FCPA

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!

2013 PCF Pharma Congress Review and Highlights

NXLevel Compliance Team , , , , , , , ,

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!

Week in Review, November 4, 2013

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Week in Review, November 4, 2013
The FDA explores the Bad Ad program, targeting misleading drug ads for younger audiences; whistleblower cases shed light on Cephalon kickbacks and the government steps up corruption investigations.

It’s the most wonderful time of the year! When we’re nestled all snug in our beds with visions of sugarplums (or dew drops) dancing in our heads. Finally, Daylight Savings Time came to end over the weekend! Oh, the joy of receiving that precious hour back. We hope you made the most of that “free” hour over the weekend. We sure did! The back of eyelids never looked so good. It’s back to the grind now, so let’s get rolling with this week’s News Week in Review.

The FDA has decided it’s about time to study how teens perceive direct drug advertising. The study will gauge how teens respond to ads for fictitious acne and ADHD drugs. Studies have shown that the part of the brain that helps in discerning risk in decision making is not fully developed until the mid-twenties. The FDA wants to understand how teenagers judge the risk and benefits associated with the drugs in the ads to determine if changes should be made in the way certain drugs are advertised online.

The FDA has sprung forward with a new CME program as a part of the Bad Ad program. The agency will launch a web-based CME program to teach HCPs how to identify misleading drug ads. The course will focus on various types of advertising, and is open to anyone, even though it’s directed to HCPs.

The government will fall back from a pair of whistleblower cases against Cephalon. The first whistleblower case focuses on the off-label promotion of four drugs Cephalon co-promoted with Takeda. This is the second case brought by this group of whistleblowers against the company. The first case resulted in a settlement. In the second, the relator alleges Cephalon promoted three drugs for off-label purposes and paid kickbacks to doctors. The relator also alleges Cephalon and WebMD conspired to locate certain patient populations and promote drugs for off-label use to those patients.

A study by Taxpayers Against Fraud found that for every dollar the federal government spends on investigating and prosecuting healthcare fraud, it recovers $16. The study showed that between 2008 and 2012 civil, criminal and state recoveries were just over $18 billion. The study also showed that since 1987, recoveries totaled nearly $40 billion. China, the U.K. and U.S. are not dilly-dallying when it comes to corruption investigations. Speakers at a conference in Beijing said the countries are stepping up corruption investigations in the food and drug industry. This year, the U.S. government initiated 11 FCPA investigations of drug and medical device companies. According to a former DOJ official speaking at the conference, the agency believes there is considerable corruption occurring in drug firms overseas, and addressing it is a priority with the DOJ. John Tan, counsel with international law firm Reed Smith, said the Serious Fraud Office has six Bribery Act investigations under consideration.

Don’t overlook the importance of having administrative assistants spend time on anti-corruption training. Addressing the question of who should be included in FCPA training, the FCPA Professor points out that while administrative assistants may not interact with “foreign officials” directly, they can be a valuable asset in identifying FCPA risks if they receive training. The article references a recent article in the WSJ about the influence and power admins hold, and points out this should not be overlooked when determining your FCPA training audience.

Well, the clock has run out on another issue of the Week in Review. If all of this news surrounding product promotion has you wondering if your field force is up-to-date on the latest compliance practices, Good Promotional Practices from the PharmaCertify™ suite of customizable off-the-shelf eLearning modules, covers topics ranging from gifts and meals to speaker programs and the handling of off-label inquiries.

Have a great week everyone!

Week in Review, October 21, 2013

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A U.S Senator calls for an investigation into the relationship between pharmaceutical companies and the FDA, the definition of “foreign official” under the FCPA is debated in Florida, the Baycol False Claims Act case moves forward and 25 manufacturers settle with Vermont over charges of failing to file required reports.

The World Series gets underway this Wednesday with the Cardinals returning after a one year hiatus to face a scraggly, scrappy Red Sox squad. With the team from Boston representing the American League, no doubt the boys from St. Louis have gained a new legion of fans in New York. So, do you have a side in the battle, or will you just be glad when it’s over, and you can get back to The New Girl and Sleepy Hollow? Whether you’re looking forward to the first pitch or the last, we’re here to help fill the time with the current version of the News in Review.

