The PharmaCertify™ Team

Big news coming out of 30 Rock this week. Did you hear? The Today show hyped a big announcement last week. Then Monday we found out. It was a brilliant set up. We thought for sure Mr. Lauer would take his leave of the Today show, but no. The big news: Where in the World is Matt Lauer is back for its 10^th installment! Really? That’s it? Well, we here at the PC News have a “big” announcement of our own! We won’t make you wait too long either. However, a small amount of suspense is needed. It wouldn’t be a “big” announcement if there weren’t some suspense, right? As you wait on pins and needles, we give you this week’s PC News Week in Review.

We start the review with a company who is not playing games. Par Pharmaceuticals has filed an action in federal court saying FDA regulations violate the company’s first amendment rights in promoting one of its drugs. The company wishes to promote the drug for on-label uses to physicians who are prescribing the drug for off-label use. Makes sense right? Apparently, because these physicians don’t prescribe the drug on-label, the company can’t promote the drug on-label to them without violating regulations. If that doesn’t have government operation written all over it, what does?

Speaking of the FDA, it was game over for a former chemist with the agency this week, as he pled guilty to insider trading and providing false financial disclosures to the FDA. According to court documents, the chemist made profits or avoided losses totaling $3.8 million using information to which he was privy in his role at the FDA. In the plea agreement, the DOJ agreed to a prison sentence between five and seven years. However, sentencing will not occur until January. The chemist, who has agreed to pay back his illegal gains, could face additional fines.

Public companies, privately held companies; everyone gets to be “it” when it comes to FCPA enforcement. FCPA enforcement actions are up 300% over the last 10 years. While the headline making cases (Seimens for example) tend to be those involving public companies, the majority of individual charges brought since 2008 have been against employees or representatives of privately held companies.

As much fun as the FCPA is, we can’t forget about its cousin across the pond, the U.K. Bribery Act. With the Serious Fraud Office looking for a high profile case, and statements about working closely with the DOJ for potential overlap, it begs the question, is there a big anti-bribery bulls-eye on the pharma industry?

There’s no need to feel that we here in the US are the only ones on the hot seat when it comes to the scrutiny of the financial relationship between healthcare professionals and the industry. A former pharma sales rep in Australia shares all about lunches, speaking fees and marketing tactics with the press. The usual calls for disclosure and changes to codes of conduct follow.

Back here in the good ol’ USA, a professor at the Yale School of Medicine has devised a medical model that promotes the release of all clinical trial data by pharmaceutical companies. He believes this level of transparency in the industry will improve medical care by allowing physicians to completely evaluate if a drug is best for his or her patients. The professor was able to persuade Medtronic to adopt this approach, and he will be meeting with more executives from the industry in December to discuss his model.

Abbott had a couple of big announcements this week as well. Most notably, the company will split into two companies. One company will be a diversified medical products company, and will retain the Abbott name. The other company will be a research-based pharmaceutical company to be named later. In less exciting news, a financial statement showed that Abbott has reserved $1.5 billion to settle a pending off-label case.

A former Guidant sales rep is awarded $2.3 million of the $9.25 million settlement of a False Claims Act suit against the company. The suit charged the company over charged the government for pacemakers and defibrillators.

We’ll wrap this week’s new up with a client alert from Morrison and Foerster, LLP, which recommends that companies consider evaluating their current procedures and processes for physician compensation, in light of risks they may face complying with the Physician Payments Sunshine Act. The data that the law requires to be reported is the type of information typically used in pursuing violations of the Anti-kickback Statute and False Claims Act.

Well that brings us to the end of this week’s review. We hope you had a great weekend pumpkin picking, tailgating or collecting pieces for McDonald’s Monopoly game (anyone out there have Boardwalk?) What? Oh yeah, our “big” announcement…

We here at the PC News have been thinking that the name of our weekly review is, well, dull. Who better than our readers to give the weekly review a great name? So, put your creative caps on and help us give this publication a great name. If you’re attending the upcoming PCF Compliance Congress, stop by our booth with your suggestion. If you won’t be there, stay tuned for more details about how to submit your suggestion. Just think, your name could live for perpetuity on the Internet. And if that isn’t reward enough, well there just might be something else in it for you as well. Keep following us on Twitter (www.twitter.com/pharmacertify) and reading the PC News Week in Review to find out. (We HAVE to leave you with a little suspense!)

