CMS

The Pharmaceutical and Medical Device Compliance Congress: A Preview

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

The Seventeenth Annual Pharmaceutical and Medical Device Compliance Congress gets underway in just a few short weeks. The annual gathering provides an opportunity for industry professionals and experts to learn from one another and hear from representatives of enforcement agencies. Whether your focus is international compliance, U.S. compliance, transparency, or risk assessment, the conference has something for everyone. We’ve reviewed the agenda and compiled a list of what we see as some the most compelling presentations.

Several sessions focus on compliance issues in managed markets. The preconference Managed Markets 101 review covers private payer systems, market access programs, and government payer systems. The session should provide helpful content and practical examples for those needing to train managed market personnel and salespeople.

If you’re not able to attend the preconference, there are also two managed markets mini summits on Day 2. The morning session covers compliance issues affecting managed markets in general and the afternoon one is focused on audit and monitoring issues. We expect both to spark worthwhile discussions among panel and audience members.

The Pharmaceutical Compliance Forum planners always do a great job of scheduling a variety of sessions dealing with compliance issues in markets outside of the U.S. This year is no exception, with preconference, plenary, and breakout sessions addressing global issues. Since the first transparency reports were filed by EFPIA members over the summer, unpacking what has been learned from the data, and discussing the challenges faced by companies thus far, will be of interest to anyone involved in global transparency.

We are also interested in the keynote address on Day 1 by Sophie Peresson, LLM, MA, Director of Pharmaceuticals & Healthcare Programme for Transparency International. (FYI – the printed brochure has this listed as the keynote for Day 2, but the website has it scheduled as the second keynote on Day 1.) The organization, well-known for its work addressing corruption, recently focused its attention on the pharmaceutical industry, so Ms. Peresson’s presentation should be valuable for companies mapping their future transparency training plans.

Finally the day two mini-summit titled, “Reimbursement Support, Patient Assistance Programs, Coupons, and Charitable Foundations” is another one on our radar. Enforcement agencies have sharpened their focus on these programs, and the area could be the next target for investigators. The panel includes both industry and legal professionals.

Now, we’re interested in your opinion. If you’re attending the conference, stop by the PharmaCertify™ booth in the exhibit hall between sessions and let us know what you think of the sessions and speakers. While you’re there, don’t forget to enter our drawing for a Bose® Soundlink® Bluetooth® speaker.

See you in Washington and stay compliant!

Compliance News in Review, July 26, 2016

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Executives on trial, an FCA settlement, a “clarification” to a change in the District of Columbia detailer law, and an Open Payments open forum…all in this edition of the Compliance News in Review.

What do Teddy Roosevelt, Rob Lowe, and a chair have in common? They have all provided some rather famous, if not infamous, moments at the national conventions of the Democratic and Republican parties. Part pep rally, part three-ring circus, and part critical component in the fabric of this great democracy, the conventions are underway, and they have certainly provided entertaining television during the doldrums of summer. If your senses need a break from the constant barrage of politicking and speechmaking, let us gavel in all compliance news fit to blog, with this edition of the Compliance News in Review.

Guilty or not guilty? It was a little bit of both for two executives from Acclarent, who were on trial for selling misbranded and adulterated medical devices. The jury found the pair guilty of misdemeanor charges distributing misbranded and adulterated devices, but acquitted them of felony charges. Lawyers for both defendants said they felt confident that their clients would eventually be cleared on the misdemeanor counts.

Speaking of Acclarent, the company agreed to pay $18 million to settle allegations that it caused false claims to be submitted to government health programs. The government contended the Acclarent marketed one of its devices for a use that was rejected by the FDA.

