Author: NXLevel Compliance Team

Week in Review- October 22, 2012

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , , ,

The PharmaCertify™ Team

Now that it is mid-October, the time has come for glitter, glamour, kings and queens. Homecoming! The one game you have to win, and for ladies, the second most important dress you’ll buy that year (it isn’t the prom after all!). Oh, and let’s not forget, everyone loves a parade- except of course the people that are stuck behind the slow moving leviathan clogging up the streets of your town. For many of us it is a time to go back to our alma mater and see old friends, and remember the “good old days.” Let’s begin our own walk down memory lane with some of the news nuggets of yester-week. Now taking the field, this week’s News Week in Review.

Leading off the parade we have a story regarding the FCPA and the life sciences industry. Federal prosecutors and regulators have widened their expectations in third-party due diligence and the oversight that companies need to have over third-parties. The expectation is that companies not only do an initial due diligence, but also look at whether the third-party is capable of conducting business in a manner that measures up to the company’s own FCPA standards. For life sciences companies the sheer number of third-party relationships is staggering, and this need to review third-parties applies not only to new partnerships, but also to already established relationships. Implementing a sound assessment process that encompasses both new relationships as well as ones that are currently active is vitally important.

No more mum corsages for doctors in India from Abbott sales reps. Abbott has implemented a policy temporarily suspending the giving of gifts to doctors in that country. An internal memo says only clinical or scientific literature may be given. The ban even includes minimal value “therapy reminder” items such as pens. Indian law prohibits doctors from accepting gifts or travel, however the law is not consistently enforced. No comment from Abbott as to the reasoning for the decision. In other Abbott news, its $1.5 billion settlement agreement for off-label promotion of an anti-seizure medication was accepted by a judge in federal court.

Are doctors not showing enough spirit for the results of studies funded by the industry? According to one doctor, the skepticism pendulum may have swung too far.  Physicians have become skeptical of the results reported in pharma funded studies as pointed out in a study published in the NEJM. Some skepticism is warranted, but as the doctor points out, physicians have gotten so skeptical that they could be overlooking important safety data by discounting pharma sponsored studies. He suggests that there needs to be more transparency in clinical studies, and suggests greater third-party statistical review and more use of public access sites like clinicaltrials.gov.

The Sunshine Act: the industry’s current homecoming queen. She sure is taking her time putting on her crown and sash to meet the public. While we all wait on the final rule, take a listen to this podcast (written transcript here) from Medsider that discusses the law and its impact on medical device manufacturers. (Much of what is discussed is applicable to those outside of med device as well.) In the podcast the Medsider host and his guest expert discuss a variety of issues including: the purpose of the law, the costs associated with preparing to implement the law, are there any loopholes in the law and what companies need to be doing now to get ready to implement the law. An important point made by the guest is that if companies do not have front-end policies and procedures in place regarding physician consulting agreements, they should seize the opportunity to do this now before their data is publically available. While Sunshine does not require any of this, he says both the government and private attorneys will likely be pouring over the information in the public database. He likens just having your back-end systems and processes in place without addressing this front-end issue to driving a car without car insurance. Nice.

Massachusetts med students want the governor to revisit the past in regards to the provision of meals. A group of med students and consumer advocates, carrying trays of champagne and lobster tails (seriously?), delivered a petition asking the governor to bring back the ban on providing meals at educational presentations outside of a practitioner’s office. The group believes the definition of a “modest meal” is vague, and that these meals do nothing to benefit patients. The group would like to see Massachusetts’ Department of Health set a dollar limit on these meals, ban the serving of alcohol and obtain information about how money for these meals is allocated.

That brings us to the end of this week’s review, but before we put away the crepe paper and streamers we’d like to float one more thing by you: mobile learning. Access is everything, so why not make sure your ethics and compliance training accessible for your learners on their terms? PharmaCertify has a variety of mobile learning solutions to help you put compliance knowledge in the hands of people when and where they need it.

That brings us to the end of the homecoming celebration. We hope you had a good time reminiscing with us. Have a great week and we’ll see you back here next week!

Week in Review, October 15, 2012

NXLevel Compliance Team

The PharmaCertify Team™

He’s golden, famous and the subject of a lot of buzz lately. He’s Oscar! (You thought we were going Big Bird didn’t you?) Yes, he’s been on the lips of critics and studio PR folks a lot lately as those “Oscar type” movies begin to show up in theaters. This weekend’s big Oscar-buzz release was Argo. Did you see it? Was Ben Affleck’s performance worthy of another Oscar statue? Several months remain before the race begins with the nominations, so kick back and view some news you can use now. Time to raise the curtain on this week’s News Week in Review.

