Pharmaceutical Compliance Congress

Week in Review, October 1, 2013

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The False Claims Act goes global, the FDA chimes in on mobile apps, and we hear from the OPDP on social media guidance…sort of.

Have you seen them yet? They’re small in number now, but if you look carefully, you’ll see them. October has only just begun, and yet, they’ve emerged…Christmas decorations. For now, it may just be a small display of collector ornaments off in a corner, or an inflatable lawn ornament, or two, slyly mixed in with the Halloween bunch. And we haven’t even started raking the leaves yet! We’re nowhere near ready to even think about the mad rush of the holiday season, but we are ready to bring you the compliance news you need to know, with this week’s News in Review.

Not rushing the holiday season might be good for the nerves, but putting off the implementation of a good due diligence program is never a good idea. The actions of intermediaries continue to be a key risk area for companies doing business overseas. FCPA investigations are on the rise and the Serious Fraud Office has levied its first charges for violations of the UK Bribery. Prosecutors are not likely to take a kind view of companies that have a “check the box” mentality when it comes to assuring their intermediaries are operating in a compliant manner. Pre-contract vetting of agents and suppliers, on-going monitoring, and compliance clauses in third-party contracts, are critical steps in demonstrating you company takes the risks posed by the use of intermediaries seriously.

Federal regulators certainly seem to be in a hurry to utilize the False Claim Act globally. With a large percentage of finished pharmaceutical products and the vast majority of active ingredients coming from outside the U.S., the FCA was bound to be applied to misdeeds occurring in other countries. The recent Ranbaxy case, involving the company’s manufacturing facilities in India, is one example. The FDA has regulatory authority over manufacturing facilities making products for the U.S. market, and the Ranbaxy case demonstrates prosecutors’ willingness to apply the FCA to actions occurring outside our borders.

Bayer found itself in the news after the company allegedly breached the APBI’s Code of Practice when a high-ranking employee provided late night drinks to healthcare professionals attending a medical congress. An anonymous healthcare professional provided the information, and said a good deal of alcohol had apparently been consumed by those present. Bayer did not dispute that the employee bought drinks for the physicians, but the company took exception with the characterization that a good deal of alcohol had been consumed, and said that only £28.15 was spent.

The Australian Medical Association (AMA) wants to slow down the physician spend reporting requirements that the pharmaceutical industry is proposing. The group supports increased transparency, but feels reporting “tea and biscuit” payments would be administratively cumbersome and weaken the transparency system. The Association sent a letter to the group working on the requirements, asking for certain limits on transparency. The limits requested include a $500 starting point for payments to be reported; a two year window for the reports to be available; and a requirement for patients to supply an e-mail address when they want to access the registry of spend data.

The FDA delivered an early gift for medical mobile app developers. The agency announced it will regulate medical mobile apps that turn smartphones into a medical device or ones that allow an attachment, like a blood pressure cuff, to be plugged into a smartphone.

It’s been a long time coming, but at the Food and Drug Law Institute’s recent Advertising and Promotion Conference, OPDP chief, Tom Abrams, said he expects the OPDP to meet the July deadline set by Congress for the release of guidance on the use of social media. So, until the guidance is released, how does the industry handle product promotion in the social media world? One panel of experts at the conference suggested a review of OPDP Warning and Untitled Letters involving web based advertising could provide some clues as to FDA’s current thinking. Panel members noted that the FDA was focusing on claims in testimonials and case studies, as well as fair balance and accuracy.

And so ends the News in Review for this week. If your end of year plans (we know, we’re rushing things) include the distribution of mobile devices to field and home office staff, the PharmaCertify™ suite of commercial compliance modules are accessible on PCs or iPads and offer the up-to-date content your learners need where they need it most – in the field and at their fingetips.

Have a great week everyone.

News Week in Review, September 23, 2013

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

The PharmaCertify™ Team

The sun, the moon, and the stars have all given their approval for the change of season, so we can make the official call…it’s FALL! Cool, crisp days and changing leaves can’t be far behind. And if that isn’t enough to make you happy, the advent of fall means that “delightful” chore of cutting the lawn will be ending soon. Gee, what a shame. Whether your favorite fall activities include pumpkin carving, apple picking, or getting lost in corn mazes, there will be plenty of time for all of that later. Now it’s time to take a look at the news from the last week of summer, with this week’s News Week in Review.