The Washington D.C. Department of Health (DOH) released an FAQ sheet that was about as clear as most political speeches. The document is intended to provide guidance regarding a recent change to the D.C. detailer law. Unfortunately, it may have raised as many questions as it answered. The DOH recently made a change establishing that anyone engaged in detailing for less than 30 consecutive days did not have to obtain a license. Confusion seems to center on the Department’s definition of “consecutive.” The FAQ states that the exemption applies to those “individuals, such as speakers at a conference, who come to the District once a year, or other persons that come once a year for a short duration of time of less than 30 consecutive days.”” Makes sense right? But the FAQ also states the exemption is not meant to cover an individual who may come to the District for a few days, more than once during a calendar year. So how many visits to D.C. require registration as a licensed detailer? Stay tuned.

The Centers for Medicare and Medicaid Services (CMS) is conducting a “focus group,” of sorts. The agency is conducting a stakeholder forum on August 2 to solicit feedback on rulemaking and potential improvements to Open Payments. The forum is intended to give stakeholders an additional opportunity to comment on the recent questions posted by CMS about Open Payments in the proposed 2017 Physician Fee Schedule.

Well, that’s a wrap on this politically-charged edition of the Compliance News in Review. We now return you to your regularly scheduled convention coverage.

Stay compliant!

Compliance News in Review, July 14, 2016

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The Serious Fraud Office has its second application for a DPA approved, CMS solicits feedback, and experts are dismissed from an advisory panel due to perceived conflicts.

It’s hot, it’s humid, and the editorial staff at the New Jersey AND Georgia offices of the Compliance News in Review is already desperately seeking safety from the sun’s intense rays. The dog days of summer have arrived with gusto. If you’re looking for a good reason to spend a few more minutes in the comfortable confines of an air conditioned office or home, we suggest a deep dive into the cool waters of this edition of the CNIR, and all of the compliance news fit to blog.

Deferred Prosecution Agreements (DPAs) seem to be no sweat for the Serious Fraud Office (SFO). The agency has had its second application for a DPA approved in a case that involves violations of the UK Bribery Act. The company involved agreed to pay $8.48 million in fines and disgorgement. It must also report annually on its third-party intermediary transactions and compliance programs, and continue to cooperate with the SFO. The DPA remains in effect until 2020, but it may be terminated in 2018 if the company meets its financial obligations by then.

The Centers for Medicare and Medicaid Services (CMS) is basking in the Sunshine these days. In the proposed 2017 Physician Fee schedule, the agency solicited feedback for a number of questions related to the Open Payments program. The questions cover record retention, issues related to teaching hospitals, and the nature of payment categorization. Of particular note, the agency is seeking feedback about the benefits of pre-vetting payments with covered recipients and issues related to uploading data to Open Payments.

In an indication that their relationships with industry were a little too hot to handle, several experts have been removed from a panel that is responsible for advising the FDA about painkillers. The panel was created by the National Academies of Science, Engineering and Medicine, a larger advisory group to the FDA. The removal of the panel members appears to have been spurred by a letter Senator Ron Wyden sent to the Academy of Medicine complaining that some panelists had received support (in the form of grants) from pharmaceutical companies. One panelist, Dr. Mary Lynn McPherson, says the support in question did not go to her directly, it went to the university where she is on staff, and was in the form of unrestricted grants so the pharmaceutical companies never had input on how the money was used. Another of the dismissed panelists, Dr. Gregory Terman, says he was removed because the nonprofit group he heads received funding from several pharmaceutical companies. Terman says his association with the nonprofit was well known, and he has gone out of his way to avoid conflicts of interest.

The last story serves as a reminder that much of the data regarding the relationship between healthcare professionals and the industry is presented with little context as to the nature and reasons for the payments. HCPs are understandably sensitive about receiving certain transfers of value, and they have questions about how those TOVs are disclosed. Your transparency training should remind learners that they need to be sensitive about these concerns, and educate them on the proper protocol for addressing HCP questions about data.

With that, we close this mid-summer edition of the Compliance News in Review. Stay compliant and stay cool.

Compliance News in Review, July 5, 2016

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Another organization calls for a ban on Direct to Consumer advertising, two former industry sales reps are arrested for kickbacks, a former executive is acquitted on kickback charges, and CMS releases update TOV data.

