Lauren Barnett

Compliance Specialist, PharmaCertify™

In the film, The American President, the campaign slogan of the challenger to the incumbent president is “it’s time to get the pride back.” This week’s CBI Compliance Congress had a similar rallying cry of “it’s time to get the trust back” – the trust of the public that is. Opening remarks by Doug Lankler, Executive Vice President and Chief Compliance and Risk Officer at Pfizer, and the keynote address by Geno Germano, President and General Manager, Specialty Care and Oncology at Pfizer, set the tone for the theme. As Mr. Germano pointed out, there was a time when the industry was revered and trusted by the public. Now, it regularly trades places with the oil and banking industries as the most distrusted industry in America and vast amounts of time and resources have been spent to address the issues behind this reputation. Mr. Germano believes that if the industry is to thrive going forward, it has to start by earning back the trust and respect of the public it once held, and it must be done now. In his opening remarks, Mr. Lankler emphasized that a compliance failure at one company represented a compliance failure for the entire industry. He noted the importance of companies learning from one another and sharing experiences (respecting anti-trust laws of course).

The idea of gaining trust, building values-based compliance systems and working together carried through to the Boot Camp breakout, other presentations and panels during the Congress. Michael Shaw, Vice President and Chief Compliance Officer, North America Pharmaceuticals for GSK, summarized the notion during his presentation when he said that sustainable concepts are the key as we work in a changing landscape and that “we have to pull it back to principles.”

The enforcement panel on Day 1 was by far one of the best I’ve attended. During a discussion covering emerging trends in state-based enforcement, panelists pointed out that as more states pass their own False Claims Acts, their AG offices are becoming more comfortable with the cases. The overall feeling was that more states (in groups or possibly alone) will pursue actions against the industry for FCA violations, whether the feds participate or not. Violations that implicate the states’ False Claims Acts may also implicate consumer protection laws, and the industry may begin to see states pursue action under those laws.

The panelists were asked about the future trends in off-label cases. Happily, Sara Bloom, Assistant U.S. Attorney, District of Massachusetts, said she felt optimistic that cases with off-label violations as we know them are largely over. The panel identified false and misleading comparisons between products and misleading claims of economic superiority as off-label risk areas. Ms. Bloom went on to say that small companies who thought they may have been off the radar, were very much on the radar now.

Jean-Ah Kang, Special Assistant to the Director of the Office of Prescription Drug Promotion indicated that guidance regarding the use of social media was still on the docket, but she gave no estimated time of arrival for the guidance. Ms. Kang also highlighted the OPDP’s work to educate physicians about its Bad Ad program. Outreach efforts, including presentations at professional conferences, have been focused on educating physicians on how to submit promotional information that may represent a violation. She reminded the audience that the program does not just apply to advertisements in journals, sales piece or DTC ads, but also what reps say in a physician’s office and information presented at speaker programs.

How does CMS intend to implement the Sunshine Act? “Slowly and deliberately,” says Jack Mitchell, Chief of Oversight and Investigations, Senate Special Committee on Aging. While Mr. Mitchell provided no hint as to when the final guidance could be expected, he did admit that there were issues with the current guidance, and a timely release could be a challenge since this is an election year. However, the Committee is focused on working more proactively with CMS on the approval of the final guidance.

Speakers at the Sunshine and aggregate spend breakouts were less optimistic. Panel participants felt there won’t be a report required for this year, but CMS may require the industry to go ahead and gather data. The panel emphasized that those in the industry need to be concerned beyond the U.S. now that France has passed a similar law and countries like China are considering the same type of regulations. Other countries are no longer waiting to see what happens with Sunshine here in the U.S., so this has become a true global issue.

During his breakout session presentation covering social media, Jim Zuffoletti, President of OpenQ, stressed the life sciences industry has the most to gain and the most to lose from the “social enterprise.” Eye-opening statistics were presented highlighting how social media is taking over the way we communicate. Communication through social media rather than email is fast becoming the preferred method for customers interested in reaching out to companies. As companies launch into the social media world, they must be conscious of the audiences they are reaching through various platforms, and the need to monitor the interactions on the front end.

