off-label

CBI’s 9th Annual Forum on Transparency and Aggregate Spend: A Review

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CBI’s recent Forum on Transparency and Aggregate Spend covered a variety of topics affecting the collection and reporting of aggregate spend data. The conference featured speakers from industry, government agencies, and service providers sharing lessons learned and best practices related to aggregate spend collection and data disclosure.

After a day of pre-conference workshops, the main conference began on Day Two, and it started with a bang. The keynote address, An Update on Open Payments Reporting, was delivered by Doug Brown, CMS Group Director, Data Sharing and Partnership Group, Center for Program Integrity. Mr. Brown shared statistics on the data submitted for the 2014 reporting year. 11.4 million records were received, covering 600,000 individual physicians. In a vast improvement over the previous year, 98% of submitted records were accepted. Brown attributed this improvement to the introduction of the validated physicians list (VPL) and better data matching. An analysis of rejected records is underway, and CMS is looking for ways to improve the taxonomies associated with covered recipients.

During the review and dispute period, CMS received 30,000 disputes on 25,000 unique records. The disputes were evenly distributed among the covered recipient type, with physicians representing 35% of disputes, teaching hospitals 38% and principal investigators 27%. According to Brown, disputes were evenly split between the general and research payments reports. Very few disputes were lodged against payments reported on the ownership report. The median value of total payments is 4.5 times greater for registered physicians versus unregistered physicians.

Brown also shared information regarding the anticipated enhancements to the Open Payments system. The restrictions around special characters in the text fields will be removed (cue the heavenly choir). CMS is also working to better facilitate the review and dispute process. According to Brown, many of the disputes were not true disputes, but could better be classified as inquiries. CMS is working to provide a method for distinguishing between a payment inquiry and a payment dispute. The agency is also working to enhance the ability for manufacturers to download their data from the site, regardless of the file size, and it hopes to extend this capability to covered recipients as well.

Brown reminded the group that new de minimums payment information and the list of teaching hospitals will be released on October 1st. CMS is planning more Q&A teleconferences in the future. Speaking of which, during the Q&A period following the presentation, Brown was asked about having a moderator on teleconferences to alleviate the “wild west” that currently exists when the call opens up for participant questions. He said that was something he would absolutely consider, but he prefers the conversational style of the current format.

William Killian, U.S. Attorney for the Eastern District of Tennessee, and Jacob Elberg, Chief, Healthcare and Government Fraud Unit, of the U.S. Attorney’s Office for the District of New Jersey, also presented on behalf of the government. They discussed current trends in government enforcement. Mr. Killian said emerging enforcement trends in his and other offices involved fraud related to Medicare Part D, lab services, hospital services and hospice care. He noted that the civil and criminal prosecutors are often involved in parallel prosecutions. Mr. Elberg referenced a continuing trend in his office involving the prosecution of kickback cases. He said those cases are typically at the individual practitioner level, and occur locally or globally. Cases that involve activities outside the U.S. can implicate the FCPA and his office shares information with FCPA fraud units. Elberg also discussed other continuing trends involving FDCA prosecutions, including those involving off-label promotion and cGMP violations.

Rounding out the “law-focused” presentations for the day was a presentation about state laws by Brian Bohnenkamp of King & Spalding. Mr. Bohnenkamp led off by discussing federal pre-emption and how it relates to state reporting. He noted that there are times where the reportable items under federal law are not reportable under state law (and vice versa), and reminded the audience of the criteria for pre-emption under the Sunshine Act. He suggested that decisions on whether pre-emption should be applied to a particular payment should be made on a case-by-case basis. He also noted that they are seeing more companies take advantage of federal pre-emption in reporting under state laws, and used the example that a number of companies did not have anything to report under Minnesota’s law due to that pre-emption. Bohnenkemp also highlighted the recent exemption in D.C.’s detailer licensing requirement for individuals who are involved in detailing for “less than 30 consecutive days per calendar year,” and he reviewed prescription drug pricing transparency proposals in a handful of states – one example being Massachusetts, which still had not provided guidance about quarterly meal reports reported under that state’s law.

