The PharmaCertify™ Team

Last Tuesday marked the “official” first day of summer! Hooray! Time for sun, sand, long days and lemonade. So just kick back and enjoy a tall glass of lemony goodness as you read this week’s PC News Week in review.

Besides the summer solstice, the other big news of the week was the 6-3 Supreme Court decision striking down Vermont’s ban on data mining. The 2007 Vermont law prohibits the sale and use of prescriber data for the purpose of marketing or promoting prescription drugs, unless the physician specifically gives permission for his or her data to be sold. The law was intended to hold down prescription drug expenditures and protect physician privacy. IMS Health and the other appellants argued that the law infringed on free speech rights. The court agreed, saying while praise worthy, Vermont’s efforts to hold down costs and protect the public health could not infringe on the free speech rights of others. Dissenting justices felt the law only affected one type of communication, and that perhaps the law would lead to companies developing better sales messages.

Nearly 40 states and the District of Columbia are basking in the warmth of a $41M settlement with GSK. The suit, headed by Oregon and Illinois, centered on manufacturing practices by GSK and a subsidiary located in Puerto Rico. The suit contended that the companies violated consumer protection laws. GSK settled federal false claims allegations on the same matter in 2010.

With the Massachusetts State Senate considering repealing the State’s gift ban, House Speaker, Robert DeLeo stepped up to the plate and said the ban is hindering job creation in the state. The Speaker said he had spoken to restaurant owners as well as those in the convention business and found companies are shying away from bringing business to Massachusetts due to the ban. While supporters of the ban contend that it is necessary to protect physicians from undue influence by drug and device manufacturers, one Massachusetts doctor says the ban actually hurts patient care. In an editorial published in the Boston Globe, the doctor points out the education and information gained from drug and device makers is important for the advancement of patient care and the additional compliance burden only hurts innovation.

Riding the wave of an investigation by two news outlets, two US Senators have demanded Medtronic turn over documents related to payments made to physicians involved with clinical trials of its spine surgery product, Infuse. The senators were troubled by allegations in articles from the Journal-Sentinel and MedPage Today that prominent surgeons who had financial ties to Medtronic and were involved in Infuse clinical trials, failed to report complications with the product in medical journals. A Medtronic spokesperson said the company would comply with the request.

And finally, as if summer wasn’t fun enough, the UK Anti-Bribery Act goes in to affect on July 1. Enjoy!

How was that for the start of your summer reading? Light and full of fun, the perfect summer story, right? Okay, maybe not. However, we can help you shed light on today’s compliance issues with custom-developed training tools or our off-the-shelf, customizable modules covering a variety of topics including state laws, the federal Anti-kickback Statute and the FCPA.

Have a great summer week everyone!

The PharmaCertify™ Team

Did you enjoy this holiday week? Holiday? Yes, it was Flag Day here in the U.S.! We hope you were able to celebrate by waving the Red, White and Blue and maybe lighting up a sparkler or two. (ONLY if fireworks are legal in your state that is. We are all about compliance after all!) With celebrations all over, it is time to greet the weekend and this week’s edition of the PC News Week in Review.

A subcommittee of the House Judiciary Committee spent Flag Day holding a hearing about everyone’s favorite anti-bribery law, the FCPA. The DOJ defended its stepped up enforcement efforts. Citing an estimate from the World Bank, the DOJ said bribery is a huge problem, and that changes in the law could signal the U.S. isn’t committed to prosecuting bribery cases. Panel chair, Rep. James Sensenbrenner, said that changes were needed in the law. He said the enforcement was “vague and impenetrable”, and lawmakers were currently drafting a bill to clarify the law. Rep. Robert Scott questioned if the law in its current state coupled with aggressive enforcement efforts could be hindering business development overseas. Lobbyists from the U.S. Chamber of Commerce are seeking six changes in the law. At the top of the list is the addition of a compliance defense similar to that in the U.K.’s anti-bribery law.