Strike up the band and light up the fireworks! The American Experiment marked its 240th year this weekend. So, it’s fitting that the hottest ticket on Broadway these days is the story of one our nation’s founders. Since most of us won’t be lucky enough (or rich enough) to score tickets to Hamilton in celebration , we had to stick with the old standbys of parades, barbecues, fireworks. To cap the holiday weekend, we offer a new tradition to add to the list, the Independence Day edition of the Compliance News in Review.

The fireworks continue regarding DTC advertising. The American Society of Health-System Pharmacists is the latest group to express a desire to see DTC advertising of prescription drugs banned. In the past, the organization has been supportive of the advertising, as long as it meets certain criteria. Since it now believes the industry is ignoring the criteria, the group has withdrawn its support. A spokesperson says a complete ban is not possible, but he hopes this action will lead to a discussion between industry and healthcare providers about DTC ads. The current model of DTC advertising is outdated according to the spokesperson, and pharmacists and providers are spending too much time explaining to patients why drugs they see in ads are not appropriate for them.

A pair of former Insys sales representatives could be losing their independence in the near future. The two were arrested for allegedly paying over $250,000 in kickbacks to doctors who wrote prescriptions for the painkiller fentanyl. The complaint alleges that most of the money was paid for serving as speakers at programs that were essentially social functions. Very little, if any, educational information was shared, according to the complaint, and following the programs, the sales reps would often take the doctors out for drinks and other entertainment. In a statement, the company says the sales reps were no longer employed and company policy prohibits the giving of cash or other items of value as inducements for writing prescriptions.

It was no tea party in Boston for the feds in a case against a former Warner-Chilcott executive. W. Carl Reichel was acquitted of charges that he paid kickbacks to doctors. Prosecutors charged that the former executive created a strategy of paying kickbacks to doctors in the form of sham speaking fees, money, and free meals in exchange for writing prescriptions of Warner-Chilcott drugs. US Attorney Carmen Ortiz said the charges against Mr. Reichel were warranted, and while cases against executives are difficult to prove, they’re necessary to deter improper conduct.

CMS sent out its annual declaration about Open Payments data. The payment and transfer of value data has been published, and is now publicly accessible. This year’s data represents nearly 12 million records covering $7.52 billion paid to physicians and teaching hospitals. As usual, research payments account for the largest share of the total amount.

This edition of the News in Review reminds us that the consequences of non-compliant behavior can be quite personal. When the big headlines tend to be about the multi-million and multi-billion dollar settlements paid to settle charges of fraud and non-compliance, convincing individuals that there is also a price to pay can be challenging. Citing cases like these in your training is one way to inform commercial staff and executives of those consequences.

While we don’t advocate turning compliance training into something akin to “Scared Straight,” sharing the full landscape of government enforcement actions is important. This is especially true following last year’s memo from Deputy Attorney General Sally Yates about the DOJ’s emphasis on holding individuals accountable in cases of corporate wrongdoing.

That’s it for this edition of the Compliance News in Review. Stay compliant!

News in Review, June 15, 2016

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Federal investigators subpoena information related to charitable organizations from three companies, Congress proposes an amendment to the FDCA, the head of the FDA speaks on off-label information, and New Hampshire’s Attorney General targets the manufacturer of a popular painkiller.

The temperatures are rising well past 70 degrees Fahrenheit and that can only mean one thing…time to hit the beach! Pack up the station wagon, minivan, or whatever mode of transportation best accommodates your gear and head to the sand and surf for some fun and relief from the heat! Of course, the standard precautions and warnings are in order: use plenty of sunscreen; mind the flags regarding ocean conditions; and above all, be wary of teens resembling Frankie Avalon and Annette Funicello bursting into fits of random dancing and singing (now there’s a dated reference for you). Of course, you’ll need plenty of reading material before you drift off into a coconut oil scented daydream. So after you finish the latest from Mary Higgins Clarke or that true crime tome, please enjoy the next best beach read…this edition of the Compliance New in Review.

