The PharmaCertify™ Team

Is it really that time of year again? The Easter Bunny hasn’t even visited yet! Afraid it is, folks.  Unless you live in Arizona or Hawaii, you’ll be moving your clocks ahead one hour this Sunday for Daylight Savings Time. The extra hour of evening light is little consolation for the loss of one hour of sleep. We won’t let our supreme disappointment (or a solar flare for that matter) stop us from springing forward with the news of the week.

The Pharmaceuticals and Healthcare Association of the Philippines (PHAP) is going to spring ahead with adopting the recently updated Code of Practice from the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). The CEO of PHAP says implementation of the revised Code shows the group’s dedication to building trust with the medical community and patients. All 44 PHAP member companies are expected to follow the Code when it goes into effect in September. The group is encouraging non-member companies to abide by the code as well.

Connecticut physicians are being questioned for being “on the clock” for pharmaceutical companies even after violating the rules. An investigation found a number of physicians disciplined by the state medical board for issues involving their prescribing continued to receive payments for speaking engagements. In one case, the physician continued to receive payments after his license was revoked. Two companies, Eli Lilly and GSK, beefed up their screening process for speakers to include a check to identify if a doctor has been sanctioned by his or her state and Pfizer is exploring the idea of implementing similar state-level checks.

Folks at the University of Rochester Medical Center may have an extra spring in their step since they received a higher grade on the PharmFree scorecard. URMC went from a “C” to a “B” on the yearly scorecard, which rates medical schools and academic medical centers on their conflict of interest policies. URMC made a number of changes to its policies, banning the acceptance of gifts from the pharma industry, and tightening the circumstances by which free samples may be used.

In legal news, a former FDA chemist, Cheng Yi Liang, received a 5 year prison sentence for insider trading. The chemist used his knowledge of drug approvals to play the stock market to the tune of $3.8 million. In a pre-sentencing memo, his lawyers stated Liang was addicted to day-trading. Liang also has a $1.7 million civil judgment against him.

A consumer group and four trade unions have sued 8 pharmaceutical companies to keep the practice of providing drug co-pay coupons from springing along. The groups claim the practice is illegal, and in the long run it drives up the cost of healthcare. Despite the savings the coupons provide the consumer, insurers are still required to pay the negotiated cost for the drug. The use of the coupons forces plans to spend money on brand name drugs over cheaper generic ones.

A bill patterned after the federal False Claims Act has been introduced in Washington to help recoup losses the state suffers due to Medicaid fraud. Despite the state’s budget challenges, the bill has met some resistance from legislators. The Washington State Medical Association fears the bill, which includes whistleblower provisions, will encourage people to file frivolous lawsuits.

A former defense lawyer for the industry is shining some daylight on her belief that the fines imposed on pharmaceutical companies facing charges for illegal marketing are not sufficient to curb the illegal behavior. Frustrated by the fact that negotiated settlements represent a small portion of total profits on the products involved in off-label or false claims cases, the lawyer wrote a 63-page paper suggesting other measures, such as exclusion from federal healthcare programs, or requiring companies to conduct clinical trials for the off-label uses they market. Gregory Demske, assistant inspector general for legal affairs at HHS, says the government has considered other options, including pursuing company executives, and revoking a company’s patent rights as a part of the settlement.

The DOJ has experienced some fall back…er…fall out (yep, that one hour loss of sleep is really weighing heavily on the mind) in its FCPA prosecutions, but they are not the only government agency pursuing companies under the Act. The former chief of the SEC’s FCPA enforcement unit, Cheryl Scarboro, sat down with the folks at TrustLaw for a Q & A about FCPA prosecution. Among the issues discussed are whether the U.S. should publish cases it declines to prosecute and Ms. Scarboro’s thoughts on the Frank-Dodd whistleblower protections.

At a panel session at Georgetown Law, an official from the DOJ says the agency is committed to moving forward in the pursuit of FCPA cases. Saying the agency is in it “for the long haul,” Nathaniel Edmonds, assistant chief of the department’s fraud section, acknowledged the DOJ had some recent setback, but they have learned from those challenges. He believes the challenges were not with the FCPA itself, but rather the specific facts in the cases. When asked about the FCPA guidance due this year, Edmonds declined to comment.