An article in the Miami Herald unfurls the off-label marketing practices of a pharmaceutical manufacturer. Documents in the recently unsealed case contained dozens of internal company documents and emails which allegedly reveal how doctors were convinced to prescribe for off-label uses. One of the whistleblowers, a former sales manager, said off-label sales were very important for one of the products involved in the suit. Documents showed the company targeted physicians that would be easily influenced, paid as much as $1,000 for preceptorships, and held dine-and-dash programs.

In Massachusetts, a new piece of legislation was run up the flag pole regarding the state’s gift ban and disclosure law. Several months ago, legislation was introduced in the MA House to repeal the law. While that is being debated in committee, legislation was introduced in the MA State Senate to get rid of the part of the law that bans meals outside of the physician’s office or a hospital setting. Restaurant representatives appealed to senators to pass the bill in support of small businesses. Restaurateurs say the current law is hurting their business in an already difficult economic climate. Those opposed to the repeal doubt that the law has hurt the restaurant business. Those who support the law in its current form say it is needed to protect the doctor-patient relationship from undue influence of industry, and to help control healthcare costs.

In Massachusetts’s neighbor to the north, Vermont, the Attorney General’s office held a conference call this week to discuss the new guidance for the state’s gift ban and disclosure law, and PC staff sat in on the call. Good points for clarifying the mergers and acquisitions section of the guidance were presented during the call. There was also much discussion around guidance of when products given to healthcare professionals should be reported on the samples report versus the regular report. The office said it would probably have to go back to the legislature regarding how reporting of donations to national patient advocacy groups were made. As the call wrapped up the AG’s office said enforcement efforts were on the way, and advised everyone that they published all settlements on their website. No ETA was given as to when the final guidance would be published. (The current draft guidance can be found here.)

Waving the white flag? We don’t think so! The Digital Health Coalition, a non-profit group, has been formed to discuss how to move forward with digital marketing and social media for the industry. The group has representatives from pharmaceutical companies, digital health companies as well as Google. The group’s position is that it is the industry’s responsibility to determine the best way to responsibly market products through digital media, and has every intention of working with DDMAC to develop a solution.

Several good stories and a few bad flag references later, it’s time to wrap up this week’s news review. But before we do, a big congratulations to Michael Shaw of GlaxoSmithKline. He was named America’s Funniest Compliance Officer! The event was held at NYC’s Comic Strip and raised money for juvenile diabetes research. Kudos to Mr. Shaw for finding the funny in “Risk. Problem. Solution.”  Not the usual fodder for comedians. We can only hope to see the act reprised at this year’s PCF. (hint, hint).

Well that’s all for this week (really…this time it is). Whether you need new training or need to refresh your current training on compliance topics such as FCPA or on-label promotion, we can help with our customizable, off-the-shelf solutions. Check us out at www.pharmacertify.com. Have a great weekend, and happy Father’s Day to all you dads out there!

The PharmaCertify™ Team

Well that was some lovely August week. Oh wait….it’s only June. Whew! It has been H-O-T, HOT! Here’s hoping it cools off outside soon, but in the mean time, stay indoors and enjoy some A/C as you read this week’s PC News Week in Review.

Speaking of the heat, the OIG uploaded video of its recent provider compliance training. The training was provided as a part of the agency’s HEAT program.

One company feeling the heat this week was UCB. The company pleaded guilty to a misdemeanor and will pay $34 million in fines and penalties for the off-label marketing of an epilepsy medication. The False Claims Act case resulted from two whistleblower claims and US and state Medicaid systems will share nearly $26 million of the $34 million dollar settlement.

Feeling the heat in the courtroom were former Synthes executives awaiting sentencing for their part in an unauthorized clinical trial for a bone cement. The executives were charged under the Park Doctrine. The US is pushing for prison time in the case, which would make this the first time the Doctrine was used to send executives to prison.

Off-label marketing proves to still be a hot topic and the New Jersey Star-Ledger discusses the topic in depth.

Likewise, FCPA enforcement is a hot topic these days, and will be the subject of a Judicial Committee hearing next week. The hearing was scheduled at the direction of committee chairman, Representative Lamar Smith of Texas. In May, Rep. Smith’s senior counsel announced that the committee wanted to review whether reforms or fixes were needed, and that staffers were looking at four potential changes. No specific reform has been proposed by any member of Congress.

