Author: NXLevel Compliance Team

Week in Review, January 21, 2014

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The Serious Fraud Office adds Deferred Prosecution Agreements to its arsenal, doctors in the UK are looking for more transparency and one generic drug manufacturer gives up on China.

The teams for Super Bowl XLVII are set! The Seattle Seahawks and the Denver Broncos will do battle in New Jersey in February. Hmm, New Jersey…in February. Nothing against the Garden State (for many of us, it is home), but wouldn’t a warmer climate be more inviting for those with a ticket? Barring any blizzards, the game should be exciting as the top offense and top defense in the NFL face off. We know we’ll be tuned in, but until then there’s other news to address. Let’s kickoff this week’s News in Review.

February is shaping up to be a big month for the Serious Fraud office as well. Beginning next month, the SFO will be able to utilize Deferred Prosecution Agreements as a tool to deal with corporate bribery. The advantage to the SFO and to corporations is that agreements can be negotiated without prolonged court cases or the eventual debarment for corporations if they were found guilty through a trial. Implementing DPAs will bring its own set of challenges though. Judges in certain jurisdictions in the UK prefer justice to be doled out in court and not in advance. Consultation with judges prior to an agreement being signed should help, but the judges are not bound to accept the agreements. That leads to an issue of consistency in the process. If companies can’t rely on agreements being ratified by judges, they will be less likely to engage in the negotiations.

British doctors and academics teamed up to ask for more transparency in physician conflicts of interest. In an open letter appearing in the British Medical Journal, the group called on the General Medical Council to set up a general registry for physicians’ conflicts of interest. The letter cited an ABPI estimate that nearly 40 million pounds are paid to physicians by the pharmaceutical industry, and that the recipients of those payments are largely unknown. The letter said transparency into just who is receiving those payments “can only be good for medical practice.” A spokesperson from the GMC said that it could not require doctors to disclose payments without a change in law.

Generic drug maker Activis is scrapping its China playbook. The company announced it would cease operations in China. It’s CEO said China was not a “business friendly environment,” and there is too much risk in doing business there. The company has a small profile in China, and while it has not run into the issues some other pharmaceutical companies have of late, the CEO said he wasn’t confident that if anything did happen, the company would get a fair hearing.

2013 was another record setting year for False Claims Act recoveries, according to the DOJ. The DOJ collected $3.8 billion during the 2013 fiscal year. Of the $3.8 billion, $2.6 billion was from healthcare fraud recoveries. The majority of that $2.6 billion was from settlements with pharmaceutical industry companies.

Congress is calling for a review following CMS’ explanation for why payments for textbooks and journal reprints are not excluded from Sunshine reporting. The explanation provided by CMS did not sit well with members of Congress, and some are exploring options for changing the requirement. An aide to Maryland Representative Andrew Harris said the Congressman plans to add language to an appropriations bill to halt the collection of the data.

The fourth quarter’s here and it’s time to wrap this thing up. Before we dump the bucket of virtual sports drink over the head of this week’s Review though, we have to ask if you feel confident with your compliance training lineup for 2014. Do you need to add a new player or get back to training on the basics? The PharmaCertify™ suite of compliance training solutions includes two key players – Good Promotional Practices offers a comprehensive review of compliant product promotion practices and concepts for your sales team, and Commercial Compliance Overview is a comprehensive review of commercial compliance for your entire staff.

Have a great week everyone!

Week in Review, January 14, 2014

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The University of Minnesota adds a medical device degree to its curriculum, Microsoft requires its partners to take anti-corruption training, Aegerion receives a subpoena from the Department of Justice and CMS clarifies its stance on textbooks and journal reprints under Sunshine.

If you weren’t watching television Sunday, you missed a night of glittering stars, flowing wine and cutting one-liners. Even with Meryl Streep pronouncing awards season as ridiculous, millions tuned into the Golden Globes to see if their favorite movie, TV show, or actor took home the trophy. Okay…let’s face it, some of us watch just to marvel at the ridiculousness of the fashion choices, which is often far more interesting than the acceptance speeches (with the exception this year of Jacqueline Bisset’s confused rambling – what was that!?). We have winners and losers of our own (of the compliance kind) to cover in this week’s News Week in Review.

The University of Minnesota plans to award individuals a medical device master’s degree in the near future. The University is currently recruiting students for a master’s level program in medical device innovation. The program will be part of the school’s College of Science and Engineering and the first class is expected to be enrolled this June.

