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.

Well, William and Catherine got to the church on time this morning in England, and what a lovely wedding it was. Best wishes to the happy couple. Now that the obligatory royal wedding reference is out of the way, onto the compliance news week in review.

The big news of the week was the presentation of arguments before the U.S. Supreme Court regarding Vermont’s data mining law. The case, Sorrell v. IMS Data Inc., centers on whether the law violates IMS’s first amendment right to free speech. The state of VT contends that the prescribing information IMS sells to pharmaceutical companies ultimately causes the state to pay higher healthcare costs by having to pay for high priced branded prescription drugs (um…okay), and hence the law prohibiting the sale of this data.

The Supreme Court is expected have a decision in the case in June. In the mean time, Vermont Law School professor, Cheryl Hanna, has an interesting perspective on the case. She asserts the state doesn’t stand much of a chance as the law itself is full of problems. Even those justices one would presume to be more receptive to the state’s argument expressed concerns with the intent of the law.

Also on the state law front is the news that the Massachusetts House voted to repeal the state’s gift ban to physicians (and the restaurant industry said “Amen!”).  Proponents of the repeal say the ban has done nothing to lower healthcare costs, has driven away medical meeting business and halted the growth of businesses in the state. Those in favor of keeping the ban dispute the notion that the law stymied growth, and argue that the law is needed to prevent conflicts of interests. Now it’s up to the MA Senate to decide if the law should be repealed.

Obviously, state laws continue to impact the pharmaceutical industry. We can help you keep your team up-to-date on these laws with our State Reporting and Disclosure Laws training module.

A couple of settlements were announced this week. The first was by the wholesaler, Cardinal Health. Cardinal agreed to pay $8M to settle allegations of violations of the federal Anti-kickback Statute. Brought by former pharmacy owner (and ex Kansas City player), Daniel Saleaumua and consultant Kevin Rinne. Saleaumua claims that Cardinal Health paid him $440,000 in exchange for an agreement to purchase drugs for his pharmacy from the wholesaler. Apparently, the government pays almost as well as Cardinal. The two whistleblowers will share an award of $760,000. Par Pharmaceuticals also announced that it had reached a settlement in principle, for $154M, to resolve claims related to price reporting in a case brought by Ven-A-Care Pharmacy. Par is just one of several manufacturers named in the Ven-A-Care suit.

As most of you know, earlier this month the CEO of Forest Labs received a letter from the OIG saying it intended to exclude him from participating in the federal healthcare programs. If the exclusion is enacted, the CEO will need to leave the company in order for Forest Labs to continue to participate in federal healthcare programs. The Wall Street Journal (subscription may be needed) reported this week that the exclusion is based on a little-used executive policy in the Social Security Act, which allows the government to exclude executives of healthcare companies found guilty of misconduct. The executive does not have to have been involved in, or even be aware of, the misconduct, in order for the policy to be enacted. The letter came on the heels of Forest’s final settlement with the government over marketing practices related to two of its antidepressants. The CEO was not alleged to have done anything wrong during that investigation.

This week also marked the start of the trial for an ex-GSK lawyer accused of obstruction, making false statements and falsification of documents related to an FDA inquiry into promotional practices of GSK’s drug Wellbutrin SR . During the opening arguments, the prosecutor categorized her as a lawyer who went too far in protecting her client. The defense argued that she acted in good faith in responding to the inquiry.

Since we led off this week’s wrap up with a mention of the royal wedding, we’d be remiss in not reminding everyone of some fireworks occurring on our country’s shore; the final launch of the space shuttle Endeavor. Sadly, today’s launch was scrubbed, but it is tentatively scheduled for Monday. The Endeavor mission will mark the second to last mission for the space shuttle program.  Good luck and Godspeed to the crew!

That’s our news for the week. Until next week, follow us on Twitter for daily news postings and visit us at www.pharmacertify.com to learn more about our off-the-shelf and custom compliance training solutions.

The PharmaCertify Team

For many of you, today is Friday, so we’re bringing you the news review a day early this week. If you are actually having Thursday on a Thursday, we hope you enjoy our little summary early, and hey, for kicks, read it again tomorrow. What would Friday be without it, right? On to the news….

To start, we’ll wind back to last Friday, with the news that the former InterMune CEO, Mark Harkonen, was sentenced to 6 months of home confinement and ordered to pay $20,000 in fines for his wire fraud conviction in the Actimune scandal. The government was asking for a 10 year prison sentence, but the judge said the government had failed to prove the press release at the center of the case had actually caused harm to anyone.

