Lauren Barnett, PharmCertify™ Compliance Specialist

We’ve all seen the headlines: “[insert state/city here] Doctor Paid thousands By the Drug Industry.” The reports tend to appear just after an update of Pro Publica data, or during a ratings sweeps period, and I can certainly understand why. Nothing is more titillating than knocking a revered person, like a doctor, down from his or her pedestal in the community with innuendo of unscrupulosity (see Don Henley’s song, “Dirty Laundry” for more details). In reading the articles over the last several months, I have noticed an interesting trend. When the paper or local television station reaches out to the named physicians for a comment, they either get no comment at all, or the doctor explains that he or she has dialed down the practice of accepting payments from pharmaceutical companies. I can’t say as I blame them.

With CMS finally publishing the rules for Sunshine, I’ve been thinking about the coming flood of information about what pharma, med device and bio companies spend on physicians, and what the publication of this information is going to mean to physicians. Back when the Sunshine Act was an annual legislative threat that most felt would pass, there was discussion among my colleagues about how (or if) we should discuss the matter with physicians. So, now that Sunshine is a reality with data collection to begin soon, I wonder: What are companies planning to do to inform healthcare providers about the Act?

Should this be something the industry should even tackle? Yes, I think so, in some small way anyway. The reports are coming from the industry, so educating the physicians on what will be reported and when the reports are due is warranted. That said, I think this would be a great topic for the OIG to tackle in its video training series, or perhaps they could reach out to CMS to help them provide similar training. Considering that the regulations couldn’t be published on time, I probably shouldn’t hold my breath, eh? The HCPs need to know about Sunshine and although there are number of articles about the Act on the AMA’s website, they’re not easy to find.

What are your thoughts on the topic? Should companies feel the need to educate physicians about the Sunshine Act? If you’re in industry, have you already done so, or do you have plans to provide materials explaining Sunshine and its ramifications to healthcare professionals in the future?

The PharmCertify™ Team

The big day is almost here. Are you prepared? Do you have your list ready? Have you been working out? What about that aluminum pole? Yes, your aluminum pole…it’s Festivus of course! It’s just a week away, and there’s so much to prepare. However, the news doesn’t stop just because Festivus is almost upon us. So we’re taking a break from our list of grievances to bring you this week’s PC News Week in Review.

We’ll start out with what can only be described as a Festivus miracle! (Well, it didn’t really occur on Festivus, but you get the point). CMS released the Sunshine Act regulations this week! (cue the Hallelujah Chorus). The regulations are posted and open for comment through February 17, 2012. After which, CMS will write the final rules. Data collection is postponed from the beginning of 2012 to once the final rules are posted. This being the case, CMS is proposing that manufacturers submit a partial year report in March of 2013. Data will be available to the public in September of 2013. For more on the proposed rules, check out R-Squared’s summary here (registration required). You can read the rules in their entirety here.

At a panel discussion hosted by Main Justice.com, lawyers representing the government and the healthcare industry discussed the future of healthcare law enforcement. No feats of strength style wrestling matches occurred (wouldn’t you have paid to see that?!), but there was healthy discussion covering some of the options the government would be using in the future. New data analysis software has already been put in place to find fraudulent Medicare and Medicaid claims. Meanwhile, a representative from HHS said that despite backing off the debarment of Forest Lab’s CEO, the agency isn’t taking that option off the table for future cases. In fact, a bill before Congress would expand HHS’s legal authority to exclude executives from participating in federal healthcare programs.

Even if HHS has backed off ever so slightly in holding executives accountable, the DOJ and SEC have heard the cries from lawmakers that individuals need to be held accountable. This week, the DOJ indicted six former Siemens executives and two intermediaries for conspiracy to violate the FCPA. In other news of personal accountability, the Synthes executive whose sentencing was delayed when his lawyer collapsed in the courtroom received an eight month prison sentence.

With that, we kick off the Airing of Grievances portion of the program with news of the government’s grievances against Medtronic leading to a $23.5 million settlement for kickback allegations.

