whistleblower

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!

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!

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.