Even though I typically walk away from compliance conferences with good information, I tend to feel a little beat up and discouraged about the industry. That wasn’t the case with CBI’s 9^th Annual Pharmaceutical Compliance Congress. This time, I felt encouraged and excited about the future of the industry. Yes, there are new and exciting areas of enforcement with which we need to contend (did I mention the prediction of the loss of exclusivity as a “what’s next” with regards to dealing with violations of promotion regulations?), but this is a wonderful industry. As was pointed out in the keynote address, our work saves and improves lives. It is noble work. The industry has come a long way since the first investigations back in the early 2000s. Mr. Germano was right when he said the time to “get the trust back” is now. After this week, I feel certain the industry is well on its way to doing just that.

The PharmaCertify™ Team

Friggatriskaidekaphobia is running rampant today because it is Friday the 13^th! (Cue the bloodcurdling scream). We promise you the News Week in Review is not written under a ladder and nowhere near a black cat. So there’s no bad luck here. However, with it being Friday the 13^th, we’ll understand if you want to keep a four-leafed clover or a horseshoe nearby as you enjoy this week’s News Week in Review.

Federal prosecutors haven’t had the best of luck lately with FCPA cases. Gaffes in several recent cases may encourage those finding themselves accused of violating the bribery law to take the fight to the courtroom rather than settle. Over the last several months, federal prosecutors have been called to task for misconduct, have had charges dismissed due to lack of evidence and had one high profile trial end in a mistrial. When convictions have occurred, judges have not necessarily been inclined to levy the penalties the prosecution recommends. In one case, the judge cited the defendants “good works” when passing a lighter sentence than what was recommended by the prosecution.

The Medical College of Georgia doesn’t want any bad juju from the relationship between doctors at the college and pharma companies; therefore it placed a limit of $25 on gifts doctors may accept from the industry. The College joins a growing number of med schools attempting to eliminate conflicts of interest between staff and the industry.

532 proved to be the lucky number for whistleblowers during 2011. Up $140 million over the previous year, whistleblowers took home $532 million for their efforts in bringing False Claims suits during the 2011 fiscal year. The percentage of whistleblower cases opened during the year increased from 75% in 2010 to 84% in 2011.

In other False Claims Act news, Iowa’s revised False Claims Act was given the thumbs up by the OIG for meeting requirements under section 1909 of the Social Security Act. The state will now be allowed to receive an increased share of recoveries from False Claims suits brought by the federal government.

Criminal proceedings began in Boston against Stryker Biotech, over marketing practices of two of its bone products. Prosecutors argue the company and its sales force marketed an unapproved mixture of two of its bone growth products. They say the mixture was unsafe and led to adverse events in patients. Defense lawyers say the company did not mislead surgeons, and they claim the government has even conceded there is no evidence that the reported adverse events could be attributed to the mixture of the products. In related news, the judge in the case granted the motion of Stryker Biotech’s former president to sever charges against him. With the motion granted, he’ll be able to use communications between himself and company lawyers in his defense.

The latest anti-bribery writing on the wall is not superstitious, but it is Portuguese. The Brazilian Congress is considering a bill that would strengthen the country’s foreign bribery law. The bill will penalize domestic bribery and the bribery of foreign government officials. It also establishes civil liability of corporations for bribing foreign officials, and holds them liable for the actions of executives and officers.

Whew, we made it! No ill-timed carpal tunnel spasms or computer crashes. And hey, this may just turn out to be your lucky day! If you’re considering attending CBI’s Pharmaceutical Compliance Congress, we can save you a few bucks on your registration with a discount voucher. If interested, drop Sean Murphy an e-mail at smurphy@pharmacertify.com. Once you’re at the Congress, come on by the PharmaCertify booth, and take a look at some of our mobile learning apps. Compliance information is just a tap away!

Even it is the 13^th, it is Friday, and we’re headed to the weekend! We hope yours is a good one!

The PharmaCertify™ Team

Ah, the start of a new year! Are you feeling all resolution-y? Even if you don’t do the whole “New Year’s Resolution” thing, the start of the year just makes you feel recharged and excited about the future doesn’t it? We are certainly feeling recharged and ready to rip here, so without further delay, let’s kick off our first edition of the News Week in Review!