Meanwhile, Allergan and Los Angeles county health officials aired their grievances about billboards that tout Lap-Band surgery but do not disclose any of the risks associated with surgery. The FDA issued a warning letter to a company known as 1-800-GET-THIN and several surgery centers associated with the marketer.

Some French politicians have grievances with the country’s regulatory system, and are calling for widespread changes to assure patient safety and rid the system of conflict of interests.

And back in the U.S., federal authorities are set to air grievances against a group of New Jersey doctors who they say accepted illegal kickbacks for referrals to a specific MRI center. Perhaps these doctors should share this OIG video intended to educate providers about the Anti-kickback Statute as they gather around the Festivus aluminum pole.

If a video from the OIG isn’t exactly the kind of tale you’d like to share with your family and friends around the pole, then perhaps this summary of the top stories of the year about the medical device industry is more to your liking.

2011 is quickly coming to an end. With new regulations for Sunshine and the increased enforcement of anti-corruption laws both here and abroad, training early and often is an important consideration for 2012. PharmaCertify helps you address  training on topics likes the FCPA, anti-bribery, state and federal disclosure promotion and on-label promotion. Our solutions range from off-the-shelf and customizable eLearning modules, to iPad apps and reinforcement tools. Check us out at www.pharmacertify.com/compliance.

That’s the News for this week. We hope you have a lovely weekend, and a Merry (is that right word?) Festivus. And if you’ve been wondering all along, “what is this Festivus craziness,” here’s a link to the Seinfeld episode that started it all.

Cheers!

The PharmaCertify™ Team

The holiday season is in full swing and it’s time to enjoy all of those wonderful family the traditions. Perhaps one of your traditions is curling up on the couch with the family to watch all of the Christmas specials and movies that make their annual appearance on television. Sure, most are available on DVD these days, but somehow it isn’t quite the same as gathering the troops on that one night when your favorite movie airs. But before you go home to scan the channels in search of the Island of Misfit Toys or the friendly streets of Whoville, warm up with this delightful tale of the news that was in this week’s PC News Week in Review.

Postal workers in Britain are having their Christmas tip Scrooged out from under them, thanks to the UK Bribery Act. It seems the postal service has put postman on notice that if they accept a Christmas tip of more than 30 pounds, they and the well-meaning person giving the tip could be accused of bribery, under the UK Bribery Act.

Want the whole world to know your blood sugar levels the way all of Bedford Falls knew about George Bailey’s legal trouble? Well, maybe the whole town won’t know, but if you use medical apps to track and store everything from your blood pressure readings to your medications, you may be surprised to know your personal information is not protected by HIPAA. Unlike a physician, app developers are not subject to HIPAA, and therefore any data stored by a developer is not subject to the law’s security or privacy provisions. Consumers need to check the privacy policy of the developer, because unless otherwise stated, the data could be sold.

The DOJ has filed an appeal after the dismissal of the Lindsey Manufacturing FCPA case last week. The judge cited “flagrant” misconduct by the prosecution as the reason for the dismissal. The DOJ may be looking for a Miracle on 34^th Street though since the appeal has to be approved at three levels before it can even move forward.

The dismissal of the Lindsey Manufacturing case was cited by another FCPA defendant in a motion before a court in Texas. The defendant in the Texas case is arguing that prosecutors cannot include evidence of the bribe involving a Ferrari and a yacht in his case since it was used in the Lindsey case. Both companies used intermediaries headed by the same person and the Ferrari and the yacht were not the only similarities between the two cases.

Quick! Hide Frosty the Snowman! Senators and Kohl and Grassley are calling for Sunshine. The Senators have called a hearing for December 15 titled, “Parting the Clouds: Implementing the Physician Payments Sunshine Act.” The purpose of the hearing is to discuss the release of the regulations and the impact of delaying those regulations.

Call out the Coal Elves; the industry is still Naughty vs. Nice when it comes to off-label marketing according to a Harvard study. Researchers reviewed past cases and noted that off-label prescriptions did not trail off until after settlements were announced. They claim that the current enforcement efforts are not enough of a deterrent to quell improper off-label marketing. The study recommends bigger fines and additional resources for enforcement.

