Highlights and Notes from the “CBI 2013 Pharmaceutical Compliance Congress”

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

Sean Murphy, PharmaCertify

CBI’s 2013 Pharmaceutical Compliance Congress featured a compelling lineup of pharmaceutical and medical device professionals, as well as government regulators, who offered tips and best practices for managing the myriad of regulations and challenges that face those working in compliance for the life sciences industry.

Here are highlights from just some of the presentations and sessions at the conference.

Day 1, Keynotes

“Few will have the greatness to bend history; but each of us can work to change a small portion of the events, and in the total of all these acts will be written the history of this generation.”

Robert Kennedy (Quoted by Cynthia Cetani, Vice President, Ethics & Compliance and Chief Compliance Officer, Novartis Pharmaceuticals Corporation)

The theme of Day 1 was “change” and Cindy Cetani of Novartis opened the conference with details of how her company has embraced change through a campaign to humanize compliance with a clearer, more approachable process. That campaign has led to a clearer understanding of expectations and responsibilities throughout the organization.

After Ted Acosta of Ernst & Young focused his presentation on how compliance has evolved over the last decade, and moved beyond the “culture of compliance” approach introduced in 2008, Victoria Browning of Allergan welcomed the “next generation” of compliance officers and brought her own insight on the unique compliance challenges facing her colleagues in the medical device industry.

Judging by the reactions in the room, one of the real highlights of Day 1 had to be Dr. Michael Koren, the immediate past president of the Academy of Physicians in Clinical Research and a practicing cardiologist. Dr. Koren’s presentation, titled “Does Sunshine Act Shed Light or Blind Us?” offered a physician’s perspective on the law. His bewilderment over the concept of the government gathering data before anyone even knows what they are going to do with that data were highlighted by a humorous story from his recent trip to a conference in Munich Germany.

After one session at that conference, Dr. Koren was wandering the exhibit floor when a woman at the Pfizer booth offered him a Smoothie as a snack. When he said yes, her manager quickly appeared and announced that if the doctor was from the U.S., he would first need to complete an HCP Disclosure form indicating that he accepted the 4 ounce drink. Koren highlighted the absurdity of the moment with a photo of a sign next to the Smoothie machines informing attendees that healthcare providers from Minnesota were not permitted to accept the Smoothie. The ridiculousness of the experience was not lost on the audience.

Later in his presentation, Dr. Koren displayed his own profile on the Pro Publica website that lists the industry payments to HCPs, and explained how the data was confusing, misleading and unclear in its origin and intention.  He then closed his comments by emphasizing that contrary to what seems to be the belief by the government, he wholeheartedly believes that physicians who have MORE relationships with our industry are better informed. His remarks certainly fell on a roomful of friendly ears.

Day 1, CCO Panel

The CCO Panel, titled, Insight and Improvements through CIA Implementation – Compliance Roundtable Takeaways, Ways to Maintain the Efforts, opened with Bert Weinstein of Purdue Pharma informing the audience that he had just received the letter officially closing out the company’s five-year Corporate Integrity Agreement (CIA). He followed the announcement by advising the audience that the OIG is looking for real integrity in compliance programs and for the industry to do a better job of policing itself. The panel then shared experiences of how they improved their compliance programs through the implementation of a CIA and how they see those programs changing once the CIAs are closed.

Sarah Richardson from Medicis stressed the common refrain of the importance of tone at the top and upper management’s participation in training. She also discussed the company’s multi-phased CIA compliance program, which concluded with a focus on adding value and making compliance a competitive advantage in Year 5. As proof of the success of that initiative, Richardson pointed out the Medicis is now recognized as one of the most ethical companies in the industry. And now, with those processes and policies in place, she considers the idea of moving into a post-CIA environment a “non-event.” Bert Weinstein agreed with that sentiment, stating that when the CIA ends, nothing should really change.

Alessandra Hawthorne from Boehringer Ingelheim focused on the importance of creating the right level of awareness as well as educating and informing colleagues around the world while Cinday Cetani of Novartis discussed the need to hire people who have extensive experience implementing a CIA and making sure a rigorous management certification process is put in place as part of that critical tone (and responsibility) from the top.  Weinstein agreed, saying that he reports to the CEO and president of the company.

Day 1, Enforcement Panel

During the U.S. Healthcare Fraud Enforcement Activity – Trends and Top Priorities, a panel of U.S. Attorneys and regulators from around the country shared their thoughts on emerging areas of focus, such as clinical trials, research and development and medical affairs activities.

Timothy Heaphy, from the U.S. Attorney’s Office for the Western District of Virginia, talked about the Abbott settlement and how his office wanted to make sure there was a change to the corporate culture at Abbott and the Board of Directors at the company would be part of the on-going compliance certification. He also reminded the audience that voluntary disclosure is meaningful and has an impact when in the settlement.

