FTC

Week in Review, April 22, 2013

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

The PharmaCertify™ Team

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

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

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

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

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

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

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

Have a great week everyone!

Week in Review, April 15, 2013

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

The PharmaCertify™ Team

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

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

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

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

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

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

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

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

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

Have a great week everyone!

Week in Review, April 8

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

The PharmaCertify™ Team

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

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

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

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

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

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

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

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

Have a great week everyone!

Week in Review, April 1, 2013

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

The PharmaCertify™ Team

Well, it’s April Fools Day and while we toyed with the idea of using some type of invisible ink for this week’s News in Review, the darn Internet got in the way of a good practical joke. We also tried writing the Review backwards but after our editor passed out in exhaustion, we went back to the left to right approach. Okay, enough joking around, time for this week’s News in Review.

The OIG wasn’t joking around when it announced that doctors involved with physician-owned distributorships (PODs) could find themselves on the wrong end of the Federal Anti-kickback Statute. The agency says the financial incentives of the arrangements can lead to unnecessary procedures and the unwarranted use of devices in the POD. The OIG says hospitals and ambulatory surgical centers also need to be concerned about PODs because the Anti-kickback Statute places criminal liability on both sides of the transaction.

No kidding, drug pricing could be the next transparency frontier. Drug stores have started to lobby state legislatures for legislation that would require pharmacy benefit managers (PBMs) to release their reimbursement rates. The pharmacies believe that if they had the information, they could negotiate better pricing deals. The move appears to be the result of patent cliff – profit margins are lower on generic drugs, and pharmacies argue the PBMs are maintaining their margins and cutting reimbursements.

According to a new survey, companies are finding the implementation of FCPA policies and procedures for managing third-party intermediaries (TPIs) to be a tricky business. The survey included financial, compliance, legal and procurement executives who manage TPIs. Determining the appropriate level of due diligence required for each TPI and then assessing the risk was the top challenge cited. Other concerns included lack of a company-specific definition of a TPI, and the timeframe for evaluating TPIs.

Conflict of interest continues to be a growing concern at medical schools and academic medical centers. According to the American Medical Students Association, medical schools are expanding their policies to include cover speaking and consulting. But according to a study published in the Journal of General Internal Medicine, the policies don’t reduce interactions between industry reps and medical students.

That brings us to the end of this week’s Review. If you’re looking to shake things up with your training as we start this new quarter, we suggest starting with PharmaCertify’s Good Promotional Practices online training module. The customizable, iPad-compatible module covers product promotion issues such as promotional speech and fair balance, proper use of promotional pieces, and social media.

Have a great week everyone and keep an eye out for those practical jokes today!

Week in Review, Easter Bonnet Edition

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

The PharmaCertify Team™

File this one in the “time flies, doesn’t it category,” but here we are already at the end of March, 2013. While we’re surrounded with the usual offerings of the NCAA tournament and spring-like weather (okay, maybe that wasn’t funny considering winter has yet to release most of the country from its cruel grip), this year, the end of March signals diversions much more significant than the usual planning of the perfect April Fools prank. Easter arrives early! Now is the time to map out the course for the annual massive Easter egg hunt and undo all of that post New Year’s weight loss with preparations for a holiday feast. As we look forward to the festivities, we begin with tasty appetizer we call the News Week in Review.

The first story hopping into the Review involves a push for a national system to track off-label drug use in Canada. Dr. Robyn Tamblyn, a researcher and scientific director with the Canadian Institutes of Health says the issue of off-label drug use needs more study. According to a study, just over 10 percent of prescriptions written in Canada are for off-label use, and the majority of those are issued without sufficient evidence to support the physician’s decision to prescribe off-label. Dr. Tamblyn proposes the idea of a national tracking system. The system would use the existing electronic prescription infrastructure, and would require physicians to note if a drug is being prescribed for off-label use and why.