Well, that brings us to the end of another News Week in Review. We hope that despite the loss of one hour of the weekend, you still have a great one and we’ll see you right back here, a little less rested, next week!

The PharmaCertify™ Team

It may have been a day late, but the need for speed was met early this week at NASCAR’s premier and premier race – The Daytona 500. The first race on the season schedule turned out to be quite a spectacle, with more delays, twists and turns than anyone could have expected. What a start! We’re all revved up and ready to run here at the News Week in Review as well. So, ladies and gentlemen, start your engines.

Let’s start the ride with a story from overseas. We all recall the less than mind blowing first prosecution under the UK Bribery Act. Well, our collective minds may be blown in the near future as the Serious Fraud Office (SFO) has several active investigations for possible infractions of the Bribery Act, according to a UK lawyer.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) gave the green light to a strengthened code that will ensure “the highest ethical and professional standards.” The new code covers interaction with healthcare professionals, patient organizations and medical institutions. It also clarifies the line between appropriate and inappropriate forms of support. Provision of entertainment is reduced to only include entertainment provided when the interaction between the drug company and physician are of a scientific or educational nature.

Representatives from 20 different medical device industry trade groups raced over to Washington, D.C. this week to meet with lawmakers. The topic: repealing the medical device tax due to be implemented next year as a part of the healthcare reform law. On the other side of the Hill, House democrats introduced legislation that would give the FDA the power to reject devices with designs based on products that were recalled for safety concerns. Jeffery Shuren, the head of the FDA’s Center for Devices and Radiological Health, says the FDA not having the rejection authority creates a loophole and challenges the credibility of some device approvals.

The sun sure wasn’t shining in Daytona for the race, but the Sunshine Act was hot…both here and abroad. A call has come from India for a law similar to the U.S.’s Sunshine Act. According to a doctor from the Monthly Index of Medical Specialties, the Medical Council of India has a ban in place prohibiting doctors from accepting “bribes” from pharmaceutical companies; however there is nothing prohibiting the pharmaceutical company from offering the bribe. The country does have the voluntary Uniform Code of Marketing Practice in place but the doctor believes a law with penalties for companies that violate MCI rules is needed.

A survey conducted by GSK in Australia found that the majority of respondents did not like the notion of their physicians receiving payments from drug companies and were in favor of the companies having to reveal those payments. However the objection melted away when context was given as to why the physician was receiving the payment.

Nearly 100 physician groups here in the U.S. have essentially black flagged the CMS’s proposed rules for dispute resolution under the Sunshine Act. The groups are concerned that the rule, as it currently stands, does not do enough to protect the reputation and integrity of physicians. They have advocated for the appointment of an independent arbiter to handle disputes in reported payments.

To that end, a teacher of medical ethics at Davidson College says the hidden cost of the Sunshine Act is really the loss of valuable interactions between industry and physicians. The author of the editorial in USA Today says the law stigmatizes the financial relationship physicians have with the industry. He fears physicians will raise their rates to participate in activities that will be reported under the Sunshine Act, in order to compensate for the loss of anonymity and the presumption of corruption.

A medical student at the Oregon Health and Science University (OHSU) has started an online petition to have the university prohibit physicians affiliated with the institution from participating in pharmaceutical speaker’s bureaus. The student, a former pharmaceutical company employee, feels participation in these bureaus presents a conflict of interest for those attending the speaker programs and their patients. Current rules at OHSU require physicians to have final approval over the content of any speeches prepared by someone in the industry and earnings over $10,000 be reported.

Well folks, we’re in the last lap now and headed for the weekend! Before we go, remember, with so many of your colleagues racing around in the field, you need compliance information and training that is accessible on the go as well. We can help with iPad-compatible modules and just-in time reference apps that bring up-to-date compliance content and training to your learners.

Have a great weekend, and we’ll see you right back here next week.

The PharmaCertify™ Team

Did the bons temps rouler for you earlier this week? Get your fill of green, gold and purple, or maybe catch a few beads tossed from a parade float? We enjoyed some King Cake, and hope you did too as the Carnival season drew to a close on Fat Tuesday. The party isn’t over for us though as we keep the good times rolling with this week’s News Week in Review.

