fair balance

Week in Review, June 10

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

The PharmaCertify™ Team

Are you ready for the World Series? The College World Series, that is. The CWS starts this weekend in Omaha, Nebraska of all places and the college sports fans at PharmaCertify are thrilled. As we ready our rally caps and foam fingers, we invite you to enjoy this week’s News Week in Review.

First up to the plate this week is news that a whistleblower case against Boston Scientific is officially allowed to move forward. A judge denied the company’s motion to dismiss the case, disqualify the plaintiff’s attorneys and strike information it deemed confidential. The whistleblowers are accusing Boston Scientific of promoting a spine product for off-label uses and defrauding Medicare and Medicaid.

Abbott didn’t exactly get a friendly call from an “umpire” this past week.  A federal judge ruled that a shareholder suit against the company, involving the marketing of Depakote, will move forward. The judge required the shareholders to show that any efforts they would have made to get the Abbott Board of Directors to deal with misconduct in the company would have been futile. The shareholders amended their complaint and Abbott’s motion to dismiss the suit was denied. The shareholders are seeking monetary damages and a court order that would require the company to improve its corporate governance program. A company spokesperson said the company disagreed with the decision and that “we continue to believe the case is without merit.”

The U.S. House of Representatives wants better scorekeeping on the movement of drugs through the supply chain. The House passed the Safeguarding America’s Pharmaceuticals Act. The track and trace bill aims to deal with theft, counterfeiting and re-entry of adulterated drugs into the supply chain. Don’t start fretting yet over how to comply though. According to the House bill, “enhanced” regulations don’t need to be in place until 2027, and it will not require unit level tracking. A similar bill in the Senate requires unit level tracking to be in place in 10 years. The Senate bill could come up for a vote later in the month.

Got questions about Sunshine? Both CMS and AdvaMed are offering some coaching. CMS released more FAQs this past week. Notable was an FAQ about whether a textbook should be classified as a gift or education. The answer is clear as mud – it depends. Well, that was helpful, thanks. AdvaMed is offering two workshops about the Sunshine Act and its impact on the medical device industry. Topics include reporting requirements, preparing assumption documents, handling disputes and trends in global transparency.

State Attorneys General are calling strike two on Google. According to the AGs, Google continues to serve up ads for illegal Internet pharmacies. Several years ago, Google paid $500 million to settle charges with the government over this same issue. According to the AGs, pharmacies known to sell counterfeit drugs turn up at the top of Google keyword searches. Further, the pharmacies are showing up in Google ads and have been permitted to post videos on YouTube, which is owned by Google.  Google says it is fighting the problem. The company claims it has removed millions of ads for illegal pharmacies over the last two years, and routinely removes videos from YouTube. The AGs have invited the Google CEO to a national meeting to discuss the matter.

According to a new study, accredited CME is a sure homerun in the fight to reduce healthcare costs. Due to the expensive and time-consuming follow up needed, studies on the economic impact of CME are rare. In this case, researchers used computer modeling to examine the potential economic impact if cardiac thoracic surgeons were to use information they learned related to bleeding complications. The study showed that if 30% of the surgeons used the information to prevent bleeding in 2% of their surgeries throughout the year, the savings would be between $1.5 million and $2.7 million.

Well, it’s about time to call in the closer and wrap up this week’s Review. One last pitch – if you’re expanding your company’s compliance training beyond sales and marketing, PharmaCertify’s Commercial Compliance Overview mohdule covers the critical topics your entire staff needs to comprehend, like the Anti-kickback Statute, off-label promotion and the False Claims Act. Drop us a note, we’d be happy to send you a content outline or show you a demo.

Have a great week everyone…and go team!

Week in Review, June 3, 2013

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

The PharmaCertify Team

With deference to Randy Newman, there are short things (okay, his song was really about short people, but you get the point) that are awesome. A shortened work week is just one example. While most of us enjoyed a shortened work week as we honored those who gave all in defense of our nation, there was no shortage of news for this week’s News in Review.