Carmen Ortiz, of the U.S. Attorney’s Office for the District of Massachusetts emphatically assured the audience that all the settlements have had an impact over the years and she reminded the audience that as part of the GSK settlement, the company’s president had to certify that they were in compliance and any breeches would be reported.

John Walsh, from the U.S. Attorney’s Office for the District of Colorado said companies need to make sure their compliance programs are set up in a way that makes them sure that someone can jump in and say “you can’t do that” while Margaret Hutchinson, of the U.S. Attorney’s Office for the Eastern District of Pennsylvania, focused on third party vendors and the use of the Parke Doctrine in prosecutions.

Not surprisingly, the recent Caronia decision was a focus, and Rick Blumberg, from the Office of Chief Counsel, for the FDA, warned that those in the industry need to be aware that the Cronia decision only pertained to free speech and it is not a reason for companies to think the government’s focus on illegal activity around off-label promotion will stop.

Day 1, Product Promotion Track

During the Lessons Learned from Recent Enforcement Actions Related to Product Promotion session of the Product Promotion Track, attorneys, Michelle Axelrod and Jennifer Romanski from Porzio, Bromberg & Newman, P.C., covered the current best practices for the promotional review process through lessons learned in recent legal actions.

Track chairman, David Sandoval, of Sigma-Tau Pharmaceuticals, began the session by revealing the 2012 statistics around OPDP letters. In 2012, OPDP issued 3 warning letters and 25 untitled letters, with the warning letters being for more egregious violations. In addition, “misleading and unsubstantiated efficacy claims” were the violations most cited in the warning letters.

Axelrod and Romanski warned the audience to beware of special promotional challenges in their material like patient testimonials. Through the use of  hypothetical scenarios, built around topics like disease awareness campaigns, they brought the potential risks and legal considerations associated with product promotion to light. They also addressed the risks of online media – pointing out that 12 of the letters issued in 2012 were for website promotions and 4 were for traditional media – broadcast or print.

The attorneys also addressed the Caronia case, saying the decision does not allow for the flexibility in off-label discussions by speakers. For example, the Merck letter was issues as a result of statements by speakers at a promotional program.

In the session focused on the role of compliance within the PRC structure, Alina Denis Jarjour, of Jarjour Legal, polled the audience on their roles in PRC. The trends in general, and in the room, showed that along with Medical, Regulatory, Marketing and Legal, compliance departments are playing more of an official role in PRC, with statistics showing:

  • 33% play a direct role (with25% being advised of minutes/attending periodically and 8% sitting on PRC as voting member)
  • 33% are consulted intermittently
  • 33% have no involvement.

Jarjour’s case for compliance being on the PRC, was extensive and included the need to help mitigate the highest level of risk on the spot and provide the required checks and balances.

In the Compliance Considerations When Participating in an Alliance session, Rich Sparago and Greg Feller of Boehringer Ingelheim Pharmaceuticals used specific examples and case studies to highlight the strategies and tactics for driving alignment between two companies during an alliance. When covering the topics to consider when entering an alliance, Feller listed speaker training as the most critical. The two men suggested a first step of sharing SOPs to determine where business practices are the same and where they are different. At BI, they use a grid to note the similarities and differences, with a red/yellow/green coding system. Then, representatives from the two companies meet to review the grids and develop an action plan to drive alignment.

Day 2, Keynotes

After a brief review of Day 1 by Kris Curry of Johnson & Johnson, Mit Spears, Executive Vice President, Executive counsel for PhRMA, spoke about the ways in which companies, regulators and law enforcement can work together to ensure compliance. He started by reminding the attendees that “a culture of compliance is more than just choosing to avoid the law” and compliance can no longer be viewed as a one-off task, separate for other businesses.

Spears was blunt in his comments though, emphasizing that he is unsatisfied with the expectations placed on the industry by OIG and FDA and he is looking forward to engaging the agencies on the realities of the relationships between industry and healthcare professionals.

Following Spears, Sean McKessey, of the SEC’s Whisteblower office provided a detailed explanation of the purpose behind the formation of his office and the rules pertaining to how whistleblower rewards are determined and subsequently paid.

Thomas Abrams, from the FDA’s Office of Prescription Drug Promotion was next, with his annual presentation covering the efforts of his staff over the past year and their focus for 2013. No surprises here, with areas like policy development and labeling reviews continuing to be a focus.  Abrams did provide a date for release of the Guidance on Social Media  – July 9, 2014 – as indicated in Section 1121 of the new FDASIA bill signed into law last year.

Matthew D’Ambrosio, Senior Vice President, Chief Compliance and Ethics Officer at Sunovion Pharmaceuticals then presented on Issues to Consider when Implementing the New FDA Guidance. D’Ambrosio delved into the FDA’s guidance on unsolicited requests for off-label information, and shared Sunovion’s process for documenting the request and providing the supporting information in an appropriate and legal manner.