The heat is on across the pond as well. Several drug manufacturers were found to be in violation of various parts of the ABPI Code of Ethics. The breaches ranged from failure to provide sufficient prescribing information to the Prescription Medicines Code of Practice Authority to inappropriate hospitality being provided to doctors.

Off-label prescribing was also a topic the ABPI tackled this week. The ABPI told the General Medical Council (GMC) it was opposed to medicines being prescribed for off-label use, when a licensed alternative was available. The GMC raised the issue in the wake of two high-profile cases where cheaper drugs, not licensed for a particular condition, were prescribed over the more expensive, licensed drug. The group is concerned about the potential risk to patients when less expensive alternatives are used for off-label purposes. GMS is also concerned that off-label use will hinder new drug development.

Former federal prosecutor, Michael Loucks, now finds himself in the hot seat as a corporate defender. Since joining Skadden, Arps nearly a year ago, he has surprised former allies with his staunch defense of the companies he once prosecuted. Loucks now calls into question practices he once employed as a prosecutor.

In a move that is likely to make attorneys like Mr. Loucks hot under the collar, a federal appeals court ruled that pharmaceutical and medical device companies can be held liable under the False Claims Act, even if the pharmacy or hospital is unaware a kickback was paid for the purchase of product reimbursed through Medicare or Medicaid.

How’s that for a bunch of heat references? Too cliché? Well we can always blame it on the heat. Until next week keep cool, and if you need help training some of the hot topics (had to get one more in) discussed this week, please visit us at www.pharmacertify.com.

The PharmaCertify™ Team

There’s nothing like a short work week to help get the days of the week confuzled. While last week may have been a short work week, there was no shortage of compliance news. So kick back and check out the week that was in PC News.

The implementation of the U.K. Bribery Act is just a month away, and the Feds have ratcheted up their enforcement of the FCPA. FCPA expert, Kevin Bennett spoke with the Star Tribune about the similarities and difference in the two laws. Additionally, Bennett discussed the trend toward increased FCPA due diligence in mergers and acquisitions.

Up on the Hill, two US Senators were busy suggesting further regulations for the FDA. Senator Max Baucus called for the FDA to require physician groups and doctors to reveal any ties to the drug industry when lobbying the agency. The call comes as the result of a revelation in a Senate Finance Committee report that a physician group, who had accepted millions of dollars over the years for conferences and sponsorship from Sanofi, had written letters to the FDA questioning the safety of generic drugs. According to the report, the letters were written at Sanofi’s urging. On a separate topic, Senator Chuck Schumer proposed legislation that would require drug manufacturers to notify the FDA when they anticipate shortages on products.

News of the government stepping up its efforts to prosecute individual executives in healthcare fraud cases continues to grow as MSNBC and the AP joined in on the coverage. More proof that training on the False Claims Act and Anti-kickback Law is crucial for your reps AND your executive committee.

Abbott is in settlement negotiations with the DoJ over False Claims related to the off-label promotion of an anti-seizure medication. Government attorneys asked the judge in the case to postpone proceedings until July 8 so settlement negotiations can continue. The case is in the US District Court of Western Virginia, and several other states have joined in the suit as well.

Despite promises to provide guidance to the industry, the FDA did not put use of social media on its Guidance Agenda for 2011. On the agenda instead is “Responding to Unsolicited Requests for Drug and Medical Device Information, Including Those Encountered on the Internet.” With no social media specific guidance on the way, the question facing the industry now is to Facebook or not to Facebook. Except for pages dedicated solely to a prescription drug, Facebook will no longer allow the “comment feature” to be disabled on industry pages. So how does a company create a forum for a truly open dialogue with consumers, while ensuring that they stay in the good graces of the FDA? Stay tuned as the industry returns once again to the digital media strategy drawing board.

Last week we shared the good news of our new arrival, Good Promotional Practices. While you’re here on the blog, check out our new entry on why GPPs offer a compelling and effective foundation for training. And for information on how we can help with training on subjects in the news this week, like the FCPA and on-label promotion, visit our website.

