Code of Conduct

Compliance News in Review, October 14, 2015

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A survey of physicians in the UK reveals negative opinions of the pharmaceutical industry, another pharmaceutical company settles kickback allegations with the DOJ, BMS enters into an FCPA settlement, and new legislation aimed at adding to industry reporting requirements is introduced in the Senate.

The boys of summer are singing their swan song. The MLB playoffs have begun! If your team is in the hunt, congratulations, but unless you’re pulling for the Cubs, getting too excited is useless. Robert Zemeckis says the Cubs will take it all, via Back to the Future 2 of course. There’s just one problem though, Miami won’t be the Cubs opponent, as predicted by the film, but hey when one predicts the future, there are bound to be just few hiccups. While we wait to test the accuracy of the director’s clairvoyance, let’s take look at the more recent past, with this edition of the Compliance News in Review.

First up to the plate are a group of physicians who are unhappy with the pharmaceutical industry. A recent survey of physicians in the UK found that almost half of the respondents had a negative opinion of the pharmaceutical industry. The primary reason was the belief the industry focused too much on sales and marketing. Other reasons included the lack of understanding of physician needs and budgetary pressures. The negative view is leading to increased resistance to face-to-face meetings with sales representatives. Ironically, the survey showed physicians who did meet with sales representatives were less likely to have a negative opinion of the industry.

After a meeting on the mound with the DOJ, PharMerica has agreed to pay $9.25 million to resolve kickback allegations. According to the DOJ, the company, which provides pharmacy services to nursing homes, received and solicited kickbacks from Abbott Laboratories in exchange for promoting the use of the drug Depakote for nursing home patients.

After some allegedly foul behavior in China, BMS has entered into a $14 million settlement with the SEC to resolve FCPA charges. The SEC alleged that BMS China sales representatives bribed doctors and then inaccurately recorded the bribes as a business expenses. The SEC claims BMS failed to respond to bribery red flags, and failed to investigate employee claims that fake invoices were being created to hide the bribes.

Industry and physician groups are not happy about a proposal by CMS to include Open Payments data on the Physician Compare website. In July, CMS sought comments on a proposal to include Open Payments data on the Physician Compare website. AdvaMed and BIO both pointing out that the payments would be presented without proper context. PhRMA said that CMS should focus on improving how the data is presented on the Open Payments website before sharing it on another website. The AMA expressed similar sentiments, saying it was opposed to the sharing of data that physicians haven’t validated as accurate, and pointed out there was still much work to be done in this area on the Open Payments website.

Team Sunshine Act is back in the game. Senators Grassley and Blumenthal introduced legislation that will require drug and device manufacturers to report payments and transfers of value to mid-level practitioners. The legislation is called the Provider Payments Sunshine Act, and if passed, would go into effect in 2017. Senator Grassley said the law closes a void in the current requirements, and it would provide a complete picture of the payments provided to healthcare providers. Senator Blumenthal said all providers need to be “held accountable,” and that this level of disclosure is necessary “in today’s world.”

Transparency continues to be a hot topic in the industry, both in the US and abroad. We’ll be watching to see if the law proposed by Senators Grassley and Blumenthal makes it out of the Senate, or if more states take up the initiative to pass laws requiring the reporting of payments to mid-level practitioners.

The evolving nature of transparency laws and requirements requires pharmaceutical and medical device companies to actively train and communicate with employees about what’s expected. Effective training is needed to ensure compliance with the laws and requirements, and, as importantly, to work toward clearer communications between sales representatives and the healthcare providers whose information will be disclosed.

Have a great week everyone!

Compliance News in Review, October 5, 2015

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CMS releases a new teaching hospital list and de minimis thresholds, ICD-10 is launched, New Hampshire investigates manufacturers of painkillers, and the UK Ministry of Justice reverses its position on expansion of the law.

It is fall y’all! Okay, so the stars and the calendar may have said fall arrived a couple of weeks back, but it just doesn’t seem real until we hit October. The air gets a little crisper, the leaves start changing, and we sadly reach that point when we hope against hope that we can make it through the night without turning the thermostat to “heat.”

Before you know it, all the pumpkins and scarecrows will give way to mistletoe and snowmen (insert collective groan here). Before we all run out for the annual jump into the pile of leaves, let’s grab a cup of cider and your favorite pumpkin spice treat, and review all the compliance news fit to blog, with this edition of the Compliance News in Review.