First to arrive on our red carpet this week is news that GSK will make detailed data from its clinical trials available to other researchers. GSK will create an independent expert panel to judge the scientific merit of data requests. The program is expected to begin early next year.

Two weeks ago, we announced it as a coming attraction, and last week the Serious Fraud Office officially released the revised guidance for the UK Bribery Act. The new guidance makes the SFO’s position on self-reporting clear – companies can be prosecuted even if they self-report violations. That’s a change from the previous version, which suggested the office would prefer to settle self-reported cases civilly.

Meanwhile the Department of Justice seems to be taking a cue from last year’s Best Picture winner, The Artist, and is staying silent on its plans to update the FCPA guidance. The long-awaited guidance was expected to be released last week. It didn’t happen. No word from the DOJ on a release date.

In the “foreign” category, India and China announced plans to roll out new medical device regulations. The Drug Controller General in India will launch a program to look for manufacturing discrepancies in  devices. In addition, the DCGI will introduce the Drug, Cosmetics and Medical Device Bill in Parliament in the winter. China’s State Food and Drug Administration released regulations for the labeling of foreign medical devices. The regulations, which go into effect April 1 of 2013, require manufacturers of foreign medical devices to include a label written in Chinese and documentation that guarantee the product’s safety and effectiveness.

Ireland’s Medical Council brought the drama this past week with the release of guidance for physician relationships with the industry. Highlights of the guidance include a recommendation that drug samples only be accepted for use on emergency night calls and a prohibition on the acceptance of gifts, hospitality or payments for travel and accommodations related to medical conferences. Physicians are allowed to accept fees for contractual services. The guidance cautions physicians that information gathered at a promotional program cannot be trusted and should not be used as continuing education credits unless the program is approved by a professional body.

The OIG was in the news last week, as they released a report that summarizes another roundtable discussion attended by representatives of 32 companies that have entered into CIA agreements since 2009. The agency will consider using the feedback to determine requirements for CIAs in the future. The participants worked in small groups discussing four topics:

  1. The definition of covered person and relevant covered persons, and CIA requirements regarding Code of Conduct, policies and procedures and training.
  2. The role of the compliance officer, internal audit and auditing plans, and the role of the Board of Directors.
  3. Claims review requirements.
  4. Arrangements review requirements.

The discussion included the burden of tracking to 100% completion and the difficulties of completing new hire training within 30 days of hire. Participants felt the OIG’s topic requirements were too prescriptive and that it would be better if companies determined their own annual training topics. The participants also suggested removing requirements around training hours in favor of a focus on whether training thoroughly addresses topics in the CIA.

Well, we’ve reached the final reel of the NWR. Before the final credits roll, we’d like to call your attention to our newest star on the rise – mobile learning. From full iPad-compatible training modules to just-in-time apps that deliver content where and when you reps need it most, PharmaCertify offers the mobile solutions you need to integrate effective compliance policies into your staff’s daily activities.

Have a great week everyone!

News Week in Review, October 1, 2012

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , , ,

The PharmaCertify™ Team

The weather has cooled, fall sports are in full swing, and the World Series is just around the corner. Then there’s that one additional reminder of the change of season: a new television season is upon us. Goodbye to the repeats and summer reality, and hello cliffhanger resolutions! We still have more premieres on the way, but for now we’d like to entertain you with  this week’s News Week in Review.

We begin our broadcast day with the news that Stryker has agreed to pay $1.5 million in legal fees to settle two shareholder suits. Stryker admitted no wrongdoing as a part of the settlement, but did agree to install a committee aimed at preventing violations of the FCPA and False Claims Act, and illegal promotional activities.

Lawmakers and the industry are asking the Administration to end the delay and implement the final rule for the Sunshine Act. Senator Herbert Kohl calls the delay unacceptable. Senator Grassley did not mince words, saying efforts to communicate with CMS had been met with resistance, and it was “[as if] Congress passing a law doesn’t make a difference in this town.” Tune in next week for the continuing drama on “Waiting on Sunshine.”

A Modern Family probably has at least one person who owns a smart phone, and a congressional representative from California plans to introduce a bill aimed to smooth the FDA’s evaluation process of apps for those phones. The bill, if passed, would establish an Office of Mobile Health at the FDA to provide recommendations on issues related to mobile apps and to support developers trying to understand regulations related to privacy. IT industry groups and developers are on board with the formation of the new office as an attempt to foster innovation while protecting patients.

A White House advisory group may have been feeling a little Grimm about the rate at which new drugs are being approved, so a plan was drafted to double the rate of approvals. The plan calls for faster approvals of drugs for high risk patients. The advisory group urged the FDA to use its “accelerated approval” process with more frequency to approve drugs for targeted patient populations. Patient and physician group representatives have praised the plan, saying it protects the public health while giving patients in high-risk situations access to medicine.