It’s back to the usual five day grind this week, we hope you enjoyed the weekend everyone!

By Lauren Barnett

Compliance Content Specialist, PharmaCertify

As a compliance trainer, I faced the challenge of convincing my learners that their training involved more than just a bunch of regulations that had little to no relevance to individuals. So the recent stories of the government actively pursuing individuals as a result of investigations of their companies caused me to wonder: will these “real world” examples of how regulations can impact them personally have an impact on how the learners view the importance of the training?

Then, just as quickly, the words of a former trainee came to mind, “I’m so glad you didn’t give us the orange jumpsuit lecture.” And with that thought, I was brought back to reality. Sure, trainees need to know the government has taken this position, but is there any need to make it a linchpin in training? No, not really. No matter how nicely delivered, I have to agree with the thought that hearing “I want to keep you out of jail” isn’t necessarily a sound approach. Don’t tell me you anticipate that I’m going to do the wrong thing, and expect me to respect the training.

Now firmly back in reality, I thought about the things that, for lack of a better phrase, keep people out of jail. Laws and their application may change over time, but far less changeable are the basic principles by which most companies conduct their business. These principles provide a foundation for decision making. It would be impossible to have a policy for every situation a person might encounter while on the job, but by applying a principle to a situation, we can have a good idea of the appropriate action to take in any situation.

With the basic principles as a foundation, a set of practices can be built from the laws, guidance and industry best practices to address the many situations one is likely to face. In commercial compliance we call these Good Promotional Practices, or GPPs for short. These GPPs can be couched in terms of company policy, which as a trainer, is a great way of presenting compliance topics. Teaching the PhRMA Code, for example, has a distant feel to it. However, the same material presented as a set of practices supported by company policy feels closer to home and more relevant.

GPPs also help us present legal topics, such as the False Claims Act, in a more relatable way. Let’s face it, most people do not hold such legal topics with the fascination that many of us compliance folks do. Rather than training people about the legal ins and outs of the False Claims Act, GPP training gives learners the tools to keep from running afoul of the False Claims Act.

While we certainly have to present the reality that the government is going to hold individuals accountable as they pursue fraud and other cases against companies, it doesn’t have to turn compliance training into a scared straight presentation. We want compliance to be accessible and relevant to the learner. Training on GPPs does just that. Built on solid practices, GPPs take what may seem remote and present it in a “personal” way that is easily understood and applied. It removes the temptation to bring in the “fear factor,” and focuses learning on what’s important – putting principles into practice.

The PharmaCertify™ Team

Woo hoo! Holiday weekend ahead! What better way to start the celebration than by reading this week’s PC News Week in Review? Okay, maybe there are better ways, but what else are we supposed to say?

We lead off this week with the California AG announcing a $241M settlement with Quest Diagnostics. It is the largest recovery ever under the state’s False Claims Act. Quest was accused of over charging Medi-Cal, the state Medicaid program, for tests over a 15 year period. Additionally, the company offered kickbacks to providers in exchange for patient referrals, with some of the referrals being Medi-Cal patients.

In an unprecedented move, AstraZeneca CEO, David Brennan, announced the company would no longer pay for doctors to attend international scientific and medical congresses; saying the company should not be doing anything that would give the perception of inducement. The head of the European Federation of Pharmaceutical Industries and Associations said it was a “dramatic change”, and that he expects others to follow suit. It’s certainly food for thought as the industry faces increased scrutiny under the FCPA and with the upcoming implementation of the UK Anti-Bribery Act.

A couple of interesting studies made the PC News this week. First was a study by Ernst and Young regarding ethics in European companies. The study showed that one third of employees were prepared to offer some sort of bribe to gain business, and that nearly half of employees were unaware of their company’s anti-bribery policy. The survey included 2300 employees, at all levels in the organizations, across 25 countries. Most employees said management offered no leadership when it came to compliance, with 25% of the respondents saying they did not trust management to behave ethically. That “tone-at-the-top” is indeed critical.