U.S. Senator, Joe Manchin, has put a call into a different type of commissioner to investigate an alleged pay-for-play scheme between the FDA and pharmaceutical companies. In the letter to FDA commissioner Margaret Hamburg, Senator Manchin expresses concern about reports of pharmaceutical companies paying thousands of dollars to attend FDA advisory meetings about the safety of pain medication. He would like to see a full senate investigation into the allegations to shed light on whether the relationship between pharma companies and the FDA caused any delay in the rescheduling of addictive pain killers.

A meeting on the mound is needed to settle an FCPA case in Florida. The case is now in the hands of three judges, and at the crux of the discussion is everyone’s favorite topic – the definition of a foreign official. More specifically, the case focuses on the definition of an “instrumentality.” Two telecom executives are accused of bribing the government-owned Haiti Teleco and defense lawyers have argued that an instrumentality has to be a direct part of the government under the FCPA, which is not the case with Haiti Teleco.

Internal controls charges are on the rise in FCPA cases, leading the Cadwalader law firm to wonder if the DOJ and SEC are poised to begin charging independent directors for failing to assure or maintain proper controls. Several companies have faced such charges recently, and as was demonstrated in the Orthofix case, companies can be charged with a violation for not having financial controls or an adequate compliance program in place. The FCPA guidance states that compliance begins with board members and senior executives, so the idea of independent directors being charged for the lack of proper controls isn’t far-fetched.

Upon further review, a whistleblower case against Bayer will move forward, but only on the grounds that the Department of Defense was defrauded, not federal healthcare programs. The False Claims Act case, which alleges that Bayer was deceptive in its marketing of Baycol, was dismissed last year because the court said the whistleblower failed to meet the specificity threshold related to false claims. The appeals court reversed the lower court’s decision.

Boston Scientific and its Guidant division have agreed to pay $30 million to settle charges of knowingly selling defective heart devices to facilities that treat Medicare patients. The government alleged that despite being aware of the problem, Guidant continued to sell defective stock and sent misleading communications to doctors in attempt to hide the true nature of the defect. The government also alleged that Guidant attempted to hide the defect from the FDA.

Vermont racked up 25 strikes against manufacturers under its Prescribed Products Gift Ban and Reporting law. The state’s Attorney General recently announced settlements with 25 manufacturers for alleged violations of the law. Most of the companies involved were small manufacturers and most of the charges levied were for failure to file the required reports. One manufacturer faced six charges of violating the gift ban.

We close with a reminder that the PharmaCertify team will be on-site at the Fourteenth Annual Pharmaceutical Regulatory and Compliance Congress next week. So if you’re attending, don’t forget to stop by the booth, say hi, and ask about our suite of compliance training modules and apps.

Have a great week everyone.

News Week in Review, October 14, 2013

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An industry watchdog group raises concerns about pay-for-play, the Supreme Court considers medical devices, one company claims its trade secrets were sent overseas and a critique of off-label promotion is, well, criticized.

“In fourteen-hundred and ninety-two, Columbus sailed the ocean blue”…certainly one of the more effective pneumonic devices from our younger days. So it is that today we celebrate the journey that would lead Mr. Columbus to “discover” the Americas. Unless of course you’re Canadian, in which case…Happy Thanksgiving! There is much to celebrate in North America today, but before you dig into the turkey and stuffing or take advantage of the Columbus Day sales at the local mattress emporium (nothing says “woo hoo, America was discovered!” like a new mattress), we set sail with this week’s News Week in Review.

The discovery of emails about meetings between government regulators and industry executives has raised concerns about the relationship between the two groups. The emails reveal that since 2002, pharmaceutical companies paid their way into the IMMPACT (an organization dedicated to improving clinical trials for new pain treatments) meeting, where they were able to discuss clinical trial procedures with regulators. The industry watchdog group, Public Citizen, says this raises concerns of a pay-for-play arrangement, in which drug companies could buy access to regulators, other health officials and academics. One of the founders of IMMPACT acknowledged that the email messages could appear problematic on the surface, but no one has complained about pharmaceutical companies paying for representatives to attend the meetings.

The U.S. Supreme Court could be exploring a case of a patient’s ability to sue a device maker under state laws when a problem with an FDA-approved device occurs. The case involves an Arizona man who has sued Medtronic over a pain medication pump which he claims left him paralyzed. At the time the man was using the pump, the device was approved by the FDA. The device was eventually removed from the market following a warning from the FDA about Medtronic’s failure to disclose all the risks. The Court has turned to the Obama Administration for an opinion on the matter.