Once Upon a Time, Assistant Attorney General Lanny Breuer said the DOJ intended to release new, detailed guidance on the FCPA. Now it seems the promised guidance will be delivered in the next few weeks. (Ahem…CMS…take note) The guidance is expected to be released in advance of the October 10 Organization for Economic and Co-operation and Development meeting. In an interview with Compliance Week, the FCPA Professor, Mike Koehler, says he doesn’t expect there to be anything “groundbreaking” in the new guidance, but it is likely to address newer issues that were not addressed in the previous guidance.

Are Board members Persons of Interest in a corporate bribery investigation? A new survey of BOD members reveals one-third believe bribery is their company’s greatest fraud risk, while 63% believe their personal liability has gone up over the last three years. Two-thirds of those surveyed indicated their company did business overseas, with nearly 60% of those indicating they did business with foreign officials. According the Corporate Fraud Index latest quarterly report, reports of corporate fraud, including those concerning violations of the FCPA and UK Bribery Act, represent 23% of all compliance reports.

It’s Elementary that pharmaceutical and medical device industries face risks when it comes to bribery and doing business in other countries and now someone has created a list of the top five corruption risks. Spoiler Alert! The top risks are: state-owned healthcare enterprises, third-party agents, sponsorship of medical conferences, foreign clinical trials, and “anything of value.” As enforcement agencies focus more on the life sciences industry, training on the risks of doing business outside the U.S. has become even more critical. We can help with the customizable Understanding and Preventing Bribery in the Global Life Sciences Marketplace eLearning module.

Well that rounds out this week’s “broadcast.” Before we sign off, there is one more piece of “news” to bring you. While turning thirty is a milestone that is often looked upon with trepidation, that is certainly not the case in central Florida today, as the fine folks at the Walt Disney World Resort celebrate the 30th anniversary of EPCOT. Congratulations to our friends at “Spaceship Earth!”

Have a great week everyone!

Week in Review, September 24, 2012

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , , ,

The PharmaCertify™ Team

Well, fall officially arrived on Saturday! Bring on the rich colors, cooler weather, outdoor festivals and fairs, and perhaps most importantly, the end of the growing season for lawns most every where.  If none of this inspires you for the turn of season, perhaps last week’s revival of Starbuck’s Pumpkin Latte will do the trick. As you take time to enjoy this beautiful time of year, don’t forget to schedule a few minutes to check in on the compliance news of the past week, with the News in Review.

Winds of change are blowing slowly in Australia. Medicines Australia’s revised Code of Conduct currently sits with a government regulatory agency awaiting approval. The change under consideration is the reporting of monies paid to physicians for speaking and consulting services, including payments for travel and hospitality while providing those services. If the change is implemented, reports will be published beginning mid-2014. Not everyone is happy. Transparency advocates would like to see individual payments reported, not aggregate payments.

Staying in the South Pacific (where it isn’t fall at all), the Penang Health Department is investigating six pharmaceutical advertising claims involving products for heart and kidney diseases. An enforcement representative said none of the ads received the required regulatory approvals.

Moving on to a cooler climate, a compliance professional in Russia explains what “compliance” means to the Russian pharmaceutical industry. He explains that a successful compliance program is not just about making sure your company is following the “rules” as defined by government agencies, but also involves the proper flow of information. A company needs to have systems that allow the information to flow from the compliance team and back from the organization.

A new study finds that physicians have a skeptical view of clinical trials sponsored by industry. Board certified internists were provided abstracts of results for clinical trials for fake drugs. The physicians were informed that the funding for the studies came from either the industry or the NIH, or there was no disclosure at all. Participants were then asked to offer their confidence in the results of the study and whether they’d prescribe the drug. Products related to those studies identified as funded by industry were less than half as likely to be prescribed as those funded by the NIH.

In corporate fraud cases, whistleblowers can definitely rake in the big cash, but the big dollar awards are rare, according to experts. That’s because most cases involve multiple whistleblowers, and the awards are split among the group. Then the relators’ lawyers and Uncle Sam take their cut. Across all industries, five of the top seven awards went to whistleblowers in healthcare cases. Three of those five are from pharma cases: Pfizer, GSK and Abbott. To keep your team reporting to the compliance office instead of their lawyers’ offices, PharmaCertify’s off-the-shelf compliance modules include topics like open door and anti-retaliation policies and are easily customized to include your hotline and contact information.