They don’t need Twitter or a fancy Facebook. They just want simple resources at which they can look. For the Europeans down in Europe contests have no meaning, but information about diseases and conditions will leave them beaming. To the industry they say, “No thanks, we’re just not interested in your social media today.

Pfizer will no longer be Home Alone in deciding how to allocate funds for medical education. The company will split its medical education grants into two tracks. The first track will require an RFP submission and a board of outside, expert advisors will make decisions about the grant awards. The other track will be for unsolicited grants involving only live national or regional meetings.

Wrapping (pun intended) up the news is KV Pharmaceutical’s settlement with the government for $17 million to settle false claims allegations. The allegations stemmed from the now dissolved KV subsidiary, Ethex. The government alleged that Ethex misrepresented the regulatory status of two of its drugs.

That brings us to the end of this week’s PC News Week in Review. Now, go on home, pop some corn, make some hot chocolate and watch the Christmas movie or special of your choice. Have a great weekend everyone!

The PharmaCertify Team™

Black Friday, Cyber Monday, did you survive? More importantly, did your credit card survive? Bumps, bruises and carpal tunnel syndrome aside, it has been a hectic ride so far for shoppers and retailers alike. However, now it’s time to gear up for round two of steals, deals and early morning lines. Until then, kick back and relax with a hot cup of coffee, cocoa or tea and this week’s PC News Week in Review.

Are sales reps working for “discounted” wages? The Supreme Court will take up the question of whether pharmaceutical sales reps should be paid overtime. At issue is the question of whether sales reps fall into the “exempt” category, which would preclude them from receiving overtime pay. The case was brought to the high court by two GSK sales reps on behalf of a larger class of sales reps from the company. The court will hear arguments in the spring.

You might be shipping some of those gifts you bought for industry colleagues a little bit farther away in the near future. A new study finds that bio, pharma and med device companies are increasingly finding homes outside the “traditional” locations of the Northeast Corridor and the San Francisco Bay area of California. Proximity to research institutions, a highly educated workforce and real-estate prices are just some of the factors for the move to other locations. Areas seeing a growth include Los Angeles, Minneapolis, suburban D.C. and Atlanta.

As we scour the papers for great deals, Serious Fraud Office director, Richard Alderman is scouring his files for high-impact Bribery Act cases. Rather than chase cases that offer quick, immediate rewards, the SFO chief says his office going after the cases that truly put UK based companies and their employees at risk. With that in mind, what can be learned from the recent and first sentencing of an individual under the Act?

If you want to stay off the SFO’s naughty list, then training is your first line of defense, according to an article by two lawyers from Pillsbury Winthrop Shaw Pittman LLP. The article provides twelve tips on developing an anti-corruption compliance program. Beyond training early and often, the authors stress the importance of focusing on local labor laws, assuring data privacy challenges are addressed by jurisdiction and developing good whistleblower protections.

Back on this side of the Atlantic, the Lindsey Manufacturing executives found guilty of violating the FCPA back in the summer appear to have received an early gift from a federal judge. The judge is set to dismiss the case against the two due to government misconduct during the investigation and grand jury proceedings.

Roche has agreed to pay $20M to settle a whistleblower suit that alleges the Genentech division promoted a drug off-label and offered kickbacks to physicians.

Failure of the federal government to monitor state agencies prescribing psychiatric medications for children in foster care has prompted a Senate investigation. Some of the children are on as many as five psychiatric medications at once, and these medications are often used off-label. Similarly, an OIG investigation raised concerns over the overprescribing of atypical antipsychotics in nursing homes. The study found there was widespread off-label use of these drugs to treat dementia.

The USF Medical College is joining the long line of med schools with policies aimed to curb conflicts of interest with the industry. The dean of the medical school told the Board of Trustees the move is intended to address the nationwide problem of industry companies paying physicians to promote their products. Last year, the school received a “C” from the American Medical Students Association for its policies on dealing with conflicts of interest.