In the breakout session on Planning and Delivering Effective Compliance Training, Jill Bruzga, Senior Corporate Counsel, Global Programs Group at Pfizer touched on the tone from the top point and as an example of how to put that policy into practice, shared the story of Pfizer’s president delivering the first 20 minutes of a recent compliance training session. Bruzga also brought up the critical need to have a comprehensive communication plan for compliance training to notify the learners in advance, inform them why they have to take the training and establish deadlines for taking the training.

My coverage of the conference concluded with Compliance Strategies for Small to Mid-Sized Companies, featuring Timothy Ayers of Dendreon, Dan Best of Meda Pharmaceuticals, David Stollman of Incyte and Jon Smollen of Endo Health Solutions, who covered the challenges of managing compliance as a one or two-person department.  While the panelists agreed that basically the risks are the same across the industry no matter the size of the company, they also agreed that they cannot approach compliance like a large organization and the key is to form allies throughout the company. As Dan Best pointed out, “compliance is still embedded in the business, that business just might be one person.”

Faced with the uneasiness of an industry in flux and on-going change, CBI managed to provide an anxious audience with two days of presentations that at least armed them with a range of useful tips and best practices to help guide them through turbulent times. Based on the reaction and participation of a grateful audience, the 2013 Pharmaceutical Compliance Congress certainly covered a list of well-targeted topics, from an impressive array of industry professionals, consultants and regulators.

Week in Review, February 4, 2013

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

The PharmaCertify™ Team

It was a big party weekend for those of us here at the News. Where else but in America can you celebrate such an awesome spectacle of determination, hope and excitement? Despite the outcome, we love the process or at least some part of it. Happily, this year the outcome was just as we’d all hoped…an early spring! Thank you Phil! We hope you all had an equally exciting Groundhog Day. And now, we begin with the other big news of the week.

Wouldn’t it be nice if we could find a groundhog that could predict when the final rule of the Sunshine Act might appear? Oh wait, we don’t need one. The fine folks at Pharmalot fired the warning shot that rule had been sent from the OMB to CMS, and the next day CMS sent out a press release saying the rule was available for viewing. The document is currently in a “preview” state and will be officially published on Friday, February 8th. Here’s what we know so far – CMS will require companies to report a few months of data in 2014 and companies must begin collecting data on August 1 of this year. The first report will be due March 31, 2014.

In response to the news, we’ve updated the PharmaCertify Sunshine Act App and we’re now offering a complimentary version on our website. The app provides pharmaceutical and medical device sales representatives with a high-level overview of the reporting requirements of the law and the information manufacturers will be required to submit to CMS. Just point your reps to http://www.pharmacertify.com/sunshine_act.asp and have them follow the download directions to get their copy.

Across the pond, the ABPI, Royal Physician’s Academy and several other organizations have formed a group looking to cast off the shadow surrounding industry payments to physicians. The group is discussing the idea of establishing a public record of payments made to physicians by the industry. The co-chair of the group, who is the president of ABPI, says that the group will develop principles on how a system of payment disclosure would work. They will not make recommendations on the type of payments to disclose.

A federal judge in the Eastern District of Pennsylvania has sent a qui tam case against AstraZeneca into hibernation. An executive with Medco accused AZ of entering into sham contracts with the company in order to induce the prescribing and dispensing of brand name drugs over generic drugs to patients on government plans. AstraZeneca argued the allegations brought by the qui tam relator were already publically known at the time he filed his case. The judge agreed and dismissed the case.

Cornell Law School has plans to bring light to False Claims Act whistleblower cases by launching a new class on the subject. The course will be taught by the law school dean and a top qui tam lawyer, and it will focus on how the law encourages and protects whistleblowers.

The Department of Defense is casting a shadow over spending on national CME. A policy put in place to reduce travel and conference costs has the Army and Navy evaluating how to make sure their physicians are getting the necessary CME. It could mean asking the physicians to attend smaller conferences and on-line programs. In a related note, the Association of Military Surgeons of the United States cancelled its November conference when they realized there would not be enough military and government physicians in attendance to make the conference worthwhile.

Well, that’s the news of the week that was. After a big weekend of Sunshine news, Super Bowl parties, and clever (and some not-so-clever) commercials, we’re happy to be back at work.

As we inch tauntingly closer to spring, have you considered freshening up your compliance training for 2013? PharmaCertify can help with updated modules and mobile apps that bring critical compliance content where your learners need it most – in the field and at their fingertips.

Have a great week everyone!