The question at Microsoft isn’t “who are you wearing?” it’s “who has taken anti-corruption training?” The company launched a global initiative requiring all its partners to provide anti-corruption training to “all employees who resell, distribute, or market Microsoft products or services.” Media reports claim the DOJ and SEC are investigating allegations of bribery involving Microsoft partners in several countries.

In a settlement that almost rivals the value of the jewels on the stars walking the red carpet Sunday night, Alcoa has agreed to pay $348 million to settle charges it violated the FCPA. The settlement is a joint effort between the SEC and DOJ. SEC officials said Alcoa subsidiaries repeatedly bribed officials in Bahrain and Alba in order to obtain government contracts. The company agreed to plead guilty to one count of violating the FCPA.

Here’s one envelope you don’t want to see your name on: a DOJ subpoena. Aegerion confirms it has received a subpoena from the DOJ for information related to the sale and marketing of its cholesterol drug, Juxtapid. The company’s CEO recently received a warning letter for misleading statements he made about the drug during a television interview. Aegerion says it is fully cooperating with the investigation.

As far as two clinical research professionals are concerned, the Sunshine Act should be nominated for the “Law Having the Most Negative Impact on Clinical Research” award. Gary A. Shangold, M.D., chairman of the Association of Clinical Research Professionals Board of Trustees, and Michael J. Koren, M.D., former president of the Academy of Physicians in Clinical Research, authored an article outlining how the Sunshine Act will negatively impact clinical research and medical innovation. They are concerned that the reports on payments related to research are not reflective of what the physicians are actually paid; the cost of complying with the law will divert money from research; and overall quality of care will ultimately be affected by the diminished investment in research. The two also call on lawmakers to change the legislation in order to provide a more accurate picture of the financial transactions between research physicians and the industry.

CMS Administrator Marilyn Tavenner recently responded to an inquiry from Congress about textbooks and journal reprints not being considered educational items under the Sunshine Act. Educational items are described as those that are intended for patient use or have a direct benefit for the patient and are therefore excluded from reporting. In her letter, Ms. Tavenner said textbooks or journal reprints do not have a direct benefit for patients the way an anatomical model does. Rather, the textbooks and reprints provide a “downstream benefit” for patients so CMS believes the items should be reported as gifts or education.

With that, the band is signaling us that it’s time to wrap up the News in Review for this week, so we’ll leave you with one last note. If you’re looking for additions to your 2014 compliance training cast, PharmaCertify™ offers up-to-date modules and apps on critical topics like Adverse Events, On-label Promotion and Good Promotional Practices.

Have a great week everyone!

Week in Review, January 7, 2014

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Industry associations implement new principles on clinical study data, Abbott settles a False Claims case, the SEC suggests that the FCPA could cover commercial bribery, and the FDA wants to know if its messages are being heard on social media.

Welcome to a new year of compliance news! As the calendar turns, our thoughts turn to the yearly rite of passage otherwise known as New Years’ resolutions. Whether your goals are personal in nature (eat right, save more money, exercise more, etc.) or more focused on your professional life, we wish you the best of luck and as we say in the training field, we hope it sticks! At the Compliance News in Review, we resolve to keep you updated every week on the news from the world of life sciences compliance. With that, we welcome you to the inaugural 2014 edition of the News Week in Review.

The  European Federation of Pharmaceutical Industries and Associations (EFPIA) and PhRMA are starting the year by changing how clinical trial study data is handled. The joint principles on clinical trial data created by the two organizations in 2013 went into effect January 1 and the new principles provide healthcare professionals, qualified researchers and others with the ability to request patient-level data, study-level data, and full clinical study reports and protocols. Some member companies, like GSK and Pfizer, have already provided directions on how to request the data.

Transparency International wants businesses to resolve not to make facilitation payments. In the latest version of the organization’s Business Principles for Countering Bribery, provision of facilitation payments is now considered bribery. Other changes to the principles include the addition of a section addressing conflicts of interest and the addition of a section on the need to complete a business-specific risk assessment when developing an anti-bribery policy.

Abbott is starting the year $5.475 million lighter following a settlement with the DOJ over charges the company violated the False Claims Act. The government alleged Abbott paid doctors to implant several of the company’s vascular products into patients. The suit was originally filed by two former Abbott employees who will receive over one million dollars of the settlement.