The waves of compliance just got slightly chopping for a trio of drug manufacturers. Three companies, Gilead, Jazz and Biogen, received subpoenas from federal investigators for information related to their relationships with charitable organizations that help patients with medication costs. Charities receiving support from industry companies claim those companies have no say or influence on which patients they help or what drugs are covered. The government’s concern centers on whether the contributions are essentially illegal kickbacks.

Oh sunny day – a panel of the House of Representatives Energy and Commerce Committee proposed an amendment to the Food, Drug and Cosmetics Act that would allow companies more leeway in sharing truthful off-label information. The proposed amendment would limit the definition of intended use to the manufacturer’s “objective intent,” and allow for the dissemination of materials for scientific exchange, if the information in the materials is backed by scientific evidence. The panel expressed concern about the need for doctors to be kept abreast of the latest medical information, and frustration at the lack of movement by the FDA on guidance related to the dissemination of off-label information.

The head of the FDA also rode the off-label promotion wave when he spoke at the BIO International Convention. In his remarks, Robert Califf noted that supportable information worth sharing should be included on the product’s label, and he questioned why companies would not include useful information on the label or in the prescribing information. Califf also encouraged the industry to embrace social media, saying, “the best way to develop products in the future is likely going to involve a lot of people with diseases to have a handle on what their needs are, what their expectations are, and what their risk tolerance may be.”

As expected, Vermont was first in the water with a law requiring transparency of drug pricing. State officials will identify 15 drugs for which they want information about the reasons for price increases. The manufacturers of those drugs will have to submit information to justify the price increases.

New Hampshire Attorney General’s office has filed suit against Purdue over the company’s refusal to provide documents related to the marketing of OxyContin. The AG’s office claims the company is providing HCPs with misleading information regarding the product. The suit claims the company touts the drug lasts for 12 hours, and it also does not appropriately address end-of-dose failure. The AG also claims the company downplays the risks associated with addiction. Purdue says it is more than willing to cooperate with the investigation, provided the AG’s office does not share any documentation with private attorneys. The company believes a financial conflict of interest exists with the firm retained to assist in the investigation, and it should not be compelled to turn over information while a court case is pending.

A report from Reuters questions the independence of firms hired by companies under a CIA to serve as an Independent Review Organization (IRO). Unlike other agencies, the Department of Health and Human Services does not prohibit companies under a CIA from hiring an IRO with which they have an existing relationship. Critics claim those arrangements represent a conflict of interest. A representative of the HHS Office of Inspector General (OIG) said she has not witnessed any issues with these arrangements. Spokespersons for various industry companies said they disclose all their business relationships to the OIG in advance.

The seas have also been choppy for Salix Pharmaceuticals recently. The company agreed to pay $54 million to settle allegations it provided kickbacks to physicians for prescribing its products. According to the DOJ, the company admitted to paying doctors to be speakers for the company as an inducement for prescribing its products. The government claims the programs at which the doctors spoke were largely social in nature and provided little or no information related to a product. In addition to resolving the federal case, the settlement will resolve several related state fraud cases.

That’s all for this edition of the News in Review. Until next time, we wish you safe sailing and calm compliance waters!

The 2016 Pharmaceutical Compliance Congress: a Preview

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On April 26 and 27, compliance professionals and government representatives will gather in Washington, D.C. for the 13th Annual Pharmaceutical Compliance Congress. As usual, the conference offers a cornucopia of sessions and workshops focused on important compliance topics. There is plenty to see and learn, but here are the topics that have piqued our interests:

Day One General Session: FMV Considerations and Emerging Compliance Risk – In this age of transparency, FMV is a hot topic for life science companies and healthcare providers alike. This session, along with the breakout sessions on the same topic, offer a great opportunity to identify emerging risks related to FMV, and learn best practices from industry colleagues.