We’ll start with a story on a topic that never gets old – CME. It’s no secret that industry funding of CME has been on the decline over the last couple of years. A recent survey sought to ascertain if doctors noticed a change in quality of the programs and a quarter of the respondents reported that the quality has declined. A lack of authoritative speakers was cited by respondents as reason for the decline.

Covered entities under HIPAA may want to refresh their training and technology as we begin a new year. A recent study revealed a more than 30% increase in data breaches in 2011. In addition, over 90% of health institutions reported at least one data breach during the past two years. Throughout last year, there was a rise in legal enforcement involving data security as well as actions against individuals and institutions.

The orthopedics chair at the University of Wisconsin starts the year under fire for his ties to Medtronic. Reports say that since 2003, the doctor has been paid in excess of $25 million by the device maker. The doctor in question has also authored several papers favorable to the company’s spine products. The university’s dean defended the doctor, pointing out that he receives no royalties for spine products used at the University of Wisconsin hospital and noting the doctor was one of the most talented orthopedic surgeons in the world.

Instead of shedding pounds, Activs Inc. will be shedding $202 million this year in settlements with the U.S. and several states over charges the company inflated prices to government healthcare programs.

An appeal filed in a FCPA case will ask the courts to take a fresh look at the “foreign official” definition. The appeal comes from a man who was convicted and sentenced in October to seven years in prison for FCPA violations. The filling contends the court made a mistake in jury instructions regarding the definition of an instrumentality of a foreign government. This marks the first time a higher court will hear arguments on this issue.

Over in the now famous, second ‘shot-show trial,’ the defendants kicked off the New Year by asking the judge to declare a mistrial since the conspiracy charges under which they were originally joined were dismissed in December.

There was much excitement as 2011 wound down and the FDA released shiny, new draft guidance on the handling of unsolicited requests for off-label information. While it’s not the much-awaited guidance on social media, the new document did provide  minimal direction on social media in cases where off-label inquiries were involved. Peter Pitts says not to eschew what this document has to offer, and offers 10 lessons the industry can learn from the guidance. The information provided could be used as a jumping off point for the industry to lead the way in opening up communications with physicians and patients through social media.

Quite a bit going on during the first week of 2012 wouldn’t you say? With the release of the Sunshine rules and the new guidance on handling off-label inquiries closing out 2011, this year promises to be full of interesting twists and turns. Are you ready to give your training a new look as well? PharmaCertify’s customizable eLearning modules address the topics of day, like the Sunshine Act and state laws, on-label promotion and anti-corruption and our mobile apps deliver critical compliance content to your team when and where they need it the most – in the field and on the run.

As we wrap up this week’s News Week in Review, we close by congratulating Sir Andrew Witty, CEO of GlaxoSmithKline, on his knighthood. Pretty darn cool! Have a great weekend everyone and marvelous New Year!

The PharmaCertitfy™ Team

The shopping’s completed, the packages are wrapped and now its time to gather around the fire or Christmas tree with family and friends to sing carols and share a story or two. We have some stories from the week to share with all of you, our friends out there on the ‘Interwebs.’ So throw some tinsel around your monitor and join us around the virtual tree, as we kick off this week’s News in Review!

Did you hear what I heard? The Department of Justice announced that they recovered $3 billion during this fiscal year, under the False Claims Act. Of the $3 billion, $2.4 billion represented fraud against the federal healthcare programs. The pharmaceutical industry represented the lion’s share of that total with $1.8 billion coming from the industry.

Some drug makers will have more of a Blue Christmas than others. Facebook blue that is. A new study, ranking the social media status of major pharmaceutical companies, compared a company’s overall promotional spending compared with its Facebook and Twitter following. Pfizer ranked number one, but the study found that a large promotional budget was not necessary to have a strong social media presence. The study also found that the number of tweets and status updates do not necessarily correlate to the number of followers.

Senators Grassley, Kohl and Blumenthal are looking for the naughty and nice aspects of several recent medical device recalls. The group sent investigative letters to three device makers inquiring about their recall and post market surveillance practices.

Anti-corruption was certainly a hot topic over the last year. Check out this list (and check it twice if you like) of the top FCPA enforcement actions of 2011.