The seal on a whistleblower case against Cephalon was lifted last week, revealing allegations of schemes to market a leukemia drug and pain drug off-label, even while the company was under a CIA. According to the suit, executives knowingly engaged in the off-label marketing plan. Alleged tactics included; paying doctors to attend programs where off-label use was discussed; paying higher than normal fees to group purchasing organizations who encouraged doctors to write off-label for the drugs; and transferring $2 million from the sales and marketing budget to the medical and scientific affairs budget in order to fund CME programs. In addition, after a sales audit showed widespread off-label promotion by sales reps, the head of global compliance told sales reps the audit was designed to not break down data at a rep level, so individual reps would not have to be fired. The federal government declined to join the whistleblower suit.

The OIG added more requirements to the basket for state false claims acts. State false claims acts that meet certain requirements can receive an extra 10% in Medicaid recoveries. The changes made by the OIG are intended to incorporate amendments to the False Claims Act brought by the Frank-Dodd Act, the Affordable Care Act and Fraud Enforcement and Recovery Act. In other OIG news, HHS Inspector General, Daniel Levinson, testified before a sub-committee of House’s Committee for Appropriations on the top management challenges faced by his office. Mr. Levinson cited the effective administration of grants and contracts, protection of security and integrity of data, systems and technology, and reduction of the reporting of improper payments as some of the top issues.

The U.S. Senate is expected to pass a resolution to repeal the medical device tax. The resolution will not actually repeal the tax though because it is attached to a non-binding amendment to a non-binding budget measure.

The debate over transparency in the relationship between the pharmaceutical and medical device industries and physicians continues. A recent article in Forbes highlighted the potential for misinterpretation of the data found in Pro Publica’s Dollars for Docs database. While the data does provide insight into who got paid what by whom, it does not provide the necessary context around the payments. For example, a speaking payment could reflect one engagement or twenty, and travel-related payments may cover a trip to an expensive resort for a conference or the cost of travel for a bona fide outreach program.

The final eggs in our basket are from Daniel Garen, Vice President and Chief Compliance Officer at Wright Medical Technology. Mr. Garen opened the 2013 Pharma Forum in Orlando with a presentation focused on what meeting managers need to know about the Sunshine Act. He emphasized that data on payments already exists and is currently being mined by federal enforcement agencies.

Have a great week everyone and enjoy the holiday!

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 11, 2013

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

The PharmaCertify™ Team

Bifocals…brilliant idea. Lightning rod…terrific concept. Public Library…amazing! Daylight Savings Time…um, not so much. What was Ben Franklin thinking when he came up with that idea? Okay, with apologies to old Ben, we admit that maybe we’re just cranky from losing that hour of sleep. So if, like us, you’re trying to ease your way into Daylight Saving Time, we suggest you ramp up slowly with this week’s News Week in Review.

Time is springing forward and so are the costs associated with FCPA investigations.   An analysis by Compliance Week shows costs related to FCPA investigations for multi-national corporations have exceeded $100 million. According to Avon’s annual report, the company has spent almost $340 million since 2009. Wal-Mart spent $600,000 per day during fiscal 2013 to investigate potential bribery issues. News Corp. paid $179 million in investigatory costs and $191 million to settle civil cases related to its bribery scandal. According to Compliance Week, companies can reduce costs and risks by simply strengthening their current policies and procedures.

A survey of procurement managers and directors finds that half of British companies are making time to vet suppliers for compliance with the UK Bribery Act. Only six percent of those vetting suppliers said they would end the relationship if they discovered a company was violating the Bribery Act. Of the mid-market companies not vetting suppliers, 60% say they have no plans to start doing so in the future. According to Ernst and Young, the company conducting the survey, directors and managers are often not aware they can be held personally liable for compliance failures.

It’s settlement time for Par. The company agreed to plead guilty and pay $45 million to settle off-label marketing charges surrounding Megace ES, its weight loss drug for AIDS patients. Par was accused of marketing the drug for geriatric wasting not related to AIDS, and making unfounded superiority claims for the drug.