The second study focused on medical students’ interactions with the pharmaceutical industry. The study found that most med students have some sort of interaction with the industry, with up to 90% of students in their clinical years receiving some sort of education material from industry representatives. Unaware of the regulations, most of the students thought there was nothing unethical about accepting the gifts. The authors recommend that education be provided to med students regarding physician-industry relationships.

Check out this video from Main Justice (the website, not the government office). Main Justice interviewed former DOJ Deputy Chief of the fraud department, Kirk Ogrosky. In the interview, Ogrosky talks about the DOJ’s healthcare fraud initiatives, including the prosecution of executives and the impact of the new SEC whistleblower program on healthcare fraud cases. The video is available on the right hand side of the page.

Want to know what the OIG is up to? Just follow them on Twitter! In addition to joining the Twittersphere, the OIG also launched a re-vamped website – definitely more visually appealing and user friendly.

Lastly, we have some exciting news of our own here at PharmaCertify! We are pleased to announce the arrival of a new module, Good Promotional Practices (we call him GPP for short). GPP covers topics ranging from gifts and meals to fair balance in promotional communications. And it’s written to be relevant for your entire commercial team, not just the sales reps. To learn more about the new addition to the PharmaCertify family, contact Sean Murphy at smurphy@pharmacertify.com.

That brings us to the end of another week in review. We hope you enjoy the long weekend, and the “unofficial” start of summer. Most importantly, we send out a big THANK YOU to the men and women of our armed forces. Have a safe and relaxing Memorial Day weekend everyone!

The PharmaCertify™ Team

The final flight of space shuttle Endeavor, Schwarzenegger scandal, and the head of the IMF tossed in jail…hardly seems like there was anything else going on this week! Never fear, if you missed some of the headlines in the world of compliance, we’ve got you covered. Time for this week of PC News Week in Review to blast off!

Maine Republican lawmakers are moving to repeal the state’s drug disclosure law. With support from the pharmaceutical industry (gasp!) the lawmakers say the disclosure should be left in the hands of the federal government. Democrats are opposed to repealing the law, claiming  that disclosure saves the state millions by keeping costs down.

An article in Time presents a physician’s perspective on data mining, the VT law and the AMA’s physician data restriction program (PDRP). The article begins by discussing an e-mail that is making its way around physicians. The email, allegedly from a physician, states that he/she can’t believe that his/her prescription data is being sold, (right) and urges the recipient to sign up for the AMA’s PDRP. The physician author also discusses the challenge the VT data mining law is facing in the Supreme Court right now, and it appears the high court will not uphold the law. He also points out that the PDRP is largely unknown and doesn’t completely protect the privacy of the physician’s prescribing habits anyway. He goes on to suggest that physicians must take a more proactive role in protecting prescription data.

Physicians (allegedly) may be upset about their prescription data being sold, but they also know better than to bite the hand that feeds them. A recent study found that a large majority of physicians felt that industry sponsorship of CME introduced a greater risk of bias, but only a small percentage were in favor of eliminating the support. Other measures, such as raising fees, holding events in less desirable locations and eliminating free food, to reduce the amount of support from industry, were met with tepid approval.

This week saw the start of an FCPA trial, in which the defendants were nabbed  through an FBI sting operation. Accused of engaging in bribery of Gabonese officials (undercover FBI agents) and money laundering, the defendants argued they did nothing wrong and the FBI manufactured the conspiracy and violated rules regarding handling of informants. The first day of the trial saw attendance from notable government types since this is first trial resulting from “enhanced investigatory techniques” in FCPA investigations. In all, 16 people were arrested as a result of the investigation; many at a Las Vegas gun show. Apparently some things don’t stay in Vegas.

If you would like to avoid being arrested for violating the FCPA in a large government sting, pick up a copy of The Foreign Corrupt Practices Act of 1977- A Lay Person’s Guide to FCPA and Federal Sentencing Guidelines from Amazon. Wow, they really do have everything! The 24 year old book provides a de-legalized explanation of the law, as well as commentary from the DOJ about how the law should be enforced.

Not to be left out of all the talk of an impending apocalypse, the CDC, proving that yes, the government does have a sense of humor, posted a highly useful blog about how one should prepare for a Zombie Apocalypse. The post was a tongue-in-cheek approach to disaster preparedness, and it may have worked. A CDC spokesperson said that in just two days it became the most popular CDC blog entry. (Note to self: more zombie stories for the PC blog).