Walgreens, Kroger Company and other large retailers have sued Pfizer (Wyeth) and Teva for violating anti-trust laws. The companies allege that the two drug makers have conspired to keep a generic version of Effexor off the market.

One sure way to make the PC News is to quote Spinal Tap in an article. We wrap this week’s News up with an article from Drugwonks.com that does just that. Peter Pitts presents 11 (it’s one louder than 10) principles for the healthcare industry to participate in the social media.

Well, that’s it for another News in Review. Remember, with all of the recent focus on corruption and bribery,  tools like our customizable, off-the-shelf FCPA module are more critical than ever as you plan your 2012 anti-corruption program.

Now, it’s time to lace up those running shoes, strap on the shin guards and head out for more Holiday sales. Be careful out there everyone!

The PharmaCertify™ Team

“Over the river and through the woods to grandmother’s house we go!” Okay, let’s face it, sometimes, it’s more like, “On the highway breathing fumes and watching the tail lights glow.” Ugh, the Thanksgiving commute – horrible whether you’re trying to get to grandma’s or just home from work. The joy at the end of that commute though is a long weekend having fun with family and friends – and eating until you just can’t move. As you bide your time this weekend, take a gander at this week’s PC News Week (short as it may be) in Review.

Senators Baucus and Grassley are not talking turkey. Concerned about possible violations of the Anti-kickback Statute, the senators sent letters to Quest Diagnostics, Lab Corp of America, Aetna, Cigna and United Health. The concern is centered on the practice of insurers steering lab tests to certain labs in exchange for pull-through discounts or payments. The senators have asked for copies of contracts with high volume providers. The inquiry was prompted by recent cases in New York and California.

Pfizer may need to lower its Black Friday shopping budget a bit. The Wall Street Journal reports sources familiar with the company’s FCPA settlement negotiations say the settlement will exceed $60 million. The company expects a public announcement regarding the settlement to be made by the end of the year.

The first person charged with violating the UK Bribery Act was sentenced to six years in prison. In October the court clerk pled guilty to one count of violating the UK Bribery Act and one count of misconduct in public office. The violation of the Bribery Act carried a three year sentence which will be served concurrently with a 6 year sentence for the misconduct charge.

While receiving a prison sentence doesn’t seem like something for which to be thankful, it could be worse if you consider a former pharmaceutical executive was sentenced to death in China just a couple weeks ago. Three of the four former Synthes executives were handed prison sentences by a federal judge earlier this week. The case against the executives was brought under the responsible corporate officer doctrine in the wake of an illegal clinical trial of a bone cement. Each pled guilty to a misdemeanor and agreed to pay a fine. Federal sentencing guidelines recommend up to a six month prison sentence, but the judge handed two of the executives a nine month sentence and one a five month sentence. The lawyer for the fourth executive collapsed during the proceedings, delaying his client’s sentencing. The lawyer was released from the hospital and back at work the next day, but sentencing has yet to be rescheduled.

Those who are worried that the payments doctors are “gobbling” up are influencing their prescribing decisions may want to take a listen to this doctor from Montana. He feels no obligation to use the medications of the company for which he speaks, and even if he wanted to use a company’s products, insurers dictate which medicines he can prescribe.

Some states attempting to pass their own version of the federal False Claims Act are routinely finding their efforts sent to the kids’ table. Repeated attempts in several states have been met with objections that such laws are not cost-effective since they require significant resources to investigate, and part of the recoveries need to be turned over to whistleblowers.

Whew! Don’t know about you, but we could use a rest now. For a short week, we certainly still got our fill of news. We hope you all have a safe holiday weekend at grandma’s house or wherever your holiday plans take you, and that your long weekend is filled with the four “F’s”: food, family, friends and fun! Happy Thanksgiving everyone!

The PharmaCertify™ Team

The wedding of the century…did you see it? We’re not talking about Kim and Kris (you can stop laughing now) or Albert and Charlene, or even William and Kate. Please! Those weddings were just the warm-up act to the wedding of Bella Swan and Edward Cullen, the heroine and hero of the Twilight series. Yes, the long awaited, much ballyhooed fourth installment of the series, Breaking Dawn – part 1, rolled out at theaters around the country. If you missed out on the early morning nuptials, you have come to the right place. We have something for you just as entertaining and no tissue is needed – this week’s PC News Week in Review.