The majority of the rest of the Day Two sessions focused on data and processes directly related to interacting with the Open Payments system. Sessions and panel discussions covered topics such as leveraging the data within the organization; using data to minimize compliance risk; and remediating data and the data attestation in Open Payments. Two key themes emerged: 1. Clean data is key (the garbage in garbage out idea) and 2. Communication with the organization and those outside the organization (your vendors and physicians) about the data is critical.

A number of speakers and panelists in the sessions stressed the importance of consistency in names, addresses, and format for physician ID numbers across the various in-house and vendor systems that house spend data. A periodic review of the data is an important best practice to deal with any issues along the way. Most panelists and speakers felt that a quarterly review was an achievable goal. More frequent reviews would be ideal, but could prove a challenge for companies with fewer resources. In addition, companies should engage the business early and often about what the data reveals and how that information can be leveraged to reduce risk and impact sales. Communication with physicians in advance of the CMS review and dispute period was recommended. This does not necessarily mean disclosing all the data, nor pre-disclosing to every physician about whom you have data. Setting a minimum TOV threshold for pre-disclosure, or pre-disclosing only to select KOLs were suggested as means of making the pre-disclosure beneficial to both the physician and the company.

Speaking of physicians, Day Two included a panel discussion moderated by PhRMA Executive Vice President and General Counsel, John Murphy, on the physician’s perspective of Open Payments. Panelists included Dr. Maya Babu of the Mayo Clinic and AMA Board of Trustees member, and Dr. David Barbe, former Chair and current member of the AMA Board of Trustees. The panelists said the main concerns of physicians are centered on the potential for bad data being presented to public, the ability for physicians to access the data, the implications of the data, and the impact the Open Payments program will have on relationships with the industry. While there have been improvements in the registration process, there are still issues with access, specifically, problems with particular browsers being able to access the site. The panelists felt strongly that being able to access the data through a site set up by the manufacturer would be helpful, or even having a sales rep provide the data personally.

The United States certainly hasn’t cornered the market on physician spend transparency. Global transparency was addressed on Day Two, predominately in a discussion group at the end of the day. On Day Three an entire morning track was dedicated to issues related to global transparency. The featured presentation (and highlight of the conference) was an address by Andrew Powrie-Smith, Director of Communication for the European Federation of Pharmaceutical Industries and Associations (EFPIA).

Mr. Powrie-Smith briefly covered the nuts and bolts of the EFPIA Disclosure Code before turning to a discussion of transparency in general. The industry believes transparency is about demonstrating that there is value in the collaboration between industry and healthcare professionals/organizations, which ultimately delivers better patient care. However, being transparent is not without its challenges. Primarily, with the exception of countries, such as France, where there are physician spend disclosure laws, managing transparency efforts in face of the EU privacy laws is challenging. The EFPIA Disclosure Code requires the disclosure of certain transfers of value at the individual practitioner level, and requires that disclosure to be made available to the public. In order to meet these requirements, companies must obtain consent from physicians to disclose private information about them. Further complicating the matter is that even if consent is given, it can be revoked at any time.

Mr. Powrie-Smith said EFPIA is currently conducting a survey regarding the industry stance on obtaining the necessary consents for disclosure of transfers of value at the individual level. Thus far, EFPIA has seen a large variance in the rate of consent across Europe. A culture shift is necessary to address the variance and the industry must take a leadership role in that shift.

The concept of gaining and managing consent was emphasized in other presentations as well. Representatives from BMI Systems shared data on the rates of consent presented by various pharmaceutical industry trade organizations at an EFPIA meeting in May. In Germany, the consent rate was 50-55%, and the industry trade organization in the country said that was about what they expected for the first year. Poland’s trade organization noted in March they were at a 20% consent rate, and Spain’s trade organization reports only a 10% consent rate. Representatives from IMS Health dug into issues with gaining consent as well. They discussed how codes and laws differed from country to country, specifically regarding the timelines for obtaining consent (e.g., at time of contract, or at any time during the reporting period); the scope of the consent (e.g., per activity type, per contract); from whom consent is required (e.g., HCPs or HCOs); and required consent documentation (paper or digital).