They may not have being Rocking Around the Christmas Tree, but a group of corporate counsel gathered to discuss the legal issues keeping them up late enough at night to hear Santa’s reindeer click. Banking and insurance industry reps discussed Dodd-Frank while pharmaceutical industry reps brought up the use of the Park Doctrine to charge executives personally for failing to prevent wrong-doing within their companies. Cross industry concerns over the rapidly rising costs of litigation and e-discovery were discussed as well.

This time of year may bring Joy to the World, but sometimes international business presents less than joyful challenges. Businesses overseas face the challenge of cultural expectations around bribery and the FCPA. While most cultures would eschew the acceptance of bribery, in practice, there are instances when bribes are part of the business landscape. Part I of the two-part article covers enforcement considerations when dealing with cultures in which such behavior is considered standard practice.

And with that, we wrap up this week’s Review! The Week in Review will be taking a break next week, so we want to thank you all for following us and we look forward to bringing you more news in 2012. Until then, we wish you the happiest of holidays and a healthy New Year!

Lauren Barnett, PharmCertify™ Compliance Specialist

We’ve all seen the headlines: “[insert state/city here] Doctor Paid thousands By the Drug Industry.” The reports tend to appear just after an update of Pro Publica data, or during a ratings sweeps period, and I can certainly understand why. Nothing is more titillating than knocking a revered person, like a doctor, down from his or her pedestal in the community with innuendo of unscrupulosity (see Don Henley’s song, “Dirty Laundry” for more details). In reading the articles over the last several months, I have noticed an interesting trend. When the paper or local television station reaches out to the named physicians for a comment, they either get no comment at all, or the doctor explains that he or she has dialed down the practice of accepting payments from pharmaceutical companies. I can’t say as I blame them.

With CMS finally publishing the rules for Sunshine, I’ve been thinking about the coming flood of information about what pharma, med device and bio companies spend on physicians, and what the publication of this information is going to mean to physicians. Back when the Sunshine Act was an annual legislative threat that most felt would pass, there was discussion among my colleagues about how (or if) we should discuss the matter with physicians. So, now that Sunshine is a reality with data collection to begin soon, I wonder: What are companies planning to do to inform healthcare providers about the Act?

Should this be something the industry should even tackle? Yes, I think so, in some small way anyway. The reports are coming from the industry, so educating the physicians on what will be reported and when the reports are due is warranted. That said, I think this would be a great topic for the OIG to tackle in its video training series, or perhaps they could reach out to CMS to help them provide similar training. Considering that the regulations couldn’t be published on time, I probably shouldn’t hold my breath, eh? The HCPs need to know about Sunshine and although there are number of articles about the Act on the AMA’s website, they’re not easy to find.

What are your thoughts on the topic? Should companies feel the need to educate physicians about the Sunshine Act? If you’re in industry, have you already done so, or do you have plans to provide materials explaining Sunshine and its ramifications to healthcare professionals in the future?

The PharmCertify™ Team

The big day is almost here. Are you prepared? Do you have your list ready? Have you been working out? What about that aluminum pole? Yes, your aluminum pole…it’s Festivus of course! It’s just a week away, and there’s so much to prepare. However, the news doesn’t stop just because Festivus is almost upon us. So we’re taking a break from our list of grievances to bring you this week’s PC News Week in Review.

We’ll start out with what can only be described as a Festivus miracle! (Well, it didn’t really occur on Festivus, but you get the point). CMS released the Sunshine Act regulations this week! (cue the Hallelujah Chorus). The regulations are posted and open for comment through February 17, 2012. After which, CMS will write the final rules. Data collection is postponed from the beginning of 2012 to once the final rules are posted. This being the case, CMS is proposing that manufacturers submit a partial year report in March of 2013. Data will be available to the public in September of 2013. For more on the proposed rules, check out R-Squared’s summary here (registration required). You can read the rules in their entirety here.