We’ll start off by sinking our teeth into this story. An attorney breaks down the Sunshine Act for physicians. After an explanation of what the law requires, the lawyer then explains  the downside for physicians. Citing current media “exposés” of the financial relationship between physicians and the pharma industry, he shows how these articles generally paint a scurrilous picture of the relationship between the physicians and the industry. Since Sunshine will link the physician’s name with a dollar amount, he urges physicians to examine the risk of public exposure will have on their business and then take the appropriate action.

In a dramatic twist, a physician finds himself on the business end of an off-label lawsuit. Just who filed this suit? A medical device company. The medical device company, being sued by a patient over the off-label promotion of one of its products, has filed a cross claim against the patient’s doctor for using the product off-label. Pass the popcorn please.

Leader of the medical device approval reform pack, Senator Al Franken, told a group of Medtronic employees that he would be introducing a bill to help speed up the approval process for devices that treat rare diseases. The bill would allow companies to make a profit on these devices (which they currently can’t, unless the devices are used for children), and it would create provisions to allow experts who may have ties to the industry to serve on FDA advisory panels for these devices. Meanwhile, several Republican senators pressed the head of the FDA’s Center for Devices and Radiological Health for answers as to why negotiations for the device user fee have gone nowhere and why device approvals are so slow.

Senator Grassley has sent a request to Attorney General Eric Holder for information about the forthcoming FCPA guidance. Among the expected questions (e.g., when will it be released), the senator asked questions about whether safe harbors will be provided for gifts of minimal value; if clarity would be provided about the extent of liability one company assumes of another’s pre-merger or per-acquisition activities; and if guidance around DOJ’s interpretation of terms such as “foreign official” and “government instrumentality” will also be provided.

Speaking of those “cloudy” legal terms, the former president of a telecom company who received 15 years in prison for FCPA violations is appealing the verdict. His initial defense centered on the definition of “foreign official.”. Lawyers this time are taking the approach that the Haitian telecom involved in the case is actually a private enterprise, thus making the FCPA a non-issue.

You don’t need telepathic, clairvoyant or any other special vampire power to know where the bribes are occurring. Check out this cool interactive map that breaks down FCPA cases by sector, country and amount of money involved. And, in a final bit of anti-corruption news – spoiler alert; The DOJ and SEC say the FCPA investigations are a top priority for the future.

We’ll wrap this week’s news up with a new study that finds reports of adverse events on social media sites are about as rare as a vampire/human baby. A study of 224 pharmaceutical brands across various social media sites found reports of adverse events occurred in .3% of posts that mentioned the brands. Of those, only 14% contained reportable information.

Since we’re talking social media, let’s talk about compliance information on the go. Tablets and smartphones are making the process for sharing and gathering information more portable than ever. Our compliance apps run on multiple platforms and offer your field-based employees access to up-to-date compliance content where they need it most – in the field and on the go. To learn more about our Navigator suite of apps, check out the mobile learning page on PharmaCertify.com.

That brings us to the end of this week’s review. As exciting as the release of the near final chapter of the Twilight series is, I think we’ll take a pass. Instead, we’ll be saving our entertainment dollars for another long awaited film – the poignant tale of a group of has-beens and their struggle to climb back to the top. We hope you enjoy your weekend wherever it takes you!

The PharmaCertify™ Team

Today is 11-11-11 and the superstitious among us are scurrying about getting married or at least buying lottery tickets. Today is also the last binary day, a date in which no digit exceeds one, (as long as you don’t write out the full year) of the century. And we even have a little joke to celebrate the day: There are 10 kinds of people – those who understand binary and those who don’t.

Most importantly though today is Veteran’s Day (or Armistice Day if you like to roll old school). Before you head out to your local parade or other celebration, we give you this week’s PC News Week in Review.