The good times rolled to a stop for the government in the FCPA sting trial. Last week the government filed a motion opposing a request by the defense to have some of the charges dropped against the next group of defendants. Their trial was scheduled to begin in March. Then,   earlier this week, the government changed direction and decided it would no longer pursue indictments against the remaining defendants. Factors that led to the decision included the outcome of the first two trials and the large number of resources required to continue with the remaining trials.

A number of industry groups are feeling less than golden about certain aspects of the draft regulations from CMS for the Sunshine Act. The groups are concerned that information on payments to physicians will not clearly explain the reason the payment is being made. In a blog post for The Hill, PhRMA’s CEO echoed the need for context around payments in order for the public to understand the nature of the payments and to be able to make the best use of the information. The Association of Clinical Research Organizations (ARCO) said reporting requirements around research payments were “highly problematic.” In a letter to HHS, ARCO’s executive director cited a study that showed a quarter of physicians said they would be less likely to participate in clinical trials if the financial proceeds were reported to HHS. He believes physicians are concerned the information will be misinterpreted.

Not to be left out of the “let’s send a letter to a government agency” parade, the U.S. Chamber of Commerce and twelve other trade organizations representing the business community have sent a letter to the DOJ and SEC asking for clarity around the FCPA. In addition to the ever popular request for clarity around the definition of a foreign official, the groups are looking for more information on the issue of successor liability in an acquisition and clarification on when donations to a charity connected to a foreign government are considered a bribe.

On the legal front, a medical equipment sales representative pled guilty to defrauding Medicaid of more than $70,000. Sentencing in the case will be in May, and the sales representative faces up to ten years in prison.

Carmen Ortiz, the U.S. Attorney for the District of Massachusetts, announced that her office collected $1.67 billion in health care fraud penalties during fiscal 2011. (Now that’s a lot of doubloons!) The total represents 40 percent of all healthcare fraud criminal and civil penalties collected nationwide.

As we wind down this Mardi Gras edition of the News in Review, we leave you with a reminder that PharmaCertify now offers iPad-compatible versions of our customizable off-the-shelf modules covering critical topics like on-label promotion, HIPAA, Good Promotional Practices and anti-bribery. Visit the mobile solutions page on Pharmacertify.com to learn how we can help roll your compliance training to where your reps need it most – in the field and at their fingertips.

Have a great weekend! We’ll see you right back here next Friday with all the news that sets us a Twitter for the week.

The PharmaCertify™ Team

Ah amore! Valentine’s Day was this past Tuesday and a day once dedicated to remembering the martyrs of the early Christian church, now is a celebration of love. According to the font of all knowledge, Wikipedia, we (and the greeting card and candy companies) can all thank Geoffrey Chaucer for associating the day with romantic love. You’d think having to read the Canterbury Tales, in olde English no less, in high school was the extent of the torture at Chaucer’s hands, but apparently not. Sorry. We’re really not jaded about love…just 14^th century English literature.  We hope you and your sweetie had a lovely celebration (no need for details), and now we present our own little valentine…this week’s News Week in Review.

Attorney General Eric Holder and HHS Secretary Kathleen Sebelius released a report showing the government collected nearly $4.1 billion in recoveries from health care fraud and abuse during the last fiscal year (now, that’ll buy a lot of flowers and candy!). Of that total, pharmaceutical and medical device companies paid $1.3 billion in criminal fines, forfeitures, etc. for violations of the Food, Drug, and Cosmetics Act. The government also collected $2.4 billion through civil cases brought under the False Claims Act.

Hopefully, the Office of Civil Rights isn’t whispering “sweet nothings.” The agency announced it was setting a March target date for the release of the final version of HIPAA modifications and the HIPAA breach notification rule.

This ought to get your heart pumping – the FDA has requested a budget of $4.5 billion for fiscal year 2013. The budget represents a 17% increase over last year and the agency said forty percent of the budget will come from user fees. The drug and medical device user fees set to expire in October are expected to be renewed, and seven new fees will be approved, including the generic drug and biosimilar user fees.

Speaking of user fees, there was no love lost between consumer groups and the medical device industry at a U.S. House hearing on the medical device user fee. Medical device manufacturers would like to see the increased fees used for streamlining and speeding up device approvals. Consumer groups say device safety will suffer in the wake of faster approvals. Device industry advocates believe the days of the U.S. being the leader in medical device technology will be a thing of the past if the approval process is not improved.