October first was quite a busy day! First, CMS released the teaching hospital list and de minimis thresholds for Open Payments. In 2016, payments to Covered Recipients of $10.22 or higher will have to be reported and the annual aggregate reporting threshold will be $102.99.

Second, Medicines Australia’s new transparency requirements went into effect. Even though the Code of Conduct was effective in May of this year, implementation of the new transparency requirements was delayed until October. One of the major changes in the transparency requirements was the requirement to report at an individual HCP level rather than in the aggregate.

Finally, October 1st was the “go live” date for ICD -10 (International Classification of Diseases, 10th edition). ICD-10 is the set of diagnostic and procedure codes used by healthcare providers to bill insurance providers and government healthcare programs. The transition to ICD-10 was mandated by the Centers for Medicare and Medicaid Services and is intended to provide more detail over the previous coding system. CMS says ICD-10 will help better “accommodate future healthcare needs, facilitating timely electronic processing of claims by reducing requests for additional information to providers.” While specificity can be a good thing, could ICD-10 be taking it a bit far? Check out some of the more unique codes in the new system. A couple of our favorites are “W56.22xA- Struck by an Orca, initial encounter,” (which apparently spawned a whole book) and “W49.01XA Hair causing external constriction, initial encounter,” also known as the Flynn Rider Code.

New Hampshire is turning a cold shoulder to opioid makers. The state’s Attorney General’s Office has announced it will be investigating the marketing practices of several manufacturers of painkillers. The AG’s Office believes the companies may have engaged in fraudulent marketing practices, which may have misled doctors and patients about the addiction risks and effectiveness of drugs.

The UK is changing its colors regarding expansion of the Bribery Act. Prosecutors had been petitioning to expand the law to make it easier to prosecute businesses involved in bribery, but in response to questions from lawmakers about the proposed changes, the Ministry of Justice said it was no longer interested in pursuing the matter. The response said there was “little evidence of corporate economic wrongdoing going unpunished.”

Conflicts or confluence – decisions, decisions. A recent editorial in the Journal of the American Medical Association (JAMA) makes a case for falling away from using the phrase “conflicts of interest” when describing the secondary interests involved in clinical research. The authors suggest “confluence of interest” instead. They say “conflicts of interest” automatically sets up the notion that something wrong is taking place. The authors point out that in academia, notoriety and fame could be a stronger influence on bias than financial reward. Universities, research institutes, the NIH and medical journals can all impact bias.

October has certainly started with a bang, in the world of physician spend transparency, both here in the U.S. and abroad. The news offers a good reminder that transparency and disclosure measures are constantly evolving. Yet another change will be upon us in 2016 with the removal of the exclusion for speaker of faculty payments for accredited CME.

With all of the changes in motion, now is a perfect time to refresh your company’s training on the requirements of the Sunshine Act and Open Payments. Ensuring your team is aware of the changes is critical, and those in the field need to understand the impact the law has on the healthcare providers they interact with on a regular basis.

That’s a wrap on this edition of the Compliance News in Review. Enjoy the cool weather everyone and have a great week!

News in Review, August 11, 2015

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Industry support of CME increases in 2014,  NuVasive settles False Claims charges while Mead Johnson deals with FCPA charges, and Amarin wins a preliminary injunction in its off-label case against the FDA.

The dog days of summer have certainly arrived in most of the U.S. with temperatures that are best described as hot, hot, hot! Thanks to Willis Carrier and his wonderful invention, we can at least find occasional respite from the sun’s rays and the humidity. So while you wait for a break in the heatwave, crank the A/C up a few notches, grab a cool beverage, and just chill with this edition of the Compliance News in Review.

According to a report from the Accreditation Council for Continuing Medical Education (ACCME), industry support of CME increased 2.4% in 2014. According to the report, industry support represented about a quarter of all CME revenue in 2014, whereas in 2007, that support was closer to half (46%) of CME revenue. Physician attendance at CME dropped by just over one percent, but non-physician attendance rose six percent.