Last week we discussed Senator Grassley’s displeasure with CMS’s delay in releasing  the Sunshine Act guidelines. This week we get news that CMS says it will most likely be spring of 2012 before the rules are issued. Wow. Let’s hope they mean early spring. Silver lining: at least we have a date, however nebulous.

Not to be outdone, Leon Rodriguez, the new head of the Office of Civil Rights, testified before a Senate subcommittee chaired by Al Franken of Minnesota about a long delayed privacy and security regulatory update mandated by the HITECH Act of HIPAA. The new chief would not offer a timeline for when the long overdue rules could be expected. This did not sit well with Sen. Franken, who said that electronic health records offered a great opportunity to improve efficiency in healthcare, but those benefits would not be realized until patients could be assured their records would be kept private. Don’t let it get you down though Mr. Rodriguez. Just repeat the wise counsel of Stuart Smalley; “I’m good enough. I’m smart enough, and doggone it, people like me.”

Where oh where has my disclosure report gone? Or, where should it go as the case may be in West Virginia. A rule change has caused the governor-elect to withdraw the rules enforcing the state’s disclosure law. The hubbub appears to center on a 2010 modification that changed how and to what agency the reports are submitted. Umm…okay. Moving along…In Pennsylvania, a proposed False Claims Act for the state sits in committee waiting approval. (Go ahead and sing it; we know you want to. “I’m just a bill, yes, I’m only a bill, and I’m sitting here on Capitol Hill). Wrapping up state-based news, the Congressional delegation from Minnesota has signed a letter urging the FDA to streamline the approval process for medical devices.

Over in the UK, Richard Alderman, the director of the Serious Fraud Office (SFO), has confirmed there is Bribery Act enforcement activity occurring in the office. The SFO is working directly with corporations, and as such, much of the information regarding the cases will remain private for the time being. Mr. Alderman said the office is investigating complicated cases, and not just going after the low-hanging fruit.

In China, the former chief executive of a government-owned pharmaceutical company found guilty of embezzlement and accepting bribes was handed a suspended death sentence, with a two year reprieve. The former CEO is said to have collected around $8 million through corrupt means. Suddenly, that 15 year sentence handed down for FCPA violations a few weeks ago doesn’t seem quite so bad.

And speaking of the FCPA, the DOJ announced that it would release new guidance on FCPA civil and criminal enforcement provisions. The new guidance will be released some time next year.

Ethics and compliance has gone from “geek” to chic. (We always knew it was chic!) The head of the Society of Corporate Compliance and Ethics (SCCE) said that companies are taking a new view of ethics and compliance programs and are growing their departments. He says he has seen an increase in membership in the SCCE, and compliance jobs are among the fastest growing in the country. As Huey Lewis said so may years ago, “It’s hip to be square.”

That brings us to the end of this week’s review. We’d like to end this week’s review by saying thank you to our veterans. It is your sacrifice that allows us to remain safe here at home, and go happily about our day writing fun little articles summarizing the news of the week in the world of pharmaceutical and medical device compliance. May God bless you all.

Sean Murphy

Being an exhibitor who also had access to all educational sessions and panels at the Twelfth Annual Pharmaceutical and Compliance Congress and Best Practices Forum in Washington DC offered me the opportunity to evaluate the conference from the perspective of a vendor, and as an attendee eager to absorb as much information as possible. As a vendor, I applaud the efforts of the PCF and the conference chairs to encourage attendees to visit the exhibit hall and explore the solutions offered by the various exhibitors. Throughout the conference, the foot traffic around our booth was high, and the compliance professionals we spoke with were genuinely interested in how our services and products could be utilized to support their training requirements. From an attendee perspective, I also appreciate the effort to schedule as many sessions as possible in the main ballroom, without concurrent sessions happening at the same time. The separate tracks, with the need to forgo some sessions in order to attend others, did not begin until the afternoon of Day 2, so everyone could take in ALL of the sessions until that point.

Of course, since I couldn’t attend all of the tracked sessions once they did begin, I welcome readers’ comments and commentaries on any I missed, or even on those I attended.  With that, here are some of the highlights.