Want to minimize FCPA risk? A good due diligence and compliance program is the key, according to two government attorneys who spoke at the Compliance Week annual conference in Washington. The attorneys stressed that simply having a due diligence program on paper isn’t enough to make an investigator happy. The program needs to be active and tied to internal controls and internal auditing. The experts also emphasized that a good compliance program helps companies identify problems and resolve them quickly, pointing out that bribery doesn’t occur in isolation. When one incident is found, others are sure to follow. Companies that identify the issues and then lock down the problem are often rewarded during an investigation.

The UK Bribery Act is up for review, and that review will be focused on facilitation payments. According to a report by a top level government group, businesses are unsure about what processes they need to have in place to keep from being unfairly prosecuted for making facilitation payments when expanding overseas. The Serious Fraud Office had no comment on the review. The agency did say it had seven investigations of potential violations in process.

ISTA Pharmaceuticals agreed to pay $33.5 million in civil and criminal fines and penalties to resolve charges it promoted one of its drugs for unapproved uses and paid kickbacks to physicians. That number may be small in comparison to other industry settlements, but the fall out is still significant. The company also pled guilty to violating the FDCA and the Federal Anti-kickback Statute. In addition to the guilty plea and monetary fines and penalties, ISTA and its parent company, Bausch+Lomb, have entered into a Divestiture Agreement with HHS. ISTA’s products will be excluded from the Federal healthcare programs, and all of the company’s assets will be transferred to Bausch+Lomb or a Bausch+Lomb subsidiary. The exclusion will last 15 years.

Dealing with the Sunshine Act can be quite an undertaking, but two experts from the Chicago law firm, Freeborn & Peters, LLC, have drilled it down to just four short steps. First, determine if the law applies to your company. (seems rather obvious, doesn’t it?) Second, put a system in place to collect the data. Next, examine the payments you make and get strategic about the data. According to the two attorneys, companies need to ask themselves if certain payments will undermine relationships with physicians and researchers. How will those payments impact the business? They need to understand what payments will be reported, and determine what changes may be needed. Finally, take advantage of the 45 day period available to review data after it is submitted.

Medical Meeting professionals have no small task in collecting data for Sunshine reporting, and according to Sr. Vice President and CCO of Wright Medical Technology, David Garen, planners need to be prepared to back up those numbers. Speaking to a group of meeting planners, Mr. Green said the Sunshine dispute resolution process is going to require companies to access their  documents quickly in order to substantiate their numbers. He expects dispute resolution to be a big deal. Those using third-parties to manage meetings need to consider who holds the data, and what additional charges may result when third-parties are asked to produce the information in short order.

Well that’s the short and the short of it folks. And speaking of small (and portable), PharmaCertify now offers iPad-compatible modules and just-in-time apps that bring critical compliance content to your reps where they need it most – in the field and at their fingertips.

Have a great week everyone!

Week in Review, Summer Kickoff Edition

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

The PharmaCertify™ Team

It’s unofficial…summer is here! Despite what the astronomers or school calendars say, summer has begun as far as we are concerned. Time to fire up the grill and drag the pool gear out of storage. As you contemplate all of the important decisions of the season, like whether to go with mustard, sauerkraut or both at next weekend’s barbeque (FYI…ditch the sauerkraut and go with cole slaw, you’ll thank us later), we present this week’s News Week in Review.

The sun has finally risen over France. The so-called French Sunshine Act went into effect last week. The law is similar to the U.S. version (a public website will be established for the reported information), but it contains some key differences, such as the requirement to report items of values provided to medical students, and the inclusion of manufacturers of cosmetics and tattooing products. The French law is retroactive to 2012. (Yikes!) It applies only to products regulated by France’s Agence nationale de sécurité du medicament et des produits de santé, which only has jurisdiction over products produced and distributed in France. So, until more information is provided by French authorities, the presumption is that the law only applies to domestic companies.

Some U.S. drug and device manufacturers need to get out of the shade and step in to the Sunshine. A recent survey found 62% of manufacturers are capturing the data needed to comply with the Sunshine Act. Of the remaining 38%, most are capturing data needed to comply with state laws and plan to do the same for Sunshine. The same survey revealed that almost 30% of companies require sales representatives and MSLs to obtain signatures when they distribute a reprint in response to an unsolicited question regarding the off-label use of a drug.