Day One General Session: EFPIA Initiatives for 2016 and Beyond — Charting the Course for Global Transparency – EFPIA members have completed their first year of data collection to comply with the Disclosure Code. We’re hoping to hear about the early challenges companies are facing and EFPIA’s plans for the future of its transparency initiative.

Day One Track: Product Promotional Compliance – In particular, we are interested in two sessions:

Social Media — New Challenges and Opportunities: While social media presents a unique set of challenges, its affect on life sciences marketing and compliance has to be taken into consideration.

Speaker Programs and Medical Roundtables — Environment and Areas of Risk: In this era of increasing scrutiny, we’re specifically interested in hearing about the emerging risks surrounding roundtables and the strategies for mitigating those risks.

Day One Workshop: Analyze FCPA Updates and Identify Areas of High-Risk to Mitigate Non-Compliance, paired with the Day Two General Session FBI address, International Corruption Squads – the FCPA and Beyond – At the end of 2015, the DOJ announced that it planned to hire 10 additional attorneys for its Fraud Division FCPA Unit. Also, the Serious Fraud Office entered into its first corporate Deferred Prosecution Agreement for violation of the U.K. Bribery Act last year. Enforcement of anti-corruption laws continues to be a priority for the U.S. and governments abroad. Learning about the emerging risk areas, and how various agencies cooperate in enforcement, is key to ensuring that your anti-corruption program is covering all the right bases.

Day Two Track: Fraud, Abuse and Kickback Prevention – The scrutiny of payments to physicians is only going to increase as more entities comb through transparency data. Concern from investigators and enforcement agencies about the potential for kickbacks is growing. The discussion on anti-kickback enforcement trends, and the establishment of compensation limits will be helpful when addressing your organizational kickback risks.

Day Two Discussion Group: Focus on Pricing – Considerations for Compliance as Scrutiny Heats Up – Last year, we saw the largest settlement ($12.4M) under the OIG’s Civil Monetary Penalties Authority. The settlement was over price misreporting, and enforcement in this area isn’t about to let up. This session presents a great opportunity to learn about best practices and the challenges compliance professionals are facing regarding government pricing.

Day Two Track: Compliance Program Structure and Effectiveness – Engage the Organization to Promote Ethics within Compliance

Okay, we may be a bit biased on this one, since Peter Sandford from NXLevel Solutions is one of the presenters, but as your training audience evolves, so should your compliance training. As millennials bring a new sense of energy and expectations to the industry, implementing modern and innovative learning strategies is more important than ever. Peter and his co-presenter, Jim Massey – Vice President, Global Compliance, Enablement & Assurance, AstraZeneca, will share five key principles for integrating creative and engaging compliance training into your organization.

We invite you to stop by the NXLevel booth to see demos of our compliance-focused training solutions and to share your thoughts on the sessions. And while you’re there, don’t forget to enter our drawing to win a Bose® SoundLink® Bluetooth speaker.

Stay compliant and we’ll see you in Washington!

Compliance News in Review, Ides of March Edition

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BMS makes changes to its promotional spend policy in China, a physician is sentenced to prison for accepting kickbacks, and the FDA agrees to allow Amarin to promote its fish oil drug for off-label purposes.

“Beware the Ides of March,” and with good reason. Not only was Julius Caesar assassinated during the Ides, but Czar Nicholas II abdicated his throne, the Nazi’s occupied Czechoslovakia, and the issuance of global health alert concerning the SARS virus all occurred on that infamous date. While plenty of good things probably happened as well, we’re stocking up on horseshoes and four leaf clovers here at the News in Review headquarters, just in case. As we wait for the clock to tick down on March 15th, let’s look at the fortunes of those who made news in the world of compliance, with this edition of the News in Review (fingers crossed it isn’t all bad).

Advice from a soothsayer isn’t necessary for BMS to make changes to its promotional spending policy in China. The company will no longer pay speaker fees to doctors, and will be cutting is spending on entertainment and donations to medical associations due to red flags identified in its Chinese operations. This is second wave of changes for BMS in China, following the company’s settlement with the SEC over violations of the FCPA.