Time is up for the FDA chemist convicted of insider trading. The chemist has now been debarred, which means he cannot provide services to anyone with a pending or  approved New Drug Application.

Physician payments in Massachusetts seem to be falling back rather than springing forward. Payments to physicians fell by 3% in 2011. Some payments increased, such as those for CME (up 16%) and those for grants/educational gifts (up 2%). Charitable contributions were down 62%, marketing studies were down 42% and expenditures for food were down 6%.

A bill requiring insurance coverage for the off-label use of drugs has sprung from committee in the New Jersey Assembly. The bill would require health benefit plans to pay for the off-label use of drugs dispensed to patients with terminal or chronic illnesses. In order for the drug to qualify, the off-label use must be recognized as medically appropriate for that condition. The bill applies to companies participating in New Jersey’s Individual Health Coverage Program, the Small Employer Health Benefits Program, the state Health Benefits Program and School Employees’ Health Benefits Program.

Time is precious and mobile technology sure helps make the most of your sales representatives’ time in the field. PharmaCertify’s custom and off-the-shelf apps and iPad-compatible eLearning modules offer access to critical compliance content when and where your team needs it most – in the field and at their fingertips.

Have a good 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.

Week in Review, February 18, 2013

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

The PharmaCertify™ Team

Ah, President’s Day; a time to celebrate our nation’s rich history of great leaders…with pomp, circumstance and of course, really good deals on furniture and new cars. As you wind down your day of patriotic reflection or bargain hunting and haggling, relax and enjoy all the compliance news you need to know, in our weekly News in Review.

We begin in Philadelphia, the city where Presidents Washington and Adams hung their tri-cornered hats, from 1790 to 1800. The U.S. Attorney for the District of Eastern Pennsylvania, Zane Memeger, says that the Caronia decision will not affect his office’s pursuit of off-label cases, for now. Memeger believes that individuals and corporations do not have the right to make false or misleading statements about drugs, and he sees no reason why he shouldn’t continue to prosecute the cases as he did before the well-publicized decision.

Over at the U.S. Supreme Court, several briefs have been filed supporting the Federal Trade Commission’s position that pay-for-delay deals are anti-competitive. A related is set to begin in late March. Representative Henry Waxman and organizations like the AMA and AARP sent briefs detailing their concern about the potential drug costs to the government and consumers. Representing several states, Washington D.C., and Puerto Rico, New York Attorney General, Eric Schniederman, sent a brief stating that the attorneys general believe any payment intended to delay a generic drug’s entry into the market constitutes an unlawful inducement.

The FDA is considering a monumental change to generic drug labeling regulations. The revised rule would allow generic drug manufacturers to change their label when the situation warrants. Current regulations dictate that generic drugs must have the same label information as the brand name product. The change would allow generic manufacturers to make label changes to add side effects that are not included on the brand label.

Now that CMS has released the final rule on Sunshine, Medical Marketing and Media has released a list of winners and losers related to the Act. The winners, including CROs, market research firms, and accredited CME providers, all benefited from the lighter level of detail required for payment tracking. The losers, including medical education providers, medical societies, and the hospitality industry, are likely to see changes in their business dealings with the industry.

When pharmaceutical company lobbyists (or in this case, sales reps) speak, medical students listen. At least that’s what two new studies about the impact of gift bans on the prescribing habits of medical students reveal. A study by the British Medical Journal followed 2,500 students who attended medical that had gift bans in place, and compared their prescribing habits to counterparts who attended schools that allowed gifts from reps. Physicians who attended the schools where gifts were banned were less likely to prescribe new and heavily marketing drugs. A similar study, conducted by Medical Care, compared the prescribing habits of doctors who completed residency before 2001 to those who completed residency in 2008, when gift bans were more common. Those in the programs that had bans in place were less likely to prescribe new, heavily marketed drugs.

And so ends another week of the pontification we call the News in Review. Have a great week everyone!