The temperatures are rising and so is the spending on digital marketing by pharmaceutical companies. According to a white paper from Compass, a media buying company, about 40% of the money spent to reach HCPs this year will be focused on digital channels. Professional marketing budgets are down, so the rise in use of digital channels is not surprising considering the cost of print. Companies aren’t shifting to digital channels for the distribution of reprints but the amount companies are spending on reprints has been dropping between 20 and 40% per year. Uncertainty around digital rights management is largely to blame, but Compass expects the use of e-prints to double in 2013 as more companies move to tablet based detailing.

According to a compilation prepared for the Financial Times, leading pharmaceutical companies paid one billion dollars to physicians last year (now that’s a lot of sand dollars). The compilation covered a dozen companies, and included expenses for research, consulting and entertainment. While the total figure shows an increase over previous years, it should be noted that the list of companies that disclosed their payments grew in 2012. Companies reporting like-for-like spend actually decreased their physician spend in 2012 over 2011. Medical device companies reported spending $188 million on physicians, the majority of which was for royalty payments.

The Washington Legal Foundation (WLF) is looking to apply some Sun(shine) block. The foundation submitted comments to CMS regarding the decision to not include textbooks on the educational items exclusion list. Since textbooks exceed the $10 threshold, manufacturers will have to track each one, and physicians will need to keep records as well in order to be prepared to review and potentially dispute the information. Further, the law places financial penalties on manufacturers for failure to report the items, whether intentional or not. The WLF argues that the decision will result in a “significant reduction of free speech,” as fewer textbooks are disseminated, as manufacturers work to reduce the compliance burden and risks.

The ACCME is ready to throw some new accreditation standards on the grill. The new accreditation criteria are intended to streamline the process and strengthen support for CME. Advertising, including corporate logos and product trade names, are not allowed to appear in educational materials distributed at a CME program. Likewise, disclosure statements cannot include corporate logos or product trade names.

The Sunshine Act was certainly a “hot” topic this week in the News. With data collection just around the corner, the news about Sunshine is not likely to cool down anytime soon. PharmaCertify now offers a customizable, off-the-shelf eLearning module covering the details of the law, along with a new iPad app, to keep your staff up-to-date, with Sunshine content where they need it most – in the field and at their fingertips.

Have a great week everyone.

Week in Review, May 20, 2013

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

The PharmaCertify™ Team

Break out the tutus and tap shoes and fire up your fingers, bows and reeds. It’s recital time! Let the tears of pride and joy flow, moms and dads. As the little ones prepare to showcase their best dance moves, we showcase all the news fit to print from the world of compliance, with this week’s News Week in Review.

Ranbaxy danced into the headlines this week, announcing a $500 million settlement to resolve charges it sold adulterated drugs and made false statements to the FDA. The company pled guilty to three felony counts of violating drug safety law and making false statements. Criminal fines and forfeitures total $150 million and the remaining $350 million will settle civil cases with both the feds and states.

Also playing out of tune was device manufacturer, C.R. Bard. The company signed a non-prosecution agreement with the DOJ and agreed to pay a $48.3 million settlement to resolve False Claims Act charges. Bard was accused of providing grants, free equipment and other kickbacks to physicians and other customers who purchased its prostate cancer radiation treatment.

The Sunshine Act is definitely in the spotlight these days. Managing all the data certainly presents a challenge, but Michael Krouse, CEO at the Ontario, California, Convention and Visitor’s Bureau offers advice for meeting planners on how to simplify the process of tracking physician spend at medical meetings.

Krouse advises planners to negotiate packages with the venues, look for hotels willing to bundle, and find venues that offer the most value for the physicians. He suggests planners negotiate a flat meal rate for physicians, have internet service bundled into room charges and work with the local convention and visitor’s bureau to find multiple hotels willing to offer lodging at the same rate.

Social media marketing has been lurking in the wings for life sciences companies. A new survey of healthcare professionals finds nearly three quarters of respondents have been conservative in the use of social media. Respondents attribute their careful approach to (spoiler alert)…lack of FDA guidance. Of the existing platforms, YouTube was the clear winner, with 68% of respondents saying it was the most appropriate for sharing information. Twitter and Flickr received the lowest marks.  About half of those surveyed say companies should monitor social media sites to understand patient needs and concerns.