Week in Review, January 28, 2012

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

The PharmaCertify™ Team

Was last week cold enough for you? Arctic cold invaded the nation and brought crazy temperatures to the mid-west, northeast, and the deep south. As some friends in the mid-west pointed out, Chicago was colder than certain cities in Alaska last week. Well, at least January is almost over and we can look forward to spring! Speaking of something to look forward to, here’s this week’s News Week in Review.

The final rule for the Sunshine Act is still out in the cold, and it seems everyone is mad about it. AARP, the AFL-CIO and a number of other healthcare advocacy groups have written the White House, urging them to release the final rule toot sweet. The groups believe that the delay is having a negative impact on healthcare in terms of money spent on expensive brand-name drugs, and on patients who take these medications when older drugs are available. Not to be outdone, Senator Chuck Grassley sent a letter asking the President’s Chief of Staff to get this thing done. Grassley pointed out that Congress drafted the legislation so that the public would be aware of the payments physicians were receiving from the industry in September of this year, but that would now not happen due to the delay.

All is not hopeless on this front though. We learned that the OMB has de-iced the final rules for HIPAA/HITECH. Yes it is possible people. The rule will be effective in March of this year, with those affected having 180 days after that to come into compliance. The new rule will require insurers to enter into Business Associates Agreements when providing risk assessment services. It also clarifies the definition of a breach of PHI and changes the breach notification requirements.

Analysis by Mike Koehler suggests that a few settlements blanketed the reality of FCPA enforcement actions over the last six years. Koehler divided activity into single case actions and events and his investigation that may yield actions against multiple companies. The majority of FCPA enforcement occurred between 2007 and 2011, with three events in particular yielding a number of actions. While the statistics would suggest that the government has been very busy in enforcing the FCPA, in many cases the settlements are the result of one investigation with multiple settlement agreements occurring at the same time. Mr. Koehler believes compliance professionals should have an accurate picture of enforcement statistics, so they can best determine how to allocate their resources.

A new study reveals companies are not addressing vendors, CROs, and other external partners in their compliance training. The study finds that external training consumes 3% of a compliance teams’ budget and 1% of their time, whereas internal training uses 9% of the teams’ budget and 10% of their time. Often, the training responsibility falls on the department that enter into a contract with the service provider. Researchers suggest companies consider making the compliance department responsible for the training of external partners. Compliance teams have the most expertise in this area and are best equipped to assure external partners are adhering to regulations.

And speaking of training…you need it, we got it.  From federal and state disclosure laws to the FCPA and anti-bribery, PharmaCertify has the modules and mobile solutions for you. If you’re attending 2013 CBI Pharmaceutical Compliance Congress, stop by our booth, or visit www.pharmacertify.com to see a demo.

Enjoy the warm up everyone, before winter rears its ugly head again. Have a great week!

Week in Review, January 21, 2013

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

The PharmaCertify™ Team

Sing along won’t you? “Hooray for Hollywood, that screwy, bally hooey Hollywood.” Awards season is underway in Tinsel Town and as exciting as it is to root on your favorite actor, movie, singer or visual effects artist, seeing who is wearing this year’s swan dress on the red carpet is more fun. While we’re all waiting to see who will win at this weekend’s Screen Actors Guild awards this weekend, let’s take a look back at what walked down the red carpet of news last week, in this week’s News Week in Review.

Someone had to plaster on their “I’m not upset I lost” smile when judges refused to revive a whistleblower suit against Takeda. The U.S. 4th Circuit Court of Appeals agreed with a lower court that there was no evidence Takeda had caused false claims to be submitted for the heartburn drug, Kapidex. The whistleblower relied on statistical evidence to make his claim, and both courts agreed the evidence was general in nature and did not point to any specific instances where the law was violated

Restaurant owners and managers all around Massachusetts can be heard saying, “you like us, you really, really like us,” as they see the return of medical meal patrons after the state loosened the ban on meals provided outside a physician’s office. One restaurant owner says that although business is improving since the change in the law, he doesn’t expect to see it return to the levels seen prior to the law going into effect. Critics of the change in the law worry that the costs of these meals will be passed on to patients, and the stipulation that meals be “modest” is not sufficient.

While we all wait on the diva known as The Sunshine Act to take the stage, the Minnesota Board of Pharmacy has decided it will not require the submission of annual disclosure reports from wholesale drug distributors and manufacturers for 2012. The Board will ask the legislature to repeal the law requiring the reporting of physician spend. The gift ban will remain.

In recent years, the Academy has doubled the number of Best Picture nominees, and it seems that pay-for-delay deals are following suit, according to the Federal Trade Commission. The FTC says the number of pay-for-delay deals jumped to 40 last year from 28 the previous year.

The winner of the “Color Me Shocked…Not” award is…<insert drum roll here> the authors of a study that showed medical students are not fazed by links their professors have with the industry. The study was conducted at a medical school that had recently adopted a policy forcing faculty to disclose conflicts of interest to their students. While students felt their professors were more likely to recommend or speak about a product when a relationship existed between the professor and a company, the majority felt that lectures were unbiased.