At a panel discussion hosted by Main Justice.com, lawyers representing the government and the healthcare industry discussed the future of healthcare law enforcement. No feats of strength style wrestling matches occurred (wouldn’t you have paid to see that?!), but there was healthy discussion covering some of the options the government would be using in the future. New data analysis software has already been put in place to find fraudulent Medicare and Medicaid claims. Meanwhile, a representative from HHS said that despite backing off the debarment of Forest Lab’s CEO, the agency isn’t taking that option off the table for future cases. In fact, a bill before Congress would expand HHS’s legal authority to exclude executives from participating in federal healthcare programs.

Even if HHS has backed off ever so slightly in holding executives accountable, the DOJ and SEC have heard the cries from lawmakers that individuals need to be held accountable. This week, the DOJ indicted six former Siemens executives and two intermediaries for conspiracy to violate the FCPA. In other news of personal accountability, the Synthes executive whose sentencing was delayed when his lawyer collapsed in the courtroom received an eight month prison sentence.

With that, we kick off the Airing of Grievances portion of the program with news of the government’s grievances against Medtronic leading to a $23.5 million settlement for kickback allegations.

Meanwhile, Allergan and Los Angeles county health officials aired their grievances about billboards that tout Lap-Band surgery but do not disclose any of the risks associated with surgery. The FDA issued a warning letter to a company known as 1-800-GET-THIN and several surgery centers associated with the marketer.

Some French politicians have grievances with the country’s regulatory system, and are calling for widespread changes to assure patient safety and rid the system of conflict of interests.

And back in the U.S., federal authorities are set to air grievances against a group of New Jersey doctors who they say accepted illegal kickbacks for referrals to a specific MRI center. Perhaps these doctors should share this OIG video intended to educate providers about the Anti-kickback Statute as they gather around the Festivus aluminum pole.

If a video from the OIG isn’t exactly the kind of tale you’d like to share with your family and friends around the pole, then perhaps this summary of the top stories of the year about the medical device industry is more to your liking.

2011 is quickly coming to an end. With new regulations for Sunshine and the increased enforcement of anti-corruption laws both here and abroad, training early and often is an important consideration for 2012. PharmaCertify helps you address  training on topics likes the FCPA, anti-bribery, state and federal disclosure promotion and on-label promotion. Our solutions range from off-the-shelf and customizable eLearning modules, to iPad apps and reinforcement tools. Check us out at www.pharmacertify.com/compliance.

That’s the News for this week. We hope you have a lovely weekend, and a Merry (is that right word?) Festivus. And if you’ve been wondering all along, “what is this Festivus craziness,” here’s a link to the Seinfeld episode that started it all.

Cheers!

The PharmaCertify™ Team

The holiday season is in full swing and it’s time to enjoy all of those wonderful family the traditions. Perhaps one of your traditions is curling up on the couch with the family to watch all of the Christmas specials and movies that make their annual appearance on television. Sure, most are available on DVD these days, but somehow it isn’t quite the same as gathering the troops on that one night when your favorite movie airs. But before you go home to scan the channels in search of the Island of Misfit Toys or the friendly streets of Whoville, warm up with this delightful tale of the news that was in this week’s PC News Week in Review.

Postal workers in Britain are having their Christmas tip Scrooged out from under them, thanks to the UK Bribery Act. It seems the postal service has put postman on notice that if they accept a Christmas tip of more than 30 pounds, they and the well-meaning person giving the tip could be accused of bribery, under the UK Bribery Act.

Want the whole world to know your blood sugar levels the way all of Bedford Falls knew about George Bailey’s legal trouble? Well, maybe the whole town won’t know, but if you use medical apps to track and store everything from your blood pressure readings to your medications, you may be surprised to know your personal information is not protected by HIPAA. Unlike a physician, app developers are not subject to HIPAA, and therefore any data stored by a developer is not subject to the law’s security or privacy provisions. Consumers need to check the privacy policy of the developer, because unless otherwise stated, the data could be sold.

The DOJ has filed an appeal after the dismissal of the Lindsey Manufacturing FCPA case last week. The judge cited “flagrant” misconduct by the prosecution as the reason for the dismissal. The DOJ may be looking for a Miracle on 34^th Street though since the appeal has to be approved at three levels before it can even move forward.

