The PharmaCertify™ Team

“We’re having a heat wave. A tropical heat wave.” A huge section of the country is baking. Triple digits temps…high humidity...”might as well be walking on the sun.” However, you are happily sitting in your air conditioned space reading about the hot news of the week. Kudos to you! You have the right idea. Crank that A/C up and grab an iced beverage as you kickback and enjoy this week’s PharmaCertify Week in Review.

The hot topic this week has to be the announcement of an FDA proposal to regulate mobile apps related to health and medical needs. (It was really just a matter of time, wasn’t it?) The proposal would only target certain apps, and the agency will be seeking comment on the proposal. The types of apps the agency is concerned with are those that act as an accessory to an already regulated medical device, and those that turn a mobile device into a regulated medical device through the use of attachments, sensors or other devices.

A physician in Massachusetts may have been feeling a little hot under the collar as he wrote a response to a Rhode Island news website article about the financial relationship between doctors and the pharmaceutical industry. The website ran the usual and customary article about the conflicts of interest when doctors accept a meal, speaking fees, etc. from pharmaceutical manufacturers, along with a tally of the reported spend on state physicians, using data from public databases such as ProPublica. The doctor responded by acknowledging that yes, there have been issues, but those times are in the past. He went on to say that insurance companies have a bigger influence on what doctors write than any marketing ploy by a pharmaceutical company. He also defended the value of the relationship in that it keeps busy physicians up to date on new medications and therapies.

A report predicts the slowdown in FCPA enforcement actions in the first half of the year is only temporary and we can expect the DOJ to heat things back up the second half of the year. The report cites the unusual number of FCPA jury trials as the likely reason for the slow down.

State laws were on the hot seat this week as Maine’s legislature voted for the repeal of three of its reporting laws. The aptly named, An Act to Make Certain Prescription Drug Disclosure Laws Consistent with Federal Law, repealed Maine’s disclosure laws on marketing costs, prices of drugs subject to the Medicaid Drug Rebate Program and negative findings in clinical studies. In Vermont, a state auditor has tallied the cost of defending the state’s data mining law, which was recently declared unconstitutional by the Supreme Court. The auditor’s tally may be incomplete, as the court can still assign costs to the state as the losing party in the case. The auditor says the case could end up costing the state as much as $2 million.

We wrap up the news this week with a story involving the always hot button issue of off-label marketing. A California woman is suing Stryker and Medtronic, claiming the off-label marketing of their spinal fusion products has left her with debilitating injuries from excessive bone growth.

There are the hot topics in this week’s news. We’d like to take moment to remind you of our “hot of the press” new module, Good Promotional Practices. The module covers the essential topics for your commercial teams in a way that supports your values-based program. To learn more, please visit http://www.pharmacertify.com/commercial_compliance/good_promotional_practices.asp.

Whew! The mercury is still climbing as we wind it down and head for the weekend. Keep cool everyone, and we’ll see you back here next week.

The PharmaCertify™ Team

A 168 year old paper printed its last edition on Sunday, July 10. Another casualty of the Internet age? No, a casualty of an ethics breach so grave that it caused the paper to shut down. Of course we’re talking about the British tabloid, News of the World. We want to assure you, our dear readers, that we have not engaged in phone hacking or bribery here at PharmaCertify™ Week in Review. Okay, enough of that tangent and on to this (past) week’s news in review. It’s past because this one’s a little late. A big thank you to our readers who asked about this addition and alerted us that we had a problem! So, here we go.

Approved! The DOJ issued an advisory opinion regarding paying for trips of foreign officials. The agency cited previous guidance that approved payment for travel in certain circumstances where travel was acceptable, because it was used specifically to promote, demonstrate or explain the requesting companies’ offerings. The DOJ cautioned that this opinion did not represent a blanket approval for other companies in similar circumstances. Clear as mud. Thanks!

Caught on tape! Excessive hospitality provided by a pharma company during a medical congress in Spain. And that was just one of several companies cited in a Prescriptions Medicine Code of Practice Authority report. The hospitality in question was provided to healthcare workers from the UK’s National Health Service. Now these companies may find themselves being investigated by the Serious Fraud Office, under new powers granted to the organization through the UK Bribery Act.