A new study finds that 25% of pharmaceutical companies do not have dedicated compliance teams in place. (Color us a bit shocked.) According to the researchers, many of the companies believe that compliance needs to be decentralized in order to be in better contact with the issues “on the ground” so they tasked “function-specific personnel with compliance responsibilities.”   Unfortunately, that approach has resulted in business units being unaware of what other units are doing in terms of compliance polices and processes. The researchers recommend that one individual be assigned to oversee all the company’s compliance efforts, and to draw a line between regulatory and commercial compliance responsibilities.

And with that, we come to the end of this week’s NWR. Enjoy the fall weather everyone and have a great week!

What I Learned on My Summer Vacation – Training with Magic

NXLevel Compliance Team

Lauren Barnett, Compliance Specialist

With school recently starting for kids around the country, I got to thinking about those “what I did for summer vacation” essays or projects we had to do when we returned to school. My essay this year would have been about going to Walt Disney World. For those who know me, that would be no big surprise. I’ll go ahead and confess it, I am a Disney nut. I love Walt Disney World and dream about my first trip west, to Disneyland. Inevitably, when people hear I go to Disney World multiple times a year they ask, “Why do you go so often?” As I consider the reasons, I realize that some of the attributes that fuel my love of Disney are of the same ones that make for successful compliance training. I can’t promise that these will make your training as magical as a trip to Disney World, but a little bit of pixie dust does go a long way.

Accessiblity. A few hours in the car and I’m there. I don’t have to fly and deal with all that entails. Even if did have to fly, Disney does all it can to make it easy for me to get to Walt Disney World. They have their own hotels, and if I stay in one of those hotels, they pick me up and return me to the airport. They have busses, boats and monorail that shuttle me around from my hotel to anywhere I want to go on property.

In compliance training, we need to be conscious of how learners are accessing the training and communication programs. We need to ask the appropriate questions related to accessibility. Is a training window a one shot deal or do we stagger courses through the year to extend the learning opportunities? Are the policies stored in areas where those who need them most are likely to access them? Are policies or other documents only available in one format? Are you offering documents or training in the format that makes the most sense for the group. When we offer learners the easiest pathways to our training and education, the more they look forward to returning.

A Place We Can All Play. When Walt Disney’s daughters were young, he took them to a carnival. While his daughters enjoyed the amusements, he was left to sit on the sidelines and watch. This did not sit well with Walt. He thought parents and kids should be able to play together, and he set about creating a place where that could happen. That place, Disneyland, recently celebrated its 57th birthday, so I’d say Walt was onto something. The challenge with the training in the commercial compliance space is that our primary audience has been sales and marketing. Times and philosophies have changed and the audience is broader. However, the temptation can be to stick with the reliable old examples because they are the most impactful and helpful in illustrating how certain laws affect the industry. Unfortunately, this leaves some people sitting on a bench, unengaged. As the landscape has changed, we have to remember those who are now playing in our park, and do what we can to show, that yes, unlike high school calculus, this information applies to all of them and they will use it again.

Similarly, since we’re dealing with laws and regulations, we need to avoid the trap of keeping the legal tone with which the laws and regulations are written. Some of us are used to that “legal style” and naturally use it in our training, policies and communication pieces. But, not everyone else is riding the “legal style” teacup. We need to broaden the language. In compliance, we like to say “compliance is everybody’s job.” Keeping the training and any supporting tools and materials in “plain English” creates a space where everybody a) understands what their job is relative to the laws and regulations, and b) makes compliance training a more compelling experience.

Tell Me a Story. Nearly every attraction at a Disney theme park has a story associated with it. Some are more obvious than others, but the story is always there. Telling stories is something Disney does well, and it’s something that separates its theme parks from its competitors. Stories paint a picture, set a mood, and most importantly, stories are what people remember – they make the information stick. Great training teaches through stories. That concept is not necessarily what learners expect from compliance training. Why not find ways to make learners part of the story and not just passive learners? Just like Disney does it.

It’s All About the Show. Anyone who knows Disney knows they are fond of using theater terms like “cast members,” “onstage,” and “backstage” to describe areas of the parks and the people who work in them. At a Disney Park, everyone’s responsibility is to put on “good show.” From the person sweeping the street to the person in the Mickey Mouse suite, everyone is a “character” (some literally some figuratively) in the show. When they step onstage, (the areas visible to guests), they have a part to play in making the guest experience magical.

In addition to the human element, putting on a “good show” includes the physical surroundings. Burned out bulbs are promptly changed, trash is constantly picked up from the ground and painting and in-depth cleaning and adjustments are regularly scheduled. And as beloved as some rides and shows are, they have to be changed or replaced with something new that reflects the Disney company as it is now, or what the patrons know and treasure now. It even extends to the types of benches, signage, landscaping and ambient music in the various areas or “lands” of the theme parks. “Good show” is about the obvious and the details coming together to give the guest the best-in-class, magical, Disney experience.