The heat is off for NuVasive now that it has settled with the DOJ. The company has agreed to pay $13.5 million to settle charges it violated the False Claims Act by marketing a product for surgical uses for which it was not approved. According to the government, the company marketed its CoRoent System for several spinal surgical procedures for which it was not approved. The DOJ also claimed kickbacks, in the form of speaker fees honoraria, were paid to induce physicians to use the system. The company was also accused of paying kickbacks for physicians to attend events hosted by Society of Lateral Access Surgery (SOLAS), an organization that was entirely organized and funded by NuVasive.

Mead Johnson entered into a settlement with the SEC to resolve charges it bribed Chinese government healthcare workers to recommend its infant formula, in violation of the FCPA. According to the SEC, the company funded the payments through distributor allowance funds paid to a third-party distributor, and then directed the third-party on how those funds were to be used. Allegedly, the payments were not properly reflected in the company’s books and records.

Insys also finds itself in the doghouse; or in this case, we’ll say the duck house (okay, it’s a reach, but stay with us here). Insys Therapeutics has entered into a settlement with Oregon to resolve a deceptive marketing case. The State claims the company marketed an opioid painkiller for treating mild pain that was only approved for treating pain in cancer patients who are not responding to other types of painkillers. The State also claims the company paid physicians for writing prescriptions and used unqualified physicians to promote the product. The settlement will be split between the State and an organization dedicated to the prevention of opioid abuse, which will be selected by Oregon’s Attorney General.

So it appears, this off-label promotion dog can hunt. Amarin, the company suing the FDA over its ability to promote its fish-oil drug for off-label uses, has won a preliminary injunction against the agency. The injunction is not a final order, but for now, the FDA cannot prevent Amarin from the truthful off-label promotion of its product. The drug is approved for treating patients with very high levels of triglycerides. Amarin would like to promote the drug for use with patients that have moderately elevated triglycerides levels, despite being on a statin.

Like the Caronia decision before it, the Amarin case certainly raises interesting questions about the future of truthful off-label promotion. While a compliance training session may not be the place and time to delve into a discussion of that future, the decision does present an opportunity to discuss off-label promotion and how to address questions related to off-label use. Why not take this opportunity to launch refresher training, or distribute an updated, quick-reference communication piece? On-going reminders about what constitutes off-label promotion, and the policies your organization has in place to address unsolicited questions, are part of any effective compliance curriculum. The case also creates an opportunity to work with commercial team managers on a plan to increase the dialogue about the topic with their teams. Off-label is in the news and the training opportunities abound.

Compliance News in Review, July 20, 2015

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The House of Representatives passes the 21st Century Cures Act, two companies settle AMP charges, oral arguments begin in Amarin v. FDA, and CMS updates its Open Payments FAQs.

Diamonds are not only a girl’s best friend…a very special mouse is fond of them as well. The Happiest Place on Earth (or, at least the one in California), is celebrating its diamond anniversary. Happy 60th Disneyland! The place has certainly changed in its 60 years, but fan favorites such as Mr. Toad’s Wild Ride and the Jungle Cruise have stood the test of time. In true Disney fashion, the party isn’t just a one day affair; it actually started back in May and will likely continue through the fall, if not into 2017. Before we cut the cake with the big ears, we have a bit of “magic” of own to administer. Grab a churro and settle in for this edition of the Compliance News in Review.

The House is celebrating the overwhelming passage of the 21st Century Cures Act. The bill is designed to fund research and change the FDA’s drug and device approval process. It includes a change to the rule its provisions are changes to the Sunshine Act which would exclude the reporting of the value of journal reprints and payments for CME.

AstraZeneca and Cephalon may be feeling a bit Grumpy. The two companies reached separate agreements with the government over charges related to underpaid Medicaid rebates. According to a whistleblower, the companies improperly reduced the Average Manufacturers Price (AMP) of their products by subtracting fees paid to wholesalers. The companies paid $46.5 million and $7.5 million respectively to settle the matter.

Oral arguments began in Amarin’s suit against the FDA. The company cited the Caronia decision and the Sorrell v. IMS decision in its argument. Much of the discussion centered on the type of disclaimers need to accompany off-label promotion and not whether Amarin even has a right to do so. The FDA’s lawyer argued the interpretation of the Caronia decision should be very narrow but the judge disagreed. A judicial order is expected in a few weeks.