The curtain continues to rise on FCPA investigatory expenses at Wal-Mart. The company nearly doubled its budgeted projections for investigations. During the first quarter, the company spent $73 million on investigation and compliance program expenses. So far, Wal-Mart has spent $230 million on its FCPA investigation.

Our grand finale this week takes us to Australia where the government is under pressure to prohibit facilitation payments. The Organization for Economic Co-operation and Development (OECD) has criticized the country for not taking ant-bribery seriously. Australian companies facing strict anti-bribery laws while operating in other countries may now face books and records violations in their own country, since facilitation payments are usually not recorded. One expert believes Australia will change its law to mirror the UK Bribery Act, and suggests companies adopt a global approach to anti-corruption rather than one focused on managing multiple local requirements.

As the final curtain falls on this week’s production, we close by focusing on your own anti-corruption training requirements. Investigatory costs are high and more countries are making the bribery of government officials a priority. If anti-corruption training is high on your radar, PharmaCertify’s Understanding and Preventing Bribery in the Global Life Sciences Marketplace features a comprehensive review of the FCPA and Anti-kickback Statute, with case studies targeted specifically to the pharmaceutical industry.

With that, we’ll take our final bow and wish everyone a good day and great week!

Week in Review, May 13, 2013

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

The PharmaCertify™ Team

Set your phasers to “Woohoo” everyone, Star Trek: Into Darkness opens in just a few days!! Not a sci-fi or Star Trek nerd? You don’t have to be, if the first movie is any indication. Great storytelling is great storytelling, regardless of genre. If nothing else, you’ll like be treated to quite a fashion show if you attend the film on its opening day. While we here at the News Week in Review anxiously await the opening, we realize there is other news to cover. So, it’s “engines to full, Scotty,” as we blast off with this week’s News Week in Review.

The Chinese government appears ready to boldly go where it hasn’t gone before – into anti-bribery enforcement. While companies doing business in China are accustomed to dealing FCPA enforcement, the Chinese government is poised to add its own anti-bribery laws to the mix. China’s high court and highest enforcement agency published guidance on the country’s two anti-bribery laws, one criminal and one civil, at the end of 2012. The emphasis has been on the criminal aspect of bribery.

The laws are not specific as to what constitutes a violation, allowing for broad interpretation by enforcement agencies. The guidance also made clear that enforcement efforts would be directed against the person giving the bribe, whereas past enforcement had been directed at the person accepting the bribe. So far, multi-national corporations have avoided prosecution, but with the government’s current penchant for pursuing high-profile and scandalous cases, the first one against a multination corporation may not be in the distant future.

Conducting anti-corruption due diligence during an acquisition is about as easy as negotiating peace with the Klingons. Mintz-Levin developed five steps to help companies minimize their FCPA successor liability in an acquisition. The due diligence is critical since the acquiring company can be on the hook for the actions of the company it’s acquiring.

Could there be trouble on the communications deck at CVS? The drug company announced it will no longer send out refill reminders that are funded by pharma companies. The company cited upcoming changes in patient data privacy requirements of HIPAA as the reason for the change. The change in the law will restrict the use of money from pharma for “only the cost of labor, supplies and postage to make the communication.”

Legal experts say CVS may be acting from an abundance of caution, but even so other pharmacies may follow suit. Determining the cost of the communications could prove difficult, and if there is no profit in continuing these programs, pharmacies may be less inclined to do so. CVS says it will continue with its own reminder programs.

Is Dr. McCoy on the list? According to a study by the New England Journal of Medicine, one in four doctors in Massachusetts have received a gift of $50 or more from a pharmaceutical or medical device company over the past two years. During that time, $76 million worth of gifts was provided to HCPs, with $67 million of that being compensation for bona fide services. (Incidentally, Leonard “Bones” McCoy did not make the list. He’s from the South, by way of…well…outer space).

On the Sunshine front, the news around the law continues to move at warp speed, with CMS coming off a busy week. The agency released the list of Teaching Hospitals for 2013, and posted a call for comments on the burden of the data collection process as they seek to refine that process.

Well, that’s it in the compliance news galaxy for last week. Have a great week everyone and we’ll see you at the movies and the conventions! Hopefully, Shatner will go easy on us.