A semi-retired Harvard doctor is suggesting that the Massachusetts legislature define a modest meal as one comparable to what one would receive at a hospital cafeteria. The doctor testified before the Committee of Public Health about a bill that would set a standard for a modest meal. He lamented the repeal of the existing meal ban and lectured about the so-called evils of pharmaceutical marketing.

Three former Lilly employees may be forced to walk the plank after they were indicted for handing over company trade secrets to a Chinese pharmaceutical company. According to the indictment, two of the employees emailed information about nine early-stage research projects to a third employee, who was also employed by the Chinese drug company. Lilly claims the company has a value of $55 million.

Fresenius, the maker of Propofol, ceased shipments of an anesthetic drug to Morrison-Dickson for several months, after the wholesaler accidently sent 20 vials of the drug to a Missouri prison for use in lethal injections. Fresenius will sell the drug to U.S. wholesalers only under the condition that they not sell it to prisons or jails. When company officials originally tried to reclaim the drug from the prison, they were told that decision would have to come from the state’s director of corrections or the governor. The state has agreed to return the vials.

In a case of the old world borrowing an idea from the new world, the U.K.’s Home Office is considering U.S. style whistleblowers awards in fraud, corruption and bribery cases. Currently, the U.K offers limited legal protections for employees who blow the whistle and the move is seen as one way to incentivize them. Some are concerned that the financial rewards will lead to bogus claims and raise questions about the credibility of a whistleblower as a witness.

A rehabilitation physician is trying to take the wind out of the sails of critics of prescribing drugs off label. Ford Vox, a physician at the Shepherd Center, responded to a recent article in the Washington Post about the number of off-label prescriptions written for patients covered by Medicare and Medicaid. Vox poked holes in the article’s assertions that off-label prescribing is inherently suspect, and that CMS has a responsibility to police physicians engaged in the practice. He notes that while focusing on one specific physician and drug, the article does not mention that the particular use is backed by research from 2006.

And so we end our exploration of all things compliance for this week. Fall has definitely arrived and as you map your compliance training curriculum for 2014, keep in mind that PharmaCertify™ offers the custom and off-the-shelf training solutions you need to help your crew navigate today’s murky compliance waters.

Have a great week everyone!

Week in Review, October 7, 2013

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PhRMA’s assistant general counsel tells physicians the industry is spending millions to avoid reporting mistakes, Canada takes steps to limit access to physicians, and two different whistleblower cases are dismissed.

The PharmaCertify™ Team
In case you missed it, last Thursday was National Techie’s Day. So, if you find yourself lining up extra early outside the Apple store on the day of a new product release, or you can’t help but play armchair engineer while watching The Big Bang Theory, or you have a room in your house with enough computer equipment to launch a space shuttle…you probably had a good week. Rather then regale you with the celebratory details of our parking lot robot battles, we’ll stick with this week’s News in Review.

Garbage in, garbage out, or GIGO, in techie nomenclature, is what PhRMA says its members are working hard to avoid in their forthcoming Sunshine reports. Speaking to a gathering of family physicians, PhRMA’s assistant general counsel, Kendra Martello, said member companies are spending millions to ensure the accuracy of reports as much as possible. She emphasized that disputes between physicians and manufacturers are not good for anyone, but admitted that the industry is unsure of what to expect in the way of physician disputes when the first reports roll out.

A Canadian medical school is rebooting its policy regarding doctors’ contact with industry representatives. The North Ontario School of Medicine is creating a policy that would limit doctors’ contact with representatives. The dean of the school, Roger Strasser, acknowledged the importance of physicians having access to medical information, but only if that information is unbiased and well-researched. He said the policy would be more of a guideline than a rule.

Sanofi’s CEO, Chris Viehbacher, believes the industry needs to interface more with the Chinese government in order to deal with corruption in China. While speaking about doing business in emerging markets, Viehbacher said the industry needs to support the Chinese government’s efforts to deal with the corruption. He went on to say that all the companies under investigation have been cooperating with the government.

A federal judge has resorted to a forced quit shutdown of a misbranding suit against Amgen. The whistleblower in the case, who is a physician, and a co-complainant rejected the $1.8 million settlement they were to share as a result of a federal settlement with the company last year. The judge said that since original settlement was rejected, the government had the right to determine that nothing further could be litigated, so the whistleblower’s case was tossed.