The whistleblower in a case against Endo may be throwing a Mad Tea Party now that she’s been awarded $33.6 million for her efforts. The case, which was settled with the government in February of last year, involved the off-label promotion of the company’s pain patch. Despite a recommendation from government lawyers that the whistleblower receive 19% of the settlement, the federal judge awarded her 24%, citing her “extraordinary effort” in the case. The whistleblower initially filed suit in 2005, and spent five of the nine years that followed working under the direction of the FBI.

CMS has sprinkled some Pixie Dust over the Open Payments FAQs, and sure enough new FAQs have taken flight. Several of the new FAQs have to do with physicians and teaching hospitals being able to access, review and dispute the data now that the review and dispute period has closed.

If the FAQ updates weren’t enough, CMS was back for a second ride with updated information about the reporting of CME payments on the Law and Policy page of the Open Payments website. Beginning in 2016, manufacturers will have to report indirect payments to CME providers if the manufacturers learn the identity of the physician attendees or speakers within the reporting year, or the first two quarters following the reporting year.

The updates to the Open Payments website remind us that the program is evolving. Your company’s training needs to evolve and grow as well. Affected personnel need to be updated on changes, and reminded of the need to communicate with their physicians. Now is the time to map out your plan for refresher training and refocus your aggregate spend and sales personnel.

That’s a wrap on the compliance news fit to blog for now. Have a great week everyone.

 

 

Compliance News in Review, July 10, 2015

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The government targets Novartis for False Claims violations, pharmaceutical companies map out a plan to keep medication flowing into Greece throughout the crisis, and the industry as a whole ponders the impact of the CMS release of 2014 transparency data.

The days are long and lazy – it’s time for summer vacation! From the beach, to the mountains to foreign destinations, the News in Review staff is finalizing plans for summer R&R. Rest assured though, we are still hard at work keeping up with all the compliance news fit to blog, starting with this sun splashed edition of the Compliance News in Review.

The Justice Department and 11 states are putting a dent in the Novartis vacation account with a $3.4 billion charge for damages and fines in a False Claims Act case involving kickbacks to pharmacies. According to prosecutors, the company offered rebate and discount programs to pharmacies in exchange for increased prescriptions of two drugs. Novartis disputes the allegations and says it will continue to defend itself. A trial has been set for November.

Pharma companies are mapping out a plan to keep medication rolling into Greece. According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), the complexity and fragmented nature of the Greek medicine supply chain makes the flow of medication vulnerable. Pfizer, Roche and Novartis said they have plans to ease any shortages during the crisis, and AstraZeneca and GSK have both said they are drawing up contingency plans to keep medicines in supply.

CMS and agg spend folks are probably ready for a break in their routine now that the 2014 Open Payments data has been published. The data shows that companies paid physicians almost $6.5 billion for the year, with over 11 million transactions reported. Research payments topped the list with over $3 billion paid, there were $2.5 billion in general payments and $700K was reported on the ownership reports. CMS was able to validate close to 99% of records submitted to the system, which is a vast improvement over the 2013 data. As was the case in 2014, the majority of the reported payments were small. Sixty-six percent were for payments of less than $20. Research and royalty payments represented the largest dollar amounts.

Once the Open Payments data was released, the numbers quickly found their way into the media. The focus on payments to physician and the influence those payments have on prescribing decisions and healthcare at large is at an all-time high. That level of scrutiny highlights the need for training on the Sunshine Act and Open Payments – especially for those interacting with HCPs. While much of the work related to the reporting requirements is a “back office” function, those interacting with HCPs are often the first to hear concerns from the field and they need to be prepared.

In addition, the public release of the data opens companies to examination of their business practices from whistleblowers and enforcement agencies. Critical evaluation of training is important. Are all the appropriate audiences being covered? Is the training up to date? Is a refresher required? Regular audits of training curriculums and plans are key to reducing the risk of questionable payments, and could spare the company expensive costs down the road.

Have a great weekend!

Compliance News in Review, July 2, 2015

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A former medical device CEO is sentence to two years in prison, the House of Representatives moves on the exemption of payments for CME, textbooks and medical literature under Sunshine, a Connecticut APRN finds herself in hot water over kickbacks, and the first full year of physician payments data is officially available for review.

Unfurl the flag and fire up the grill! It’s time to celebrate the good ole U.S.A. Independence Day is almost here! Whether your celebration of the shot heard ‘round the world and 239 years of the great experiment take you to the shining sea, across the fruited plain, or just to your backyard, we hope it’s a safe and joyous weekend. Until the party begins, we’ll dole out a little history less of our own, with this edition of the Compliance News in Review.