As with Disney, the “training show” is about pulling all the other elements together in a way that captivates the audience and inspires action on their part. It’s about keeping things timely (you aren’t still talking about that settlement from 2007, are you?), making it interesting, and evaluating the training for re-boots. It is about ensuring the “little things” in your training are on theme. Using branded slides, colors, fonts and imagery that is representative of the company are all critical in telling the story of compliance and enhancing the training show.

Ultimately, I believe the Disney experience boils down to this: by and large, the people who work for the parks are genuinely excited to deliver a magical guest experience. Most people are happy to be there, they smile and they are beyond helpful. The “behind the scenes” folks are passionate about what they do. It all comes together to deliver a magical experience.

The same is true for compliance training. Conveying excitement and passion for the topic is the key. All the shiny, branded and most up-to-date training is not captivating if the people behind it aren’t conveying their excitement for the topic. That means finding that thing that makes compliance “magical” for you, and conveying it to the learner. We all ended up here because for some reason we really enjoy compliance. Zero in on that joy and communicate it through the training. You’ll be excited about delivering it, and learners will appreciate your enthusiasm. To me, that’s what the magic is all about.

Week in Review, September 17

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , ,

The PharmaCertify™ Team

It starts earlier every season, and before long, you’re sick and tired and just ready for all the hype to end. “Christmas sales?” you ask. No. (Although the fact there are trees up and decorated in stores before we’ve even brought out our fall clothes is disturbing.) We’re talking about campaign season. We’ve had enough of all the posturing, the non-answer answers, the ridiculous campaign and PAC ads that run more often than beer ads during a ball game. There should be some sort of rule, law or generally accepted practice that there is to be no campaigning by candidates, or thought provoking messages by PACs, more than six months prior to the first primary! Okay, we’ll step off the soapbox now and move on to news you can actually use: this week’s News Week in Review.

We’ll lead off the NWR with a politician attempting to hold the bureaucracy accountable. Senator Chuck Grassley issued a statement regarding the current status of the Sunshine Act during a roundtable session of the Senate Special Committee on Aging. After some brief background regarding the Act, Senator Grassley expressed his frustration with CMS’s continued delay in releasing the final rule for Sunshine, and their lack of communication regarding the reason for the delay. He even brought up the rumor that CMS has sent the final rule to the Office of Management and Budget (OMB), and the OMB is holding up releasing the rule until after the election. He called on CMS to confirm whether there is any truth to the rumor, and if there is to clear up why the rule is being held. Grassley closed his comments by defending the companies that will have to implement the law by saying companies need the final rule released to assure their systems would allow them to meet the “letter of the law.”

From the halls of the Capitol comes the shocking story that fighting over budget cuts by our elected officials now threatens to hold up the dollars paid in user fees by drug and device makers. In order for the FDA to access the money paid by the industry, it must first receive certain funding from Congress, and the budget stalemate in Congress is delaying that funding.

In news from the FDA, the Office of Prescription Drug Promotion (OPDP) issued an untitled letter to Eli Lilly questioning the use of color on an image of a brain that appeared  on a product website and on promotional materials. The OPDO said Lilly was misbranding the product, a radioactive agent used for PET Scans, because the color images suggest that scans can be displayed and reviewed in color. The prescribing information specifically calls for the use of black and white scale and gives several examples of how to read scans in black and white.

On the political history front, the DOJ has re-released the original FCPA document signed by President Carter and Speaker of the House, Tip O’Neal. A nice slice of history, but what isn’t history is the DOJ’s focus on investigating healthcare companies for potential violations of the law. The medical device industry has found itself squarely in that bull’s eye. An article in Compliance Week examines recent settlements and the risks that make the industry vulnerable to potential violations. The author says the top factor regulators take into consideration during investigations and settlements is a strong culture of compliance within an organization. Robust training is an important part of building a culture of compliance, and we can help with our Understanding and Preventing Bribery in the Global Life Sciences Marketplace module.

Hey, look who’s jumping on the Pinterest bandwagon; it’s pharma! A handful of companies are embracing this rapidly expanding social media platform. Bayer was the first to “pin it,” and now, they’ve been joined by Boehringer Ingelheim and GE Healthcare.

BI also upped the social media game for the industry with the beta launch of its Facebook game, Syrum. The game allows players to run their own pharmaceutical company and develop drugs for a variety of diseases. The company also has a YouTube channel, Twitter feed, and blog focused on the game. The game is in public beta in Europe, with a global launch expected in 2013. We can’t wait to see the FB requests for lab equipment appear in our news feed.