The PharmaCertify™ Team

Oh happy day! It’s finally here…iDay! The new iPhone is available! Granted, the iPhone 4S was met with a lukewarm reception by some of the technorati, but the lines formed early this morning anyway. Hey, if the Woz is willing to wait in line for one, it can’t be all bad, right? So while you wait for yours (or are sitting comfortably somewhere laughing at those who have camped out), here’s this week’s PC News Week in Review to keep you occupied.

Facetime with Apple good; face time with judge, not so good. A Washington doctor was sentenced to pay $12,700 in fines and restitution for gifts he accepted from Guidant (a unit of Boston Scientific). The judge said the fine represented every payment the doctor had received from the company. While $12,700 is no small change, this guy certainly wasn’t at the top of Pro Publica’s list of these types of payments. However, the doctor in question worked for the federal government, where accepting payments and gifts over $20 is prohibited.

It was a slow quarter for DDMAC (make that the OPDP) in terms of enforcement. The office issued only four letters; two warning letters and two Notices of Violation. The letters covered both digital and printed media, and dealt with a variety of issues, including unsubstantiated claims and promotional of an investigational drug.

Lawyers are finding a way to “jailbreak” HIPAA for consumers affected by security breaches of their personal health information. HIPAA offers no recourse for consumers to sue covered entities when their information is exposed, but lawyers are finding avenues to sue using state privacy laws.

A couple of stories from the “we’ve got an app for that” file: First, in the wake of the Mediator scandal in France, the French National Assembly has approved a law that would fine advisers to the country’s regulatory agency for failing to reveal conflicts of interest. The law must still be approved by the French senate. If it passes, the law would also require companies to maintain a public register of payments and agreements with those involved with health care. Shades of Sunshine, no?

Also taking a cue from pharma are veterinary medicine schools. Many of the schools are concerned about the influence gifts and meals from feed and pharmaceutical companies may have on decisions made by students and faculty. Some vet schools have created policies that ban or restrict the provision of meals and free products to students and faculty, and require faculty to disclose any relationships they have with these companies. The American Association of Veterinary Medicine Colleges recently adopted a set of ethical guidelines, in the hope that colleges will use the document to develop their own policies.

A new benchmarking survey has revealed that the increase in FCPA enforcement is causing businesses to upgrade their anti-corruption operating systems. The study surveyed over 100 companies globally in areas such as internal audits, procedures in acquisitions, and third-party intermediaries.

If you’ll be doing some Halloween costume shopping after waiting in line for the new iPhone, the FDA has a word of warning for you. Beware of decorative contact lenses. Yes, that set of vampire or werewolf eyes may permanently cause damage if they are not worn, handled or fitted properly. The agency says there is nothing inherently dangerous with the lenses, but they should be purchased from, and fitted by, a qualified healthcare professional and not through a costume store or other outlet. The agency says a qualified professional can also provide proper instruction in care and handling of the lenses.

We’ve reached the end of this week’s review. For those still waiting in line to purchase that phone, we hope you’ve at least moved up a few spaces since you started reading.

One more reminder: The PCF Compliance Congress is scheduled for November 2-4 in Washington DC. Don’t forget to get your early bird discount by registering through PharmaCertify!

Have a good week everyone!

The PharmaCertify™ Team

It’s October and the frost will soon be on the pumpkin, the dreams of a World Series dance in the heads of some lucky baseball fans, and we lament the seemingly earlier and earlier arrival of holiday decorations in our shopping malls and on our city streets.

But before you stress over the prospect of being inundated yet again with the familiar barrage of holiday advertising and mall crowds, let’s take a few minutes to kick back, sip a bit of warm cider and fall into another edition of the PC Week in Review, with the United States Navy Concert Band’s performance of October, by composer Ed Whitacre, for musical accompaniment.