Former OtisMed CEO will have his liberty temporarily revoked. The executive was sentenced to two years in prison for intentionally distributing an unapproved medical device in violation of the FDCA. He was also order to pay a $75,000 fine.

The “people’s house” has been busy recently. The House Energy and Commerce Committee announced that over 200 representatives have signed on to the 21st Century Cures Act. The exemption of payments for CME, textbooks and medical literature from the Sunshine Act is included in the bill. The House also approved a bill to repeal the Affordable Care Act’s tax on medical device manufacturers. The bill now moves to the Senate for a vote.

A Connecticut APRN has admitted to accepting $83,000 in kickbacks from the drug maker Insys Therapeutic. The nurse was a top prescriber of the company’s cancer pain drug. Most of the kickbacks were in the form of payments for serving as a speaker and according to prosecutors, more often than not, the nurse and the sales rep were the only people in attendance at the speaker events. On some occasions, the attendees were friends or colleagues of the nurse who were allowed to prescribe drugs. She will be sentenced in September.

We’re waiting for the fireworks to start now that the first full year of physician payments data has been released by CMS. The payments for 2014 totaled nearly $6.5 billion, and represented 11.4 million transactions to over 600,000 physicians and teaching hospitals. Data from the 2013 program year that could not be posted during 2014 is also included in this year’s release. According to a CMS press release, “registered physicians and teaching hospitals reviewed nearly 30% of the total value of the data and the agency plans on continuing its efforts to work with HCPs to increase that review rate.”

While it’s the multi-million dollar corporate settlements that make the headlines, this week’s news shows that in the world of compliance, individuals suffer significant consequences as well. From the Board to the C-suite, across the corporation and even to the contractors, training needs to emphasize that potential violations are not just a “company problem.”

The release of the 2014 Open Payments data highlights the amount of money being spent by industry on physicians, and exposes physicians to potential criticism and scrutiny. HCPs need to be aware of the rules and regulations companies face because as far as the government is concerned, they represent the company just as the employees do. Providing training that respects these contractors as men and women of science, while fully covering product promotion regulations and law, not only protects the company, it enhances the relationship with these valued partners in healthcare as well.

Have a great Independence Day everyone!

Compliance News in Review, June 29, 2015

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The universe has spoken – summer is officially here. (If you’re living in a part of the country that is in the midst of a heatwave, I’m sure you’re thinking “never mind what the calendar says, summer has been here for two weeks!”) Now that we’ve crossed the solstice for another year, let’s take a look back at how spring ended, in this issue of the Compliance News in Review.

PetroTiger escaped the heat of an FCPA prosecution. In a highly unusual move, the DOJ announced it would not charge the oil company with violating the FCPA. Three company executives have already pled guilty to the same charges, and typically charges against the company follow. In this case, the DOJ decided otherwise, saying PetroTiger had fully cooperated with the investigation.

The Sunshine Act is never far from the minds of physicians, no matter the season. 100 physician organizations sent a letter to Representatives Richard Michael Burgess and Peter DeFazio expressing support for a bill that would exempt payments for CME and educational materials from the Sunshine Act. The Representatives introduced the bill in an effort to correct the “unintended consequence of over-burdensome reporting requirements that made access to educational materials for physicians difficult to obtain.” The physician groups claim that the dissemination of medical education materials has already slowed as a result of the law.

The sun has set on an off-label marketing case for a former Merck company. The company settled with the government for $5.9 million in an illegal marketing case involving its former Inspire Pharmaceuticals unit. According to prosecutors, Inspire claimed its pink eye drug was effective for treating blepharitis, a condition for which the drug was not approved. According to the government, the promotion of the drug for the off-label use led to false claims being paid by government healthcare programs. Merck claims the activity occurred before it acquired the company. Inspire was sold to Akorn in 2013.

FDA officials shed some light on advertising and promotion enforcement at the 2015 Develop Innovate Advance conference. Deborah Wolf of the Division of Premarketing and Labeling Compliance discussed several promotional issues surrounding devices, including the risk of physicians promoting devices for unapproved uses.

