Week in Review, July 1, 2013

The PharmaCertify™ Team

Strike up the band, fire up the barbecue and prepare to proudly fly the flag high! It’s almost Independence Day; the time of year when, despite our differences, Americans come together to celebrate the birth of our nation. But before we find the best spot on the curb to watch the parade pass by, there is still the matter of the work week, albeit a short one. What better way to get us started, than with the News Week in Review.

The US Supreme Court has certainly been busy. In a 5-4 decision, the Court decided that a federal law regarding pharmaceutical promotion pre-empts a person’s ability to file a state suit over a poorly designed generic drug. The case involved a woman who sued Mutual Pharmaceuticals after she suffered an adverse event allegedly caused by one of the company’s generic products.

The British are coming! The British are coming! And they’re serious about anti-bribery. Speaking at an anti-corruption conference, the Serious Fraud Office’s chief investigating officer, Kevin Davis, revealed the organization is actively investigating two cases under the UK Bribery Act. Despite drastic reductions in the SFO’s budget, Davis said cost would not deter the SFO from pursuing bribery cases, and stressed the importance of companies having robust procedures in place to deal with bribery. Davis also discussed the shift in the SFO’s approach to handling bribery cases. He told conference attendees, “We are not an agony aunt or advice service. The SFO had tipped too far towards settlements.”

Medicines Australia took another step toward joining the transparency parade. The agency’s Transparency Working Group released its model for reporting physician payments. The model is similar to the US Sunshine Act, and is currently being reviewed by the larger organization.

John Hancock would be a bit disappointed with recent petition response from the FDA. The agency was petitioned by a non-profit group to increase the type size on DTC ads. The group is concerned that the type is too small for the elderly to read and they are hopeful that a change will reduce accidental overdose and adverse events. The FDA rejected the petition, saying while the concerns are valid, current regulations and two draft guidance policies address the issue satisfactorily. The group was disappointed with the decision, saying that the FDA had turned “its back on millions of patients and consumers nationwide.”

Medtronic declared its independence from an FCPA investigation. In a regulatory filing, the company said it was informed by the SEC and DOJ that the agencies would not be prosecuting the company on FCPA charges. In 2007, the company received letters from both agencies, seeking information on potential violations of the bribery law.

Well, that’s it for this week’s Review. Amidst your plans for the weekend celebration, it’s easy to forget that we are now under the 30 day mark for Sunshine Act data collection to begin. PharmaCertify’s The Sunshine Act: The Federal Physician Spend Disclosure Law covers the reporting requirements and includes practical tips for tracking and reporting crucial spend data.

Have a great week and July 4th celebration!

Week in Review, June 17, 2013

The PharmaCertify™ Team

Fore! Even for the casual golf fan, the U.S. Open offered moment-to-moment nail biting action over the weekend. The greens at Merion offered twists and turns the golfing world will be discussing for months to come. When a major ends with all of the participants, including the winner, being under par, the course indeed had the last laugh. As the pros are left wondering what happened to their razor sharp instincts and trusty putters, we clear the fairway for another week of busy compliance news.

The lie…rather important in golf, and not a good idea when testifying before the grand jury, as a Virginia doctor discovered. The doctor was indicted for lying to a grand jury during an investigation into a case involving Orthofix and the illegal marketing of a bone growth product. Prosecutors say the doctor lied about falsifying medical records in order to justify Medicare reimbursement for procedures using the company’s bone growth stimulators.

As we witnessed over the weekend, golfers need to take whatever risk is needed when the tournament is in jeopardy on the back nine. For pharma and med device companies, FCPA risk is an inherent part of the clinical trials process. Nearly 75% of clinical trials occur overseas, and the physicians conducting the trials are often considered foreign officials under the FCPA. Due diligence of those CROs bring used to manage trials is critical to keep the risk of bribery low.

Are governments “laying up” in their anti-corruption efforts? According to the World Bank Institute, worldwide bribery amounts to one trillion dollars every year. Enforcement tends to focus on the corporation paying the bribe, which is the easier, safer and more immediate solution to deal with the problem. What about the person accepting, or soliciting the bribe? More often than not, companies are not offering bribes outright, but are having the bribes coerced from them in order to conduct business in a specific area. The International Anti-Corruption Resource Center (IARC), a non-profit organization, is providing training to local law enforcement and investigatory agencies to help spot issues like bid rigging.

It was a good day for Britain on Sunday when Justin Rose claimed the U.S. Open title. The news hasn’t been quite so good for British drug maker GSK though. The company is investigating allegations that doctors in China were paid to prescribe its drugs. An anonymous source informed the GSK board that doctors were offered cash, speaking fees, expensive dinners and travel in exchange for writing prescriptions. GSK says it has spent four months investigating the allegations and company officials have yet to find any evidence of bribery.

India may not be on the leader board when it comes to transparency in physician-industry relationships. While the U.S. and France have transparency laws in place, and countries such as Belgium and Slovakia, are in the process of passing transparency laws, India’s government has ignored recommendations from doctors and a parliamentary health committee to implement a law.

Medicines Australia’s Transparency Working Group is dealing with a deep divide as it develops a transparency program. There are two programs under consideration; one is similar to the Sunshine Act, with payments over $10 having to be reported and a $100 threshold for smaller payments; the other would require payments over $25 to be reported and no threshold for smaller payments. Supporters of the more stringent requirements say even the lower value payments can create a sense of reciprocity or obligation for the physician. Those supporting the less stringent requirements say the $10 threshold will require companies to implement new systems to capture the data, while current systems could handle the $25 threshold.

The New England Journal of Medicine recently teed up a couple of articles about the Sunshine Act. The first was authored by the architects of CMS’ National Physician Transparency Program. It provided information about the requirements of the law and suggested physicians help manufacturers in the reporting process by tracking payments themselves and providing companies with their NPI and state license numbers. In the second article, the authors claim the Act may not regulate the provision of payments to physicians, but it will change behavior by showcasing potential conflicts of interests. Further, the law will provide a “free flow” of information related to healthcare costs, which will be of benefit to the government and to private payers.

As we head to the clubhouse, you may have noticed that transparency is certainly the topic of the week. With Sunshine Act data collection set to begin in just a few weeks, now is time to train sales reps, research personnel and others who interact with physicians. PharmaCertify’s off-the shelf eLearning module, The Sunshine Act: The Federal Physician Spend Disclosure Law, covers topics like reportable expenditures, food and beverage, and the process for data review. As with our entire suite of compliance-focused training, the Sunshine Act module is easily customized to incorporate your policies and procedures.

Have a great week everyone!

Week in Review, June 10

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, Summer Kickoff Edition

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

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

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

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

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

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

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!