Well, that’s it for this week’s News in Review. Remember, if your 2013 compliance training premiere plans include mobile, PharmaCertify can help, with iPad-ready modules and research apps that put critical compliance content at your audience’s fingertips.

Have a great week everyone!

Week in Review, January 14, 2013

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

The PharmaCertify™ Team

Achoo! Sniffle…Cough…Cough. Hearing a lot of that these days? The seasonal flu is at a full on charge, and the vaccine is in shortage in some areas. The best thing to do these days is wash your hands often and invest in facial tissue manufacturers! While you get your broker on the line and sanitize your keyboard, take your mind off the germs and catch up on the week that was in this week’s News Week in Review.

The FDA may be cutting short sleep time for women dealing with the flu, especially for those who are taking drugs containing the active ingredient, zolpiden. Clinical studies found that even after a good night’s sleep, levels of the drug were high enough to cause impairment the next day. The FDA is requiring the recommended dosage for women be cut in half and the labels changed for any products containing the ingredient.

The Texas Medicaid system received a $36 million shot in the arm from Pfizer and Endo when the companies reached a settlement in a Medicaid fraud case. The companies were accused of misreporting prices of generic drugs to the Texas Medicaid system. Each company will pay just over $18 million plus attorney’s fee.

The U.S. Supreme Court has agreed to hear arguments in the case of the Federal Trade Commission vs. Watson Pharmaceuticals Inc., which deals with whether reverse payments violate anti-trust laws. “Reverse payments” arise when a company holding a patent pays a generic company to stay out of the market for a period of time. Arguments are scheduled for late March.

It’ll take more than some Vitamin C and chicken soup to cure what is ailing a group of pharmaceutical executives in S. Korea. A group of current and former executives from the country’s largest pharmaceutical firm, Dong-A, were indicted for providing kickbacks to hospitals and clinics. The group is accused of providing $500,000 in goods and services, which included the remodeling of a hospital.

Apparently, Google may have passed a “virus” to UPS and FedEx. The two carriers find themselves in the throes of an investigation for their part in aiding and abetting the illegal sale of drugs by online pharmacies. Google settled similar charges in 2011, and some believe UPS will settle again. FedEx will fight the charges saying, “settlement is not an option when there is no illegal activity.”

You know what else is as widespread as the flu? Answer: False Claims Act recoveries. And by “widespread” we mean record breaking. In fiscal year 2012, the government brought in an eye-popping $5 billion in FCA recoveries. This brings the four year recovery total to over $13 billion. The DOJ is devoting more resources to investigating and prosecuting fraud and whistleblower filings are on the rise, so the upward trend is likely to continue. Qui tam relators also did quite well in 2012, receiving $439 million in share awards.

That brings us to the end of this week’s Review. Speaking of under the weather – how is your compliance training curriculum feeling these days? Could it use a shot in the arm? A little refresher perhaps? PharmaCertify offers the custom and off-the-shelf training needed to help ensure your reps have access to critical compliance content, when and where they need it most – in the field and at their fingertips.

Have a great week everyone, go wash those hands, and we’ll see you back here next week!

Week in Review, January 7, 2013

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

The PharmaCertify™ Team

Despite the doom and gloom “allegedly” predicted by the Mayans, 2013 arrived, and we’re all here raring to go for a new year! Well, maybe not raring…quite yet, but there is something rejuvenating about the turn of the year isn’t there – contemplatively looking back on the past year while looking ahead to the new year with hope. So time marches on, and so does the news. Let’s take a look at the happenings between the holidays in this week’s News Week in Review.

Victory Pharma didn’t go out on the happiest of notes in 2012, agreeing to pay $11.4 million to settle criminal and civil allegations surrounding the marketing of several of its products. Of the total settlement, $1.4 million was to resolve criminal allegations of violating the Anti-kickback Statute. The remaining $10 million is to resolve allegations of violating the False Claims Act. The case was brought by a whistleblower who was a former company sales representative.

And speaking of sour notes, 2013 didn’t start happily for a physician who blew the whistle on Amgen. A circuit court has denied the NJ physician’s petition for a court hearing to challenge the government’s recent $612 million dollar civil settlement with the company. The physician claims the government told him to either agree with the settlement or face the possibility of seeing his case dismissed. He declined to sign on, and now the government has asked the court to dismiss the case against Amgen. A lawyer for the physician says his client did not agree to the settlement because government prosecutors would not inform him of his share of the settlement.

A new survey from Ernst and Young shows that mid-market UK companies need to put learning about the UK Bribery Act on their resolution list for 2013. The survey of procurement managers and directors reveals that 64% of mid-market companies do not understand the law. Of those familiar with the law, just over half vet their suppliers for information on how to comply.