Misfortune has certainly followed one Chicago doctor into March. Dr. Michael Reinstein was sentenced to nine months in prison for accepting kickbacks when issuing prescriptions for clozapine. The doctor admitted to accepting close to $600,000 in kickbacks for prescribing the drug. The defense requested probation, but the judge rejected the request, saying Dr. Reinstein’s patients were among the most vulnerable in society and he violated the trust of those patients when he accepted the kickbacks.

The news isn’t all bad in the Ides, though. The FDA has agreed to allow Amarin to promote its fish oil drug for off-label purposes. Amarin filed suit against the FDA claiming the agency was violating its free speech rights by trying to restrict the company from sharing truthful off-label information in its promotion of the drug. The FDA agreed to be bound by the decision issued in US District Court, which allowed the truthful off-label promotion of the drug. The agency says “the settlement is specific to this particular case and situation, and does not signify a position on the First Amendment and commercial speech.”

As witnessed by the FDA’s statement on the Amarin settlement, a definitive stance regarding the use of off-label information when promoting a product seems to still be a moving target. While companies and legal-types debate how this decision, and other free-speech cases, should be interpreted and applied, we see it as another opportunity to highlight all the legal requirements around product promotion. Providing fair-balance, making accurate, truthful and not-misleading statements are just as important when promoting a prescription drug or device. As an example, notice of violation letters sent by OPDP in recent years typically site inaccurate and misleading statements as the reason for the notice.

With that, we put a green ribbon on this “pre” Saint Patrick’s Day edition of the Compliance News in Review. Here’s hoping the Ides treat you well. Have a great week everyone and stay compliant!

Compliance News in Review, February 23, 2016

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Did you feel the awakening? It was as if a million voices cried out in joy, then were suddenly, silently going about their business again. Geekerati rejoice! The Star Wars: Episode VII video announcing the beginning of production on the next installment has been released. December 15, 2017 can’t get here fast enough! We’ll have to wait to learn about what happens in that galaxy far, far away, but in the meantime, we can at least keep up with the recent news from the compliance universe, with this edition of the Compliance News in Review.

Do you have questions about this year’s Open Payments submission? There’s no need to seek answers using the Force while CMS is around. The agency held a webinar to discuss this year’s submission and take questions from stakeholders. CMS presented an overview of enhancements to the system and the timeline for submissions before taking questions. Those questions focused on reporting requirements, the dispute process, and the deletion of records.

UK government officials are launching an “urgent investigation” (hopefully not urgent enough to break out the mind probe) into the possibility that National Health Service (NHS) officials received consulting payments from pharmaceutical companies. The investigation is based on a report by the Telegraph that more than 130 NHS officials, most in positions to assess what medications would be used by patients, were receiving the payments. The payments were allegedly provided to the NHS workers in return for serving on advisory boards. Activities related to the advisory boards ranged from participation in teleconferences to travel to meetings outside the UK, where the participants stayed at luxury hotels.

Negotiations in the Amarin case are moving slower than a space slug. The FDA and Amarin have requested a third extension in the process as they look to reach a settlement in the case involving the off-label promotion of Amarin’s omega-3 drug. The extension will delay the court proceedings until March 18.

Pfizer has reached an agreement in principle with the federal government in a False Claims Act case involving the calculation of Medicaid rebates for the drug Protonix. The product was marketed by Pfizer’s Wyeth unit. The company will pay $784.6 million to resolve the charges, and will not admit any liability in the case.

The Jedi Master of the Serious Fraud Office (SFO) will remain in his post a bit longer than planned. The UK’s Attorney General extended the contract of SFO head, David Green, for two years. Green’s contract was set to expire in April, and now will expire in April of 2018.

France could be joining the Alliance of countries beefing up their anti-corruption laws. Draft legislation of an anti-corruption law will be presented to the French State Council for validation, and will then move on to the legislative process. The French Parliament is expected to begin its review in April of this year. Highlights of the draft include the creation of anti-corruption agency with the power to impose sanctions; a requirement mandating corporations have a compliance function in place; and the implementation of a number of Sunshine requirements, most notably the disclosure of payments to lobbyists.