The Massachusetts legislature is kicking off fall with a number of bills aimed at the relationship between physicians and industry companies. A joint senate and house committee will discuss the bills on October 1st. The bills under consideration include a ban on drug advertising; a ban, with a few exceptions, on gifts to healthcare professionals and their family members, which will also require annual reporting on the value of permitted gifts (um…isn’t there a law in place for this?); and one that will define what constitutes a modest meal at an educational/informational presentation. The last bill prohibits the provision of alcoholic beverages at the presentations, and prohibits educational or informational meetings from being held at “resorts, sporting clubs, casinos or other vacation destinations.”

While you’re watching those fall television premieres, watch out for those drug advertisements…they’re deceptive! Or so says a new study in the Journal of General Internal Medicine. According to the study, 8 of 10 ads for OTC drugs and 6 of 10 ads for prescription drugs contained exaggerated or misleading formation, left out vital information, or made meaningless lifestyle associations. The ads aired from 2008 to 2010 during the evening news timeslot (30 minutes) on the three major networks and CNN.

Two industry trade groups are looking for companies to turn over a new leaf when doing business in China. PhRMA and RDPAC (a trade group for foreign companies in China) prepared a joint memo to address industry corruption issues in China. The memo calls on companies to employ the highest ethical standards while conducting business in China, and to react swiftly if something occurs outside the parameters of a company’s code of conduct. The memo also calls on trade organizations to enhance their efforts to ensure physicians are better paid by the Chinese healthcare system, and to encourage the introduction of ethical standards for the entire healthcare sector.

The corruption scandals and investigations in China have put a chill on the relationship between physicians and the industry. Pharmaceutical sales representatives are making fewer visits to hospitals simply because physicians are refusing to see them, and because companies have been cutting back or eliminating the visits out of caution. Sales are also down in the country as a result of scandals and the lower sales have lead companies to cut back on their marketing and promotional activities. The CEO of Sanofi says there is “a lot of confusion out there” and he expects there to still be “turbulence” in the marketplace over the next few months.

Prosecutors in the U.K. have harvested new laws and guidelines to help them pursue Bribery Act cases. A law that will allow the use of Deferred Prosecution Agreements to settle Bribery Act cases should become effective in February. The use of DPAs is expected to reduce the number of lengthy investigations, and provide companies a way to avoid the stricter penalties. The U.K. Sentencing Council has also released draft sentencing guidelines for violations of the Bribery Act. The guidelines include a tiered rating for determining a violator’s level of guilt under the law (e.g., a violator was an instigator vs. being coerced or intimated in to violating the law). The guidelines also state that fines against a company must be significant enough to have a real financial impact.

Google’s leaf pile just keeps getting bigger! The company announced it’s going to step into the bio-pharmaceutical industry, and form a research company dedicated to “health and well-being, in particular the challenge of aging and associated diseases.” The company will be called Calico, and the CEO will be Arthur Levinson from Genentech.

Now that fall is here and the daylight hours are waning, this is a good time to shift back to Sunshine. With Sunshine Act data collection in full swing, PharmaCertify’s, The Sunshine Act: The Federal Physician Spend Disclosure Law, will help you ensure customer-facing colleagues are well-versed on what information needs to be collected and reported.

Have a great week everyone!

News Week in Review, September 9, 2013

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

The PharmaCertify Team

That plaintive wail you heard in the distance last week may have actually been the low groan of children across the country as they boarded buses, or trudged their way back to school last week. With the passing of Labor Day, summer came to an unofficial end, and schools welcomed al (those eager and those less enthusiastic) back to reality. And for those of us who have aged beyond the school years, a heavier rush hour commute was our welcome back to reality. Good times all around. Enough waxing poetic, it’s time to swing open our own school doors and ring the first bell on this week’s News Week in Review.