The techies at Google have done an about face and are now offering Business Associates Agreements (BAA) for users of three of its apps, Gmail, Drive and Calendar. The BAAs do not cover any Protected Health Information transferred from one of the three apps to another Google app.

A whistleblower suit against the medical technology company, Masimo, has been dismissed. Three former sales reps brought the suit, saying the company had promoted two of its patient monitoring devices for off-label uses and improperly billed the government. The sales reps also claimed the company withheld sales data and interfered with subpoenas for sales records issued to federal insurance companies. The judge dismissed the case, saying the plaintiffs failed to provide any evidence that the company knowingly promoted the products for off-label use.

And with that, we reach the end of another News Week in Review. We close out this celebration of all things technical by asking if you are making the most of technology to deploy your compliance training solutions. The PharmaCertify™ eLearning modules and iPad apps are designed to deliver critical compliance content where your team needs it most – in the field and at their fingertips.

Have a great week everyone!

Week in Review, October 1, 2013

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The False Claims Act goes global, the FDA chimes in on mobile apps, and we hear from the OPDP on social media guidance…sort of.

Have you seen them yet? They’re small in number now, but if you look carefully, you’ll see them. October has only just begun, and yet, they’ve emerged…Christmas decorations. For now, it may just be a small display of collector ornaments off in a corner, or an inflatable lawn ornament, or two, slyly mixed in with the Halloween bunch. And we haven’t even started raking the leaves yet! We’re nowhere near ready to even think about the mad rush of the holiday season, but we are ready to bring you the compliance news you need to know, with this week’s News in Review.

Not rushing the holiday season might be good for the nerves, but putting off the implementation of a good due diligence program is never a good idea. The actions of intermediaries continue to be a key risk area for companies doing business overseas. FCPA investigations are on the rise and the Serious Fraud Office has levied its first charges for violations of the UK Bribery. Prosecutors are not likely to take a kind view of companies that have a “check the box” mentality when it comes to assuring their intermediaries are operating in a compliant manner. Pre-contract vetting of agents and suppliers, on-going monitoring, and compliance clauses in third-party contracts, are critical steps in demonstrating you company takes the risks posed by the use of intermediaries seriously.

Federal regulators certainly seem to be in a hurry to utilize the False Claim Act globally. With a large percentage of finished pharmaceutical products and the vast majority of active ingredients coming from outside the U.S., the FCA was bound to be applied to misdeeds occurring in other countries. The recent Ranbaxy case, involving the company’s manufacturing facilities in India, is one example. The FDA has regulatory authority over manufacturing facilities making products for the U.S. market, and the Ranbaxy case demonstrates prosecutors’ willingness to apply the FCA to actions occurring outside our borders.

Bayer found itself in the news after the company allegedly breached the APBI’s Code of Practice when a high-ranking employee provided late night drinks to healthcare professionals attending a medical congress. An anonymous healthcare professional provided the information, and said a good deal of alcohol had apparently been consumed by those present. Bayer did not dispute that the employee bought drinks for the physicians, but the company took exception with the characterization that a good deal of alcohol had been consumed, and said that only £28.15 was spent.

The Australian Medical Association (AMA) wants to slow down the physician spend reporting requirements that the pharmaceutical industry is proposing. The group supports increased transparency, but feels reporting “tea and biscuit” payments would be administratively cumbersome and weaken the transparency system. The Association sent a letter to the group working on the requirements, asking for certain limits on transparency. The limits requested include a $500 starting point for payments to be reported; a two year window for the reports to be available; and a requirement for patients to supply an e-mail address when they want to access the registry of spend data.

The FDA delivered an early gift for medical mobile app developers. The agency announced it will regulate medical mobile apps that turn smartphones into a medical device or ones that allow an attachment, like a blood pressure cuff, to be plugged into a smartphone.

It’s been a long time coming, but at the Food and Drug Law Institute’s recent Advertising and Promotion Conference, OPDP chief, Tom Abrams, said he expects the OPDP to meet the July deadline set by Congress for the release of guidance on the use of social media. So, until the guidance is released, how does the industry handle product promotion in the social media world? One panel of experts at the conference suggested a review of OPDP Warning and Untitled Letters involving web based advertising could provide some clues as to FDA’s current thinking. Panel members noted that the FDA was focusing on claims in testimonials and case studies, as well as fair balance and accuracy.

