ACCME

Week in Review, September 16, 2013

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

The PharmaCertify Team

If you are reading this, we’ll assume you survived another Friday the 13th. How did you spend the day? Did you stay at home and not take any chances or was it business as usual? We of course stayed abreast of the compliance news of the week, albeit while keeping our lucky rabbit’s foot at the ready and digging out the usual four leaf clover. After all, Friday “December” 13th will be here in a flash. So, now that you’ve thrown a dash of salt over your shoulder and safely navigated the cracked sidewalks of your daily commute, we invite you to check out the News Week in Review.

Accepting drug samples could prove to be bad luck for Australian physicians if new ethical guidelines are accepted. The Royal Australasian College of Physicians is proposing a ban on drug samples in its draft guidelines on interactions with the industry. The RACP says samples are largely a “marketing exercise,” and access to samples is in the best interest of patients.

Not long ago, representatives from the European Union Chamber of Commerce were talking about how no Chinese pharma companies were being investigated for bribery. Well those words must have had brought some bad voodoo with them. No sooner was the ink dry on that announcement then news came that Chinese insulin maker, Gan & Lee, and a division of Sino Biopharmaceutical, were both accused of paying bribes to doctors to increase sales. In the case of Gan & Lee, a whistleblower says the company gave away overseas trips to doctors in order to boost sales in advance of an initial public offering. The revelations about Sino were made via a report on China’s state run television network. Sino was also accused of providing vacations to physicians in order to increase its sales.

Executives at Quest Diagnostics and LabCorp should have avoided ladders and black cats since they now find themselves the subjects of a false claims whistleblower suit in Virginia. The case, which was unsealed in August, alleges the two companies overcharged Virginia’s Medicaid system for diagnostic tests. In one instance, Quest is accused of charging Medicaid $10.42 for a test it charged others as little as $1.42. The complaint, which was filed by Hunter Laboratories and its CEO, Chris Reidel, is asking for $11,000 in civil penalties for each false claim.

PhRMA and the Maine Pharmacy Association are two of the groups looking for all the luck they can get as the group challenges Maine’s drug importation law in court. The new law allows consumers to purchase drugs from mail order pharmacies in Canada, Australia, New Zealand and the UK. The lawsuit claims drugs from the other countries are not subject to the same safety controls as those produced in the U.S. and the FDA has already warned states about their residents purchasing drugs from other countries.

The International Society of Medical Publication Professionals (ISMPP) has created a task force to help clarify the impact of Sunshine on medical publications. While publishers have no direct reporting responsibility, the activities publishers perform in conjunction with researchers could fall under the definition of indirect payments. The task force identified a variety of activities that should be tracked, including statistical support provided specifically for the publication. In addition, applicable manufacturers should track all transfers of value associated with publication costs and keep the data available for reporting and the dispute process.

CME providers have been making good use of their good luck charms recently. According to a report from the ACCME, the number of providers receiving accreditation with commendation has risen from just 3% in the November 2008 cohort to 28% in the July 2013 cohort. The total number of accredited CME providers of CME is down, suggesting that the tough ACCME standards may be thinning the herd.

With that, we’ve reached the end of another Review. While you may have been lucky enough to navigate another Friday the 13th, leaving your compliance training to chance in this age of increased regulatory focus is not such a good idea. More than ever, your sales and marketing teams need to integrate solid compliance practices into their daily activities. That’s why our Good Promotional Practices module includes topics like Gifts, Meals and Entertainment, Meetings and HCP Consultants and On-Label Promotion. Contact Sean Murphy at smurphy@nxlevelsolutions.com to see a content outline.

Best wishes for a great week everyone!

News Week in Review, August 26, 2013

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

The PharmaCertify Team

Summer is winding down, and while we look forward to a holiday weekend, it’s time to get ready for the return of college football! It’s that wonderful time of the year – when we meticulously organize the tailgate party shopping list and dust off the car flags. And as we ponder the critical question of “pork or beef for the weekend barbeque?” we start you with a full menu of the compliance news you need to know, in this week’s News in Review.

We start this tailgate party off with a new state twist on Sunshine. The Oregon Department of Justice accused two heart doctors of breaking the state’s Unlawful Trade Practices law for not revealing to patients they received payments from device maker, Biotronik. The doctors were paid between $400 and $1250 for allowing Biotronik sales representatives in the operating room while the company’s defibrillators were being inserted. The Oregon DOJ said the doctors misrepresented their services as being for the “exclusive benefit of patients” when they didn’t inform patients that the sales representatives would be present during their procedures. A $25,000 settlement was reached and the two doctors agreed to tell patients about any potential conflicts of interests in the future.