As you may know, in December of 2012 Eli Lilly settled allegations of violating the FCPA. In case you haven’t had time to read the enforcement action against Lilly, we have good news for you; Tom Fox has posted a brief video with an overview of the enforcement action, along with the specific internal audit function lapses cited by the government.

The American College of Obstetrics and Gynecology (ACOG) is ringing in the New Year with an update to its policy on professional interactions with the industry. The new policy encourages ACOG members to refrain from taking part in speaker’s bureaus; discourages professionals from accepting gifts (including meals) tied to promotional information; and encourages the provision of  vouchers or samples only to those with a “true need.”  The new policy also encourages physicians to  attend device training conducted by a professional association that has CME accreditation or only attend training focused on the FDA-approved use of the device. The policy also covers ghostwriting and research.

So is the idea of updating your compliance courses on your list of 2013 resolutions? How about investigating mobile technology for expanding the delivery of compliance content? Pharmacertify can help, with custom and off-the-shelf solutions designed to integrate compliance training throughout your company. Check out our course listing and mobile learning options at www.pharmacertify.com.

Happy New Year from all of your friends at the News Week in Review! Have a great start to the year everyone.

Week in Review, Fa-la-la-la-la Edition

NXLevel Compliance Team

The PharmaCertify™ Team

Stockings hung? Presents wrapped? Run out of ideas for your Elf on a Shelf? Christmas Day is just about here! Woo Hoo! But before visions of Sugarplum Fairies begin dancing (rule 1, stay away from the punchbowl at the office party) or you face the challenge of another gingerbread man, we have some news from the world of compliance. We know it’s not necessarily as much fun as popping another rum ball, but it’s definitely more fun than facing the crowd at mall. So grab a cup of eggnog and check out the news that was in this week’s News Week in Review.

Break out the Christmas Crackers, our first story takes us across the pond to the U.K. Since the U.K. Bribery Act went “live,” there hasn’t been much noise on prosecutorial front. But don’t let the silent act fool you, there were a number of  significant developments with the law.  The Serious Fraud Office (SFO) issued new guidance and guidelines, largely revolving around self-reporting. The new head of the SFO made it clear that self-reporting was not a guaranteed way to avoid prosecution.

Now we’ll pass the paper crown over to the folks from the land down under. The Australian Competition and Consumer Commission (ACCC) has approved a pharmaceutical industry Code of Conduct, which will require companies to disclose how much they pay physicians in speaker fees and sponsorships to attend medical conferences overseas. The ACCC gave the industry two years, instead of the five that had been requested, to come clean on the payments.

Speaking of physicians, pharma, money and conflicts of interests, a joint analysis by the Milwaukee Journal Sentinel and MedPage Today found that committees responsible for writing treatment guidelines are rife with physicians who have financial ties to the pharmaceutical industry.  In their analysis, the publications looked at treatment guidelines for 20 of the top 25 drugs sold in the U.S. They found that the committees to be largely populated by doctors with ties to the industry and some panels did not require doctors to disclose those ties. In addition, guidelines were sometimes written without scientific evidence showing the drug is safe for use.

Cash for Christmas: some think it’s a thoughtless and callous idea, others think it’s filled with logic. We think the feds may be in the latter camp considering the number of settlements announced recently. This week’s givers are Amgen, Sanofi and after much wrangling, Orthofix.

Amgen will pay $762 million to resolve criminal and civil allegations it illegally marketed one of its products. The company pled guilty to misbranding and will pay $150 million in criminal fines and forfeiture. The remaining $612 million of the settlement is to resolve civil claims.

Sanofi will pay $109 million to resolve allegations that it violated the Anti-kickback Statute and False Claims Act. According to the DOJ, the company provided free samples of product to physicians in order to induce them to purchase the product. The company also submitted a false Average Sales Price (ASP) to the government.

Orthofix gained court approval on a $43 million settlement in an Anti-kickback case and the company will pay $7.6 million in criminal fines and $32.3 million to settle civil allegations. The whistleblower case alleged sales reps submitted false certificates of necessity to Medicare for several of the company’s bone growth stimulators. The company pled guilty to failing to disclose the information during a Medicare audit in 2008.

2013 planning and resolutions are in the air at the various government agencies who handle compliance matters. At the Food and Drug Law Institute’s “Enforcement, Litigation and Compliance” conference, Greg Demske of the OIG said the agency hopes to hold more roundtables with the industry in the coming year. Michael Blume of the Consumer Protection Branch (CPB) of the DOJ, discussed whistleblower cases and said CPB will most likely start imposing its own requirements on companies, in addition to those imposed by the OIG through CIAs.