The dismissal of the Lindsey Manufacturing case was cited by another FCPA defendant in a motion before a court in Texas. The defendant in the Texas case is arguing that prosecutors cannot include evidence of the bribe involving a Ferrari and a yacht in his case since it was used in the Lindsey case. Both companies used intermediaries headed by the same person and the Ferrari and the yacht were not the only similarities between the two cases.

Quick! Hide Frosty the Snowman! Senators and Kohl and Grassley are calling for Sunshine. The Senators have called a hearing for December 15 titled, “Parting the Clouds: Implementing the Physician Payments Sunshine Act.” The purpose of the hearing is to discuss the release of the regulations and the impact of delaying those regulations.

Call out the Coal Elves; the industry is still Naughty vs. Nice when it comes to off-label marketing according to a Harvard study. Researchers reviewed past cases and noted that off-label prescriptions did not trail off until after settlements were announced. They claim that the current enforcement efforts are not enough of a deterrent to quell improper off-label marketing. The study recommends bigger fines and additional resources for enforcement.

They don’t need Twitter or a fancy Facebook. They just want simple resources at which they can look. For the Europeans down in Europe contests have no meaning, but information about diseases and conditions will leave them beaming. To the industry they say, “No thanks, we’re just not interested in your social media today.

Pfizer will no longer be Home Alone in deciding how to allocate funds for medical education. The company will split its medical education grants into two tracks. The first track will require an RFP submission and a board of outside, expert advisors will make decisions about the grant awards. The other track will be for unsolicited grants involving only live national or regional meetings.

Wrapping (pun intended) up the news is KV Pharmaceutical’s settlement with the government for $17 million to settle false claims allegations. The allegations stemmed from the now dissolved KV subsidiary, Ethex. The government alleged that Ethex misrepresented the regulatory status of two of its drugs.

That brings us to the end of this week’s PC News Week in Review. Now, go on home, pop some corn, make some hot chocolate and watch the Christmas movie or special of your choice. Have a great weekend everyone!

The PharmaCertify Team™

Black Friday, Cyber Monday, did you survive? More importantly, did your credit card survive? Bumps, bruises and carpal tunnel syndrome aside, it has been a hectic ride so far for shoppers and retailers alike. However, now it’s time to gear up for round two of steals, deals and early morning lines. Until then, kick back and relax with a hot cup of coffee, cocoa or tea and this week’s PC News Week in Review.

Are sales reps working for “discounted” wages? The Supreme Court will take up the question of whether pharmaceutical sales reps should be paid overtime. At issue is the question of whether sales reps fall into the “exempt” category, which would preclude them from receiving overtime pay. The case was brought to the high court by two GSK sales reps on behalf of a larger class of sales reps from the company. The court will hear arguments in the spring.

You might be shipping some of those gifts you bought for industry colleagues a little bit farther away in the near future. A new study finds that bio, pharma and med device companies are increasingly finding homes outside the “traditional” locations of the Northeast Corridor and the San Francisco Bay area of California. Proximity to research institutions, a highly educated workforce and real-estate prices are just some of the factors for the move to other locations. Areas seeing a growth include Los Angeles, Minneapolis, suburban D.C. and Atlanta.

As we scour the papers for great deals, Serious Fraud Office director, Richard Alderman is scouring his files for high-impact Bribery Act cases. Rather than chase cases that offer quick, immediate rewards, the SFO chief says his office going after the cases that truly put UK based companies and their employees at risk. With that in mind, what can be learned from the recent and first sentencing of an individual under the Act?

If you want to stay off the SFO’s naughty list, then training is your first line of defense, according to an article by two lawyers from Pillsbury Winthrop Shaw Pittman LLP. The article provides twelve tips on developing an anti-corruption compliance program. Beyond training early and often, the authors stress the importance of focusing on local labor laws, assuring data privacy challenges are addressed by jurisdiction and developing good whistleblower protections.

Back on this side of the Atlantic, the Lindsey Manufacturing executives found guilty of violating the FCPA back in the summer appear to have received an early gift from a federal judge. The judge is set to dismiss the case against the two due to government misconduct during the investigation and grand jury proceedings.

Roche has agreed to pay $20M to settle a whistleblower suit that alleges the Genentech division promoted a drug off-label and offered kickbacks to physicians.