Day 1, Wednesday November 2, 2011

The highlights of Day 1 included the annual presentation by Mary Riordan, Senior Counsel for the OIG, who led off with the news that the OIG will be hosting a roundtable discussion in early 2012 for companies currently under a Corporate Integrity Agreement (CIA). The meeting is intended to allow the companies to share best practices for dealing with the compliance-related issues and a summary of the comments and suggestions will be posted on the OIG website following the meeting. Stay tuned for more details to come from the OIG on the roundtable session.

When reviewing the OIG’s 2012 work plan, Ms. Riordan reminded the audience that holding individuals, including board members and managers, accountable will continue to be a focus of the agency. She also emphasized the need for manufacturers to implement an active Risk Evaluation and Mitigation (REMS) program to address potential issues as early on as possible.

In a session titled, “Coordinating Pharma Prosecutions,” Joyce Branda, Director, Commercial Litigation Branch, US Department of Justice, updated the audience the audience on qui tam cases and informed the audience that there are currently in excess of 150 qui tam cases under seal and the primary issue is off-label promotion. As Ms. Branda put it, “For those of you who say off-label promotion keeps you up at night, it should.”

During his presentation, Thomas Abrams, Director, Division of Drug Marketing, Advertising, and Communications at the FDA, addressed the “hot topic” of social media guidance from the FDA. The FDA held a two day public meeting at which comments were accepted and the data was reviewed and considered in preparation of the guidance. Mr. Abrams informed the audience that guidance on social media will be based on the issues, not on the platforms. Stay tuned.

Day 2, Thursday November 4, 2011

Day 2 began with Kendra Martello, Assistant General Counsel for PhRMA, offering an update on the Sunshine Act. The bottom line – if you’re looking for any news on the CMS releasing the details regarding the procedures for submitting data, don’t hold your breath.

The Thursday presentation on the FCPA and the UK Bribery Act was particularly compelling considering the emphasis on anti-bribery prosecution by the DOJ and other regulatory bodies around the world. In case anyone forgot, Nathaniel Edmonds, Assistant Chief, FCPA Unit, US Department of Justice, told the assembled compliance professionals that the prosecution of individuals, including sales directors, is a stated goal of the DOJ. Vivian Robinson, Partner, McGuireWoods and Former General Counsel of the UK Serious Fraud Office, described the UK Bribery Act as the toughest anti-bribery regulation in the world and gave four reasons why:

• The regulation applies to both public and private companies
• It applies to the recipients of bribes as well as the individual offering the bribe
• It has no allowances for facilitation of services
• It creates a single offense – failing to prevent a bribe from taking place

Mr. Robinson pointed out that the UK Bribery Act does allow for a defense if a company can prove it has anti-bribery procedures in place and the Administry of Justice website lists the six principles required to demonstrate those procedures are in place.

Colleen Conry, Partner , Ropes & Gray, presented a thorough review of the well known “Lauren Stevens” case. Stevens, former in-house counsel for GSK was charged and ultimately acquitted of obstruction of justice and making false statements in connection with GSK’s response to a voluntary request from the FDA for information concerning the promotion of Wellbutrin. The key takeaways from the presentation included the importance of being transparent with all material no matter how irrelevant you think they may be and don’t assume the matter is closed if you don’t hear back from the FDA for many months.

In an afternoon session dedicated to the annual compliance administration survey by PricewaterhouseCoopers, Keith Korenchuk, Partner at Arnold & Porter, Erinn Hutchinson, Director at PwC and Victoria Browning, Senior Director, Corporate Compliance at Allergan, revealed some of the results of the survey. The topic of training was at the top of most respondents’ concerns as 74% of those surveyed said that education and training is where they spend most of their budget and time. The survey also showed the top five compliance areas of concern as:

1. Sales and marketing
2. Use of third parties
3. Anti-bribery/FCPA
4. Aggregate Spend
5. Expansion to less established markets

I was happy to see the organizers and chairs of the conference created sessions dedicated to compliance for the medical device space. During a session titled, “Compliance Lessons Learned from Medical Device,” the challenges unique to the industry were reviewed by a panel led by Arjun Rajaratnam, Chief Compliance Officer at Smith & Nephew and Sujata Dayal, Corporate Vice President and CCO at Biomet. Gray areas like the questions surrounding a rep’s interaction with a surgeon using a device off-label in the operating room were debated and all agreed that the industry presents challenges very different than those in pharma, and professionals on the med device side need to be alert for the nuances.