The recent U.S. v. Alfred Caronia decision was a hot topic at the conference as panel members suggested the ruling could have implication on future calculation of damages to the government, particularly when false claims are involved.

That brings us to the end of this week’s Review. Time for us to sled off into the weekend and toward a joyous holiday! Or perhaps to fit in one more last minute trip to the mall.

Have a save and very Merry Christmas everyone!

The Year in Review

NXLevel Compliance Team

The PharmaCertify™ Team

(Hey, everyone does one. Why shouldn’t we?)

We’re shaking things up a bit. Rather than bring you our weekly review of the news from the world of life sciences commercial and corporate compliance, we’ve decided to take a look back at 2012. That’s right, this week we’re bringing you a “Year in Review.” We’ve selected a few key developments that stood out as noteworthy and very well may shape the landscape of compliance going forward. So, settle in and fire up Call Me Maybe (The song of 2012. This is a safe space, you can admit you downloaded it) in the background, and join us for our first Year in Review.

First up is GSK’s $3 billion settlement with the DOJ. According to the DOJ, GSK illegally promoted certain drugs, concealed safety data and falsely reported prices to the government. While the fines and penalties involved were record breaking, what made this case notable was the resulting Corporate Integrity Agreement with the OIG. Two of the new provisions in the CIA involved compensation. First, the OIG usurped GSK’s change in its incentive compensation plan for sales representatives and made it part of the CIA. The OIG also required GSK to set up a program to recoup bonuses and long term incentives of any executives found guilty of misconduct.

Time will tell if the GSK provisions will only be implemented in the more “egregious” cases going forward, or will become the norm. Either way, the OIG has sent a message that the industry does need to examine how it handles incentive compensation for executives and customer-facing employees.

In 2012, we witnessed the release of the long-awaited DOJ guidance on the Foreign Corrupt Practices Act. One year after an update was promised by Assistant Attorney General Lanny Breuer, the DOJ delivered the document. While the guidance was largely a restatement of existing prosecutorial thinking from the DOJ and SEC, it did provide clarity on some issues, like the definition of foreign official and successor liability. The document also included a number of helpful case studies regarding the provision of gifts and entertainment.

The lack of movement on the Sunshine Act is our next big story for 2012. CMS had provided the draft rule for the Sunshine Act in December of 2011, and at that time delayed the data collection start date until after publication of the final rule. Comments on the draft were then submitted by various stakeholders and we expected a final rule to be published in April of this year. Well, the final rule languished, and CMS eventually pushed back the data collection start date to January 1, 2013. There was plenty of finger pointing, with legislative types coming down on CMS and CMS blaming the Office of Management and Budget. In November, the OMB owned up acknowledged that it had received the final rule November 27th and would be reviewing the document. (Please note – OMB has 90 days to issue the final rule.) So here we are, nearly a year later, still no final rule, and data collection is just around the corner. Stay tuned. Who knows, maybe Santa will bring us all a final rule for Christmas.

We complete our look back at 2012 with the recent developments in the U.S. vs. Caronia off-label case, which could also be known as “FDA Regulations vs. the  First Amendment.” For now, the First Amendment is winning. The U.S. Second Court of Appeals overturned a lower court decision, saying the previous conviction violated Mr. Caronia’s First Amendment rights. The case was sent back to the lower court to be re-tried. In its decision, the Appellate Court said that “the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA approved drug.” The court does not believe the FDCA precluded the sharing of truthful information about off-label uses of FDA approved drugs. While off-label promotion cases have been the bread and butter for government efforts the last several years, most companies choose to settle rather than go to court over the interpretation of the law.

Since this is an Appeals court ruling, the decision only applies to handful of jurisdictions, although some legal experts have suggested this could end up before the Supreme Court. Do you get the feeling we might still be talking about this one as a top story in 2013?

Well, that brings us to the end of our Year in Review. Are there any big stories we’ve missed? Feel free to comment on this blog, hit us up on Twitter (@pharmacertify) or start the conversation in our LinkedIn group. We’d love to hear from you!

Thank you so much for checking in with us weekly as we review the news nuggets from around the world of corporate and commercial compliance. We hope 2012 was a great year for you and yours and best wishes for a safe and joyous Holiday Season!

Compliance and the Petraeus Scandal

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By Lauren Barnett

PharmaCertify™ Compliance Specialist

CBS Moneywatch recently ran an article about the lessons businesses could learn from the situation that brought on the resignation of General Petraeus as Director of the CIA. Is there a compliance lesson to be learned here? If we look at the situation through the corporate lens and skip past the “soap opera” elements, we have a classic whistleblower situation. Let’s set the scene.