Week in Review, May 6, 2013

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

The PharmaCertify™ Team

Sweet! Today is No Diet Day. Now, in all fairness this is not about eating unhealthily, but more about not letting diets consume your life and the importance of what the experts refer to as a “healthy relationship with food.” Good stuff right? Of course, if a cheeseburger happens to make its way into onto our table today, so much the better. So while you contemplate what diet rules you’re going to break this week, we’ll get started with this week’s News Week in Review.

The Executive Director of the Healthcare Communication Coalition, John Kamp, says the FDA needs to develop a new relationship with off-label promotion regulations. As we know, the landmark decision in the Caronia case established the precedence that truthful promotion of off-label uses of drugs was protected by the First Amendment. Mr. Kamp says the FDA needs to re-evaluate its regulations and look beyond the product label when developing a standard of truthful promotion. PhRMA’s General Counsel, Mit Spears, agrees, saying the current standard is too high, considering off-label use of some drugs is the current standard of care and appear in Compendia.

According to a study in PLoS Medicine, Sweden’s model of self regulating drug advertising may not be quite the right “diet” for assuring that ads are not violative. The study analyzed anti-depressant advertising between 1994 and 2003 and found that 34% of the advertising failed a review by the industry’s monitoring group. Study authors say that number should have been higher because their review found ads with exaggerated claims that made it through the review. The authors say that since only a third of the advertising was flagged, there is a problem with the system. They point out that while fines for unethical advertising have risen, they are still too small.

Pharmaceutical and medical device companies may want to start tracking physician spend outside the U.S. as they implement systems to comply with the Sunshine Act. The SEC and DOJ are turning up the heat on FCPA enforcement and healthcare companies may find tracking this data helpful in their FCPA compliance monitoring efforts. In addition, physician transparency laws and polices are quickly popping up around the globe. While the impact of complying with Sunshine is a daunting task, collection of data internationally needs to be a consideration as well.

Australia’s generic drug makers say their prices will feel a lot more bloated if a pending transparency bill is passed. The Generic Medicine Industry Association says the administrative and cost burden would force drug makers to raise the price of the medicine. Other groups complain the bill is too restrictive because it only applies to pharmaceutical companies and not medical device companies. In addition to requiring companies to report spend information, the bill would prohibit companies from paying sponsorships for physicians to attend international medical conferences.

A new study finds physicians aren’t exactly eating up the details of the Sunshine Act. The survey of primary care physicians found that the vast majority were either unfamiliar with the Act or only somewhat familiar. The numbers are somewhat better for principal investigators, with about two-thirds of those surveyed either having a basic understanding of the law or at least having heard of it. Good news on that front though – 77% of principal investigators said the law would not change the likelihood of them participating as an investigator site.

With Sunshine hotter than ever, the DOJ ramping up it enforcement of the FCPA and the FDA holding fast to current drug marketing regulations, now is the time to rethink your company’s compliance training diet. At PharmaCertify, we focus exclusively on commercial compliance for the life sciences industry. Our customizable eLearning modules and iPad apps bring your reps up-to-date promotional and regulatory training where they need it most – in the field and at their fingertips.

Have a great week everyone and enjoy every sandwich!

Week in Review, April 28, 2013

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

The PharmaCertify™ Team

This is quite an exciting week in the world of entertainment! No, we’re not referring to an award announcements or anything else equally as mundane. This is much more news worthy…Friday is the kickoff of the summer blockbuster movie season! It begins with the release of Iron Man 3…or as it is better known by some of us here at the News, That Movie that is Opening Two Weeks before the New Star Trek. That’s a lot to put on a movie poster so we can see why Disney/Marvel just went with Iron Man 3. And if that isn’t enough drama and excitement for you, we pull the curtains back on this week’s News Week in Review.

The drama in state Attorney Generals’ offices is high these days with states getting more aggressive in the pursuit of deceptive marketing cases against pharmaceutical companies. While the multi-state nature of many of the cases leads to large settlements, an assistant attorney in the Oregon Justice Departments points out that more states are feeling empowered to pursue these cases on their own. Several states have filed suits against GSK over Avandia. J&J faces a similar situation with Risperdal, and is currently appealing decisions in cases in Arkansas and South Carolina. For the states involved, the cases are appealing because they don’t have to prove that consumers have been harmed.