A new survey shows that physicians need more education about the Sunshine Actor. The survey shows a ten percent increase in physicians who say they are “somewhat aware” to “very aware” of the law’s requirements. However, almost half of the respondents stated that they are unaware of the law. The survey also delves into the impact of the law on industry-physician relationships. Almost 40 percent of the physicians say they believe the law will negatively impact their relationships with the industry, and 21% said they would end their relationship with a company if inaccurate payment information is made public.

A federal Circuit Court has offered a whistleblower an eighth opportunity take what some would consider to be a generous makeup test. The court asked for yet another amended complaint from the whistleblower, who had filed a False Claims Act case against Bayer. The whistleblower alleges Bayer hid the dangers of two if its drugs and provided kickbacks when promoting those drugs. She claims that when she objected to the marketing tactics, she was fired. The seventh complaint alleged violations of the false claims acts of twenty one states, Washington D.C. and New York City. The Circuit Court judge tossed the state claims, along with her emotional distress and misbranding claims, but gave her thirty days to file an amended complaint.

Major Pharmaceuticals found itself in detention as a result of its settlement with Texas. The company agreed to pay $5 million to settle claims it misreported prices of generic drugs, which resulted in the state overpaying for the drugs. The case was initially brought by whistleblower, Ven-A-Care Pharmacy, and the state recently decided to join the case.

In China, foreign pharma companies haven’t exactly been the teacher’s pet lately. But, the chair of the European Union Chamber of Commerce in China’s pharmaceutical work group, Bruno Gensburger, said China is unfairly targeting foreign pharmaceutical firms in its bribery and price fixing investigations. Gensburger said the targeted firms have global SOPs in place and have generally been operating in a responsible manner. He went on to say that no Chinese company has been targeted for investigation.

In its recent analysis of the global reach of the Sunshine Act, the law firm of Fulbright & Jaworksi LLP explained that Sunshine has applicability to foreign firms that have a business presence in the U.S. CMS has established an applicable manufacturer as one having a physical location in the U.S. or conducting business in the U.S., either directly or through a legal representative. Manufacturers need to consider payments made to U.S. physicians who practice abroad, but are actively licensed in the U.S.

Well, the dismissal bell is ringing on this edition of the News Week in Review. The start of a new school year reminds us that 2014 isn’t far away and this is a great opportunity to review your compliance curriculum and see where a fresh take might be needed or a new topic could be added. From Commercial Compliance Overview, to Good Promotional Practices to the Sunshine Act, PharmaCertify offers the up-to-date training your learners need to help integrate critical compliance awareness into their daily activities.

Have a great week everyone!

Week in Review, September 3, 2013

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

The PharmaCertify Team

September has finally arrived! While the temperature says summer is still upon us, fall sports are in full swing. The finale of MLB season is just a few short weeks away, college football opened with a bevy of thrilling games (we’re talking to you Clemson and Georgia fans!), and the much-anticipated NFL season begins this weekend. As you ponder the possibility of your team making a magical run at the 2014 Super Bowl in the league where they play for pay, we offer our picks for the News Week in Review.

We start with that new Titan of regulation in the pharmaceutical industry, the Sunshine Act. In a piece for MedCity News, Dr. Westby Fisher, reveals what he feels are some of the cloudier aspects of the law. Dr. Fisher doesn’t believe patients are really interested in scanning a database to learn what their doctor is receiving from pharmaceutical and device makers, and he points out that the government already holds much of the information on payments to doctors in the form of IRS 1099-R forms. He contends the Sunshine Act casts a light on interactions that have no effect on the costs of drugs and devices, while “back room deals” with insurers, which do have an effect on the costs of drugs and devices, continue.

A Pack of pharmaceutical companies are facing an antitrust lawsuit in Florida. The insurance trust fund of the Ft. Lauderdale Fraternal Order of Police is suing Medics and several other companies for actions that kept a generic version of an acne medication, Solodyn, from the marketplace. The suit contends that lead defendant, Medicis, filed a “sham” Citizen’s Petition with the FDA to delay the approval of the generic. The suit claims that Medics also created alternative versions of the product, in new strengths and had physicians write prescriptions for the new strengths. Impax Laboratories, Mylan and Sandoz are a few of the other companies named in the lawsuit.

