assistant general counsel, Kendra Martello, said member companies are spending millions to ensure the accuracy of reports as much as possible. She emphasized that disputes between physicians and manufacturers are not good for anyone, but admitted that the industry is unsure of what to expect in the way of physician disputes when the first reports roll out.

A Canadian medical school is rebooting its policy regarding doctors’ contact with industry representatives. The North Ontario School of Medicine is creating a policy that would limit doctors’ contact with representatives. The dean of the school, Roger Strasser, acknowledged the importance of physicians having access to medical information, but only if that information is unbiased and well-researched. He said the policy would be more of a guideline than a rule.

Sanofi’s CEO, Chris Viehbacher, believes the industry needs to interface more with the Chinese government in order to deal with corruption in China. While speaking about doing business in emerging markets, Viehbacher said the industry needs to support the Chinese government’s efforts to deal with the corruption. He went on to say that all the companies under investigation have been cooperating with the government.

A federal judge has resorted to a forced quit shutdown of a misbranding suit against Amgen. The whistleblower in the case, who is a physician, and a co-complainant rejected the $1.8 million settlement they were to share as a result of a federal settlement with the company last year. The judge said that since original settlement was rejected, the government had the right to determine that nothing further could be litigated, so the whistleblower’s case was tossed.

The techies at Google have done an about face and are now offering Business Associates Agreements (BAA) for users of three of its apps, Gmail, Drive and Calendar. The BAAs do not cover any Protected Health Information transferred from one of the three apps to another Google app.

A whistleblower suit against the medical technology company, Masimo, has been dismissed. Three former sales reps brought the suit, saying the company had promoted two of its patient monitoring devices for off-label uses and improperly billed the government. The sales reps also claimed the company withheld sales data and interfered with subpoenas for sales records issued to federal insurance companies. The judge dismissed the case, saying the plaintiffs failed to provide any evidence that the company knowingly promoted the products for off-label use.

And with that, we reach the end of another News Week in Review. We close out this celebration of all things technical by asking if you are making the most of technology to deploy your compliance training solutions. The PharmaCertify™ eLearning modules and iPad apps are designed to deliver critical compliance content where your team needs it most – in the field and at their fingertips.

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!