Person P is a high ranking, highly esteemed individual knocking on the door of the c-suite. As it turns out, Person P and Person B are engaged in some sort of activity that is at best unethical, and at worst, illegal, and that activity could cause a problem with the government. Person K knows about it, but doesn’t feel the need to say anything until Person B starts dishing out threats; perhaps saying to keep quiet, or threatening Person K’s position within the company. Person K decides the time is right to come forward and report the threats, as well as the activity of Person P and Person B. The investigation eventually results in Person P resigning his position.

So what went right? First, Person K identified the questionable activity and had access to a method for reporting it. Through training provided by the company, Person K knew the activity was not permitted. The company had procedures in place  to allow Person K to report the issue, and also created an environment in which Person K felt comfortable coming forward to report the issue.

Second, the report was taken seriously and was investigated. The high ranking status of Person P was a non-issue and the evidence brought forward was not swept under the rug to protect Person P.

Third, there were repercussions (as far as we know) for Person P and for Person B. Again, the rank of Person P was not an issue. We don’t know if the company allowed Person P to resign or if Person P saw the writing on the wall and chose to leave before the company imposed its own discipline. In either case, there was no effort to cover up the situation or simply slap Person P on the wrist.

Sounds like a textbook handling of the situation, right? Well not completely. Unfortunately, Person K didn’t come forward as soon as she knew Person P and Person B were involved in unethical or illegal activity. She waited until she was  threatened to file a report. Maybe Person K simply didn’t care about the activity, despite the fact it could mean trouble for the company. Or, perhaps she feared retaliation or assumed no punishment would occur due to the status of Person P.

Communication is key. Employees need to know the policies apply to everyone, regardless of rank or their perceived value in the company. The policies regarding the protection of those who do come forward also need to be communicated throughout the organization.

These situations are never easy, and admittedly it can be daunting for employees to come forward. (And if we’re being honest here, whistleblower awards from the government don’t make it any easier.) It all starts with training and communication about what constitutes appropriate behavior and the responsibility of each employee to ensure that business is conducted appropriately. Whether through an open door policy and/or an anonymous reporting hotline, employees need a clear pathway to report problematic behavior. However, it will all be for naught if the company doesn’t take reports seriously, conduct a thorough investigation and then act to correct the behavior.

Week in Review, December 10

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The PharmaCertify™ Team

Tis the season for giving. And if you ask us, “giving” represents the best part of the season. Sure, there’s the stress of coming up with just the right gift for that friend who doesn’t want to offer any hints, or the pressure of deciding whether to pick from the pile or “steal” from your coworker at the company’s yearly White Elephant. So before you’re faced with such daunting decisions as whether a Chia Pet or Pet Rock (how’s that for a dated reference?) makes more sense, we offer our gift to you: the week’s News in Review.

We begin with the week’s big surprise gift. The Second U.S. Court of Appeals overturned the conviction of a former sales representative for promoting a product off-label. The court agreed with the sales rep’s contention that his First Amendment rights were violated and the case was sent back to the lower court for reconsideration. The court also cited the reversal of Vermont’s data mining law by the Supreme Court in support of its decision.

Speaking of First Amendment cases, a former InterMune executive is appealing his conviction for wire fraud, which was based on a press release that touted the use of one of the company’s products for unapproved uses. The executive’s argument is based on his right to express a scientific opinion and the government is arguing that the First Amendment does not protect fraudulent speech, even if it “concerns scientific matters.”

While some may consider the FCPA guidance to be a gift that keeps giving throughout the year, the pharmaceutical and medical device industries would be hard pressed to agree. Michael Volkov, partner at the law firm, LeClairRyan, points out that the guidance confirms that life sciences professionals are operating in a high risk environment, where interactions with physicians can be problematic in regard to the FCPA. Volkov cites three takeaways for pharma and med device. First, doctors are foreign officials or instrumentalities and nothing in the guidance indicates that the government intends to back away from that position. Second, companies are liable for their distributors and sub-distributors and due diligence is a must when doing business overseas. Third, companies need to be careful when considering medical conferences, since foreign doctors have significant expectations for company-sponsored attendance.

Healthpoint Ltd. and DBF Pharmaceuticals picked the gift that no one wants; a fine. The companies agreed to a settlement of up to $48 million to deal with False Claims allegations over the product, Xenaderm. The government contends that the active ingredient in Xenaderm was found to be less than effective for its intended use in 1970, making the ointment ineligible for reimbursement by Medicare and Medicaid. Further, the companies were not forthcoming about the regulatory status of the ointment, causing false claims to be submitted to the government. The companies will pay $28 million to resolve the allegations, with another $20 million to be paid if either of the companies experiences a change in ownership over the next three years.

It’s time to tie the last ribbon and bow onto this week’s News in Review. Remember, if iPads are on the gift list for your sales reps this year, PharmaCertify offers the app development and mobile training programs you need to ensure critical compliance information is at their fingertips year round.

Have a great week everyone, and happy giving…and we suggest the Chia Pet.