All the recent publicity about bribery of Chinese doctors is hardly making the industry look like a bunch of Saints, but perhaps a piece of the puzzle is missing. According to some who work in the healthcare industry in China, Chinese companies, which control 70 percent of the market, are involved in the same behavior as the western companies, yet no Chinese company has been called to task. Analysts speculate that the Chinese government is targeting western companies in order to create a competitive advantage for the homegrown companies. Western companies in other industries, including automotive and technology, are facing scrutiny as well.

The FCPA is no longer the only Cowboy at the anti-corruption rodeo. Over the last several weeks, the Serious Fraud Office in the U.K. and Canadian courts have been busy with anti-corruption cases. The SFO brought its first charges stemming from the UK Bribery Act, and the Canadian Courts found an individual guilty of violating the Corruption of Foreign Public Officials Act. The risk of multiple prosecutions is more pressing than ever for global businesses.

An L.A. retailer may be feeling like a saucy fashion Buccaneer now, but the celebration may be short-lived. The retailer created a line of tee shirts featuring the names of several drugs made by manufactured like Pfizer, AbbVie and Shire. None of the manufacturers granted permission for the names of their drugs to be used on the t-shirts. Pfizer and Shire are considering options for dealing with the unauthorized use of their trademarks. AbbVie, expressed concern that the shirts trivialized the serious health conditions that its drug is meant to treat.

Well that’s it for this short workweek folks. As you plan your 2014 compliance training curriculum this fall, our mobile solutions can help you extend critical compliance content where your learners need it most – in the field and at their fingertips. Contact Sean Murphy at smurphy@nxlevelsolutions.com for a demo.

Have a great week everyone!

Week in Review, July 22, 2013

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

The PharmaCertify™ Team

Apparently, the British media nicknamed Kate Middleton “Waity Katie” while she waited on Prince William to pop the question, and she proved to live up to that nickname again while she and her prince waited on the arrival of their first born. The waiting is finally over! As of press time, the Duchess of Cambridge was in labor. While the world waits to learn if the third in line for the throne is a boy or a girl, we’ll help you pass the time with this week’s News Week in Review.

With Sunshine’s due date quickly approaching, CMS released more FAQs and a couple of apps to help track payments. The latest additions cover the definition of an accredited CME program, and how (sort of) payments to physicians for promotional speaking engagements should be categorized. As to the latter question, CMS states those payments could be categorized as “honoraria” or “payments for services other than consulting,” depending on the ”specific facts.” Hmm…that’s helpful. The apps are available for industry professionals or physicians and are primarily designed to help with the payment tracking process.

The Journal of the American Medical Association has a gift for those submitting studies for publication. JAMA will no longer require independent statistical analysis for clinical studies funded by the industry. JAMA’s editor-in-chief cited improvements clinical trial reporting, including clinical trial registries and more transparency in trial data, as the reason for dropping the requirement.

There’s a new arrival in the Pennsylvania legislature. A bill has been introduced to institute a state false claims act. The bill has many of the same provisions as the federal False Claims Act, including protection and incentives for whistleblowers.

On the bribery front, China has been the focus of a number of bribery investigations in all business sectors, with the pharmaceutical industry taking center stage. The focus has been on GSK to this point, but several other pharmaceutical companies are under investigation by Chinese law enforcement, prompting one multinational company to tell employees in China to choose compliance with Chinese regulations over winning business. The regulatory climate, poorly paid doctors, and underfunded hospitals have fueled the fire for bribery in China, and made the industry a target for enforcement agencies. Chinese officials may also have another reason for focusing on the industry – the rising cost of healthcare in the country. Those costs are expected to top one trillion dollars by 2020.

Canada has decided to dress up its anti-bribery law with new amendments designed to strengthen the law. The amendments make it easier to investigate and prosecute offenses, and exposes corporate directors, officers and employees to expanded criminal liability. A criminal books and records offense (a civil offense under the FCPA) was added, as was a provision for phasing out facilitation payments. The maximum penalty for individuals was increased from 5 to 14 years imprisonment.