Senators Grassley and Kohl expressed their own bit of October surprise as they joined the chorus of voices questioning whether and when the rules pertaining to the Sunshine Act will be finalized. The October 1 deadline for drafting those regulations came and went without a word from the Center for Medicare and Medicaid Services (CMS). The Senators sent a letter to CMS questioning the agency on the implementation of the provision requiring manufacturers and group purchasing organizations to report all ownership or investment interest held by physicians or members of their family. CMS promptly deflected the blame onto the Office of Management and Budget, saying that agency is responsible for publishing the rule. Oh what a tangled web we weave.

It takes more than ghost and goblins to frighten the University of Rochester Medical Center…it takes the American Medical Student Association (AMSA). With what the organization describes as “the goal of removing drug companies from the practice of medicine,” the AMSA issues grades to American medical schools for their conflict-of-interest policies. The group gave URMC a C on its most recent report card and URMC responded by implementing new rules intended to plug the holes in its policies. The results: gifts from pharma and med device companies are banned and the use of free drug samples is permitted only in limited situations.

According to a new study, 60% of drug companies avoid the gray area of compensating key opinion leaders (KOLs) for the preliminary work associated with consulting services. The study, from Cutting Edge Information, found that the companies are hesitant to compensate for the time spent preparing for a consulting engagement to avoid any potential fines for overpayment. 100% of the companies surveyed did report that they compensate for any travel expenses associated with the consulting services.

If it’s October, it’s the beginning of a new fiscal year for the OIG and it’s time for the release of the OIG FY 2012 Work Plan. The agency posts a new plan every year and in great length (about 165 pages) it explains the activities the government will be monitoring throughout the fiscal calendar.

On the anti-bribery front, FCPA investigations often start where the buck stops. A new study, by Chadbourne and Parke LLP, reveals that top corporate officials are frequently the target of FCPA investigations. In fact, more than one-third of the 61 individuals who were the subject of government investigations under the FCPA in the last six years were top officials in their respective companies. Good anti-bribery training starts with the FCPA and that’s why more clients are utilizing the content in our Essentials of the Foreign Corrupt Practices Act module as a starting point for their comprehensive training.

Speaking of the FCPA, we wonder, if the recipients of a bribe aren’t identified as government officials, should a bribery conviction be dismissed? A Haitian man, who was convicted along with a co-defendant for conspiring to violate and violation of the FCPA and money laundering laws, filed a motion arguing that the government’s evidence was “to show that he knew that Haitian government officials were bribed.” Unfortunately for the defendant, Carlos Rodriguez, and his lawyers, defense lawyers in other cases have not had success in arguing that US has adopted too broad of a definition of “foreign official” to include anyone working for a state-owned enterprise.

Well, that’s it for another edition of the PC News. As we head into the final three months of the year, and you evaluate your 2012 training plan, remember, PharmaCertify offers the custom, and off-the-shelf training modules and mobile apps you need to truly integrate a culture of compliance into your company.

Have a great weekend everyone, and for those of you with baseball teams still in the hunt, good luck. For everyone else waiting for a championship or for finalization of details of the Sunshine Act, hope springs eternal and there’s always next year.

The PharmaCertify™ Team

Shut out and shut down. No, not the Atlanta Braves or Boston Red Sox with their spectacular season ending meltdown, (we can see where one might think that); we’re referring to the NBA’s season opener and who knows how many more regular season games. Contract talks between players and management went no where on Tuesday, so the lockout continues and the season opener appears done for. The good news is both sides are meeting today, so fingers crossed folks. As we wait with baited breath to find out whether we’ll have the joy of seeing Justin Timberlake and Jack Nicholson sitting courtside at Lakers games, check out what news dribbled in here at PC News. Let’s kick off this week’s review. (wait, that was a football reference!) Ally oop! Here we go.

With the full court press on against the financial ties between physicians and the industry, a psychiatrist stands up to point out the educational benefits physicians receive from attending company sponsored education event. The physician, a paid speaker himself, spoke of the positives of learning how colleagues are using certain drugs. He also says talking to other physicians at these programs allows physicians to identify side effects once the medications are used in the “real world.”