The commitment hasn’t quite risen to the level of a resolution yet, but the SEC seems to be indicating it may expand how it enforces the FCPA. At a recent conference, FCPA Unit Chief Kara Brockmeyer told participants that the books and records provision of the Act makes the prosecution of corporate bribery fair game. If corporate bribery is discovered during the course of an investigation, a company’s books and records will be scrutinized and action can be brought against the company.

China is starting 2014 with a renewed focused on bribery involving pharmaceutical, medical device and nutritional products companies. The country is planning to blacklist companies that pay bribes to doctors or healthcare authorities. The first offense will result in a regional ban, and the second in a full country ban.

The FDA is taking new steps to make sure its messages are being heard. The agency will monitor online chatter to see if its social media messages are reaching an audience and if that audience is paying attention.

That’s all for this week folks. Remember, if you’re 2014 compliance training curriculum could use a refresher, the PharmaCertify™ suite of off-the-shelf modules and mobile apps bring up-to-date compliance content on topics like the Sunshine Act and on-label promotion to your staff where they need it most – in the field and at their fingertips.

Have a great week and Happy New Year!

2013 Year in Review

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

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

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

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

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

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

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

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

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

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

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

Happy New Year everyone!

Week in Review, Holiday Edition

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With the holidays approaching, one co-pay charity falls onto the “not so nice” list, whistleblowers get the gift of protection against retaliation, and the state of Maryland finds an extra present of its own.

Well, here we are in the final stretches of the Christmas shopping season and either you’re resting peacefully, content in the knowledge that your mad dashes through mall mania are behind you, or you’re in full “take whatever is left on the shelf” panic mode. As you unwind with a cup of eggnog and a slice of recycled fruitcake, we offer a compliance-themed distraction of our own, with this edition of the News Week in Review.

Tis the season for giving, but at least one charity needs to be careful about the process. The Chronic Disease Fund (C.D.F), which provides co-pay assistance to patients with chronic conditions, has come under scrutiny for its relationship with pharmaceutical industry donors. Questions were raised in investor publications about the relationship between the charity and pharmaceutical manufacturers. C.D.F. has hired a law firm to review its practices and recommend new policies to comply with legal requirements. The organization’s president/founder has resigned.

In the spirit of the season, the U.S. Senate Judiciary Committee wants to give whistleblowers the gift of protection against retaliation. The Committee approved the Criminal Antitrust Anti-Retaliation Act of 2013 to protect whistleblowers involved in antitrust cases. The bill will allow for recourse against retaliation through a cause of action in civil court, through which compensatory damages would be possible. The bill has been sent to the House for approval.

Maryland is getting a little extra in its stocking this year since GSK has agreed to a $15 million settlement with the state over accusations the company improperly marketed three diabetes drugs. The suit was filed under Maryland’s False Health Claims Act. The company allegedly touted the drugs as being superior to competitive products, without justification, and allegedly neglected to share information about the heart disease risks associated with the drugs.

Speaking of GSK, the company announced it will no longer pay doctors to promote its drugs, and it will no longer pay for physicians to attend medical conferences. According to CEO Andrew Witty, the moves have nothing to do with the current investigation into the company’s business practices in China, but are rather an ongoing effort to “stay in step with how the world is changing.” The plans should be rolled out globally by 2016. The company also announced that starting in 2015 it will no longer compensate sales representatives based on the number of prescriptions written by doctors on a global basis. The revised compensation policy is already in place in the U.S.

The head of the Canadian Medical Association is among those caroling the approval of the move by GSK. The CMA president said it was a welcome change, and should serve as a “wake up call” for those who are too “cozy” with the industry. He said the CMA has had rules regarding relationships with industry companies for some time, and that he hopes the move by GSK will promote a larger transparency discussion in Canada.

With the final shopping hours ticking away, we won’t keep you from your appointed rounds (or from your happy dance if you happen to be in the “woo hoo I’m all done” category) any longer. We leave you with a reminder that if comprehensive compliance training on topics like on-label promotion, adverse events and the Sunshine Act are still on your own gift list, the modules and mobile apps available through the PharmaCertify™ suite of solutions offer  up-to-date and customizable content where your staff needs it most – in the field and at their fingertips.

Have a great holiday everyone!

Week in Review, December 16, 2013

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The Serious Fraud Office hits another bump in the road, Brazil expands its anti-corruption efforts, and the Pew Charitable Trusts and the CME Coalition disagree on suggested changes for the industry’s interaction with medical schools.