Our next case proves that doing the right thing does pay, but maybe it should just pay better. Last week we told you about the settlement of the false claims case against Mequon, the maker of Dr. Comfort inserts and shoes for diabetics.  One of the whistleblowers, a manufacturing worker, received a reward of $800,000, which after taxes and lawyer fees, will net the man about $250,000. Meanwhile, an executive of the company received a $4 million reward for his part in the case. While the manufacturing worker is happy to have received a reward, he is not happy that someone who he felt was part of the problem received immunity from the government and now has a substantial share in the award.

Ultimately these two individuals went to the government on two separate issues related to the case.  Each filed his own qui tam suit about a month apart. The government felt both cases had merit, and the two were combined and each individual received a share of the reward. It just so happened that the executive had the better paying dirt.

The hit parade of stories about local doctors being paid by pharmaceutical companies and the evils of these arrangements continued this week. On the hot seat this week were central FL doctors. When is sweeps period over?

Not to be out done, the Association of the British Pharmaceutical Industry is requiring companies to make public what they pay to physicians in consultant fees. This requirement is a part of the ABPI’s updated Code of Practice for the Pharmaceutical Industry, which becomes effective on May 1. Healthcare professionals will also be required to declare their ties to the industry when speaking or writing on behalf of a company, and companies will have to ensure the disclosure is made.

While we’re across the pond, Deloitte released the results of a poll in which 73% of respondents said they were not familiar with the provisions of the UK Bribery Act, which becomes effective July 1 (or 1 July for the internationally minded). Not surprising, considering the confusion that exists as to whom this law actually applies.  Deloitte conducted the poll during a webcast centered on remaining compliant with the FCPA while doing business in Brazil, Russia, India and China.

Back in the good ol’ U.S. of A., a Stanford University report calls in to question the safety of off-label use of an expensive blood clotting drug. The drug is supposed to be given to hemophiliacs, but the Stanford report found the majority of the drug’s use is off-label for non-hemophiliac patients undergoing certain surgical procedures. Due to the powerful clotting ability of the drug, researchers are concerned that  patients are at risk of developing dangerous blood clots, endangering the patient’s health with no notable benefits.

That’s our shortened week in the news. Enjoy your Good Friday, Earth Day and Easter holidays! We’ll see you right back here next Friday.

For those who are heading to SPBT in a few weeks, be sure to attend our workshop on compliance training, with Cinda Serianni of Gilead! To learn more about our suite of compliance courses, covering topics such as FCPA, On-label Promotion and the False Claims Act, visit www.pharmacertify.com.

The PharmaCertify™ Team

It’s April 15, and it’s not tax day! What a way to start out a Friday! Here’s the week that was in PharmaCertify compliance news.

There were more developments this week in the FCPA case against Lindsey Manufacturing. The judge in the case heard arguments to dismiss, on the basis that the law was not intended to apply to employees of entities like the government run power company in Mexico. The defense argued it was not the intent of the Act to include such entities in the definition of “foreign official,” and to include them made the law untenably broad. The judge disagreed, and held that the employees of the power company were indeed foreign officials, under the FCPA.

Also on the FCPA front, Grant Thorton and Ethicspoint teamed up to write a whitepaper on 10 common misconceptions that could expose companies to FCPA violations. The DOJ has made it clear that FCPA is an area of priority for them, and has even created special units to investigate possible violations.  The misconceptions range from “my ethics and compliance program is already clear” to “provision of travel expense is common place in my industry.”

In settlement news this week, J&J agreed to pay $78M in fines to both the U.S. and U.K. to settle bribery and kickback charges. The investigation arose after a self-disclosure by J&J, and the U.S. authorities praised the drug maker for its cooperation and remedial efforts. Other pharma companies have announced they are subject to similar investigations. Are we on the verge of seeing similar settlement announcements?

The week also found individuals entering into settlement arrangements. The former CEO of Mequon agreed to plead guilty to mail fraud and pay $27M in fines for improper Medicare reimbursements to the company. The company makes Dr. Comfort shoes and inserts for diabetics. The plea and fines come as a condition of sale of the company to DJO Global Inc. In addition to possible jail time, the CEO will be barred from participating in federal healthcare programs, and the company will enter into a CIA with the OIG.

In the words of Gomer Pyle, “Surprise, surprise, surprise.”  Just weeks after the case was dismissed, a former GSK lawyer was re-indicted on charges of making false statements and obstruction in connection to an investigation of the company’s marketing practices. The trial is tentatively scheduled to begin next month.