HHS’ Agency for Healthcare Research and Quality (AHRQ) is calling a foul on the off-label use of atypical antipsychotic drugs. The AHRQ released an article saying research shows little evidence that the drugs are effective for anything other than the use for which they are approved. Doctors prescribe antipsychotic drugs to treat other conditions such as insomnia and eating disorders. There was some evidence that three drugs in the class were effective in treating dementia, general anxiety disorder and OCD. Beyond the specific drugs cited for the specific conditions, there was no evidence that atypical antipsychotics were effective at treating those same conditions or other conditions for which they might be used off-label.

Federal prosecutors are hoping for a slam dunk this time as the second FCPA sting trial got under way this week. Defendants in the case are accused of bribing foreign officials of Gabon in order to secure lucrative arms contracts. The “foreign officials” were actually FBI agents. Defense lawyers accuse the government of inventing a crime and claim their clients are victims of a shoddy, overzealous investigation. The first trial ended in a mistrial after the jury could not reach a verdict.

Cephalon may find itself in “contract talks” with the government again over off-label promotion allegations. In an SEC filing, the company disclosed it had received a subpoena from the US Attorney’s office for records related to a leukemia drug. No comment from Teva as to what impact, if any, this development will have on its acquisition of Cephalon.

A couple of FCA settlements were announced involving medical device companies. Guidant will lay up (err…lay out) $9.25 million to settle allegations it failed to provide promised warranty services on its defibrillators and pacemakers. Durable medical equipment supplier Hill-Rom will pay $41.8 million to settle allegations it submitted claims for its bed support surfaces for patients who did not qualify for the equipment.

During her comments at the Advanced Medical Technology Conference, HHS Secretary, Kathleen Sebelius, said the government would like to see improvement in the medical device approval process, but more resources would be needed. This means higher user fees. She credited the implementation of a user fee program in the pharmaceutical industry for speeding up the drug approval process. The government and medical device industry have been in talks over a new user fee, but no progress has been made.

The possession arrow is now pointing back to Kentucky in its lawsuit against Purdue Pharma over OxyContin. The state and Pike County, KY filed suit against the company in 2007, alleging the company lied about the addictive nature of the drug, thereby costing the state and county millions in healthcare and law enforcement costs. The case was moved to a federal court in NY in 2008. The Kentucky AG argued that the case should be sent back to Kentucky, and a federal judge in NY agreed.

The shot clock is about to run out on CMS. Regulations for the Sunshine Act are due by October 1! Hope they make it. Vermont marketing disclosure reports are also due October 1. It’s the last state report due for the year. And speaking of state and federal disclosure laws, PharmaCertify can help you train the folks in your organization affected by these laws as well as state laws which prohibit or ban the provision of gifts. Our State and Federal Spend and Disclosure Laws is designed to allow your reps to focus on just the laws that apply to them.

We’re nearing the final buzzer on the work week, and we are happy to let the clock just run on out. Hope you all have a great weekend, and we’ll see you right back here next week for the PC News Week in Review.

Lauren Barnett

Compliance Specialist, PharmaCertify™

Recently, the Financial Times published the results of an analysis of physician spend data conducted in conjunction with a pharmaceutical industry data firm. Publically available data showed that last year firms spent $437 million on meals, speaker fees, travel and the like. A few days later, Pro Publica updated its Docs for Dollars database. Their total for last year was $220 million.

Quite a difference, no?

The Financial Times article went on to say that data thus far this year showed companies had spent $150 million, which put the industry on pace to outspend the previous year. The Pro Publica report in particular was followed by the media hysteria over the amount of money doctors were receiving from physicians. Some local publications reported that spending on doctors in their states was up. One reported doctors were actually paid less.

While it’s entirely possible that companies are spending more, it‘s a bit of a wild west situation in terms of the data being reported at this point. The Financial Times referenced the lack of consistency in the data, with some companies reporting direct spend only and others including spend through institutions. Further, there is the issue of aggregating the data. Over time, the process of collecting and reporting the data is likely to improve. As the number of companies dedicated to helping manufacturers gather the data grows, so too does the accuracy of that data, and the appearance of an increase in spending across the industry.