The incentive compensation “claw back” provision in two recent CIAs has prompted a spin-off of sorts. A working group featuring six pharma companies created a set of principles by which a company may reclaim the bonuses of executives in the wake of corporate compliance or other violations. Members of the group believe the principles will aid in deterring unethical behavior. The principles include the claw back being at the discretion of the board’s compensation committee, and the compensation committee having full discretion as to whether a violation caused serious financial harm to the company.

Don’t let the fact that there haven’t been any recent record-breaking FCPA settlements or cases announced recently fool you. The government isn’t taking a break from enforcement. According to a report from the law firm, Miller and Chevalier, the number of government-initiated investigations was at its highest in 2012, and four investigations are already underway in 2013. The number of companies self-reporting potential violations is also on the rise.

There’s nothing like success to get your next project “green lit,” and the OIG is using that approach to justify its proposed FY2014 budget. Some of the highlights in that justification include the $7.90 recovered for every dollar the agency spent on investigations, and the $15 billion in savings and recoveries expected for FY2012. The OIG is asking for $320 million for Medicare and Medicaid oversight, which includes continued support for the Health Care Fraud Prevention and Enforcement Action Team (HEAT).

Ah, the plot twist, the cornerstone of any thriller…but why should the movie makers have all the fun? One twist is playing out in Federal court in California, with two pharmaceutical companies facing off in a False Claims Act whistleblower case. In 2009, generic manufacturer, Amphastar, brought a whistleblower case against Aventis, saying Aventis (now Sanofi) fraudulently gained the patent for an anti-clotting drug. The suit claims patent allowed Aventis to raise the price of the drug, which caused Medicare and Medicaid to overpay for the drug. Aventis argued that the information regarding the patent had been publically disclosed, and as such, Amphastar could not use the information to bring a suit under the False Claims Act. Amphastar argued that the fraudulent patent was discovered only through their investigation and therefore, they were the source of the information. As an original source, Amphastar is able to bring suit under the False Claims Act. The judge agreed and another hearing is expected to occur later this year.

Last week, CMS posted FAQs for the Sunshine Act on the OPENPAYMENTS website. Are the FAQs helpful? Sure, but with all respect, it isn’t the most user-friendly section of the website. Sunshine is hotter than ever and the information is flying fast. That’s why we cover topics like reportable and excluded payments and the differences between Sunshine and state laws, in our new user-friendly and customizable eLearning module titled, The Sunshine Act: the Federal Physician Spend Disclosure Law.

Have a great week everyone, and we’ll see you at the movies!

Week in Review, April 22, 2013

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

The PharmaCertify™ Team

I scream, you scream, we all scream for ice cream! Spring has definitely flung and the dreams of a visit to the local ice cream shop dance in our head. There’s nothing like that cold, sugary treat on an early spring day. So, while you contemplate your choice of chocolate/vanilla twist, gelato or a froyo, we’ll launch into our own little treat: this week’s News in Review.

If you thought 31 flavors was impressive, the American Medical Student Association has that beat, as they will add 400 teaching hospitals to its PharmFree Scorecard that evaluates conflict of interest policies at American Medical Schools. Going forward there will be two scorecards; one for medical school and one for teaching hospitals.

The plain old vanilla payment information posted by Pro Publica and subsequently reported by various media outlets around the country often miss the point of the purpose behind those payments, according to Policy and Medicine. A summary of several of the articles shows that while the headlines focus on the dollars, a deeper dive into the articles reveals the research and physician education behind the numbers. One physician even said he received none of the money attributed to him in the database. All of the money went to the research institute where he works. Physicians cited the importance of learning from their peers, and felt there was no conflict in being a paid speaker for products which they believed in.

The ban in India on doctors accepting gifts from pharma may be melting just a bit. The industry is concerned that the ban on doctors accepting sponsorships to medical conferences will leave doctors uninformed about the latest treatments. In response, India’s department of pharmacy is moving to legalize pharma sponsorship of medical education conferences. The proposed change to the code of ethics would allow doctors to accept economy class travel to meetings, as well as meals and registration fees for up to three international conferences per year.