Confession! A doctor relays his personal experiences with pharmaceutical sales representatives; from accepting a consulting offer that included a free trip to the unintended consequences of his decision to no longer see sales reps. The doctor also discusses current transparency efforts and the need for more regulation.

Violated! Canadian cosmetic surgeons have been warned that prescription drug information posted on their practice websites is considered marketing and is in violation of laws that prohibit the marketing of drugs to consumers.

Getting cozy! Cozying up to the pharmaceutical industry, Google may have solved some of the trepidation pharmaceutical companies face in embarking in social media. AstraZeneca raised concerns that the videos popping up in the suggestions column of the YouTube Channel they were developing were not ones they wanted associated with their brand. Google developed a feature through which channel owners with a certain number of videos can control what videos appear in the column.

Denied! The appeal of a compliance officer’s wrongful termination suit was denied by the 8^th Circuit Court of Appeals. The CO accuses her employer of having fired her over reporting concerns that the company was violating CMS requirements.

No Comment! Or comment if you feel so moved. The FDA is seeking public comments on its plan to remove a portion of PDMA regulations that require unauthorized distributors of drugs to provide the purchase history of the drugs they sell to their customers. The history, also known as a pedigree, traces the sale, and trade of drugs starting from the manufacturer through to the unauthorized distributor.

Enough! A panel of healthcare lawyers discussed the direction of health care fraud and enforcement at a forum hosted by Main Justice. One of the panelists commented that enforcement has moved from straightforward cases of wrongdoing to complicated cases where it is not even clear if items such as kickbacks were provided. They claim companies are subsequently having difficulty complying with the law.

Finished! Here we are at the end of another PharmaCertify™ Week in Review. But it isn’t the end of the compliance training tools we offer here at PharmaCertify. We’re here to help with your training needs on topics such as the FCPA, PDMA and the False Claims Act. Check us out at www.pharmacertify.com.

Keep cool!

The PharmaCertify™ Team

It is the end of an era, as the last space shuttle flight lifted off today at 11:29 EDT. In case you missed the launch, you can check it out here. Awesome sight, no? It’s time to launch into this week’s PC News Week in Review.

Despite a recent ruling to dismiss, a UK businessman says his False Claims lawsuit against Quest Diagnostics is “a go.” The man is accusing Quest of offering reduced pricing to insurance companies in exchange for government business, actions that resulted in inflated laboratory charges to the government to the tune of $1B.

A false claims whistleblower suit has caused the DOJ and several states to launch an investigation into a pain medication management company. The suit filed in a Massachusetts federal court alleges the company encouraged healthcare providers to either bill Medicare and Medicaid for services they did not receive or overbill for the service.

The difficulty of navigating cyberspace for pharma companies makes the news this week. Bayer has issued an apology for tweets that appeared on its UK Twitter feed. The tweets violated advertising regulations set forth by the Prescription Drug Medicines Code of Practice Authority. The primary issues were that the tweets did not appear to have been drafted by lawyers or compliance officers, and they promoted a drug to the public.

In the US, the director of DDMAC says that social media guidelines for the industry are the division’s top priority. Meanwhile, several of pharma’s heavy hitters filed a citizen’s petition with the FDA, requesting clarity around the issue of how to respond to unsolicited requests for off-label information. The petition could delay the release of the planned guidance document on the topic. The document is to include the topic of how to address the requests when they are received over the internet.

To twist a phrase from Jim Lovell – California, we have a problem. A state auditor has urged the governor of California to collect on the $355M in disputed drug rebates the state’s Medicaid program, Medi-Cal, is owed. A PhRMA spokesperson said disputes arise when states submit claims which aren’t in concert with the amount of drugs sent to wholesalers. Also, clerical errors contribute to disputes. The state’s pharmacy benefit chief said these disputes are complicated and take time to resolve. Complicating matters is a shortage of manpower to help resolve the disputes.