That’s the news for this week! Please check www.pharmacertify.com for more information on our off-the-shelf, customizable training modules on compliance topics ranging from the FCPA to CME and beyond. Have a great weekend, and we’ll see you right back here next week.

The PharmaCertify™ Team

It’s Friday Saturday (I think Friday the 13th got the better of us)!  Woo Hoo!  Well some of us are woo hooing anyway.  It’s Friday the 13^th! (insert scary music here) For all the friggatriskaidekaphobics out there, take heart.  There’s only one more Friday the 13^th left this year. So step away from any ladders, don’t touch any mirrors, check for black cats, and then bathe in the soothing light of your monitor as you read this week’s PC News Week in Review.

The two big stories of the week happened in the courts. First there was the guilty verdict in the FCPA case against Lindsey Manufacturing. The jury returned a guilty verdict making Lindsey Manufacturing the first company to be found guilty in a jury trial of bribery under the FCPA.  Sentencing in the case will occur in September. Lawyers for the government called the verdicts a milestone in enforcement efforts, and said Lindsey would not be the last company found guilty at trial. Lindsey is appealing the decision. Lawyers for the company have filed a motion to dismiss based on government misconduct. This one ain’t over yet folks.

On the flip side of the coin, the government lost in its efforts against former GSK lawyer, Lauren Stevens. The government alleged that Ms. Stevens made false statements and obstructed an investigation in to GSK’s marketing practices of Wellbutrin. The judge acquitted Ms. Stevens before the case ever reached the ears of jurors. In a rare move, the judge basically called the government out on the carpet saying Ms. Stevens should never have been charged with anything, and it would be a “miscarriage of justice” to continue the case. The defense’s argument had been that Ms. Stevens had conducted herself appropriately in her representation of her client; even seeking the advice of outside counsel. The judge agreed, and he further stated there was “enormous potential for abuse in allowing prosecution of an attorney for the giving of legal advice.” Government lawyers felt the case was well-founded and deserved a chance to be heard by a jury. The decision by the judge dealt a blow to the government’s efforts to hold individuals accountable for corporate misconduct.

Thomas Fox has written a strong blog entry on the impact these two cases could have on the compliance officer position.

The OIG went on “damage control” this week with the release of a fact sheet in the matter of Forest Labs and the exclusion notice to its CEO, Howard Solomon. The fact sheet was an effort to clear up what the agency referred to as “inaccuracies in the media.” The sheet explained the exclusion authority available to HHS through the Social Security Act, the conditions by which the agency may exclude a person, the exclusion process, and the details of the recent settlement with Forest Laboratories. The OIG made clear that Howard Solomon has not been excluded from participating in federal healthcare programs.

On a more upbeat note, the OIG announced a free webinar on healthcare compliance for providers. The webinar is a part of the HEAT initiative, and will teach providers the basics of healthcare compliance, how to cultivate a culture of compliance, and what to do if an issue arises. The webinar will be held May 18^th, and no registration is required.

This week, Ernst and Young published results of research that showed the oil and gas industry was most likely to face prosecutions under the U.K. Anti-Bribery Act, with life sciences companies coming in second. The research is based on FCPA prosecutions since the inception of the Act.

And speaking of the FCPA, SciClone announced the findings of its internal investigation of possible FCPA violations. The company found possible violations did exist, and cited a lack of internal controls and lack of transparency between the US and its China operations. Based on recommendations by the investigatory committee, the Board of Directors directed the company to take a number of remedial measures, including a revamp of company policies on the FCPA and their policies regarding, meals, honoraria and entertainment. The recommendations also included expanded training to employees on the FCPA and other anti-bribery, anti-corruption laws.