For an executive at a pharma or med device company, being excluded from federal healthcare programs is never a good career move. So the former CEO of InterMune is fighting his five-year exclusion handed down last year. The CEO claims that since his wire fraud conviction had nothing to do with delivering a health care item or service, the OIG had no basis for exclusion. He claims the OIG based the exclusion an unproven allegation of misbranding, for which he was acquitted. The OIG says the CEO is misinterpreting the law, and that a direct correlation between the conviction and the provision of a health care item or service is not required.

That certainly was a big week for political mudslinging, but we’ve hosed off and we’re hoping to evade the muck this week. Oh well, that’s what they make volume buttons for, right? On the bright side, we are one week closer to the election, so it will all be over soon. We can take some comfort in the fact that this sort of craziness has been around since well, since a political system existed in this country. If you think political races of modern times are harsh, take a look at some old school mudslinging.

Have a great week everyone!

Week in Review, September 4, 2012

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , ,

The PharmaCertify™ Team

At last, this past weekend was the time to dust off the pompoms and break out the stadium seats! Fall “officially” arrived with the start of the college football season! This is truly the most wonderful time of the year! Decorating the car with magnets and flags, preparing a game day feast for family and friends, and let us not forget the ever important ritual of face and body painting. Good times, good times. After such festivities and a long holiday weekend, it’s hard to focus and get back to work, but we’re here to help kick off this first work week of fall with the News Week in Review.

We’ll kickoff this week’s review with a story of kickbacks. Omincare has struck an agreement in principle in a whistleblower suit that accuses the company, and its owner, of paying kickbacks when it purchased a pharmacy services company. The government declined to join the suit. Omincare has agreed to settle the suit, but the company’s owner has not, and that case continues.

Pharmaceutical sales reps in India haven’t exactly been cheerleaders for their industry, as made obvious by the day-long strike by the Federation of Medical and Sales Representatives’ Associations of India. The group protested against threats to job security, high prices of drugs and corporate corruption in the industry. In a letter, the FMRAI said the effort to shift responsibility for corporate corruption onto sales representatives has led to reps being banned from hospitals and medical institutions. The group says the true corruption is occurring at the corporate level and it is demanding that a statutory code of ethics be enacted.

And now for the halftime show! Taking the field is the American College of Informatimusicology with their salute to obtaining your medical information. Sit back, relax and enjoy the show!

The California Assembly passed a bill that will amend the state’s False Claims Act. The amendment will more closely align California’s law with the federal statute. Changes in the California law include increased protections for whistleblowers, provisions for awards to relators even if those relators were involved in the action that led to a violation, increased penalties for violations, and broadening of the definition of what constitutes a claim. The bill has been sent to the governor for signature.

The much anticipated FCPA guidance from the government appears to be advancing down the field ahead of schedule. Assistant Attorney General Lanny Breuer had said the guidance would be released in November, but now sources say the government will release the guidance in advance of the OECD meeting in October. The release could come this month with the officials from the Justice Department scheduled to speak about the guidance at the National Conference on the FCPA.

Some Georgia men may find themselves wearing a black and white striped uniform, but it won’t be as referees. The Securities and Exchange Commission charged eight men with insider trading related to Sanofi-Aventis buying publically traded Chattem, a pharmaceutical products company. The SEC says one of the men, an accountant, learned of the pending sale from a client who had come to him to discuss the tax implications the Chattem purchase would have on his stock options. The accountant then shared the information with four friends and as the cliché goes, “they told two friends, and they told two friends, and so on, and so on.”  The SEC said the group made just over $500,000 in trades. Four of the accused have agreed to settlements with the government without admitting wrongdoing. Cases against the other four men are moving forward.

Well folks, the clock has run down on this game, and all that’s left is to tune up the band and sing the Alma Mater before we head out of the stadium. We hope your team, high school or college, emerged victorious over the holiday weekend! Have a great, short, work week everyone.

Week in Review, August 27, 2012

NXLevel Compliance Team , , , , , , , , , , , , , , , ,

The PharmaCertify™ Team

Time is a ticking on summer with Labor Day just around the corner and now is the time to squeeze in those final cookouts and road trips. Of course, any proper barbecue or cross country trip wouldn’t be complete without a list of great summer tunes. Remember that great anthem that you heard all summer long and brought back great memories when you heard it years later? Well, as you start building this year’s Labor Day weekend playlist of guilty pleasures, we have a bit of “list” to tune up ourselves, the News Week in Review.

There’s been a British invasion over at Shire as the company joins the Association of the British Pharmaceutical Industry (ABPI) as a full member. Regarding the decision, company representatives said, “we seek to play a role in the development and growth of our industry, so joining the ABPI will be one way of contributing to this.”  Shire will also have a representative joining the ABPI Board of Management.