Perhaps we’ll have a better sense of the state of the financial relationship between physicians and the industry once the Sunshine Act comes on line and all companies are reporting the same information. Until then, I suppose there is some value in evaluating the data now. The recent Pro Publica release did show some interesting changes at the company level, and there is something to be said in knowing your doctor “made the list.” I for one would like to know my doctors at least rate a deli platter for an occasional lunch and learn. If not, I’m asking questions. However, the media hysteria that typically follows this type of report should be dialed down a notch, until there is some consistency in the data.

The PharmaCertify™ Team

Something new and exciting was in the air this week. Or rather on the airwaves. The new TV season kicked off! Finally, after a summer of re-runs and reality shows, the new comedies and dramas (oh, okay, and more reality) are back to entertain. There will be more premiers next week, but in the meantime let us entertain you with this week’s PC News Week in Review.

Are doctors largely avoiding Law and Order when it comes to kickback cases? Avoiding may be a strong word, but despite the lawmakers’ feelings on the topic, doctors are generally not prosecuted when pharma companies are charged with violating the Anti-kickback statue. Why?  One reason cited by an article in the Washington Post was that doctors are not an attractive target for a prosecutor. Doctors face the loss of their license as well as prison time, and thus are willing to spend heavily on their defense. Other reasons include the difficulty in proving a doctor was recommending a product because of a kickback and not because he or she believes in the product, and, prosecutors simply being burned out after dealing with the pharmaceutical company side of the case.

It appears that states Attorneys General are not embracing their authority to bring cases for HIPAA violations with Glee. Since being granted the authority in the HITECH Act, only two AGs have brought cases forward. Rather than use the authority granted them under HIPAA, AGs are choosing to prosecute cases under their states’ own consumer protection and privacy laws.

It’s not Gossip, Girl (a little creative license with the punctuation). The FDA has created some drama (e.g. reorganized) and has turned DDMAC in to the Office of Prescription Drug Promotion. Like any good makeover, the OPDP has more power and authority than it did as DDMAC. The OPDP will have one division dedicated to promotion to physicians and a division dedicated to DTC advertising.

Are you a Modern Family, opting for video chat over that old school technology called the telephone? If so, rest assured that calls you make from your iPad to your doctor are HIPAA compliant. Apple announced that calls made using its FaceTime program are HIPAA compliant with the right network security set up.

Out for Revenge possibly? Two Harvard professors have authored a paper denouncing that changes be made to the FCPA as suggested by the U.S. Chamber of Commerce. The paper’s authors believe changes would undermine the anti-corruption progress that has been made. In particular, the pair call out the compliance program defense and the Chamber’s assertion that a company shouldn’t be held liable for the corrupt activity of a subsidiary.

And if that last story didn’t have the anti-corruption X-Factor you were looking for, check out this video from Main Justice. Main Justice sits down with former head of the SFO’s Business Fraud Group to discuss enforcement of the Bribery Act.

The president of a French pharmaceutical firm may find himself Up All Night for a while as he was placed under investigation this week as part of a probe surrounding an anti-diabetic drug produced by the company. The president and founder of Servier Labortories is under investigation on suspicion of dishonest practices, deception related to the drug’s safety, and falsely obtaining authorization to sell the drug. The drug was largely prescribed as weight loss drug, and its use is being linked to the deaths of 500 people in France.

While we are certainly happy for the new fall shows, we’d be remiss if we didn’t remark on the sad ending of a show that has been around for 41 years. Today marks the last episode of ABC’s daytime soap opera, All My Children. Good-bye Erica Kane and Pine Valley!  It was a great run, and you’ll be missed…evil twins and all.

That brings us to the end of our broadcasting day. Before we sign off, we have a question: what are you doing to renew your compliance training this fall? Do you have a “time slot” to fill with a new topic or maybe there just needs to be a shake up in your current line up. Either way PharmaCertify can help with our selection of off-the-shelf and custom eLearning modules on topics ranging from Aseptic Technique to the PDMA and Sample Management.

We’ll see you right back here next week. Same bat-time, same bat-channel. Have a great weekend!