US law enforcement delivered multiples last week; multiple settlement announcements that is.  Amgen agreed to pay $15 million to settle allegations it violated the federal Anti-kickback Statute and False Claims Act. According to prosecutors, the company used data purchase agreements to incentivize oncologists to use one of its chemotherapy drugs. Mallinckdrot Inc. also agreed to pay $3.5 million to settle allegations of violating the Anti-kickback Statute and False Claims Act.  The company was accused of incentivizing doctors to prescribe “outdated and third-rate drugs.” The whistleblower suit claimed the company paid speaking and consulting fees to physicians in exchange for prescribing its anti-depressants and sleeping pills. The suit claimed that without the incentives, the drugs would not have been prescribed, since several of the drugs were approved decades ago.

Well, that’s about it on the news front for this week. As people around the world monitor their mobile devices for news of the royal delivery, we’ll use this opportunity to ask if you’ve incorporated mobile solutions into your compliance plan. PharmaCertify’s mobile apps and iPad-compatible training modules bring critical compliance content where your staff where they need it most – in the field and at their fingertips. For more information or a demo, contact Sean Murphy at 609-466-2828, ext 25 or smurphy@nxlevelsolutions.com.

Have a great week everyone!

Week in Review, July 8, 2013

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

Te PharmaCertify™ Team

Well, here we are again…Monday already. Back to work we go, after what was hopefully a long weekend for you. While having one or two days off is refreshing, it tends to leave you a little foggy on Monday, doesn’t it? Never fear, we kept our ear to the ground throughout the July 4th holiday and what better way to jump start the week than with the News in Review.

A study finds that Canadian medical schools’ policies about interactions with industry are falling short. The study evaluated the conflict of interest policies of Canada’s seventeen medical schools in twelve categories, including samples, curriculum and scholarships. In most of the categories, only one school had what researchers considered restrictive policies. Some of the schools have developed new polices or revised existing policies since the study was conducted in 2011.

Bribery is no small matter, and a new report finds that bribery and corruption risks are on the rise. Nearly half of the businesses in the study say their bribery and corruption risks have increased in the last two years, and they expect that trend to continue in the future. Expansion into new markets and heightened enforcement are the top two reasons cited for the increase in risk. Nearly 20% of the businesses in the study said they either don’t require employees to read their anti-bribery policy or they don’t even have one in place.

Several GSK employees were detained by Chinese officials for suspected “economic crimes.” The detention follows allegations from an internal tipster. The company said it was aware of an investigation by Chinese officials, but the nature of the investigation was not known.

The London Police will soon start training businesses about the UK Bribery Act. The training, which is slated to begin in September, will be conducted in conjunction with the British Standards Institution, a business standards company. The London Police have 25 bribery cases under investigation.

Transparency is going global, as the European Federation of Pharmaceutical Industries and Associations (EFPIA) is now requiring its member companies to disclose payments and transfers of value to physicians. The requirement was adopted by the EFPIA’s board last month, and will require member companies to begin publishing the information in 2016.

Medical device manufacturer, Baxano Surgical, formerly TransS1 Inc., agreed to pay $6 million to settle allegations it violated the False Claims Act. The company was accused of causing healthcare providers to submit incorrect diagnosis or procedure codes to Medicare for the use of its spinal fusion products. The government claims the company advised providers to use a code intended for more invasive spinal procedures than those associated with use of the their own product. The company was also accused of providing kickbacks to physicians in the form of consulting and speakers fees as an inducement to use its product, and for promoting the product for unapproved uses.

The settlements for violations of global bribery law are growing in numbers and dollars. That’s why PharmaCertify’s, Understanding and Preventing Bribery in the Global Life Sciences Marketplace is designed to help your staff and representatives evaluate the degree of risk inherent with every transaction and understand the level of due diligence and monitoring needed to ensure compliance with the FCPA and the UK Bribery Act. Contact Sean Murphy at smurphy@nxlevelsolutions.com to learn more about the module.

Have a great week everyone!

