The PharmaCertify™ Team

Bright colors, green grass and the search for small round objects await us this weekend. Yes, it is that time of year again folks; its Master’s time, golf’s storied event. Where legends are made, and the greatest of the great find themselves brought to their knees by the course’s challenging twists, turns and temptations. Joy and disappointment played out before us all in the pursuit to be the owner of what has to be one of the ugliest pieces of clothing in professional sports…the coveted green jacket. Well we’re all pretty excited for this year’s tournament, but before we stake out our spot somewhere in Amen Corner to watch the spectacle, we have a little bit of business to take care of here, this week’s News Wweek in Review.

Pharma, AdvaMed and BIO are concerned with the FDA’s current lie on its guidance for handling unsolicited requests for off-label information. Comments submitted to the FDA by the three industry groups were generally supportive of the guidance’s objectives, but each had concerns with some aspects of the document. All three groups were concerned with the FDA’s handling, or lack thereof, of oral requests for information. The groups say treating oral requests as written requests is not practical, and creates a burden that is not in the interest of the public health or scientific discussion. PhRMA and AdvaMed also said the FDA needs to provide specific guidance on the use of social media. AdvaMed made the point that companies should be allowed to respond in a timely manner with truthful, non-misleading information online, rather than just through traditional off-line methods.

Next we’ll shoot over the water hazard known as the Atlantic Ocean, to Britain, where a group representing various healthcare and life sciences organizations came together to create a set of guidelines for working with the pharmaceutical industry. The group, known as the Ethical Standards in Health and Life Sciences Group, hopes to forge a collaborative partnership with the pharmaceutical industry in order to better patient’s lives. A statement of best practices was created and signed by organizations involved with the group. The document describes the current environment in which healthcare providers and the pharmaceutical industry operate, and rules by which each will abide as they interact.

Certain Asian countries may need to consider teeing up new local anti-corruption laws. Singapore, a country that has traditionally been tough on corruption, has found itself dropping from the number one position to the number five position on Transparency International’s Corruption Perceptions Index. It may be time for Singapore, and other countries in Asia, to take a page from the UK Bribery Act and address not only bribery of government officials, but also corporate bribery.

The FDA could be guilty of slow play where medical device approvals are concerned, according to a report from the General Accounting Office. The GAO report says the FDA is technically meeting its approval time lines for 510(k) devices, but that time line stops when the FDA asks a manufacturer to provide more information. When the time that occupies that process is factored in, device approvals timelines have increased from 100 days in 2005 to 161 days in 2010.

A federal judge gave a former sales representative permission to play through on her wrongful termination lawsuit. The former rep questioned her training that she claims encouraged the promotion of a heart device for an off-label purpose. She questioned the legality of what she was being asked to do during training, and was reprimanded. The rep continued to raise concerns that the off-label promotion could violate the False-Claims Act, at which point her employer then invented reasons to fire her, according to her argument.

Well we’ve approached the 18^th fairway and are heading for the green of the weekend. We hope you all have a wonderful weekend, and remember…see the ball, be the ball.

The PharmaCertify™ Team

Is it the end of March already?! This first quarter of the year has flown by hasn’t it? Well with the end of March also comes the end of March Madness. The final games in the NCAA basketball tournament will be played this weekend in the Big Easy. How have your brackets held up? If they haven’t done well, you can always take your chances with the $500+ million Mega Ball drawing this weekend. Okay, time to put the dreams of scoring big aside, and get back to the real world; this week’s News Week in Review.

The Massachusetts Restaurant Association is hoping a new bill in the Massachusetts legislature will get them back in the game of hosting meals between pharma companies and physicians. Massachusetts legislature’s small business and community development committee signed off on a bill which would allow meals to be provided to physicians in restaurants. The Massachusetts House of Representatives has been supportive of such measures in the past, but the Senate has been more resistant. The CEO of the restaurant organization says restaurants are suffering due to the ban, and he hopes legislators will see the job creation benefits of passing the bill.

Seems the drug sample possession arrow is pointing toward pharmaceutical companies rather than doctors’ offices. The number of samples left by sales reps is down 25% since 2007. The reduction is largely due to the cut back in the sales force numbers and the fact that many offices are refusing to take samples. According to a survey, 23% of physicians’ offices do not accept drug samples.

The OIG and forty-two industry compliance professionals met at center court in February to discuss a number of compliance issues facing the pharmaceutical industry. Industry attendees at the meeting were all from companies currently under a CIA, and as you might imagine a top topic was the challenge in implementing CIAs. Other topics on the agenda included: compliance program structure and oversight; risk assessment and monitoring activities; policies, procedures and training activities; and compliance post-CIA. As the meeting wrapped up, industry participants noted a number of changes which would pose challenges for the future such as regulatory changes (ex. Sunshine Act), social media and lack of regulatory guidance in that area, and a changing business model in the industry.