On the state forefront, two members of the Ohio General Assembly introduced legislation that would create an Ohio False Claims Act. The legislation, which has the backing of state AG, Mike DeWine, would make the submission of fraudulent reimbursement claims illegal and give the Attorney General’s Office investigatory authority. The law also includes a Whistleblower provision, allowing whistleblowers to collect a portion of the recoveries and protect them from retaliation by their employer.

In North Carolina, a bill has been introduced that, according to Attorney General Roy Cooper, will jeopardize the state’s ability to receive recoveries in Medicaid and other settlements. The AG warned that if passed, the bill would cost the state hundreds of millions of dollars in settlements over illegal marketing and other violations.

Our final story is so full of twists, turns, and scandal, that if hadn’t appeared in the Wall Street Journal, you’d swear it was a plot line of one of the soaps ABC canceled this week.

A Portland, OR neurosurgeon had his operating room privileges revoked in the wake of a controversy of unnecessary surgeries and his business relationship with the medical device distributorship that supplied him with spinal implants. In a previous article, the WSJ found that the surgeon in question was performing spinal fusion surgeries at ten times the national rate. In the latest developments, the WSJ found the surgeon had a business interest in the distributorship that supplied him with the spinal implants. Apparently, the distributorship paid the surgeon a “dividend” each time one of its spinal implants were used. Both the OIG and CMS have stated that this type of business arrangements (known as physician-owned distributorships, or PODS) may violate the Anti-kickback Statute. The surgeon has denied that he performed unnecessary surgeries and that he has a business interest in the medical device distributorship.

That’s the PC news roundup for this week. Remember, PharmaCertify offers training on a variety of commercial compliance topics, including the Anti-kickback Statute, False Claims Act and the FCPA. Please visit www.pharmacertify.com for more information.

Until next week, keep an eye on this blog, and don’t forget to follow us on Twitter.

Enjoy the weekend!

The PharmaCertify™ Team

There were a couple of interesting items this week on the international compliance front. First, an important FCPA case featuring a small family owned business in California. Employees at Lindsey Manufacturing are accused of giving a yacht and a Ferrari to executives at the state owned Mexican power company. The executives say they had no idea that their sales representatives in Mexico used the money they were given in this manner, and they are seeking their day in court.

At the center of this case is the question of who is “a government official.” In many countries, the lines are blurred between private enterprise and government agencies. The case also sends a message that small companies are just as much a target as the large multi-nationals when it comes to the DOJ pursuing FCPA violation charges. Since Lindsey Manufacturing can no longer get credit from suppliers or vendors due to the charges, the company has nearly been driven out of business.

The Lindsey case points to the clear need for smaller companies to be sure their employees and agents have been trained on the requirements of the FCPA, and that executives in these companies are aware of what their agents are doing.

The UK Ministry of Justice and Serious Fraud Office (SFO) recently released guidance on the UK Bribery Law going in to effect this year.  Unfortunately, the guidance has not proved to be particularly helpful in the minds of UK consultants working in this area. According to a report in Operational Risk and Regulation (registration required to view), the guidance does clear up some questions, but other gray areas, including exactly who this law will affect, are not clarified.

Back in the U.S., CMS held a teleconference this week with stakeholders, including representatives from PhRMA, BIO and AdvaMed, on the pending regulations for the Physician Payments Sunshine Act. Industry representatives answered with a resounding “No” to the question of whether additional spend categories and requirements should be included in the regulations.

Discussion also included clarification of how payments that could be reported in multiple categories should be handled, and expanding the types of providers on which spend must be reported. The latter being proposed by a consumer-advocacy firm based in Massachusetts, where the law requires companies to report spend on Nurse Practioners and Physician Assistants. A representative from AdvaMed urged that context be provided as to the nature of the payments since patients could easily misinterpret the relationship between a company and the physician, without an explanation of why the payment was made.

The DOJ filed a compliant against Healthpoint Ltd. for False Claims in relation to reimbursements for an unapproved drug. The government claims Healthpoint stated their drug was eligible for Medicare and Medicaid reimbursement, despite the active ingredient being declared ineffective and having its market approval revoked by the FDA in the 70s. The statements caused millions of dollars in ineligible claims to be paid.

In the resolution of a similar case, Pennsylvania received its $1.8M payout from a government settlement with two pharmaceutical manufacturers over False Claims resulting from claims submitted for unapproved drugs. Like the previous compliant, the drugs involved in this case were not approved as safe and effective by the FDA and therefore not eligible for reimbursement under Medicare and Medicaid.

Are the days of the in office meal and physician consultants coming to an end? Very possibly. Spend disclosure requirements have become more widespread, and now with the passage of the Sunshine Act, doctors are questioning whether it is time to sever ties with the industry. As we know in the compliance world, just the perception of “wrong doing” is enough to raise an eyebrow, and doctors are feeling the same way about the perception of a conflict of interest in their relationships with pharmaceutical companies.