Love hurts, or so the song goes, but could love hurt as much as debarment in the wake of an FCPA violation? A law professor and one of his students published an article in the Fordham Law Review arguing the time has come for the government to begin using debarment for FCPA violations. The FCPA does allow for debarment, but rarely does the government take that step when penalizing violators. The professor argues debarment would actually serve as a determent. He believe the fines currently levied in these cases represent a fraction of the money made in contracts gained illegally, and therefore monetary penalties do not serve as a deterrent to potential violators.

Instead of cards and candy, the U.K. Attorney General gave the Serious Fraud Office (SFO) an operations inquiry. The inquiry is to be conducted by the Crown Prosecution Services Inspectorate, and will include a review of how the SFO selects cases. The inquiry comes in the wake of high-ranking individuals leaving the SFO, and the organization dropping several high profile cases. The Attorney General’s office said the inquiry was not prompted by specific cases, and that the review had been under discussion for some time.

Democrat Senators Amy Klobuchar and Chris Coons sent a love note to Attorney General Eric Holder regarding the forthcoming guidance on the FCPA. The senators urged Mr. Holder to consult the business community when drafting the expected guidance on the FCPA, and asked that the guidance provide clarity and predictability for those affected by the regulation. To that end, the Senators asked for clear guidance on nine enforcement issues, including a definition of foreign official and the benefits that will be afforded companies who self-report and cooperate with investigations.

European life sciences companies are lovin’ life in the Sunshine. Well, maybe loving life is a bit of an overstatement, but according to a recent survey of European pharma, med device and biotech company executives, they are feeling more confident in their ability to meet transparency requirements in countries like France and the Netherlands. Survey results showed that compared to 2010, more companies are “enforcing corporate standards for spending on HCPs.” While there is greater confidence in companies’ abilities to meet transparency requirements, the survey showed respondents are concerned about data errors and data collection process inefficiencies.

That brings us to the end of this week’s News Week in Review. Now that you’re feeling all warm and fuzzy about Valentine’s Day, we’ll leave you with this warning – the FDA found 400 popular lipstick shades contained small amounts of lead, so make sure you check the list before you start smooching with your sweetie. On that happy note, we bid you a Happy Friday, and wish you a wonderful weekend. See you back here next Friday.

It’s finally Friday! We have our 3D glasses ready, and our costumes pressed because today, Star Wars: Episode 1 – The Phantom Menace makes its way back into theaters and this time it’s in spectacular 3D! Okay, let’s face it, for many fans the movie can only be made better by the addition of 3D. Well that and perhaps having Jar Jar Binks digitally removed and replaced by anyone…let’s go with Salacious Crumb. He was just as freaky looking, but he was funny! Now that we’ve unofficially kicked off Celebration VI a few months early, we’ll get down to the important stuff in this universe – this week’s News in Review.

There’s A New Hope for states looking to manage Medicaid costs. A rule change will allow states to reimburse for drugs based on what pharmacies actually paid for them, and not the price of the drug as self-reported by the manufacturer. The rule is based on a program pioneered by the state of Alabama through which the state collected receipts from pharmacies to determine what they should be paying for drugs. The federal government will provide assistance to the states in collecting the pricing data. The rule also increases what pharmaceutical companies pay in drug rebates to state Medicaid programs.

Maine is looking to jump on board the false claims (star) ship. A bill has been introduced into the state legislature to create a False Claim Act. The bill would include whistleblower provisions similar to those in the federal statute. And, in a different part of the galaxy, Louisiana has reached a $25.2 million settlement with five pharma companies to resolve claims of Medicaid fraud.

The force may not be with federal prosecutors in the FCPA sting case. Prosecutors have been granted a request to delay moving forward with proceedings and they have until February 21 to decide if they want to continue with the case. You may recall that the second trial in the case ended with the acquittal of two of the defendants and a mistrial for the remaining defendants after a verdict could not be reached. The jury foreman offered an explanation to the FCPA professor.

Lando’s agreement with Darth Vader may not have worked out as expected, but we’re sure that won’t be the case for the maker of the orthopedic product, Orthofix. The company has reached an agreement in principle with the DOJ to resolve possible violations of the FCPA after disclosing an improper payment by one of its distributors in 2010.