The apparent freeze in enforcement of the UK Bribery Act may be about to thaw. According to a Compliance Week insider, vigorous enforcement of the Act is close at hand. Legislation that would allow American-style deferred prosecution agreements is in the final stages of adoption. The Serious Fraud Office will have the ability to resolve cases quickly, and companies may be more inclined to self-report.

The cherry on top of our sundae this week is the Pharmalot interview with OPDP chief, Tom Abrams, regarding the much ballyhooed guidance for social media drug promotion. Guess what, kids, it’s coming…someday…soonish. According to Abrams, the guidance is a top priority for the FDA. He says the agency is continually meeting with industry groups, technology companies and other stakeholders as they work on developing the guidance. Pharmalot talked to Mr. Abrams about topics like the one-click rule, limited text media for promotion, and pre-dissemination guidance. A firm date was not given for release of the guidance. However, Mr. Abrams said OPDP would make the required July 2014 deadline, and their intention was to release the guidance as soon as it was ready.

Well, that’s the scoop on this week’s News. Before we start chasing the ice cream man down the street, we have a question about your FCPA and UK Bribery Act training. With this week’s news of increased UK Bribery Act enforcement and the DOJ’s continuing interest in pursuing the pharma and med device industries for FCPA violations, anti-corruption training is more important than ever. PharmaCertify’s Understanding and Preventing Bribery in the Global Life Science Marketplace customizable eLearning module covers the details of the laws, and the unique situations that make our industry a target for enforcement agencies.

Have a great week everyone!

Week in Review, April 15, 2013

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

The PharmaCertify™ Team

“April showers bring May flowers.” And around here, we’re ready for the blooms of May! With any luck, the last gasps of winter passed through last week, and spring is here to stay…for a while anyway. A happy thought to start the week, right? Now that visions of daffodils are dancing in your head, let’s check out what was “dancing” in the world of compliance in this week’s News Week in Review.

According to the American Medical Students Association, everything is coming up roses with conflicts-of-interest policies at medical schools. The latest edition of the AMSA Scorecard, which assesses COI policies of medical schools, showed more schools are improving their COI policies and curricula. Of the 158 schools reviewed, only 13 received an “F” from the organization, and eight of those “Fs” were due to schools not responding to information requests. Of the 158 schools surveyed, 115 received an “A” or “B,” which represented an increase from the previous year’s scorecard. The AMSA said it was pleased to see the increase of schools moving to what it considered a model policy.

Look what the Sunshine helped to create. Industry and physician groups have come together to form Partners for Healthy Dialogues. The group, formed largely in response to the Sunshine Act, supports the transparency that will be brought by the Sunshine Act, and plans to provide background information on how the industry and physicians work together for the benefit of patients. The information will be provided to three main groups: patients, physicians and industry professionals.

And speaking of the Sunshine Act, CMS has posted Fact Sheets for Applicable Manufacturers, Physicians and other stakeholders on the OPENPAYMENTS website. The Fact Sheets provide a summary of information contained in the CMS final rule.

The bloom is off the rose for UK businesses when it comes to checking suppliers for adherence to the UK Bribery Act. A survey from Ernst and Young revealed that 48% of firms are not checking to see if their suppliers are compliant with the UK Bribery Act. The survey covered companies of a variety of sizes, and found 60% firms with turnover of £5-50m did check to see if suppliers were compliant, but of that group, 16% would do nothing if the supplier was not compliant. 40% of companies with turnover of more than £50m said they would stop doing business with suppliers if issues were found.

Pharmaceutical and medical device companies need to be more vigilant than ever when it comes to anticorruption efforts, with the DOJ creating special units to investigate the industry for violations of the FCPA. According to industry experts, life sciences companies draw special attention for three reasons: the heavily regulated nature of the industry; nationalized healthcare systems; and the use of global sales and distribution networks. With enforcement efforts and the resulting fines and penalties increasing, elevating anticorruption programs to match the level scrutiny levied against the industry is critical.