The 9th Annual Forum on Aggregate Spend and Transparency offered useful information for any attendee responsible for data collection, report submission, or analytics inside or outside the U.S. Beyond the nuts and bolts of aggregate spend, the presentations focused on the value of the data for the organization and the physician. Data provides insight for commercial teams and their programs, and the compliance risks for the company. Most importantly, as communicated by Andrew Powrie-Smith, transparency around spend data is important, because it reveals the benefits of the industry/HCP relationship to patients, payers and the public.

 

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!

Week in Review, May 13, 2015

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European Medicines Agency changes its conflicts of interest policy, ACCME updates its requirements related to the disclosure of commercial support, Siemens may be facing corruption charges in China, Bio-Rad tries to block access to FCPA settlement documents, the FDA schedules a summer session with stakeholders to discuss the topic of off-label, and another pharmaceutical company adopts the First Amendment argument in a fight to promote off-label.

Well, the world welcomed a new royal at the beginning of May, and last week, we even learned the name of the latest little princess, Charlotte Elizabeth Diana. A lovely name for a lovely little girl, and a touching tribute to the proud papa’s mother. Of course, if you’re not an Anglophile, you undoubtedly couldn’t care less, so we’ll quickly move on to our own little bundle of joy…the latest version of the Compliance News in Review.

In other news from across the sea, the European Medicines Agency (EMA) has made changes to its conflicts of interest policy. The agency will no longer allow individuals with connections to the pharmaceutical industry, or those who know they will be working for the industry, to sit on drug review panels. The previous policy left that decision up to the individual.

The ACCME has issued a royal proclamation updating its requirements for disclosure of commercial support. CME providers will now be allowed to use tabs, hyperlinks, or other electronic means to communicate commercial support to attendees. The ACCME says the move is an effort to “simplify compliance expectations and make them consistent across activity types.” The organization expects learners, as they always have, to receive disclosure information prior to the start of a CME session.

Siemens announced that its healthcare unit’s marketing and business practices are being investigated by Chinese regulators. The company denies media reports that the investigation deals with corruption, and says that it is working with regulators to resolve the matter. A Chinese government website stated that regulators were not investigating the company over bribery concerns. Siemens sells medical equipment and biochemical tests in China.

Bio-Rad raised the drawbridge on a records request from an investor. That investor has now filed a petition to have access to records related to Bio-Rad’s FCPA settlement. In 2014, the company entered into a non-prosecution agreement with the DOJ and accepted an Order issued by the SEC to resolve the matter. The investor made a request for records that related to the bribery allegations, but the company said there was no proper purpose for the records and the request did meet certain legal requirements.

The FDA will hold audience with the public during the summer to discuss off-label promotion. The agency says the meeting is being called to discuss the issue with a variety of stakeholders. The industry has been vocal about how the regulations infringe on First Amendment rights and have called on the FDA to relax its regulations. Critics worry that allowing companies to promote off-label will lead to less clinical trials and risks to patient safety.

One drug maker has decided to not wait for that summer meeting to take action. Amarin Pharma has filed suit against the FDA over its ability to share off-label information with physicians. Lawyers representing the company say the company is within its First Amendment Rights to share the information, as long as it is truthful and not misleading. The lawyers believe Amarin is the first company to pre-emptively sue the FDA over the issue. At the center of the suit is the company’s ability to share company-sponsored clinical trial information with doctors. The information indicated that the drug may be helpful for a wider patient population than what was approved. Lawyers for the company say the company knows physicians are already prescribing the drug off-label for a wider patient population, and more information, not less, should be shared with the physicians. A director with the health advocacy group, Public Citizen, says if the suit succeeds, it will undermine the FDA’s drug approval process. The FDA had no comment.

With that news of the on-going battle over off-label, we proclaim this issue of the Compliance News in Review as complete. Clearly, the focus on off-label isn’t going away anytime soon. That’s why we continually update our PharmaCertify eLearning module, On-label Promotion, with the content your representatives need to stay in compliance as they interact with HCPs.

Have a great week everyone!