Anticorruption efforts by government agencies have certainly been a hot topic of late. From the announcement that the FBI would be hiring additional FCPA investigatory staff, to the SciClone settlement, and the news of a new law on the horizon in France, governments around the world are taking steps to root out bribery and corruption. That’s why now is as good a time as any to review your company’s current anticorruption program, including the training that addresses anticorruption laws. For multinational companies, training on the FCPA alone is not enough. The UK Bribery Act is just as far reaching, and your colleagues need to understand the differences in the two laws. In addition, both Mexico and Brazil have implemented tougher anticorruption laws in the last several years, and training should be provided on those as well.

Thanks for reading everyone, and may the Force be with your compliance training efforts.

The 2015 Compliance Year in Review (and Look Forward to the Rest of 2016)

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The start of 2016 may be filled with hope for good compliance-related news to come, but before we travel too far forward with our prognostications, let’s take a look back at some of the stories that really struck a chord in 2015. Charge up your flux capacitor everyone, as we travel back a few weeks and months, with this edition of the Compliance News in Review: the Yearly Edition.

In 2015, a full year’s worth of data was submitted to the Open Payments program. Considering the rejection of massive amounts of 2014 data, as well as the registration issues and delays that plagued the first Open Payments data submission period, system users certainly had cause to be concerned about the 2015 period. Happily, CMS made improvements, and the process, while not problem free, was smoother in 2015. The agency improved its validated physician list for manufacturers and its data matching processes, which resulted in fewer records being rejected. The improvements in the registration process seemed to help manufacturers, but did little to improve the physician experience.

CMS announced additional improvements that will hopefully improve users’ experience in 2016, including the removal of limitations around entering special characters in text fields, and improving users’ downloading capabilities.

The life sciences industry certainly pushed the free speech issue with the FDA in 2015. Two companies filed suits against the agency, arguing that they had the right to truthfully promote drugs for off-label uses. In the Amarin suit, the court granted an injunction, and the company is free to promote the drug for use in a wider patient population than the drug was originally approved.

On the heels of that case, Pacira filed suit over the FDA’s insistence that the company was promoting a pain killer for post-surgery pain, an unapproved use.  After the company received a warning letter, stating that drug was only approved for use following a specific type of surgery, Pacira argued that the FDA was illegally trying to narrow the approved use. The company also argued that even if it was promoting the drug for an off-label purpose, it had the right to do so, as long as it was sharing truthful information. The FDA quietly removed the warning letter from its website and eventually settled the case.

After years of chatter, but very little visible action, the Serious Fraud Office entered into its first deferred prosecution agreement with a corporate entity, over violations of the U.K. Bribery Act. Standard Bank was accused of failing to prevent bribery by an allied person. The DPA remains in effect for three years and requires the bank to pay $32.6 million; submit to a review of its anti-bribery policies by an independent reviewer and make any changes recommended by the reviewer; and cooperate with authorities in any other matters that arise from the indictment.

The year was devoid of multi-billion dollar settlements in the industry, but 2015 did see the largest settlement by the OIG under its civil monetary penalty authority. The OIG settled with Sandoz for $12.64 million over allegations the company submitted inaccurate ASP data to the Medicare program. The agency alleged that the company submitted inaccurate data between 2010 and 2012, which “undermined the integrity of the Medicare Part B drug pricing system.”