As the song goes, “the weather outside is frightful.” The string of winter storms over the last week has brought snow for some, ice for others, and a lovely cold rain over much of the country. Welcome to early winter! Yes, we know, the calendar still says we’re in the fall. If you’re one of the unfortunate ones scraping snow and ice off your windshields and sidewalks already, we can’t offer much in the way of help with that shovel, but we can help you catch up on the compliance news you need to know, with this week’s News in Review.

The Serious Fraud Office is facing more stormy weather. The agency abruptly called off the high-profile bribery case against businessman Victor Dahdaleh. Dahdaleh was accused of paying millions in bribes to managers at Aluminum Bahrain (Alba) over a period of eight years.  The trial began in early November, and the SFO had to call an end to their prosecution when two U.S. lawyers who had helped with case refused to testify and a third witness changed his testimony. The two U.S. lawyers also represent Alba in a civil case, which raises questions about whether they should be used in the British criminal case. The case is the latest in a string of embarrassing and expensive missteps for the SFO.

New legislation has been introduced in Canada that would require doctors and pharmaceutical companies to reveal more information about the adverse effects associated with pharmaceutical products. The law would require doctors to notify Health Canada when patients have an adverse drug experience, and pharmaceutical companies would then be required to make immediate changes to a drug’s label to reflect the new safety concerns.

A change in the anti-corruption weather is on the horizon in Brazil. The Clean Companies Act (CCA) will go in effect January 29, 2014. The anti-bribery law shares a number of similarities with the FCPA and U.K. Bribery Act. The law applies to any company or legal entity doing business in Brazil, and applies to the bribery of both domestic and foreign government officials at any level. It also prohibits facilitation payments and implements strict liability for legal entities involved in corruption.

The courtroom had to be frosty when Boehringer Ingelheim was handed a $931,000 fine for losing documents related its Praxada drug. The judge said the company allowed the documents to be destroyed, and that attempts to create back up versions were even thwarted. Further, the company disabled programs that would have preserved voicemail and text messages. The loss of the documents affects 1,700 patient lawsuits.

A report from the Pew Charitable Trusts suggests industry-physician interactions at the nation’s medical schools need to be put in the deep freeze. The recommendations from Pew include the typical ban on rep visits, meals, gifts, etc., as well as a suggestion that school staff not accept speaking fees from pharmaceutical companies.

The CME Coalition would like to put the Pew recommendations on ice though. Senior advisor to the CME Coalition, Adam Rosenberg, says the recommendations in the report are “irresponsible,” and “they are nothing short of dangerous to America’s health.” For example, even though Pew recommends that CME should be free of industry funding, the organization cites no studies or evidence showing that funding is leading to poor patient outcomes, or is unduly influencing prescribing decisions.

And so we come to the end of this chilly edition of the News Week in Review. If adverse events reporting is at the top of your holiday and new year wish list, the newest off-the-shelf module from PharmaCertify™, Adverse Events and Product Complaints, covers the definitions and sources of events and complaints, as well as the information needed to ensure accurate reports are filed. As with all of the PharmaCertify™ solutions, the module is easily customized with your  organization’s procedures and policies.

Stay warm everyone, and have a great week!

News Week in Review, December 10, 2013

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Studies reveal non-clinician HCPs have a favorable view of industry relationship, AstraZeneca partners with Harvard to improve drug testing, and the focus on the FCPA intensifies.

Well, the year is almost over, and if you’re like us, you’re probably wondering how December got here so fast and what happened to the rest of 2013. Before we put another year in the books though, we at least have the usual list of holiday movies and specials to enjoy. While you search the listings and set your DVRs to record, we’ll deliver a little entertainment of our own, with this week’s News in Review.

In terms of their relationships with the industry, non-physician clinicians generally feel It’s a Wonderful Life, albeit one with the potential for risks and conflicts of interest. An analysis of multiple studies related to the industry and non-physician HCPs like registered nurses, nurse prescribers, and Physician Assistants, shows the providers typically have a favorable view of industry interactions and say they rely on industry representatives for important information. The authors of the review suggest institutions expand policies on industry interactions and the Sunshine Act to include non-clinician HCPs.

AstraZeneca researchers will Deck the Halls with researchers at Harvard. The company announced they will collaborate with the institution on an initiative to improve drug testing in humans. The technology, called Organs on Chips, uses human cells in a flexible polymer to imitate human organs. The two organizations will work to develop an animal version of the technology that will then be used to compare drug testing results between humans and animals.