Research from the University of British Columbia showed that 66% of sales representatives are failing to disclose serious side effects of the drugs they detail to physicians. Researchers surveyed 250 doctors in Canada, the U.S. and France between 2009 and 2010. The lead author of research paper noted that in Canada there was no monitoring of sales representative visits, and few sanctions for misleading promotion exist. She noted that due to the increased scrutiny of drug marketing in the France and the U.S., physicians were more likely to hear about side effects.

Rain may start falling on the parade of doctors looking for a free lunch from pharmaceutical companies. According to a report in the Wall Street Journal (sub. req.), a number of pharmaceutical companies are cutting spending on meals and speaker programs. Sales representative layoffs and drug patent expiry were cited as reasons for the reduction in spending related to meals. Companies that increased physician payments were generally doing so in the areas of consulting and clinical research.

Well, that’s it for the News in Review this week. Enjoy the weather everyone – we hope that in between the showers, you find a few minutes to venture out and smell the early blooming roses.

Have a great week everyone!

Week in Review, April 8

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The PharmaCertify™ Team

Team jersey…check. Foam finger…check. Mitt…check. The boys of summer are back, and here at the News Week in Review, we’re ready for some Cracker Jack fun! Granted, the opening day weather here felt better suited for football, but the start of the MLB season is a sure sign that spring is here! The smell of peanuts and fresh cut grass hangs thick in the air, but before we head off to the ballpark for the game, there’s a little business to take of first. Batter up! Play ball!

Stepping up to the plate first is news that the FBI plans to continue to use undercover techniques in FCPA cases. Despite the outcome of the “shot-show” FCPA trial, which turned on FBI undercover investigatory techniques, Ronald Hosko Assistant Director of the agency’s Criminal Investigations Division says,  “We’ll do it again…see you out there.” Hosko says that the FBI is working dozens of FCPA cases at any given time, and that branches throughout the US are involved in the investigations. Due to limited resources, he says the FBI only pursues cases with strong evidence, and if the agency pays you a visit you should assume there is a good why.

A Dow Jones survey of compliance professionals shows companies are digging in when it comes to their anti-corruption efforts (sub. req.). Seventy-one percent of respondents to the survey say they have delayed or stopped activities with business partners over concerns of breaking anti-corruption laws. More than half of the respondents say the FCPA and U.K. Bribery Act have had a major impact on policies, and 61% say the laws have impacted decisions about doing business in certain countries. The number of companies implementing an anti-corruption program rose to 87% from 83% in 2012. Confidence in due diligence processes took a dip though. While 56% of companies are “very confident” in their due diligence processes, the number that were “extremely confident” declined slightly to six percent.

Is it time to break out the celebratory wave? A new study of warning letters and notice of violation letters shows that social media may not be the regulatory nightmare it is generally thought to be. The digital communications consulting firm, Fleishmann-Hillard reviewed 173 letters sent between 2008 and 2012, and saw no increase in the proportion of social media violations versus traditional media. Company VP, Mark Senak, said guidance and violation letters are the two ways the FDA expresses policy, and there was nothing in regulatory enforcement to suggest that use of social media is riskier than traditional media.

In the social media game, Google is allowing the pharmaceutical industry an extra month to switch over to YouTube’s new One Channel format due to the regulatory issues faced by the industry. YouTube Channel clients are supposed to have their channels switched to the new format by May 15.

The replay review did not pay off for Pfizer. A federal appeals court ruled that the $142 million dollar verdict won by Kaiser Foundation Health Plan against the drug company stands. Kaiser said it was damaged when, based on fraudulent marketing by Pfizer, it prescribed Neurontin for a variety of conditions for which the drug proved ineffective. Additionally, the judges restored two similar lawsuits against Pfizer which had been thrown out by a lower court.

Speaker program budgets went on a downward slide in 2012 according to a new survey. The survey showed that while budgets for speaker programs declined an average of $500,000 in 2012, 60% percent of companies said they did not intend to reduce budgets for these programs in 2013. That cuts that are planned are substantial. For example, companies anticipating a cut to their speaker program budgets will slash 20-50%.

Well folks, we’re rounding third and heading for home on this week’s News Week in Review. We leave you with a reminder that PharmaCertify offers the custom and off-the-shelf solutions you need to ensure your team takes the field prepared with the most up-to-date compliance content.

Have a great week everyone!