An article on Boardmember.com examined the building of a compliance program at Medicis, a dermatology company. While in the midst of a government investigation, Medicis’s Board decided to transform its compliance efforts with an emphasis on going beyond the minimum government expectations.  Enter new Compliance Officer, Seth Rodner. He removed the compliance function from legal, where it resided when he was hired. Rodner faced the challenge of not only transforming the compliance function for the company, but also introducing compliance concepts to the aesthetic end of the business, which does not face the same level of scrutiny as the therapeutic side of the business. With the support of the Board of Directors and upper management, he was able to do just that.

Our final story this week comes from the “she did what?!” file. Warner Chilcott received a letter from the FDA regarding a video a sales representative posted on YouTube to promote an osteoporosis medication, and, wait for it…this was at the direction of her district manager. (gasp!) The 60 second video failed to present a number of FDA requirements for advertising and labeling such as fair balance and drug indication. You know, the minor details. This was the only video cited in the letter and not surprisingly, it was removed from YouTube quickly. It may be Pollyanna-ish, but we have to believe that this rep and her district manager simply acted out of ignorance. Worried the reps at your company are capable of the same mistake? We have training that will help.

That’s the round up for Friday the 13^th  (reprise scary music here). While some may find Friday the 13^th scary, compliance training doesn’t have to be.  Whether you’re looking to expand FCPA training, or equip sales reps with what they need to know to stay compliant with federal and state laws governing interactions with healthcare providers, we can help. Check out our suite of compliance training topics at www.pharmacertify.com.

Have a great weekend everyone!

The PharmaCertify™ Team

It has been quite a week! Osama Bin Laden..departed. And while that story rightly dominated the headlines, there were developments in the world of healthcare compliance. So without further adieu, here’s this week’s PC News in Review.

The government continues its aggressive investigation into FCPA violations in many sectors of the business world. News this week focused on settlements and investigations of companies ranging from Avon to Rockwell, and the pharma industry certainly has been no exception. This week Eli Lilly announced it was in advanced discussions with the SEC to resolve an investigation for alleged violations of the FCPA. The allegations center on activities at Lilly’s Poland subsidiary.

In a regulatory filing, SciClone said it would be delaying finalizing executive compensation until its internal investigation regarding FCPA compliance in sales and marketing matters in China is concluded. The company announced its internal investigation in November, and is cooperating with a parallel investigation by the SEC.

Pfizer joined Seimens, Telecor and Shell in a roundtable discussion in Thailand about governance and corruption. Pfizer’s representative, the Thailand and Indonesia country manager, said they strictly follow the FCPA. He pointed out that 80% of clients deal with the company in a straight forward manner. Employees are told to walk away from the other 20%. He also indicated that top management must take a lead in anti-corruption measures and not rely on regulation to prevent corruption.

In a land Down Under, GSK announced it would be releasing the overall payments made to physicians for consultancies, sponsorships and grants. GSK Australia country manager, Deborah Waterhouse, called this a first step. Indications are the end goal is to release this data at the physician level, as is required in the US.  Waterhouse said the company needs to understand the privacy implications of publishing the data at the physician level. She also said the move to release the information is part of a global initiative at GSK and that the company is committed to “enhancing the transparency of how we manage our business.”  While the announcement was commended by ethics experts, they said the information is of little value since individual doctors won’t be identified. There’s always at least one in every crowd isn’t there?

In the words of Princess Leia, (hey, it was Star Wars Day this week) “It’s a trap!” The “go-live” date for the Physician Payments Sunshine Act is quickly approaching, and companies are working to get processes in place to collect and report the required spend data. An article in Medical Marketing and Media poses the question: do companies need to re-work their policies involving transfer of value (TOV) items (meals, lodging etc.)? The article states the nearly perfect transparency created by the Sunshine Act is a potential trap for pharmaceutical companies who don’t address their TOV practices and policies. As this information becomes available, the fact that a company pays millions of dollars in meals to physicians will not sit well with the public, and will present a field day for the media. As evidence, the article cites the recent uproar over ProPublica’s compilation and publication of publically available spend data. Definitely food for thought.