Santa Claus is Comin’ to Town, with early gifts, by way of Vermont and CMS. The Vermont AG’s office released a memo announcing the 2013 disclosure forms and databases will be ready sometime this week, and that the draft guidance for 2014 will be released soon. A conference call to discuss the guidance will be held December 19. CMS posted several documents to the Open Payments website, including XML and CSD schema for reports and sample report examples.

Some in the industry might say the Department of Justice and Securities and Exchange Commission are acting more and more like Scrooge when it comes to FCPA investigations. According to the head of the DOJ’s FCPA Unit, the DOJ is investigating 150 cases and expects to bring “very significant cases” in 2014. The SEC has received over 3,000 whistleblower tips involving FCPA investigations and with cooperation increasing globally, regulators expect the prosecution of individuals for FCPA violations to continue.

Was that The Grinch Who Stole Christmas lurking about the offices of Reckitt Benckiser? Perhaps it was one of the agents from the OIG and IRS who removed boxes of documents from the company’s offices in Virginia. A company spokesperson confirmed that a warrant was served by the US Attorney’s Office for Western Virginia, and that the company was cooperating with the investigation. The purpose for the warrant was not disclosed.

Employees at Advance Sterilization Products haven’t been feeling merry lately. The FDA announced a $1.25 million settlement with the company and two of its executives for the selling of adulterated and misbranded product. The FDA claims the company knew it did not have sufficient data to support the expiration date on its sterilization monitoring product.

That brings us to the end of the News in Review for this week. As you close out 2013 and finalize your compliance curriculum for next year, remember the PharmaCertify™ suite of eLearning modules and mobile apps offer your staff the up-to-date content they need where and when they need it most – in the field and at their fingertips.

Have a great week everyone!

News Week in Review, November 25, 2013

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The Sunshine Act’s payment reporting is still a worry for physicians, the FTC monitors its pay-for-delay deals closely and the U.K. Bribery Act fails to boost confidence of small and medium enterprises – all in time for Turkey Day.

Gobble, Gobble everyone…Thanksgiving is this Thursday! (and for our Canadian friends, we hope you enjoyed your Thanksgiving back in October!) We at the News are excited and busy making those last minute trips to the grocery store to prepare for the feast with family and friends. Let’s face it though, sometimes all the togetherness can be a little “stressful,” and there’s no better way to deal with the stress than comedy. Laughter is the best medicine right? So, while we serve up the week’s main course, the News in Review, we’ll add a side of corny jokes to the plate for your Thanksgiving festivities – we’ve put the punch lines at the end of each paragraph, just to build the suspense.

Why did the turkey cross the road?

The Sunshine Act payment reporting continues to be a concern for physicians, particularly, the accuracy of the reported data and the ability to address inaccuracies within the 45 day dispute timeframe. How those payments appear to the public also weighs heavily on physicians’ minds and could lead to changes in how they interact with the industry.  According to HealthLeaders Media author, Greg Freeman, concern over having their name associated with industry payments may cause physicians to limit their consulting or speaking engagements.

It was the chicken’s day off of course.

If April showers bring May flowers, what do May flowers bring?

Targeting pay-for-delay deals will continue to be a top priority for the Federal Trade Commission, according to FTC Competition Bureau Chairwoman Deborah Feinstein. The agency has two pay-for-delay cases currently in litigation and Ms. Feinstein says it will continue to monitor filings submitted under the Medicare Prescription Drug Improvement and Modernization Act.

Pilgrims (okay, we admit it – that “May flowers” pun is best delivered through the spoken word and falls apart when written).

Why do turkeys gobble?

The Drug Quality and Security Act received its senatorial stamp of approval last week and has been sent to the President for his signature. The bill was created to clarify the law around drug compounding and compounding pharmacies. It includes a drug track and trace requirement to address the issue of counterfeit drugs entering the marketplace. Beginning January 1, 2015, manufacturers and distributors that transfer ownership of products will have to provide a document showing the ownership trail of the product.

Because they never learned table manners.

What kind of music did the pilgrims listen to?

More than half of accountants surveyed by the Association of Chartered Certified Accountants (ACCA) agree with the statement that the U.K. Bribery Act has failed to increase the confidence of small and medium enterprises. Only 17% percent of the respondents say the U.K. Bribery Act has given confidence to small and medium enterprises to resolve corrupt practices. While 48% say small and medium enterprises are likely to face corruption risks overseas, only 43% say anti-bribery is something they consider when looking at overseas business opportunities.

Plymouth Rock.

What is the best thing to put into a pie?