The PharmaCertify™ Team

Ah, a short work week. Thank you Labor Day! However, this September day is bittersweet as we bid the carefree days of summer and wearing white shoes good-bye for fall. As the weather turns cooler we do have the turning of the leaves and all the great fall activities to look forward to, so it isn’t all bad, right? As we look forward to the fall and all it brings, let’s take a look back at the week that was in the PC News.

Pro Publica has updated its Docs for Dollars database. According to their analysis, $220 million was paid by pharmaceutical companies to doctors for meals, travel, speaking fees, and other services. Then like leaves in the fall, local news stories began drifting down. In Massachusetts, payments to doctors actually fell. Oregon doctors received $5.8 million from Pharma companies and in Tennessee that number was $20.8 million.

The lack of fair balance in ads for products cross promoted on Liptor.com left DDMAC feeling a little cool and resulted in an untitled letter being issued to the drug’s maker. The complaint, which came through DDMAC’s Bad Ad program, dealt with the “online resources” section of the website which cross-promoted three other drugs as “Medicines that may treat Heart Disease Risk Factors.” Links to the drugs’ websites were provided, but DDMAC did not feel that did enough to address the risks associated with drugs.

The U.S. has joined in a False Claims Act whistleblower suit against Par Pharmaceuticals. The suit alleges the company conspired with pharmacies to switch prescriptions for a generic acid reflux drug from the cheaper tablet form to the more expensive capsule form to get around Medicaid price limits.

Across the pond, the first person to take the fall under the U.K. Bribery Act is a magistrate court employee. The individual is accused of soliciting £500 in exchange for influencing the direction of criminal proceedings against a person charged with a motoring offense. Interestingly the charges were not brought by the Serious Fraud Office, the lead prosecutorial agency for offenses under the Act, but through the UK Crown Prosecution Service. It is expected the CPS will handle domestic cases.

Also in the Old Country, the European Federation of Pharmaceutical Industry Associations (EFPIA) says it believes virtually all data from clinical trials should be published once a medication has been cleared for marketing. The EFPIA communicated its position in a response to a guidance document on the topic put out by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA).

According to recent statistics, healthcare fraud prosecutions are doing anything but falling. Analysis by the Transactional Records Access Clearinghouse shows that the number of healthcare fraud prosecutions is on track to increase 85% in 2011.

We’ll wrap up the news with a report from the Office of Civil Rights. The OCR released information that since the implementation of HITECH in 2009 there have been 30,000 reported data breaches affecting nearly 7.9 million individuals. Major breaches, those that affect more than 500 people, represented less than one percent of the total breaches reported. The most common cause of a breach was theft.

This brings us to the end of the PC News in Review, and just a bit closer to the end of the work week. We would be remiss if we did not acknowledge the tenth anniversary of the September 11^th attacks that occurs this weekend. Still today, seeing the images from the day brings back that exact feeling of shock and heartbreak. However, in all the tragedy we were reminded of the bravery of first responders who ran toward the danger to help, and the heroism of everyday Americans who fought back on a plane to save people they didn’t know hundreds of miles away. We saw the immediate outpouring of help from fellow Americans through donations of time and money to help those affected by the tragedy and those working at Ground Zero. So as we go about our weekend let’s all take time to remember those who were lost, and be thankful to live in a country that despite any differences we may have, the citizens become united as one in the face of adversity. God bless America.

Just as summer has dwindled away we find ourselves here at the end of this week’s PC News Week in Review. If your fall plans include a refresh of old or adding new compliance training, we can help. Our off the shelf e-learning modules cover compliance topics from the FCPA to the PDMA for both pharmaceutical and medical device companies. Check us out at www.pharmacertify.com.

Enjoy the weekend!

Lauren Barnett, Compliance Specialist

The Huffington Post recently ran an article by Maggie Kozel, M.D., that raised the usual and customary issues involved with gifts physicians receive from the industry. Dr. Kozel believes the relationship between the industry and physicians does impact the cost of healthcare, and she praised the inclusion of the Sunshine Act in the healthcare reform law. One of the troubling areas cited in her article was the industry’s support of CME. While she does concede the industry has taken steps to separate support of these programs from marketing, she is concerned about the nuanced influence resulting from the physician speakers crafting their presentations around disease treatment, rather than prevention. The inference here is that the industry, which is about treatment, is influencing the doctors doing the speaking. She closes the section with the following:

“To justify industry insertion into the medical education process because educating doctors ultimately benefits the patient is like allowing soft drink vendors into schools because that will help fund after-school sports. The means shouldn’t run counter to the end.”