And so ends the News in Review for this week. If your end of year plans (we know, we’re rushing things) include the distribution of mobile devices to field and home office staff, the PharmaCertify™ suite of commercial compliance modules are accessible on PCs or iPads and offer the up-to-date content your learners need where they need it most – in the field and at their fingetips.

Have a great week everyone.

News Week in Review, September 23, 2013

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The PharmaCertify™ Team

The sun, the moon, and the stars have all given their approval for the change of season, so we can make the official call…it’s FALL! Cool, crisp days and changing leaves can’t be far behind. And if that isn’t enough to make you happy, the advent of fall means that “delightful” chore of cutting the lawn will be ending soon. Gee, what a shame. Whether your favorite fall activities include pumpkin carving, apple picking, or getting lost in corn mazes, there will be plenty of time for all of that later. Now it’s time to take a look at the news from the last week of summer, with this week’s News Week in Review.

The Massachusetts legislature is kicking off fall with a number of bills aimed at the relationship between physicians and industry companies. A joint senate and house committee will discuss the bills on October 1st. The bills under consideration include a ban on drug advertising; a ban, with a few exceptions, on gifts to healthcare professionals and their family members, which will also require annual reporting on the value of permitted gifts (um…isn’t there a law in place for this?); and one that will define what constitutes a modest meal at an educational/informational presentation. The last bill prohibits the provision of alcoholic beverages at the presentations, and prohibits educational or informational meetings from being held at “resorts, sporting clubs, casinos or other vacation destinations.”

While you’re watching those fall television premieres, watch out for those drug advertisements…they’re deceptive! Or so says a new study in the Journal of General Internal Medicine. According to the study, 8 of 10 ads for OTC drugs and 6 of 10 ads for prescription drugs contained exaggerated or misleading formation, left out vital information, or made meaningless lifestyle associations. The ads aired from 2008 to 2010 during the evening news timeslot (30 minutes) on the three major networks and CNN.

Two industry trade groups are looking for companies to turn over a new leaf when doing business in China. PhRMA and RDPAC (a trade group for foreign companies in China) prepared a joint memo to address industry corruption issues in China. The memo calls on companies to employ the highest ethical standards while conducting business in China, and to react swiftly if something occurs outside the parameters of a company’s code of conduct. The memo also calls on trade organizations to enhance their efforts to ensure physicians are better paid by the Chinese healthcare system, and to encourage the introduction of ethical standards for the entire healthcare sector.

The corruption scandals and investigations in China have put a chill on the relationship between physicians and the industry. Pharmaceutical sales representatives are making fewer visits to hospitals simply because physicians are refusing to see them, and because companies have been cutting back or eliminating the visits out of caution. Sales are also down in the country as a result of scandals and the lower sales have lead companies to cut back on their marketing and promotional activities. The CEO of Sanofi says there is “a lot of confusion out there” and he expects there to still be “turbulence” in the marketplace over the next few months.

Prosecutors in the U.K. have harvested new laws and guidelines to help them pursue Bribery Act cases. A law that will allow the use of Deferred Prosecution Agreements to settle Bribery Act cases should become effective in February. The use of DPAs is expected to reduce the number of lengthy investigations, and provide companies a way to avoid the stricter penalties. The U.K. Sentencing Council has also released draft sentencing guidelines for violations of the Bribery Act. The guidelines include a tiered rating for determining a violator’s level of guilt under the law (e.g., a violator was an instigator vs. being coerced or intimated in to violating the law). The guidelines also state that fines against a company must be significant enough to have a real financial impact.

Google’s leaf pile just keeps getting bigger! The company announced it’s going to step into the bio-pharmaceutical industry, and form a research company dedicated to “health and well-being, in particular the challenge of aging and associated diseases.” The company will be called Calico, and the CEO will be Arthur Levinson from Genentech.

Now that fall is here and the daylight hours are waning, this is a good time to shift back to Sunshine. With Sunshine Act data collection in full swing, PharmaCertify’s, The Sunshine Act: The Federal Physician Spend Disclosure Law, will help you ensure customer-facing colleagues are well-versed on what information needs to be collected and reported.

Have a great week everyone!