Louisiana’s Attorney General announced an $88 million settlement with 25 pharmaceutical companies over allegations of overcharged state Medicaid system. The settlement brings a 2010 case involving 109 manufacturers to a close. Total recoveries in the case were $238 million. The companies were accused of inflating Average Wholesale Price, violating the Louisiana Unfair Trade Practices and Consumer Protection Act and violating the state’s Medical Assistance Programs Integrity Law.

Your teeth!

Well that brings us to the end of this week’s News Week in Review and thankfully, the end of our lame jokes. Happy Thanksgiving everyone! As always, we’re grateful that you’ve taken a few minutes of your time to read our weekly review.

See you right back here next week!

New Week in Review, November 18, 2013

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The APBI amends its Code of Practice, a doctor in Scotland looks for Sunshine, PhRMA sues the state of Maine over drug importation, and a congressman from New Jersey seeks clarification on how food provided to CME program speakers and attendees is reported.

The big day is almost here…if you have a tween or teenager, you are probably well aware that the long-awaited opening of the film, The Hunger Games: Catching Fire, is this Friday! With a number of theaters premiering the film a day early, we’re left with precious few hours to practice our skills for the archery tournament and best braid contest. But before we prepare for our time in the Arena, we pause to present you with a week’s worth of compliance news, with the News in Review.

Our first “tribute” comes courtesy of the ABPI, whose members have agreed to amend the Code of Practice to include greater transparency on payments made to HCPs and healthcare organizations. APBI’s chief executive views the changes to the Code as an important first step in correcting the public’s misconception of the relationship between the industry and HCPs. According to a recent British Medical Journal article, he may be onto something. The article reported the results of a recent survey, which found 90% of the nearly 1,055 respondents felt that payments to HCPs should be made public.

As the ABPI moves on with determining the details of its transparency program, a Scottish doctor is hoping a Sunshine Act style law will “catch fire” in his country. The physician has petitioned the government to create a Sunshine Act of Scotland, which would publicly disclose payments to NHS healthcare professionals.

A compliance uprising has been started in Maine as PhRMA and several Maine pharmacy associations are suing the state over its drug importation law. The law allows Maine’s citizens to obtain prescription drugs pharmacies in Canada and from licensed retail pharmacies in the U.K., Australia and New Zealand. PhRMA, and the other plaintiffs, say the law violates the U.S. Constitution and federal laws that control the sale of drugs.

If you’re looking for more information on Open Payments and data submission, CMS has announced a series of webinars, designed to introduce features of the Open Payments system, on November 19. While the webinars are targeted to manufacturers and individuals responsible for creating data submission files for manufacturers, anyone is welcome to attend. A follow up question and answer session will be held December 3.

Speaking of “hunger games,” the language regarding meals at CME events continues to cause confusion. So much so that New Jersey Congressman Robert Andrews sent a letter to CMS requesting that the cost of food provided to speakers, faculty AND attendees of CME events be exempt from individual reporting requirements.

The rule already exempts the speakers and faculty as long as three requirements are met: the program is accredited by one of five designated organizations; payments or transfers of value are not made by the manufacturer directly to speakers or attendees; and the selection of faculty and speakers is not influenced by the manufacturer.

In his letter, Congressman Andrews points out that CMS has already acknowledged that accreditation bodies and industry standards create safeguards against sponsor involvement in educational content. He says the same logic should be applied to the meals provided to attendees.

Well, that’s the news for this week. We leave you this week with a recommendation for a different type of trilogy – one that weaves a compelling and engaging tale of compliance best practices and risk reduction across a broad array of topics. PharmaCertify’s Compliance Overview, Good Promotional Practices and On-label Promotion eLearning modules offer the regulatory and practical content your sales representatives and office staff need to understand the compliance rules and promotional policies that affect their daily activities. They’ve been met with rave reviews by learners of all ages!

Have a great week and, “may the odds be ever in your favor.”

2013 PCF Pharma Congress Review and Highlights

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Sean Murphy, NXLevel Solutions

Day 1

The first day of the Fourteenth Annual Regulatory and Compliance Congress and Best Practices Forum opened with a roundtable session featuring chief compliance officers from Eisai, Shire, Merck, Bristol- Myers Squibb and Purdue Pharma. Analytics and data were the primary themes and Anne Nielsen from BMS emphasized the need for companies to use data to spot the trends and the risk areas for compliance. Eve Costopoulos from Eisai agreed, noting that a coordinated effort addressing risks is crucial and web-based tools should be put into place to collect the data. Caroline West from Shire shifted the conversation to the importance of having a serious conversation with the sales force about what they can and can’t do and Eve suggested that the level of understanding among the sales team may not be what the audience of compliance officers believed it to be.