Any worthwhile year-end retrospective needs to include a look forward. So here are the issues that we think will be hot topics in 2016:

  1. Drug pricing transparency. In 2015, several states proposed laws that would require companies to disclose costs for drugs that run in the thousands of dollars per-dose or course of treatment. This push isn’t likely to go away, considering recent dramatic drug price hikes by companies like Valeant and Turing, which resulted in inquiries by lawmakers in the latter part of the year.
  2. Transparency in Europe. Staying on the transparency theme, we expect physician spend reporting in Europe to be a prominent news story toward the middle of the year. The first round of reporting under the EFPIA Transparency Code is due then, and the first round is sure to be thoroughly dissected and analyzed.
  3. Individual accountability. In September of 2015, the Department of Justice released a memo from Deputy Attorney General Sally Quillian Yates saying the agency plans to focus on holding individuals accountable in cases of corporate crime. Not exactly earth shattering news, but the DOJ has put it in writing, so they must really, really mean it. Whether the agency brings a case against an individual in 2016 or not, the policy is sure to be widely discussed by federal prosecutors and other agency representatives at conferences throughout the year.

Have a great 2016 everyone! We’ll see you at CBI’s Pharmaceutical Compliance Congress January 26 and 27.

Compliance News in Review, December 10, 2015

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One of the great traditions of the Christmas season is the performance of Tchaikovsky’s The Nutcracker by ballet companies and dance schools around the world. Whether performed by professionals or students, the ballet is full of magic and fantasy. A young girl, Clara (or Marie, depending on the production), receives a nutcracker, which comes to life, fights an army of giant rats, and then whisks Clara away to land of sweets ruled over by the Sugarplum Fairy. Almost as delightful as the prospects of watching giant rodents fight on stage is what’s been happening in the world of life science compliance. Places everyone! Time for the Compliance News in Review.

Standard Bank is taking a bow as the first company to enter into a deferred prosecution agreement (DPA) with the Serious Fraud Office over violations of the U.K. Bribery Act. The company was accused of failing to prevent bribery by an allied person. The DPA remains in effect for three years and requires the bank to pay $32.6 million; submit to a review of its anti-bribery policies by an independent reviewer and make any changes recommended by the reviewer; and cooperate with authorities in any other matters that arise from the indictment.

It’s not a dream Clara, the DOJ announced it has recovered $3.5 billion in False Claims Act cases in 2015. As in years past, healthcare fraud represented the lion’s share of the recoveries. In 2015, healthcare fraud cases totaled nearly $2 billion. Cases against the pharma industry represented $96 million of that total. It was a good year for qui tam relators as well. Of the $2.8 billion recovered from qui tam cases, a record $1.1 billion came from cases in which the U.S. chose not to intervene.

Harvard Medical School has made a slight change to its conflict of interest policy. The school is relaxing a policy that prohibited faculty from accepting equipment or other support from a private company in which they have equity, or from a public company in which they hold equity of $30,000 or more. The school will now allow faculty conducting basic research to petition for an exclusion from the rule if they can show that the benefits of the research outweigh any potential conflict of interest. Faculty would also need to show they have measures in place to guard against conflicts of interest.

Physicians may need Uncle Drosselmeyer to come guide them through the Sunshine Act sine a new study shows professional medical organizations aren’t doing so. The study appeared in the journal, Postgraduate Medicine. Researchers reviewed 59 articles and found there was very little guidance regarding the Act, and professional associations tended to focus on sharing broad information about reporting requirements. Rarely was there information regarding payments for research grants, trial participating and medical publication. The authors conclude that expert guidance about the Final Rule itself is needed, and suggest a lack of guidance may impact physician investigators’ participation in clinical trials and publishing results.

Clara’s trip to the land of sweets may have all been a dream conjured up by the mysterious Drosselmeyer, but after years of anticipation, the SFO is making its promise of dealing with corporate bribery a reality. In addition to the Standard Bank DPA, another corporation was recently charged by the SFO with violating the U.K. Bribery Act by failing to prevent bribery. If the lack of prosecutorial action has made training on the U.K. Bribery Act a lower priority for you, now is the time to move it up the priority list. Likewise, if you haven’t trained on the Act recently, a refresher course may be in order to ensure employees and third parties are up to speed on the requirements and your company’s policies.

That’s a wrap for this edition of the Compliance News in Review. Keep dancing everyone…and stay compliant.