A study published in PLoS Medicine, concludes that most common off-label marketing practices are the ones most difficult to control through regulations. The study authors analyzed 41 off-label complaints brought by whistleblowers and found that there are three primary goals of off-label marketing. The researchers found that to achieve these goals, companies employed a variety of “internal” methods that encouraged off-label promotion. Methods included setting sales quotas which could only be achieved if products were marketed off-label and evaluating patient files for possible off-label uses of drugs. The cases reviewed were either settled or unsealed between 2004 and 2010.  While the authors admit the information contained in the documents could not be verified as accurate, they believe their research may help in developing better regulations.

And finally – To double glove or not to double glove, that is the question. Infection Control Today deals with the myths and the truth around the protection double gloving provides. The article presents compelling evidence that double gloving does provide additional protection against accident sharps sticks and glove failure without compromising dexterity. So the next time you have blood drawn, you may want to insist the nurse, phlebotomist etc. double glove!

That’s the PC news roundup for this week. For those of you attending CBI’s West Coast Aggregate Spend Forum next week be sure to attend Kim Life’s (subject matter expert for PharmaCertify’s State and Federal Spend and Disclosure Requirements module) session, Strategies and Best Practices for Aggregate Spend Training.

Please visit us at www.pharmacertify.com for more information on training topics such as On-label Promotion and Bloodborne Pathogens.   Until next week, follow us on Twitter.

Enjoy the weekend!

Peggy Whitmore

R-Squared Services & Solutions, Inc.

The Foreign Corrupt Practices Act (FCPA) bribery provisions apply to U.S. companies and citizens, foreign companies listed on a U.S. stock exchange, or any person acting while in the United States.  While determining whether the law will apply to a particular person or entity may depend on the particular facts and circumstances of the situation or relevant relationships, and may well depend on differing legal theories (for example, technically the law does not apply to foreign subsidiaries of U.S. companies but the Department of Justice has taken the position that it does), U.S. companies can be held liable for the actions of their employees and agents.

A company may be held responsible even if it does not explicitly approve an employee’s or agent’s improper actions, but simply goes along with the actions; or if a third party responsible for a bribe is deemed to be the company’s agent because the company has “effective working control” over that third party.  As such, it is a good idea to train employees and agents about FCPA prohibitions and their obligations to prevent and refrain from engaging in bribery.

The PharmaCertify™ Team

To borrow a quote from Yogi Berra, it was déjà vu all over again with this week’s big story. The long awaited release of guidance from the FDA regarding use of social media by industry was delayed…again.  The FDA gave no timeframe as to when to expect their guidance.

Other activity from federal agencies this week included an announcement from HHS that training would be offered to the state attorneys general on how to file HIPAA lawsuits. The HITECH provision allows states to bring lawsuits regarding HIPAA violations. For your reading pleasure, the OIG posted updated CIA information.

In the Federal Court of Appeals for the 4^th Circuit, a divided court held up a lower court’s ruling that the secrecy provision for False Claims Act suits brought by whistleblowers does not violate the public’s right to access court proceedings. The court said the provision does not prohibit whistleblowers from discussing the fraudulent actions which are at the center of the suit, but just from revealing that a qui tam lawsuit has been filed.

In state news, the Kentucky Attorney General, Jack Conway, announced a $10.2M settlement with Alpharma USPD, Inc. and Purepac Pharmaceutical Co. over inflated Average Wholesale Pricing.

This week both Pfizer and GSK released information about monies paid to physician for their services as consultants, speakers, clinical trials and for other items. And speaking of aggregate spend, if you missed our webinar “Practical Strategies and Tips for Aggregate Spend Compliance Training” with Kim Life, it is now available at pharmacertify.com.

Across the Pacific, the chief executive of industry group, Medicines Australia, says the “industry feels besieged” in the wake of a slew of new laws aimed at the industry. The Medicines Australia chief believes these laws will make it even more difficult for the industry to compete in the world market, hurting the $4B export market in Australia.

In an interview, former DOJ deputy chief, Mark Mendelsohn, says the trend toward prosecuting individuals for violations of the Foreign Corrupt Practices Act is likely to continue. A subscription is required to read the full Wall Street Journal article.

That’s the PC news roundup for this week. Remember, PharmaCertify has the subject matter expertise and solutions you need to train on critical compliance topics like HIPAA, On-Label Promotion and the FCPA. Please visit us at www.pharmacertify.com for more information. Until next week check out our blog, and follow us on Twitter.

Enjoy the weekend!