Mary Riordan, Senior Counsel to the Office of Inspector General was next with her annual OIG Update presentation. She began with an update on enforcement activity from the previous year and in particular, the large number of kickback cases, including the Sanofi Hyalgen case, the Boston Scientific/Guidant case and the Purdue Frederick case.

Riordan also stressed that promotional activities need continued scrutiny to be sure what messages are being conveyed and as in years past, she suggested the compliance officers look to recent CIAs for lessons. She specifically referenced the Par CIA and its recoupment program. And in agreement with the comments made by the chief compliance officers on the preceding panel, Riordan said the risk assessment process was a good way to bring businesses into compliance efforts and ensure an effective process.

Next on the docket was the Assistant US Attorney Roundtable with representatives from New York, Boston, Philadelphia and Los Angeles in attendance. Margaret Hutchinson of Los Angeles echoed earlier comments, saying that when investigations are conducted, her office focuses on the time period from when the company learns of a problem to when that company acts on the problem, while Paul Kaufman from New York urged the audience to consider their personnel, claiming that he has seen good compliance departments staffed by people who “really don’t know what they’re doing.” He also suggested that incentivizing employees on sales may lead to more compliance issues and offered the idea of taking away bonuses if employees violate compliance regulations.

Tom Abrams, Director of the Division of Drug Marketing, Advertising, and Communications for the FDA returned this year to speak to an audience anxious to hear his FDA-OPDP Update, especially the status of the agency’s guidance on social media. While Abrams did commit to providing guidance that will be high in quality and relevant, which was stated with a disclaimer that his office was limited in resources, he did not commit to meeting the deadline set forth in the Prescription Drug User Fee Act (PDUFA).

Abrams also updated the audience on the FDA’s Bad Ad program, and the most common violations found over the last year. Omissions of risk, misleading efficacy and misleading superiority claims led the pack in terms of those violations.

Mit Spears, Executive VP and General Counsel for PhRMA closed the first day with a keynote presentation that mostly amounted to a compelling argument in defense of promoting off-label. Spears’ points on the frequency of off-label use and the potential benefit to patients were not lost on an audience that was sure to agree with his thoughts. Unfortunately, the regulators who presented earlier in the day were most likely no longer in the room.

Day 2

The second day of the conference opened with a panel session of industry leaders and an interactive dialogue that included audience response questions designed to gauge compliance priorities and readiness.

When asked about their top priorities, 41% of attendees answered “improving compliance systems and processes,” and “aggregate spend and Sunshine” was the second most popular choice. On the subject of their top global issues, the audience cited “FCPA/Anti-corruption” as their primary concern. Kelly Freeman, Senior Director of Ethics and Compliance at Eli Lilly, took the opportunity to remind attendees that they can no longer just focus on the FCPA and the UK Bribery Act – anti-corruption in globally needs to be the focus of their training.

On the question of which area of aggregate spend they are most worried about implementing, 60% of the audience answered, “accuracy of data.” The panelists pointed this to the biggest benefit of the Sunshine Act – the data is critical and helpful. Kris Curry, formerly of Johnson & Johnson, issued a warning not to spend too much effort and too many resources on the smallest details.

On the question of whether their companies regularly assess employee perception about compliance culture, 62% of the audience answered yes, which was definitely considered a positive trend by the panelists.

Speaking of trends, when asked about the background of their compliance staff, audience members said 40% had a legal background, 16% came from the sales and marketing function, and the remaining staff was spread across a number of disciplines.

During the session covering the View from the C-Suite, panelists Jean-Luc Fleurial of Bristol-Myers Squibb, Adrienne R. Takacs of Takeda and Michael Goolsby of Fresenius Vascular Care, agreed that compliance has to start in the hiring process. Goolsby advised those in a hiring role to look for employees who bring integrity coupled with coachability. He also touched on the training process, stressing that training needs to extend beyond the check-the-box approach recognizable to real-world scenarios.