Tom Abrams of the Office of Prescription Drug Promotion said the most common areas of enforcement for his office involved unsubstantiated superiority claims; overstatement of efficacy; and omission and minimization of risk information. Lisa Stockbridge of the CEBR’s Advertising and Labeling branch said that biologics faced many of the same issues as prescription drugs. She referenced an untitled letter sent to a company for claims made by the company’s CEO in a video interview posted on the company website, which included unsubstantiated claims about one of its products.

Obviously, product promotion remains a hot topic, and with good reason. As we continue to see in the news, off-label promotion violates the FDCA and implicates the False Claims Act, and can result in pretty hefty penalties. However, training needs to go beyond on-label promotion, and cover the topics referenced in the stories above. Misleading statements, false efficacy claims, and omission of risk lead to untitled letters from the FDA, and as seen in the 2014 Shire case, can be used by the DOJ in cases against manufacturers.

All facets of promotional speech need to be covered in your compliance training, especially since the FDA has essentially deputized healthcare professionals to be on the lookout for promotional speech missteps through their Bad Ad program. More and more eyes are focused on product promotion, so making sure everyone responsible for making promotional statements, in any form, is aware of the requirements, is more critical than ever.

That’s the news for this edition. Stay cool and have a great week everyone!

Compliance News in Review, June 16, 2015

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Dinosaurs roamed the earth again (at least in the land of movie theaters), over the weekend, with the release of the summer’s first big blockbuster, Jurassic World. You’d think after three films, the characters would have learned not to fool with Mother Nature. Apparently not, and considering the $200+ million the film racked up at the box office, we are not tired of watching them make those same mistakes.

It may not involve death, destruction and extinct creatures, but we have our own epic tale to tell. Break out the popcorn and 3D glasses, and silence your phones please. It’s time for this week’s feature presentation – the Compliance News in Review.

Transparency International is undertaking a project of Giganotosaurus proportions. At the International Pharmaceutical Compliance Congress and Best Practices Forum, Executive Director Robert Barrington spoke to attendees about corruption in the healthcare sector and an initiative underway to evaluate corruption in the pharmaceutical industry specifically. The project will focus on five key areas: procurement and distribution, manufacturing, marketing practices, product registration, and research and development. Barrington noted that the industry should prepare for more scrutiny, with patients demanding to know why increased spending has not led to an improvement in the quality of healthcare.

Public Citizen has accused the FDA of improperly expanding the original approved use of a sleep disorder drug, and has filed a petition with the agency to have the label changed. According to the organization, the drug was initially approved for use in treating the disorder, Non-24, in blind patients, however the drug’s label does not specify the patient population. Public Citizen says this opens the door to the drug being used for other sleep disorders with patients that are not blind. Following the initial approval, the FDA did send the manufacturer a second approval letter which stated a mistake was made and the drug was approved for treatment of Non-24 in general. The second letter notes that the condition is experienced almost exclusively by those who are blind.

Could this be another “blockbuster” decision by the FDA? The FDA sent a letter to Amarin Pharmaceuticals and the court in response to Amarin’s lawsuit against the agency for violating its free speech rights. The company would like to share study information showing its drug reduces the risk of heart attack when taken in conjunction with a statin, which is not an approved use. In its response to the lawsuit, the FDA says it does not have concerns with most of the information the company wanted to share, and it does not consider the sharing of that information to be false or misleading. The letter also reminded the company that new guidelines for sharing off-label information are forthcoming.

In our opinion, the letter from the FDA to Amarin is certainly not an invitation for pharmaceutical and medical device companies to start sharing information about unapproved uses of their products. Situations like this, as well decisions like the Caronia case, may lead some to think the rules have changed, when in fact they have not. Training and communication efforts need to emphasize that the laws and regulations remain the same. Promotional statements still need to be truthful, accurate, not misleading and balanced.

The message should be clear – only company approved studies and statements may be shared, and done so in the way described by the company. The way in which companies play the game may be evolving, but the rules of the game remain the same. Playing within those rules benefits all stakeholders, including the company, and most importantly, the patient.

Have a great week everyone!

Compliance News in Review, June 5, 2015

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Cephalon settles a generics case with the FTC over its sleep disorder drug and the OIG releases its mid-year update to its 2015 Work Plan, and we offer our take on how it impacts training.

Well, the summer blockbuster season is almost here. Superheroes, Sundance darlings, reboots and rom-coms will all be competing for our attention and discretionary dollars (is that a contradiction in terms?). While it may not carry the cache of the newest Clooney or Cruise release, we proudly offer our own little feature for your entertainment and edification…the latest edition of the Compliance News in Review. On with the show!