Call me crazy, but this sounds like Dr. Kozel is calling for the industry to be removed from CME. To this I ask, if the industry isn’t providing support, who will? According to a report from the ACCME, industry support has fallen for a third year in a row representing 37% of total funding. Additionally, advertising and exhibit hall revenues from companies are down as well. The study also points out that as industry support has dwindled, the number of programs available is dropping and attendance is rising. With CME being required by most states, I suppose physicians have no choice but to deal with what will be the rising cost of these programs.

Perhaps increasing the number of online programs would keep the costs reasonable. Of course this does not change the issue with the speakers. Asking CME providers to accept only speakers who have no financial relationship with the industry shrinks the pool of viable candidates to the point of being unrealistic.

I do agree with Dr. Kozel that transparency in the relationship between the industry and physicians is a good thing. That being said, eliminating industry support of CME is tantamount to cutting off your nose to spite your face. The industry has made great strides in separating the grant-making function from influence by sales and marketing. Thanks to the Sunshine Act, if people are concerned that a speaker’s remarks are being tainted by industry, they’ll have access to data on the payments that particular physician has received from a specific company. Completely removing the industry from CME simply does not benefit physicians and ultimately hurts patients.

The PharmaCertify™ Team

We’re a little bit early this week, but with good reason. We’ve got to head to the grocery store, and the sporting goods store and get the portable grill and folding table all cleaned up to get ready for Saturday – the start of the collegiate football season!! Finally, the day has arrived! Noon to midnight football on network and sports channels galore! Have we died and gone to heaven? We think so. (Okay some of us think so. Check that…the person writing this thinks so, and he who writes the review, speaks for the group.) However, before we (I) get busy with the tasks at hand, there is the important business of this week’s edition of the PC News Week in Review. Fire up the band, get on your feet and cheer, ‘cause it’s game time!

Let’s kick this off with a story that has a football twist. Well, actually it’s a football story with a compliance twist. After his recent activation from the physically unable to play list, Peyton Manning made the following comment about his recovery from neck surgery, “I don’t know what HIPAA stands for, but I believe in it and I practice it.”  Well, Peyton, we’re pretty sure HIPAA doesn’t preclude you from sharing information about your condition, but props for referencing the law. (By the way, it stands for Health Insurance Portability and Accountability Act.) We hope that the change in Peyton’s playing status means he’ll be back in DSRL action soon as well!

An article in the Canadian Medical Association Journal is calling for Health Canada to take a page from the United States playbook. The article is calling for public disclosure of clinical trial results to the public. There are laws that prohibit Health Canada from releasing companies’ trade secrets, so the clinical trial results, which could be valuable to physicians and the public, are not known.

Down…set…has there been a hike in the dollars spent by the industry on doctors? According to an analysis by the Financial Times and a pharmaceutical industry data provider, it looks like that might be the case. The analysis shows that nearly $150M has been spent on physicians so far this year. The majority of the data is from the first quarter, and represents a potential increase in spending over last year. We’ll let the clock run down on this one before making a call as to whether spending is really on the rise.

The co-founders of the Digital Healthcare Coalition are adding their voices to the crowd calling for the FDA to issue guidance on the use of social media. In an interview with CNET, the two founders said the FDA not only needs to issue guidance on the matter, but also that guidance should be specific. Vagueness will not work in the world of social media and the lack of certainty from the FDA is causing too much inaction. According to the Digital Healthcare Coalition, nearly 90 percent of the industry is not willing to experiment in social media.

According to MedAd News, industry insiders are saying the penalty flag that was dropped against Bayer over tweets on its UK and Ireland pages does not necessarily signal that the industry should be out of the social media game. While the regulations in the US present their own challenge, the situation with Bayer points more to the cultural differences between the UK and the US regarding drug advertising and the regulatory differences between the two countries.