Canada scored on its first foreign bribery trial. As a paid agent for a Canadian technology company, the defendant violated a section of Canada’s Corruption of Foreign Public Officials Act (CFPOA) when he provided bribes to Air India officials and the India Ministry of Civil Aviations to secure a contract to supply facial recognition software. The case demonstrates the wide berth in the definition of a foreign official under the CFPOA. The court held that the intent of paying a bribe was enough to constitute a CFPOA offence. Sentencing is pending.

The consultant detained in China in the wake of pharmaceutical industry bribery scandals has now been sidelined. According to the British Embassy the consultant, a British national, was arrested by the Chinese government on August 19th. The embassy declined to comment on the specific charges related to the arrest. A spokesperson for the consultant’s family said that his wife and his business partner were also arrested.

A penalty flag has been thrown on another pharmaceutical company for illegal activities in China. A whistleblower told a Chinese newspaper that Eli Lilly paid Chinese doctors $4.9 million in bribes and unlawful payments between 2011 and 2012. Lilly said it had not been able to verify the allegations, but company officials would continue their own investigation into the matter.

Medical meeting planners huddled to discuss the challenges facing their industry. The roundtable meeting of senior level meeting planners cited compliance requirements as one of their biggest challenges. One of the attendees said the issue extended beyond compliance with ACCME standards to industry requirements (e.g. PhRMA Code) and country and state laws. Planners also referenced the increasingly stringent approval requirements necessary to obtain CME credit.

At least one physician can see both sides of the ball when evaluating the Sunshine Act. Cardiologist John Mandrola points out that while patients should know what transfers of value their physicians receive from industry, there are drawbacks to the Act. Mandrola is concerned that the transparency brought by Sunshine will harm innovation by causing most physicians to pull back on their interactions with the industry.

We’re almost a full month past the start of data collection and the Sunshine Act continues to be a hot topic. PharmaCertify’s customizable eLearning module, The Sunshine Act: The Federal Physician Spend Disclosure Law, covers the topics needed to keep you team up-to-date on the scope of data that needs to be collected and what will eventually be made public. Contact Sean Murphy at smurphy@nxlevelsolutions.com to learn more or see a content outline.

With that, we blow the final whistle on this edition of the News Week in Review. Have a great week everyone and Go Team!

Week in Review, August 12, 2013

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

The PharmaCertify Team

Break out those LPs and dust off your turntable, Monday was Vinyl Record Day! Count us among those who still miss that crackling and popping quietly emanating from our favorite disco, rock or R&B album. And we can’t forget all of that amazing cover art – Kansas, Left Overture, Yes, Relayer, or of course the Beatles, Sargeant Pepper’s Lonely Hearts Club Band, just to name a few. Before we lose ourselves (and you) too deeply in the musical formats and artwork of yesteryear, we first turn our attention to the rhythm and blues of this week’s News in Review.

Allegations of bribery by pharmaceutical companies in China continue to spin. Documents provided to a Chinese media outlet accuse Sanofi of paying $280,000 in bribes to over 500 doctors. In the documents, a whistleblower claims doctors were paid 80 yaun every time a patient bought one of the company’s drugs. Sanofi officials claim they are taking the allegations very seriously, but made no comment as to whether they were conducting their own investigation.

The DOJ is marching firmly to the False Claims drum beat, as the agency has filed a brief asking a federal appeals court to overturn a decision by a US district court against Takeda. The whistleblower suit claimed the company hid adverse events associated with a pair of drugs, causing those drugs to be prescribed more often than if the adverse events had been known, and subsequently causing false claims to be submitted. A U.S. district court judge dismissed the case, saying the whistleblower had failed to provide evidence of the false claims, and the adverse events were not material to the decision by the federal government to pay for the drugs.  The ruling went on to assert that False Claims Act liability could not be premised on failure to report adverse events to the FDA. The DOJ believes that adopting such reasoning could affect the government’s ability to enforce the False Claims Act.

The CME Coalition has a new release to help CME program providers and others navigate the Sunshine Act. The group’s Sunshine Act Compliance Guide provides recommendations on issues like meals for attendees and speakers and unaccredited CME. The guide also features a “compliance decision tree” to help CME program organizers make quick decisions on physician payments.

CMS had a hit of its own with the release of more FAQs on the Open Payments site. The list now includes information on how newsletters that include disease state information should be handled; an answer on whether textbooks donated for general use are reportable; and clarification on the 90 day exclusion for the loan of a medical device.

It’s been more of the same old sad song for reps trying to access oncology practices over the last year. For the second year in a row, oncologists were the most restrictive specialty, with 65% enforcing moderate to severe access restrictions. New products seemed to be the key, as reps carrying a new product saw doctors 10 times per year on average, compared to 7 times per year for those detailing older drugs.