The second half of Day 2 featured a series of “mini summits” in topics as diverse as third party relationships, government pricing, data sharing and cGMPs. I was anxious for an update on the FCPA and UK Bribery Act so I started with the Anti-corruption Update session with a panel of experts, including Nathaniel Edmonds, Former Assistant Chief, FCPA Unit of the DOJ and Vivian Robinson, Former General Counsel of the UK Serious Fraud Office. In noting that while there have been no significant UK Bribery Act cases to date, Robinson reminded the audience that the law had not been in place long and he was aware of “a number of cases on the books that were likely to come into the public domain in a short time.”

Edmonds focused on recent trends in FCPA enforcement and in particular, Fair Market Value and the importance of proper methods for reimbursing CROs and other third parties. Robinson agreed that third party due diligence is essential but warned that the focus on gifts and entertainment can be a distraction from that third party focus.

China was of course a topic of discussion with so much anti-corruption news emanating from the country in recent months. Edmonds called China “one of the most important recent developments for the pharmaceutical industry” and Robinson emphasized the need for clearly recorded due diligence, “you can say what you did and back it up.”

After a disappointing start to one of the late afternoon sessions, which started more as an advertising opportunity for the companies presenting, I joined a number of other attendees in moving to the Interplay between Company Culture and Compliance, where the key message seemed to be the importance of emphasizing the positive when evaluating employees. Or, as Gina Dunsmuir from Ortho Clinical Diagnostics said, “give the employees examples of what they are doing right.” Tom Costa from Bristol-Myers Squibb believes employees “want to be proud of their corporation,” and that’s even more reason why compliance officers need to be out in the field listening to employee feedback.

I decided a dose of medical device compliance would be a good way to close Day 2, and took in the Medical Device Compliance Issues Update session with Paul Kalb of Sidley Austin, Seth Whitelaw of Deloitte & Touche, and Sandy Kalter, Chief Regulatory Counsel for Medtronic. The panel pointed to the trend toward more med device CIAs and the increased focus on executive management and directors in those CIAs. For example, in 2012, of the $260 million dollars collected in anti-corruption fines, $50 million was from three device companies.

For Kalter, the biggest priority is managing off-label risks by first studying recent CIAs and developing a policy around the results. The different areas where off-label arises are key, according to Kalter, including areas like consultative meetings and MSL interactions.

Day 3

Day 3 opened with a keynote presentation from Bret Saunders, the new CEO of Forest Laboratories who was once a compliance officer for Schering-Plough. Saunders offered a unique view on how he perceives compliance from the CEO role. He believes “integrity includes compliance, yet goes beyond to include following your moral compass.” It took three days, but I knew I’d hear a reference to “tone at the top” and Saunders didn’t disappoint. But he used the oft-quoted phrase effectively, stressing the need for that tone to be communicated from the Board.

Understanding the background of his audience, Saunders included tips for presenting compliance concepts to directors. For example, keep concepts clear and in perspective. These are often people who don’t know the industry, so the information has to be right and it has to be organized. He advised the CCOs to approach their role as in a way in which they understand what the organization is trying to accomplish and which risks have the most impact on business. The best way to measure compliance readiness is to repeatedly survey internal and external stakeholders, according to Saunders, and conduct focus groups with employees to reveal how they feel about compliance and the related issues.

After an intriguing presentation on the role of unconscious biases in everyday life by Shankar Vedantam, NPR Correspondent and author of The Hidden Brain, and two panel discussions covering topics as diverse as Sunshine, state laws and lessons learned by attorneys who formerly worked in public service, Arun Sharma, from the University of Miami closed the conference with his take on the future of compliance. PCF planners may have made a mistake in scheduling Sharma for the last session because his comments were some of the most compelling and certainly controversial ones made during the conference. Leave it to academia to think outside the box and challenge the audience to approach compliance as a strategic opportunity to enhance marketing opportunities. The audience that hadn’t left for an early train or flight stirred uncomfortably as Sharma emphasized that “compliance 2.0” should be viewed as a chance to enhance a brand and grow that brand within the letter of the law. He challenged those audience members to be “more creative within the rules.” During a follow up question and answer session, one remaining audience was grateful for Sharma’s unique ideas but lamented the fact that government regulators hadn’t stayed to hear the presentation because he was sure they would disagree with the approach.

While some attendees anecdotally expressed frustration over the lack of new information presented at the Fourteenth Annual Regulatory and Compliance Congress and Best Practices Forum, conference organizers continue to seek new and innovative methods, e.g., mini summits, to present an ever-evolving stockpile of information to an eager audience. The conference, along with CBI’s Pharmaceutical Compliance Congress, remains the premiere opportunity for the industry to share the latest best practices and concepts.

See you at PCC in January!