Failure of the federal government to monitor state agencies prescribing psychiatric medications for children in foster care has prompted a Senate investigation. Some of the children are on as many as five psychiatric medications at once, and these medications are often used off-label. Similarly, an OIG investigation raised concerns over the overprescribing of atypical antipsychotics in nursing homes. The study found there was widespread off-label use of these drugs to treat dementia.

The USF Medical College is joining the long line of med schools with policies aimed to curb conflicts of interest with the industry. The dean of the medical school told the Board of Trustees the move is intended to address the nationwide problem of industry companies paying physicians to promote their products. Last year, the school received a “C” from the American Medical Students Association for its policies on dealing with conflicts of interest.

Walgreens, Kroger Company and other large retailers have sued Pfizer (Wyeth) and Teva for violating anti-trust laws. The companies allege that the two drug makers have conspired to keep a generic version of Effexor off the market.

One sure way to make the PC News is to quote Spinal Tap in an article. We wrap this week’s News up with an article from Drugwonks.com that does just that. Peter Pitts presents 11 (it’s one louder than 10) principles for the healthcare industry to participate in the social media.

Well, that’s it for another News in Review. Remember, with all of the recent focus on corruption and bribery,  tools like our customizable, off-the-shelf FCPA module are more critical than ever as you plan your 2012 anti-corruption program.

Now, it’s time to lace up those running shoes, strap on the shin guards and head out for more Holiday sales. Be careful out there everyone!

The PharmaCertify™ Team

“Over the river and through the woods to grandmother’s house we go!” Okay, let’s face it, sometimes, it’s more like, “On the highway breathing fumes and watching the tail lights glow.” Ugh, the Thanksgiving commute – horrible whether you’re trying to get to grandma’s or just home from work. The joy at the end of that commute though is a long weekend having fun with family and friends – and eating until you just can’t move. As you bide your time this weekend, take a gander at this week’s PC News Week (short as it may be) in Review.

Senators Baucus and Grassley are not talking turkey. Concerned about possible violations of the Anti-kickback Statute, the senators sent letters to Quest Diagnostics, Lab Corp of America, Aetna, Cigna and United Health. The concern is centered on the practice of insurers steering lab tests to certain labs in exchange for pull-through discounts or payments. The senators have asked for copies of contracts with high volume providers. The inquiry was prompted by recent cases in New York and California.

Pfizer may need to lower its Black Friday shopping budget a bit. The Wall Street Journal reports sources familiar with the company’s FCPA settlement negotiations say the settlement will exceed $60 million. The company expects a public announcement regarding the settlement to be made by the end of the year.

The first person charged with violating the UK Bribery Act was sentenced to six years in prison. In October the court clerk pled guilty to one count of violating the UK Bribery Act and one count of misconduct in public office. The violation of the Bribery Act carried a three year sentence which will be served concurrently with a 6 year sentence for the misconduct charge.

While receiving a prison sentence doesn’t seem like something for which to be thankful, it could be worse if you consider a former pharmaceutical executive was sentenced to death in China just a couple weeks ago. Three of the four former Synthes executives were handed prison sentences by a federal judge earlier this week. The case against the executives was brought under the responsible corporate officer doctrine in the wake of an illegal clinical trial of a bone cement. Each pled guilty to a misdemeanor and agreed to pay a fine. Federal sentencing guidelines recommend up to a six month prison sentence, but the judge handed two of the executives a nine month sentence and one a five month sentence. The lawyer for the fourth executive collapsed during the proceedings, delaying his client’s sentencing. The lawyer was released from the hospital and back at work the next day, but sentencing has yet to be rescheduled.

Those who are worried that the payments doctors are “gobbling” up are influencing their prescribing decisions may want to take a listen to this doctor from Montana. He feels no obligation to use the medications of the company for which he speaks, and even if he wanted to use a company’s products, insurers dictate which medicines he can prescribe.

Some states attempting to pass their own version of the federal False Claims Act are routinely finding their efforts sent to the kids’ table. Repeated attempts in several states have been met with objections that such laws are not cost-effective since they require significant resources to investigate, and part of the recoveries need to be turned over to whistleblowers.