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, March 18, 2013

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

The PharmaCertify™ Team

So, was your weekend full of excitement? Were your wearing that special color as you waited anxiously for the excitement to begin? Then suddenly, like a pot of gold at the end of the rainbow, it happened…the NCAA Tournament teams were announced! Release the brackets, it’s March Madness! If you’re team didn’t make it to the tourney, you can at least seek redemption with the office pool, right? As we wait for the madness to begin, and the games to get underway, let’s catch up on week’s compliance news with the News in Review.

Taking the jump ball in this week’s Review is a story that raises the question of whether the Sunshine Act could have the unintended consequence of stifling research. At an event sponsored by the Healthcare Leadership Council, Dr. David Caraway announce that his colleagues who receive no more than $250 in transfers of value in a year have told him they will no longer participate in industry-sponsored education or collaborations. They simply do not want their name appearing in newspapers. The Health Leadership Council said its members were satisfied with the way the rules were presented in general, but they had concerns about the public database. Panelists at the event agreed that the context around the data will be the key to the public understanding the details.

Stakeholders representing a wide range of healthcare industry concerns have released a statement of principles to guide collaborations between physicians, researchers and pharmaceutical and medical device companies. The principles include an acknowledgment that; physicians and researchers must have autonomy; all involved in healthcare must be responsible for their own actions; and collaborations at any level should ultimately be for the benefit of patients. The groups participating in the development of the principles include the Association of American Medical Colleges, AdvaMed, Cleveland Clinic, Eli Lily and PhRMA.

As the industry waits for the FDA to release guidance on social media, the Federal Trade Commission has released its own guidance on the subject. The folks at Pharmalot raised the question of whether the FDA steal from the FTC guidance as the agency develops its own policy. Of particular interest to those in the life sciences industry may be the FTC’s take on what is known as the “one-click rule.” The FTC insists that information regarding the safety of the product should be on the original page or message, and not relegated to a page available through a hyperlink.

Slipping in at the final buzzer is a story that points out the success states are having in the pursuit of Medicaid fraud. A report from Health and Human Services (HHS) shows that states recovered $2.9 billion in Medicaid fraud in fiscal year 2012. Part of the total is the result of joint federal and state investigations. The states collectively engaged in over 15,000 investigations, with over 11,000 of those being for Medicaid fraud.

That brings us to the end of the Review for this week. Good luck cheering on your favorite team or alma mater this week and remember, PharmaCertify offers the eLearning modules and mobile apps needed to keep your sales and marketing team up-to-date on the latest in good promotional practices and compliance regulations.

Have a great week everyone!

Week in Review, March 4, 2013

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

The PharmaCertify™ Team

No doubt you’ve seen the ads already – storage bins, cleaners, mops, brooms, vacuums – available everywhere, from the big box stores to your local hardware store. Spring cleaning is just around the corner, but before you run off to stock up on your supplies, let’s take a look at what’s been sweeping through the world of compliance, with the News Week in Review.

Could the FDA be starting to clear some of the cobwebs around social media marketing? The agency took issue with the use of a company’s Facebook “like” of an unsubstantiated claim. The company, a dietary supplement manufacturer, received a warning letter citing multiple violations associated with its drug product, Poly-MVA. The letter included the complaint about the company “liking” a product testimonial, which concerned the FDA because the claims made in the testimonial could not be substantiated by good science.

The temperatures are warming and according to a study by Deloitte, Sunshine is spreading around the world. The study shows that by 2015, 70% of drug sales will occur in countries with payment disclosure requirements.

Not everyone is warming up to the idea of Sunshine though. The BioIndustry Association in the UK is questioning whether the benefits of transparency are worth the aggravation and added requirements. The organization’s chief executive, Steve Bales, says the transparency requirements could put early stage research investment at risk. His members are nervous about some of the early phase research reporting requirements. In addition, a representative from the Medical Research Council’s clinical trials group raised concerns about the potential for an increased workload due to the new requirements.