Speaking of social media, the industry may essentially be on the sidelines when it comes to participating in social media, but a recent survey suggests companies are getting into the game of using social media for market research. Survey respondents predicted their companies would be using social media for market research in the coming year. At the Pharmaceutical Marketing Research Group National Convention, companies already engaged in this practice said listening to patients through social media outlets helped them shape clinical trials and product messaging. In addition, this type of research can have an advantage over more traditional market research methods in that companies have more than one shot at gaining patient feedback.

Just when we all thought the final buzzer had sounded on the FCPA sting case, more news emerged this week. Government prosecutors petitioned the court to have the convictions dismissed of three of the defendants who previously pleaded guilty to conspiracy charges in the case. Charges were dismissed against 16 other defendants still facing prosecution when the government decided not to proceed further with the case. The dismissal did not apply to the three defendants who had already pled guilty. The government said the dismissal of charges should also apply to these three defendants.

On the settlement front, Biomet Inc. entered into a Deferred Prosecution Agreement with the DOJ to resolve charges of improper payments under the FCPA. The company will pay $17.8 million in criminal penalties, and in agreement with the SEC, another $5.4 million in disgorgement of profits. Cypress Pharmaceuticals, its subsidiary Hawthorn Pharmaceuticals, and its CEO have agreed to pay $2.8 million to resolve allegations the company violated the False Claims Act. The government alleged the company promoted several products that had not been designated “safe and effective” by the FDA. The company promoted the drugs in this manner to physicians which  resulted in improper payments by state Medicaid programs and the military’s TRICARE program.

Well the game clock is dwindling down, and the weekend buzzer is about to sound. We hope yours is full of fun and excitement. If your plans involve watching the NCAA Tournament, consider a chocolate bunny as your game time snack. Apparently chocolate is good for the metabolism among other things. Now that, is truly news you can use!

Have a good one everyone!

The PharmaCertify™ Team

Spring officially arrived this week. Of course for many of us around the US, we’ve been enjoying spring-like weather for a while now (so much for that groundhog being right). If you live south of the Mason Dixon line, you may have had the additional seasonal joy of a chartreuse haze in the air. It’s record high pollen. Pollen so thick it coats everything in sight, as well as the inside of your nose and throat. Don’t know about you folks, but right about now we are wishing we had stock in the makers of allergy meds! Enough about the business of sneezing, let’s get down to business of this week’s compliance news.

We’ll start this week’s review off with a couple of stories from the medical device sector. Senator Kelly Ayotte of New Hampshire told med-tech companies in the state she is committed to repealing the medical device tax that is due to be implemented in 2013 as part of the healthcare reform act. Some experts say implementing the tax will be more complex than most companies are expecting.

Later this spring, Scotland will implement new regulations preventing companies linked to individuals convicted of bribery from bidding on public contracts. Two existing sets of regulations will be updated to include new offenses created by the Bribery Act and Scotland’s Criminal Justice and Licensing Act 2010. The new regulations will go into effect May 1.

Excitement may be blooming in England for this summer’s Olympics in London, however, corporate hospitality packages are selling slowly due to concerns over the Bribery Act. A representative of the firm providing official legal services for the games said clients are asking if they can bring guests, to which he replies yes. However, he suggests that companies scrutinize the reasons for inviting guests, not invite guests for whom there may be sensitive contract issues pending, and keep a log of all guests and the reasons why they were invited. The SFO has indicated they will be watching to see if companies are offering extended hotel stays and free travel for friends or family of guests.

There are calls from Australia and Canada for public disclosure of the green the industry spends on physicians. In Australia, a former GP says that company sponsorship of a physician’s medical conference attendance should be put to an end. And, an upcoming review of Medicines Australia’s Code of Practice by the country’s Competition and Consumer Commission has prompted some companies to suggest it’s time to move away from hosting physicians’ attendance at conferences. In Canada, a former pain specialist calls on the government to pass legislation similar to the Sunshine Act. He believes physicians have become indifferent to the influence industry funding has on the practice of medicine.

Every FCPA action brought in 2011 involved bribery by third-party business partners, and FCPA regulators are paying more attention to the research that companies conduct on their third-party partners. Despite the risk, a recent poll found companies are only scratching the surface when it comes to due diligence and risk assessment of third-parties. 30% of the respondents said they worked with 1,000 or more third-party partners and just over 20% said they performed due diligence and risk assessment on only about a quarter of their third-party partners. 5% said they did no due diligence at all. Cost of implementation was the top reason cited.

Itching to create a successful whistleblower program? Look no further than the SEC whistleblower program created under the Frank-Dodd Act, or the whistleblower provisions in the US False Claims Act, for examples. According to an article in Forbes, there are seven keys to a successful program and topping the list is the need for mandatory monetary rewards for the whistleblowers. Other suggestions include provisions for back-pay or reinstatement if the whistleblower is fired, and encouraging whistleblowers to first report issues through their company’s internal program.

We’ll wrap up this week’s news with two stories from the state of Oregon. First, Pfizer agreed to pay $3.3 million to the state to settle an investigation into illegal marketing practices of an antibiotic. According to the state’s department of justice, the company used flawed clinical trial study information to claim its product was superior to another antibiotic available as a generic. Pfizer denied any wrongdoing in the matter. In the second story, the Oregon Health and Science University is set to review its policies on outside income for its researchers in response to scrutiny on the influence of industry funding. The University has convened a task force comprised of staff, students and administrators to review the policies and discuss where improvements are needed.