It’s a turnover for CardioNet. The cardiac monitoring company was asked to turnover documents dating back five years in relation to a false claims act investigation by the DOJ. The company said it could not predict the course of the investigation, which stems from claims that the company used inappropriate diagnosis codes when submitting Medicare claims for its monitoring services. The company’s fans reacted with boos and a stock sell off of over 20% on the day the investigation was announced.

That’s it for this week’s PC News Week in Review. Remember, if you’re looking to complete your company’s commercial compliance game plan with up-to-date training on topics ranging from the Anti-kickback statute to state and federal physician spend disclosure laws and everything in between, hustle over to www.pharmacertify.com to see a demo of our modules.

Whether or not your weekend plans involve tailgating and cheering along with 100,000 of your closest friends, either in person or on television, we hope you have a great long holiday weekend. Be safe and go team!

The PharmaCertify™ Team

To borrow quite liberally from Carole King, did you feel the earth moving under your feet this past week? Will the sky be tumbling down on you this weekend?  Earthquakes (yes, plural, Colorado had one the same day as Virginia) and now a hurricane on the way. It’s a busy week for Mother Nature, and full week for us here at the PC News Week in review as well. Make sure everything is secure around you, and let’s get going!

The DOJ is trying to shake some change loose from the defendants in the shot-show FCPA trial. In a filing Wednesday, the DOJ said it was changing the way it will produce material for the defendants in the case. The DOJ has contracted with a third party vendor to store all the material related to the trial and the defense will now have to pay to access the material. The government, at its own expense, will produce trial-related material to the relevant defendants. Material not relevant to a defendants’ trial will have to be paid for. Guess the $500M recovered from Google for directing the ads of Canadian pharmacies to U.S. consumers was just not enough to meet the budget needs.

A new survey finds doctors like attending dinner programs, if you keep it bouncing along and leave time for Q&A. The survey conducted by Sermo shows that nearly three quarters of the respondents like to attend speaker programs at medical meetings, and just over sixty percent attend traditional speaker programs. Interesting was that 27% said they don’t attend speaker programs due to the transparency movement in the industry. Wonder if that changes when the Sunshine Act goes in effect?

And speaking of the Sunshine Act, one M.D. is praising the transparency it is bringing to the industry-physician relationship. In her article, Maggie Kozel rolls out the case on how everything from providing drug samples to support of CME, influences physicians’ decisions. She goes on to point out that slowly the profession is recognizing the influence of the industry. Professional organizations are taking steps to raise awareness among their members about the influence even small gifts have on decision making, and the number of offices banning sales reps and samples is rising.

Physicians could find themselves on shaky ground if they aren’t prepared for the increased scrutiny that will be brought by the healthcare reform law according to comments made by a lawyer to a group of ophthalmologists. The new law drastically increased the money spent on enforcement, and provides for stiffer penalties under the Anti-kickback statute and False Claims Act. Medicare and Medicaid overpayments can now be considered false claims if they are not repaid within 60 days, and to catch those overpayments the government will be starting a special audit program. The same lawyer also spoke to the group about the reporting required by pharmaceutical companies under the Sunshine Act.

AstraZeneca breaks new ground with their physician spend reporting database. The company announced this week it was expanding the payment and support information it reports on its U.S. website. The company will include all direct and indirect payments made to physicians for meals, travel and the like as well as payments (both direct and indirect) made to clinics, hospitals or physician groups engaged in pre-clinical and clinical studies.

Don’t mess with Texas (or the Feds) when it comes to Medicaid and Medicare claims. The state’s AG announced a $24 million settlement was reached with Par Pharmaceuticals over the inflated drug prices to Medicaid. And just to prove that saying applies to cracking down on its own cities, the state joined the federal government in collecting $1.69 million from eleven Texas cities for false claims against Medicare and Medicaid.

That brings us to the end of this week’s PC News Week in Review. If your compliance training could use some shaking up we can help out with everything from games to off-the-shelf customizable eLearning on topics ranging from the FCPA to state gift ban and disclosure laws.

For those of you facing Hurricane Irene this weekend, batten down the hatches, be safe and try to stay dry. For the rest of you go out and get some extra enjoyment out of the weekend for our friends along the east coast.