The DOJ is planning on being more aggressive about cleaning up violations of current Good Manufacturing Practices (cGMP), according to Deputy Assistant Attorney Maame Ewusi-Mensah Frimpong of the agnecy’s Consumer Protection Branch (CPB). CPB worked closely with the FDA and was involved in recent settlements with GSK, Abbott and Merck involving consumer safety issues and marketing claims. Ms. Frimpong insisted that companies failing to follow cGMP practices put consumers at risk, and there was no way for the patient or physicians to know about that risk. Companies need to ensure their employees have access to the  proper training and establish incentives for recognizing and reporting problems, according to Ms. Frimpong.

And so we close another Week in Review. As spring draws tantalizingly near, the PharmaCertify team is hard at work refreshing our list of compliance training and mobile solutions. In fact, now that CMS has released the final rule on Sunshine, we’ve added an eLearning module and iPad app focused on the topic. Contact Sean Murphy at smurphy@pharmacertify.com to see a content outline or demo.

Have a great week everyone!

Week in Review, February 26, 2013

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

The PharmaCertify™ Team

May we take a moment and celebrate the start of another week? We know…who celebrates the start of a week? Normally, we’d be right there with you, but we are now just a few days away from the start of March! Finally, spring (almost). We realize there’s still cold and snow to be had, but don’t you feel like budding trees and blooming flowers are almost at hand when we cross into March? So, with those happy thoughts, we march right into this week’s News Week in Review.

The U.S. Chamber of Commerce is renewing its fight for change to the FCPA. The group sent a letter to officials at the Department of Justice and Securities and Exchange Commission saying they hoped that the guidance would continue to be updated as FCPA compliance evolves. The Chamber again brought up its desire to see a “compliance program defense” option for companies to protect them from rouge employees who pay bribes, despite the company’s efforts to quell that activity. The Chamber also called the agencies to task for not providing hypothetical situations on the definition of foreign officials or instrumentalities. In response to the letter, the DOJ said they welcome a continuing dialog on FCPA guidance. The SEC has not issued a comment.

According to an anonymous complaint filed with PMPCA, the party was in full bloom at a medical conference overseas, and that party was hosted by Roche. The complaint alleged that Roche employees were having a drunken fête with several physicians attending a conference. According to the complaint, shots flowed like lava at the rowdy affair, and eventually one person was ejected from the bar. Roche was censured for breaking one clause of the ABPI code, “high standards must be maintained at all times.” The PMPCA’s investigation did not yield definitive proof that doctors were entertained at the gathering.

Maryland Attorney General, Douglas F. Gansler, has marched into court and filed suit against GSK for falsely saying three of its diabetes drugs were better than others on the market. The suit also claims the company withheld information that the drugs could increase the risk of a patient suffering heart attacks, liver damage and a number of other side effects. The state spent $38 million dollars on the drugs, and is suing to recoup that money as well as the money the state spent to treat patients who suffered side effects.

A survey conducted by MedPage Today shows that many physicians think Congress should go fly a kite where Sunshine is concerned. Following the release of the final rule, MedPage Today surveyed 2700 physicians for their feelings about the Sunshine Act. While Congress received a heap of criticism from the respondents, a large number of them did not have any particular negative feelings about the law itself. Close to 38% felt it was a great idea, 20% felt the law wasn’t strong enough and 17% said it was good idea, but wouldn’t change anything. Even with those good vibes, a quarter of the respondents felt the law represented an invasion of their privacy.

CME providers have a little spring in their step following the release of the final rule for the Sunshine Act. The CEO and president of the ACCME, Murray Kopelow, M.D, commented that the final rule was validation of the ACCME standards for CME. He went on to say he was glad CMS recognized the value of accredited CME and the value of the ACCME standards in protecting the independence of accredited CME programs.

Well, that’s it for the week. We hope, like us, you’re looking forward to warmer temperatures and sunshine (that’s sunshine with a lower case S of course). The home stretch approaches as we enter March on Friday. If it’s time to freshen up your compliance training, PharmaCertify can help, with the custom and off-the-shelf training you need to prepare your staff for today’s evolving marketplace. And now that CMS has released the final rule on the Sunshine Act, don’t forget to ask about our new training module covering the law.

Have a great week everyone.