It was touch and go, but we made it to the end of this week’s News Week in Review without sneezing all over the keyboard (okay, we admit, that was gross). For those suffering from pollen-induced allergies, we hope the weekend brings some rain and relief. For those of you missing out on the chartreuse nightmare, just think, you’ll have fewer people in line in front of you for tickets to The Hunger Games.  Have a great and sneeze-free weekend everyone!

The PharmaCertify™ Team

This has been a week of festivities, hasn’t it? Girl Scout’s Day (Happy 100^th GSUSA), Pi Day, the kickoff, or maybe that is the tip-off, of March Madness, all culminating on Saturday with St. Patrick’s Day (we’re going to forget about the Ides of March)! At the News Week in Review, we’ll keep the party going and get you ready for the Wearing o’ the Green by keeping this week’s review festive and green! Time to get this party started.

Our first story comes from a country near the Emerald Isle, Scotland. A Scottish lawyer includes the pharmaceutical industry as one of the most prone to practices that can run afoul of the Bribery Act. The lawyer points to two bribery investigations underway in Scotland, and urged businesses to consider taking advantage of the Crown Office’s self-reporting program. Doing so puts the business in control of the process.

Moving on to an island that is sometimes described as a desert with green edges, a report reveals drug companies spent $40 million on physician education events in Australia in six months during the last year. The total represents an $8 million increase since 2008.

Consumer Reports is hoping for the luck of the Irish in its effort to organize the public to protest the 510(k) medical device approval process. The publication’s president, Jim Guest, sent an e-mail blast to one million people warning them that devices approved through the 510(k) process have never been safety tested in humans. The consumer advocacy arm of the magazine would not comment how much money it had allocated to the fight.

The proposed Sunshine regulations have not left medical organizations in a celebratory mood. The organizations are concerned physicians’ careers could be in jeopardy and their professional reputation damaged as a result of the rules. A number of medical societies have asked that physicians have more time to deal with information they feel is erroneous. They would also like to see changes to the way meals are allocated and reported.

The federal government has not always found gold at the end of the rainbow in  pursuing enforcement of the FCPA. Prosecutors have had trouble winning cases recently, with the shot-show sting case being the latest example of unsuccessful prosecutions. The US Chamber of Commerce and other organizations have decried the aggressive investigative and enforcement techniques the DOJ employs to pursue the cases but for its part, the DOJ is committed to pushing forward. Assistant US Attorney General, Lanny Breuer, says the US needs to be a leader in combating corruption, and he continues to grow his staff. The feds certainly have their work cut out for them, as the World Bank estimates that government officials are paid $1 trillion in bribes each year.

Being on the business end of an FCPA investigation sure can cost a company a big pot of gold. Investigations costs are on the rise, with many companies spending as much on the investigation as they spend on settlements. Even across the pond, the costs can be quite high, as indicated when News Corp. spent $104 million to deal with its 2011 phone hacking and corruption scandal.

We keep the anti-corruption party going with a story that raises the question of whether the Travel Act could be the Eli Manning of anti-corruption prosecutions. FCPA (the Travel Act’s big brother) prosecutions have taken some high profile hits lately, and the feds have showed “renewed interest” in the Travel Act. The Act is designed to combat racketeering overseas and gives the federal government more leeway in bribery cases. Unlike the FCPA, the Travel Act can be applied when the bribe occurs or is offered to someone other than a government official.

The FCPA isn’t the only area in which the DOJ has traveled a bit of a rough road lately. The effort to hold executives personally responsible when their companies are involved in cases dealing with healthcare law infractions has hit some hard times as well. At the beginning of the year, the government dropped charges against a Stryker sales manager and two other colleagues five days into a trial for illegal marketing. Charges were eventually dropped against a fourth individual in the same case. Last year, a judge dismissed obstruction charges against a former GSK lawyer, saying the lawyer never should have been charged, and it would be a “miscarriage of justice” for the case to go to a jury. Lawyers for the industry say the government needs to think about the evidence they have against individuals before they bring charges.

Moving on to action in the states, supporters of false claims act legislation in South Carolina may need the help of a four-leaf clover if they hope to have the legislation heard during the current legislative session. The AG’s office says the state missed out on $2.3 million for its Medicaid program since it does not have a false claims act on the books. Despite the potential monetary benefit, the state senator overseeing the committee reviewing all pending legislation says the calendar is crowded and the bill may not move this session. The story was different in the state of Washington, as the legislature approved the Medicaid False Claims Act in the waning hours of the legislative session. The law now moves to the governor’s desk for signature.

That brings us to the end of this week’s News. With anti-corruption continuing to trend to the top of the news, PharmaCertify’s eLearning course, Understanding and Preventing Bribery in the Global Life Sciences Marketplace, offers the updated content your global staff and third party representatives need to stay in compliance with the myriad of laws and regulations.

Have a wonderful and green weekend everyone!

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.