It’s finally a wrap on the Federal Trade Commission’s case against Cephalon. The FTC settled its pay for delay case with the company (now part of Teva) for $1.2 billion. The case involved Cephalon’s attempts to delay entry of generics for its sleep disorder drug. The settlement is the largest ever secured by the FTC.

The OIG has premiered its mid-year update to its Fiscal 2015 Work Plan. The update includes several new items, one of which is a review of the financial interests reported via Open Payments.

“We will determine the number and nature of financial interests that were reported to CMS under the Open Payments Program. We will also determine the extent to which CMS oversees manufacturers’ and group purchasing organizations’ (GPOs’) compliance with data reporting requirements and whether the required data for physician and teaching hospital payments is accurately and completely displayed in the publicly available database.”

The OIG’s report on its findings is expected during fiscal year 2016. As Policy and Medicine points out, it will be interesting to see what sort of enforcement follows the OIG’s review, and if the information is used by the agency for its other activities involving fraud and abuse. This potential for enforcement involving this data should not be overlooked.

The first full calendar year of data has not even been released to the public yet, and the OIG is jumping right into a review. The agency’s actions underscore the importance of accurate data and the need for training to ensure that accuracy. From those engaging in transactions with covered entities, to those responsible for the reporting on the back end, understanding data collection and reporting requirements is critical. In addition to in-house staff, third-party vendors and partners that may be involved in reportable transactions on a company’s behalf need training on the basic requirements of the Sunshine Act and Open Payments.

Enjoy the weekend everyone, and we’ll see ya at the movies!

Compliance News in Review, May 27, 2015

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Legislation nullifying the need to report payments associated with CME moves to the House of Representatives for a vote, a new article in the NEJM offers thought proving insight on the relationship between industry and physicians, and OPDP issues untitled letters to two pharmaceutical manufacturers.

The monotonous strains of Pomp and Circumstance fill the air…graduation season is here! From kindergarten to college, students are donning caps, gowns, cords and stoles in celebration of their academic achievement. If you happen to have a student crossing the graduation stage this spring/summer, congratulations! We hope the commencement address is at least as thought provoking as this one. While you’re sitting there waiting for your loved one’s name to be announced, feel free to fill the time with this edition of the Compliance News in Review.

The 21st Century Cures Bill graduates from the House Energy and Commerce Committee and moves on to a vote by the whole House. The legislation aims to improve healthcare through support for research and development and by streamlining regulations. If passed, the law would nullify the requirement for reporting payments associated with CME; require the FDA to provide guidance on the sharing of health economic information; and require the FDA to issue guidance on the sharing of truthful, not misleading scientific information about off-label uses of drugs.

A new article in the New England Journal of Medicine explores the relationship between physicians and the industry. The article suggests the need for a reasoned approach when addressing conflicts of interest. The author acknowledges that conflicts exist, but that there are benefits to the physician industry relationship that shouldn’t be discarded simply because such relationships with industry are perceived as a negative.

Over a period of five days, the Office of Prescription Drug Promotion (OPDP) issued two untitled letters. Until this point, the agency had issued only four letters this year. The first letter, issued to Oak Pharmaceuticals, dealt with misleading statements on an exhibit banner. The statements did not include information about risks or material information about the approved indication of the product. According to OPDP, the only reference to prescribing and safety information on the banner was a directive to talk to a representative at the company’s booth.

The second letter was issued to Actavis over misleading statements on a Watson Pharmaceutical product webpage. The OPDP said the webpage was misleading because it contained unsubstantiated claims. The agency cited a specific marketing statement indicating the drug would help with conditions (sleep disturbance and work productivity) for which there was no evidence in the clinical studies.

When training about promotional speech, life sciences companies often focus on off-label statements, and with good reason. Off-label promotion continues to be a dominant issue in False Claims Act cases. However, other promotional speech issues should not be ignored or forgotten. The OPDP has least one letter every month so far in 2015. Additionally, the agency continues to dedicate considerable resources to educate healthcare providers about its Bad Ad program. That’s why promotional speech training needs to go beyond off-label, and address the need for company representatives to present the benefits and the risks of the products they promote.

Enjoy the week everyone!