Dava Pharmaceuticals has agreed to pay $11 million to settle allegations the company violated the False Claims Act. The government alleged the company had underpaid Medicaid rebates by incorrectly calculating the average manufacturing price of several of its drugs, and also by treating those drugs as generics.

Well, that’s a wrap on all the news in the compliance galaxy for this week. As you pack up the plastic light sabers and head off to the theater, we invite you to consider methods for delivering up-to-date compliance content straight into the hands of your own Rebel Army (aka sales reps). While we’re still working on that “good promotional practices delivered via hologram” concept, we do offer the iPad-compatible training modules and reference apps you need to help integrate a true values-based culture into your company.

Have a great weekend and may the Force be with you.

The PharmaCertify™ Team

It is almost here – the Sunday that we’ve all been waiting for since least September, if not this time last year. No doubt there will be excitement, laughter and maybe even a few tears shed as we gather around our television sets on Sunday evening to watch the best of the best compete for bragging rights. Yes, it’s finally time for Super Bowl commercials! And if you’re so inclined, there’s also a football game played in between these delightful bits of entertainment. While some in the PharmaCertify ranks are excited about that team with the NY on their helmets, the rest of us are once again left to mumble “maybe next year.”

In order to ‘warm up the audience’ as they say in the biz, we present our own delightful bit of entertainment and information, the PC News Week in Review.

We’ll kick off this week’s News with an op-ed regarding everyone’s favorite topic – the Sunshine Act. Written by a physician, the piece expresses a sentiment we rarely see in articles about the law; that is not likely to “have the purifying effect that its proponents promise” and not stop potential conflicts of interest from occurring. The author goes on to say the medical community is suffering from “over disclosure” as it is, and he wonders if anyone even pays attention anymore.

Could the Travel Act be the next player called off the bench in the government’s effort combat foreign bribery? Unlike the FCPA, the Travel Act addresses commercial bribery. So far, the regulation has only been used in a small number of cases involving foreign bribery, however the DOJ’s guide to the FCPA mentions the Travel Act as an alternative charge for bribery.

It was a tough week for prosecutors at the second Shot-show FCPA trial. First, the judge acquitted two defendants, leaving the fate of the three remaining defendants in the hands of the jury. After ten days of deliberation, the jury could not reach a unanimous decision, and the day after the acquittal, the judge declared a mistrial. For those keeping score at home, the government has now gone 0 for 2 in the prosecution of the individuals arrested through the government’s sting operation. There’s no indication as to whether the government will re-try this group of defendants.

The DOJ hosted a celebration to commemorate the 25^th anniversary of the amended False Claims Act. The amended Act, which passed in 1986, strengthened the qui tam provision and provided incentives for whistleblowers. The celebration featured remarks from Attorney General Eric Holder and members of congress, as well as a panel discussion with experts from the government and the private sector. No news of any flashy touchdown dances or excessive celebration penalty flags being thrown.

This year, NBC raised the cost of a 30 second Super Bowl ad by 17 percent over last year. By comparison, the medical device industry will see a doubling of the fees it pays to the FDA for the next five years. The industry has agreed to pay the FDA $595 million in fees to help create a more efficient and consistent approval process.

The estimated cost of Super Bowl advertising may be going up, but what pharma is spending on DTC television advertising is going down. According to Nielsen, the industry has been on a downward trend since 2007. Between 2007 and 2011, the industry spent 23% less on television advertising. Analysts attribute the decline to the controversy surrounding DTC advertising and new generic competition against blockbuster drugs that are going off patent.

Upon further review from the officials, the U.S. government has decided to drop its case against a former president at Stryker. The charges stemmed from the company’s promotion of an unapproved use of two of its products in combination. With their client facing up to 20 years in prison for wire fraud, defense attorneys provided the government previously privileged documents that indicated their client had acted in good faith. Government attorneys reviewed the documents and decided to drop the case.

Before the final whistle blows, we’ll leave you with the news that GSK will settle 20,000 lawsuits related to Avandia. The settlement was the result of a court ordered mediation process.

That brings us to the end of this week’s News Week in Review. Whether you spend your Sunday watching the big game for the football or just the commercials, (or watching the new episode of Downton Abbey because it won’t be a repeat, unlike most shows that air during the Super Bowl), we hope you have a great weekend.

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!