Well, that’s about it for this week’s Review. If you’re looking to round out your compliance training playlist, PharmaCertify’s Good Promotional Practices module covers the “classics,” like gifts, meals and entertainment, while mixing in new topics like promotion through social media.

Have a great week everyone and we’ll see you right back here on this same frequency next week!

Week in Review, July 29, 2013

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

The PharmaCertify™ Team

Christmas in July. It’s gone from a fun little saying to a marketing gimmick to help clear out the last of the summer merchandise with Christmas shopping-esque sales. Oh, and let’s not forget the cable networks breaking out all your favorite holiday movies and specials in an effort to gain summer viewers. (BTW…still waiting on someone to show the Star Wars Christmas special. Where’s the love??!!) So, who are we at the News Week in Review to buck this trend? Pull out your jingle bells and put on your Santa hat, it’s time for Christmas in July in this week’s News Week in Review.

Facilitation payments – naughty or nice? Well in certain countries they are definitely naughty, and while “nice” may not be the exact term one wants to use when talking about them, facilitation payments are certainly a reality of doing business in some countries. A columnist with Compliance Week points out that no compliance officer wants to see bribes labeled as facilitation payments, but if paid as intended – to speed up an action a government official would do anyway – then there shouldn’t be an issue. Governments are increasingly including bans on facilitation payments in their anti-corruption laws, but are such bans realistic considering the reality of the global business environment? The U.K. Bribery Act was the first to ban facilitation payments, but now there is a movement within the government to repeal that section of the law. Canada’s recent amendment to its anti-corruption law will phase out facilitation payments, but the no time table was indicated for the phase out.

The Chinese government has been busy handing out lumps of coal as it expands its probe into the pharma industry. Thirty-nine hospital workers will be punished for taking bribes, two more Chinese employees with Astra-Zeneca were questioned in connection with an investigation of that company, and an American from an unnamed company was detained by the government in connection with an industry investigation. A spokesperson for the U.S. Embassy said they were aware of the situation and were providing appropriate assistance.

The industry can expect some unwrapping of the details relative to drug patent settlements from the Federal Trade Commission going forward. Speaking to lawmakers, FTC Commissioner Edith Ramirez said the agency plans to continue on with current pay-for-delay cases it is litigating and will be investigating new settlements to determine if they are legal. She acknowledged that most patent settlements do not involve a pay-for-delay component but the FTC’s goal will continue to be to stop the anti-competitive settlements that do.

In Chile, where it actually feels like Christmas, the Chilean Medical Association (CMC) and the Council of Pharmaceutical Innovation (CIF) signed an agreement to address conflicts of interests between the industry and healthcare professionals. The agreement prohibits the provision of donations and gifts to influence healthcare professionals’ decisions and paying physicians to conduct clinical trials of new drugs. The Presidents of both organizations said they hoped the agreement would show the public they are serious about stopping conflicts of interest. The signing of the agreement comes in advance of a vote by the Chilean legislature on the Pharmacy Law which will bring transparency to the relationship between physicians and the industry.

The need for Rudolph’s shiny nose is starting to dwindle as the CMS starts clearing up some of the fog surrounding Sunshine requirements. Andrew Rosenberg of the CME Coalition met with CMS’ Sunshine implementation team to clarify some of the requirements related to reporting payments at CME events. He was able to confirm that events considered accredited under the final rule the following are exempt from reporting; speaker travel and lodging, attendee buffet style meals and most educational items. Rosenberg was pleased with the clarification, and said, “The goal here should be to continue to encourage doctors to pursue CME and not create a barrier for uncertainty about the rules.” The CME Coalition hopes to see CMS make changes regarding the accrediting bodies whose programs fall under the CME exemption in the final rule. Rosenberg points out there are number of other accrediting bodies that have adopted ACCME standards and follow the same rules as the organizations listed in the final rule. He also said that CME events supported by accrediting bodies with rules similar to CMS’ final Sunshine rules should be exempt from reporting. The Coalition plans to continue to push this point with CMS and Rosenberg believes eventually they will win on this issue.

Christmas may still be several months off, but the start of Sunshine Act data collection is just a few days away! It is essential that those who interact with physicians understand the requirements under Sunshine to avoid a “garbage in- garbage out” scenario with all necessary data. To ensure a clear understanding of Sunshine consider our customizable, off-the-shelf module. Click here to learn more about our effective eLearning program.

Unfortunately, we must wrap up our little holiday fantasy and return to the warm reality of summer. 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, June 17, 2013

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

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

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.