Loose lips sink ships, and apparently they sink whistleblower suits as well. A whistleblower suit against Quest Diagnostics was dismissed this week on the grounds that one of the whistleblowers shared confidential information with the rest of the plaintiffs’ group. The individual in question is former general counsel at Unilab, the Quest subsidiary at the center of the False Claims suit. Lawyers for the whistleblowers argued that the disclosure of the information was a permitted exception since it prevented the commission of a crime. The judge disagreed, saying that revealing confidential information dating back to 1996 was beyond the scope of information the lawyer could have believed was necessary to prevent a crime in 2005. The dismissal does not preclude the government from taking on the case.

That’s it for now. If you’re attending the Society of Pharmaceutical and Biotech Trainers (SPBT) Annual Conference in Orlando, FL next week, stop by Booth 417 and say hi. We’d love to talk to you about how we can help you in training topics like FCPA, the federal False Claims Act and state disclosure laws with our eLearning solutions and iPad apps.

Oh, and Happy Mother’s Day to all you mom’s out there. Have a great weekend everyone!

By Lauren Barnett

Compliance Content Specialist, PharmaCertify

The end of April was filled with exciting events for the United Kingdom. Apparently there was a wedding of some importance happening, but more importantly, April marked the end of the “grace period” for the implementation of the latest version of the Association of the British Pharmaceutical Industry’s (ABPI) Code of Practice for the Pharmaceutical Industry. Like PhRMA here in the U.S., the ABPI is a trade association of the pharmaceutical industry in the U.K. With PhRMA updating its own Code of Interactions with Healthcare Professionals not too long -ago, it naturally begged the question, what are some of the differences and similarities between these two documents?

One notable difference between the two Codes is the breadth of topics covered by the ABPI Code. As made evident by the full titles of each document, the PhRMA Code deals specifically with interactions with healthcare professionals. The ABPI Code deals with commercial practices in general; from sampling, to relationships with patient organizations, to advertising.

Also notable is that the ABPI Code is mandatory for its members and affiliate members. The PhRMA Code is voluntary. Membership in the ABPI comes with the commitment that the company will “abide by the Code in both spirit and the letter.” Like PhRMA, the ABPI welcomes non-member companies to publically commit to abide by their code. This raises another difference; the ABPI requires documented training on its Code. Since the PhRMA Code is voluntary, certified training is not required, although expectations for that training are presented.

Let’s take a look at how the ABPI and the PhRMA Code line up in the areas specific to interactions with healthcare professionals. Both call for careful documentation when using healthcare professional as consultants and both suggest that consulting contracts should be for bona fide activities and not offered as an inducement. The ABPI, taking a page from the Sunshine Act, also includes the requirement for public disclosure of financial arrangements. And like the provision of the Sunshine Act, the disclosure provisions of the ABPI Code are effective in 2012 and 2013.

Like the most recent update of the PhRMA Code, the ABPI Code prohibits the provision of practice related items such as mugs, notepads, pens and the like. The ABPI Code does allow for the provision of notebooks and pens at bona fide meetings. These items cannot have product logos, (company logos are permitted), and may not exceed 6 pounds in value. The ABPI Code also prohibits the provision of entertainment by representatives and specifies that any meal provided during a call on a physician must be secondary to the discussion with the physician. Also, like the PhRMA Code, the ABPI Code limits the offering of these meals to the physician and appropriate office staff only. The ABPI also allows reps to provide items for patient education. The ABPI differs from the PhRMA Code in that it specifically addresses how DVDs, memory sticks and other items should be presented for patient education. For example, DVDs may be distributed for educational purposes, however they must be formatted to prevent re-use or alteration.

Unlike the PhRMA Code, the ABPI Code provides detail on sales representatives’ conduct beyond the provision of a meal or gift. The ABPI Code calls on representatives to ensure that the frequency and length of visits do not prove to be a disruption to the healthcare professional.  Interestingly, the ABPI also prohibits the use of subterfuge to secure a meeting with a healthcare professional, prompting curiosity about what could have gone on in the past to make that prohibition necessary.

Ultimately these two codes have the same objective; create a standard of conduct which helps ensure that the industry’s relationships with healthcare providers (and its promotional activities in the case of the ABPI) are about education and patient care. So the next time the regulated environment of commercial compliance feels overwhelming and uniquely frustrating, remember the ABPI shows us it’s a small world after all.