Whew! Don’t know about you, but we could use a rest now. For a short week, we certainly still got our fill of news. We hope you all have a safe holiday weekend at grandma’s house or wherever your holiday plans take you, and that your long weekend is filled with the four “F’s”: food, family, friends and fun! Happy Thanksgiving everyone!

The PharmaCertify™ Team

The wedding of the century…did you see it? We’re not talking about Kim and Kris (you can stop laughing now) or Albert and Charlene, or even William and Kate. Please! Those weddings were just the warm-up act to the wedding of Bella Swan and Edward Cullen, the heroine and hero of the Twilight series. Yes, the long awaited, much ballyhooed fourth installment of the series, Breaking Dawn – part 1, rolled out at theaters around the country. If you missed out on the early morning nuptials, you have come to the right place. We have something for you just as entertaining and no tissue is needed – this week’s PC News Week in Review.

We’ll start off by sinking our teeth into this story. An attorney breaks down the Sunshine Act for physicians. After an explanation of what the law requires, the lawyer then explains  the downside for physicians. Citing current media “exposés” of the financial relationship between physicians and the pharma industry, he shows how these articles generally paint a scurrilous picture of the relationship between the physicians and the industry. Since Sunshine will link the physician’s name with a dollar amount, he urges physicians to examine the risk of public exposure will have on their business and then take the appropriate action.

In a dramatic twist, a physician finds himself on the business end of an off-label lawsuit. Just who filed this suit? A medical device company. The medical device company, being sued by a patient over the off-label promotion of one of its products, has filed a cross claim against the patient’s doctor for using the product off-label. Pass the popcorn please.

Leader of the medical device approval reform pack, Senator Al Franken, told a group of Medtronic employees that he would be introducing a bill to help speed up the approval process for devices that treat rare diseases. The bill would allow companies to make a profit on these devices (which they currently can’t, unless the devices are used for children), and it would create provisions to allow experts who may have ties to the industry to serve on FDA advisory panels for these devices. Meanwhile, several Republican senators pressed the head of the FDA’s Center for Devices and Radiological Health for answers as to why negotiations for the device user fee have gone nowhere and why device approvals are so slow.

Senator Grassley has sent a request to Attorney General Eric Holder for information about the forthcoming FCPA guidance. Among the expected questions (e.g., when will it be released), the senator asked questions about whether safe harbors will be provided for gifts of minimal value; if clarity would be provided about the extent of liability one company assumes of another’s pre-merger or per-acquisition activities; and if guidance around DOJ’s interpretation of terms such as “foreign official” and “government instrumentality” will also be provided.

Speaking of those “cloudy” legal terms, the former president of a telecom company who received 15 years in prison for FCPA violations is appealing the verdict. His initial defense centered on the definition of “foreign official.”. Lawyers this time are taking the approach that the Haitian telecom involved in the case is actually a private enterprise, thus making the FCPA a non-issue.

You don’t need telepathic, clairvoyant or any other special vampire power to know where the bribes are occurring. Check out this cool interactive map that breaks down FCPA cases by sector, country and amount of money involved. And, in a final bit of anti-corruption news – spoiler alert; The DOJ and SEC say the FCPA investigations are a top priority for the future.

We’ll wrap this week’s news up with a new study that finds reports of adverse events on social media sites are about as rare as a vampire/human baby. A study of 224 pharmaceutical brands across various social media sites found reports of adverse events occurred in .3% of posts that mentioned the brands. Of those, only 14% contained reportable information.

Since we’re talking social media, let’s talk about compliance information on the go. Tablets and smartphones are making the process for sharing and gathering information more portable than ever. Our compliance apps run on multiple platforms and offer your field-based employees access to up-to-date compliance content where they need it most – in the field and on the go. To learn more about our Navigator suite of apps, check out the mobile learning page on PharmaCertify.com.

That brings us to the end of this week’s review. As exciting as the release of the near final chapter of the Twilight series is, I think we’ll take a pass. Instead, we’ll be saving our entertainment dollars for another long awaited film – the poignant tale of a group of has-beens and their struggle to climb back to the top. We hope you enjoy your weekend wherever it takes you!