Two congressmen are not singing the praises of the current 510(k) approval process for medical devices. In a letter to the head of the FDA’s Center for Devices and Radiological Health, the pair expressed concern that faulty medical devices are able to reach the market through a loophole in the 510(k) approval process. The congressmen would like to see the FDA’s authority extended to deny approval for devices with designs that are based on devices that have previously been recalled.

On the legal front, former baseball star, Eddie Murray, and Abbott executive, James Mazzo, were indicted by the SEC on charges of insider trading related to the purchase of Advance Medical Optics by Abbott. Mr. Mazzo, former CEO of Advance Medical Optics, is alleged to have shared non-public information regarding the sale with one of Murray’s teammates. Murray learned of the sale from the teammate and profited from the inside information. Mr. Mazzo denies the allegations while Mr. Murray has agreed to a settlement with the SEC, but has denied any wrongdoing.

A former employee at Abbott is whistling an interesting tune about the company’s marketing practices for its cholesterol drug, TriCor. A new whistleblower case has been filed alleging the company used misleading and off-label marketing practices and provided kickbacks to doctors, which all led to Medicare and Medicaid paying for unnecessary prescriptions.

The definition of a foreign official under the FCPA, an oldie but goodie, was making the rounds on the anti-bribery playlist last week. This time, the case involves a Haitian telecommunications company. One of challenges to the defendants’ conviction centers on whether Haiti Teleco could be considered an instrumentality of the government simply because Haiti’s national bank owned a majority of shares in the company. In its brief, the government said 97% of the telecom company is owned by the bank, thereby making it an instrumentality of the government. The government also said the defendants could have requested an opinion from the DOJ as to whether the telecom company counted as an instrumentality.

Boehringer Ingelheim wants to “blind you with science,” but not in the typical fashion. Rather than announcing a breakthrough drug, the company announced they launch a social game that lets players run their own lab. The game, Syrum, is scheduled for beta trial in September. The company says they developed the game to educate “players about the pharmaceutical industry in a fun and engaging way.”  Game on!

And so we’ve reached the end of our playlist. If you’re like us, you’ll soon be breaking out the seersucker suit and white shoes for one final spin as you relish the memories of another summer season? Have a great week everyone. Enjoy the Labor Day festivities!

Week in Review, August 20, 2012

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The PharmaCertify™ Team

It’s that time of year again. It’s the season when we’re inundated with television commercials compelling us to wait in long lines for the latest must-have items. It’s back to school time! And we have a reading assignment for you…this week’s News Week in Review. The bell is about to ring, pencils out please.

Medicines Australia is starting the school year with a group project: determine the best way to publically disclose information about payments to doctors. The organization’s Working Group on Transparency is comprised of members of the medical community, consumer groups and pharmaceutical companies. While Medicines Australia has stated its commitment to improving transparency of physician payments, the Australian Medical Association is concerned about the identification of individual doctors. Their concerns echo those that have been raised by medical groups here in the U.S. about the Sunshine Act, including the potential for misrepresentation of the data to the public.

The DOJ appears to be cutting back the amount of “school supplies” it requires of companies accused of FCPA violations. During 2012, the DOJ pulled back on the requirement that companies hire an independent monitor. Only three of seven companies have been required to hire the monitor thus far this year. The others have been asked to self-monitor and then report to the DOJ. In recent years, the problems with the independent monitors have been a source of embarrassment for the Department, and that may be the reason for the cut back. While we’re on the FCPA, check out this list of the top 10 corporate settlements. Guess what industry did not make the list?

A new study finds doctors are more likely to move sales reps carrying iPads to the head of the class.  According to the study, 65% percent of doctors say when they’ve seen reps carrying an iPad. More importantly, 35% of doctors say they are more likely to request a sample from a rep that is carrying an iPad, and 29% say they are more likely to prescribe.

We’ve reached the lunch portion of our “school day.”  If your beverage of choice is chocolate milk made with Hershey’s syrup, it may not be as nutritious as the label led you to believe. The FDA issued a warning letter to the chocolatier regarding wording on the labels of a couple of the syrups. One product said “plus calcium” and another used the wording “fortified with vitamins and minerals.” Neither product met the guidelines necessary to make those claims. The company has since changed the labels.

Vein treatment device maker, Vascular Solutions, seems to have gotten on the class monitor’s list. The company has announced the federal government will intervene in an off-label investigation. The investigation stems from a complaint filed with the U.s Attorney’s office alleging the company’s promotional practices cost the government around $20 million in damages. The company said it will continue to cooperate with the U.S. Attorney’s investigation, but will defend the case “as something that’s factually inaccurate and without merit.”