Minnesota’s Congressional contingent has joined in the blasting of the FDA for its drop in Investigational Device Exemption approvals. The lack of approvals is blamed for squelching innovation, the rash of new device companies closing or leaving the state and moving overseas. The FDA admits there is room for improvement on their end, however it is quick to point out that there is plenty of blame on the industry side as well. The agency claims companies submit applications with errors and propose poorly designed studies for their devices, which adds to the delay. Ouch. Maybe those involved should listen to the advice of this Minnesotan.

In a recent federal court case, a judge struck down a challenge to a Florida law that prohibits doctors from referring patients for lab work to companies in which they have a financial interest. The group that brought the suit claimed the FL law is pre-empted by the clinical services exemption in the federal Stark Law. The judge disagreed, saying there was no indication that Stark was meant to pre-empt state referral laws.

It was a no-go on a verdict in the infamous gun sting FCPA trial. After six votes, jurors in the case were unable to reach a verdict, and a mistrial was declared by the judge. The government says it will retry the case.

As we wrap up this edition of the News Week in Review, we’d just like to wish the final four astronauts of the shuttle program good luck and Godspeed on their mission. We’ll see you back here on earth July 20^th. Yes, you read that right. Atlantis is scheduled to return to earth on the anniversary date of man landing on the moon. The whole thing calls for a Tang toast don’t you think?

Have a great weekend everyone!

Independence Day… the day we celebrate the Shot Heard ‘Round the World with Fireworks. Yes, the quintessential American celebration is just a few days away! Before you start “rockin’ and a rollin’; splishing and a splashing” to celebrate all things America, kick off the weekend with this week’s News Week in Review.

While it may seem like a circus sometimes, our Three Ring Government was busy this week. Over in the Executive Branch, the FTC reached a $900,000 settlement with German company Beiersdorf AG, the makers of Nivea My Silhouette skin cream. The FTC charged that the company falsely advertised that regular use of the product would result in a reduction in body size.

In the judicial branch, the judge in the landmark Lindsey Manufacturing FCPA case has called into question the behavior of the government prosecutors. It seems prosecutors neglected to provide a transcript of grand jury testimony of an FBI agent to defense. The testimony is at the center of a defense motion to dismiss the indictment due to government misconduct. The judge said both parties should file new briefs regarding the dismissal of the convictions of the Lindsey defendants.

In other judicial news, questions were raised regarding the impact of the Supreme Court’s decision striking down Vermont’s data mining law. The technology website, Ars Technica questions if the decision will have an effect on behavioral advertising, like that used by Google. Likening the use of prescriber data in product detailing to the use of browser history data being used to feed ads while on line, Ars Technica questions whether the decision set precedent that using such data is not a privacy issue.

The legislative branch’s interest in Medtronic’s financial relationship with surgeons involved in clinical trials of the company’s spinal surgery product continues to make the news this week.

Since we are celebrating our nation’s independence, it is only appropriate that we give a nod to our friends across the pond. Seeking to advance the discussion of social media, the ABPI has issued a whitepaper and its own guidance around the handling of adverse events received through social media and company sponsored websites. This comes in advance of expectations of new government guidance regarding pharmacovigilance due in 2012. Well done! Necessity is the mother of invention.

The anti-corruption topic du jour has to be the implementation of the UK Anti-bribery on July 1. While companies scramble to prepare for the Act’s implementation, questions have been raised as to whether the Special Fraud Office (SFO) will have the funding needed to enforce the new law.

Finally we bring it back home to our own anti-corruption bill turned law, the FCPA. TrustLaw reports that at a recent conference on FCPA compliance, the topic of BRIC countries posing FCPA challenges was discussed. Each country has its own business environment challenges, which can lead to potential FCPA violations. Training and documenting that training was recommended for employees and contractors a company may have working in country. As it turns out, PharmaCertify can help you with just that.

That concludes our star-spangled edition of the PC News week in review. We the people of PharmaCertify hope you enjoyed the review this week. Now go out and fight for your right for some elbow room at the beach, barbeque, fireworks viewing or other festivity of your choice!

HaHave a safe and wonderful Independence Day!

Happy 235^th Birthday USA!

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!