PhRMA, AdvaMed, Biotechnology Industry Organization (BIO) and Medical Imaging and Technology Alliance (MITA) teamed up on a letter writing assignment this week. The industry trade groups sent a letter to CMS this week regarding the pending final rules for the Sunshine Act.  The groups expressed their appreciation to CMS for their careful consideration of the many comments received on the proposed rules and requested CMS allow manufacturers 180 days to implement the final rule before beginning data collection.

Speaking of AdvaMed, a gold star goes to the group for its hiring program for returning military veterans. The program is called MedTech Veterans Program Boot Camp for Returning Heroes, and it will provide training in resume building and interviewing skills. Additionally, 25 vets will be provided mentors to help them transfer their skills into jobs in the med tech sector.

The bell is about to ring, so time to pack up and head to the next class. For those of you who are still on “summer vacation,” enjoy the final beach weekends before you’re rockin’ the school’s carpool line. Have a great week everyone!

Week in Review, August 13, 2012

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The PharmaCertify™ Team

The thrill of victory, (US Women’s soccer team), the agony of defeat (Aly Raisman and Catalina Ponor both finding themselves out of a bronze medal due to gymnastics’ tie break rules) as well as the human drama of athletic competition (Oscar Pistorius and the first Saudi female athletes), has played out in London as the Olympics came to a close this weekend. And shockingly it ended without an overload of Miley Cyrus’ “Party in the USA” from the broadcast team at NBC. Something to be thankful for! Now it is time to return to the grind. If you’ve been glued to your computer for the around the clock, live stream, we’ve got your back with the News Week in Review.

In the Olympic spirit, an international group of researchers conducted a study regarding the disclosure of conflicts of interest in medical journals. The researchers targeted articles published by physicians and scientists that were reportedly involved in off-label marketing activities. The group found that one in seven authors fully disclosed their conflict of interest. Of the articles reviewed by researchers, only 15% contained adequate disclosure. Researchers are concerned because journal authors may have a strong influence on the prescribing habits of other physicians considering an off-label therapy.

Not defeated but most likely in some agony, KV Pharmaceutical filed for bankruptcy. The company’s CEO said the company has not realized the full value of its most important drug because the FDA has not enforced KV’s marketing exclusivity on the product. Since the exclusivity has not been enforced, several state Medicaid programs have made access to the drug more difficult.

Forest Labs has received another yellow card, in the form of an untitled warning letter, from the Office of Prescription Drug Promotion at the FDA, for statements made by two of its sales representatives. According to the letter, the representatives failed to communicate the drug’s appropriate patient population as well as its limitations of use. In addition, the reps allegedly minimized the risks associated with the product. The OPDP is especially concerned because the company is already under a CIA.

A law firm in Hong Kong has issued a report indicating that more Asian countries are joining in the anti-corruption game. While the FCPA and UK Bribery Act remain the top dogs in driving anti-corruption reform, individual countries are increasingly enacting their own anti-corruption laws. The group found that while the laws are similar in structure, enforcement varies from country to country.

And speaking of anti-corruption, there was certainly a whirlwind of enforcement activity last week. First on the podium is Fresenius Healthcare AG, the world’s largest provider of dialysis equipment and services. The company notified the SEC and DOJ it was conducting an internal investigation into possible violations of the FCPA. Next up, generic drug maker Teva says it has received a subpoena for documents related to its business practices in Latin America. Teva is cooperating with the feds and has hired independent counsel to conduct an investigation. Rounding out the anti-bribery “awards,” Pfizer  announced FCPA settlements with the government for over $60 million. The company’s subsidiary, Pfizer H.C.P. Corporation, agreed to pay $15 million to resolve an FCPA investigation and will enter into a Deferred Prosecution Agreement with the DOJ.  Pfizer H.C.P. admitted to paying $2 million in bribes to government officials in Russia, Bulgaria, Croatia and Kazakhstan. The DOJ says self-disclosure and cooperation led to a reduction in the base fine and the company is not required to hire a corporate monitor. Apart from the subsidiary settlement, Pfizer Inc. and Wyeth negotiated settlements totaling $45 million with the SEC, to resolve civil FCPA charges.

Well, that brings us to the end of this week’s Review.  We’ll be going through a bit of Olympics withdrawal this week without the nail-biting competition, or of course, those awesome interactive Olympic-themed Google Doodles! On the up side though, we can finally look forward to a good night’s sleep. That television coverage to midnight and beyond is a killer! Time to get back to normal, and that includes keeping an eye on the news for all of you. Have a great week everyone!