Day 3, Friday November 4, 2011

On Day 3, we we’re all back in the grand ballroom and during a panel on the best practices for interfacing between third party vendors and client companies, Emma Boyev and David Young of Quintiles, joined Scott Miller of InVentiv and Don Soong of Cegedim to discuss topics that arise as sales teams are outsourced more and more. The panelists stressed that the days of vertically aligned pharmaceutical companies are over and among other topics, offered thoughts on how to organize training in areas like sample management when a third party relationship is in place.

Based on the comments from the attendees, one of the more anticipated presentations was Michael Loucks’ session title “Reflections on My Transition from Government Service to Private Practice.”  Mr. Loucks,  Partner, Skadden Arps and Former First Assistant US Attorney, shared emails and letters he received from those who felt he should be ashamed to now be representing the industry in compliance-related cases.  No matter how one feels about Mr. Loucks, his practice or his opinions, his transition to private practice has certainly generated passion in the industry and with the public.

What I found to be the best presentation of the conference was saved for the last day and it wasn’t even focused on compliance in the pharmaceutical industry. Richard M. Mullane, former astronaut and Colonel, USAF, Retired, took the stage to offer his presentation titled, Creating a Culture of Compliance and Transparency: Lessons from the Challenger Disaster.” Colonel Mullane centered his discussion around what he referred to as the “normalization of deviance” and presented a clear step-by-step case for how the acceptance of short-cutting best practices that had been established early on led to the Challenger disaster. NASA had proof from earlier flights that the o-rings that failed on Challenger had failed in previous flights, but through rationalization brought on by budgetary and political pressure, repeated success of shortcuts in safety became the norm – with the tragic results we all witnessed being the result. Colonel Mullane left the audience with five tips for avoiding this normalization of deviance in dealing with compliance challenges:

• Realize that you are vulnerable
• Plan the work and work the plan (with allowances for situational awareness)
• When the heat is on, reference the plan
• Listen to the people closest to the plan
• Archive and review near misses

I could never fully explain the impact of Colonel Mullane’s comments in this blog, so I suggest if you ever have an opportunity to hear him speak, run, don’t walk. You can also visit his website at www.mikemullane.com to learn more about the man and his message.

Overall, as an exhibitor and an attendee, I was impressed with the Compliance Congress.  The world of pharmaceutical and medical device compliance is changing rapidly and more than ever, well-organized and researched conferences such as this one are a necessary tool for sharing best practices, experiences and knowledge.

There is a crispness in the air, and leaves (and perhaps snow, depending where you are) are falling. It is a wonderful time of year for sure, and this Sunday marks one of the most joyful days of the year – the return to standard time.  We all get an extra hour of sleep! Oh happiness!  We have some business though before Sleepfest 2011 occurs. Keep the fluffy pillow and warm blanket on hold for now, as we present this week’s PC News Week in Review.

We’ll start this week’s review off with a story from the city that never sleeps. New York City agreed to settle charges that it overbilled Medicaid for $70 million.  The DOJ alleged that the city routinely renewed applications for 24 hour continuous care without a review by a local medical director as required by law. City Attorney, Michael Cordoza, said it was in the best fiscal interests of the city to settle the allegations due to the “highly punitive and draconian application of the False Claims Act.” Insert your own Captain Obvious comment here.

Is CMS sleeping on the job when it comes to producing draft guidance for implementing the Sunshine Act? In a letter to Senators Grassley and Kohl, CMS Administrator Don Berwick said the agency was working on the guidance for the implementation of the Sunshine Act, but gave no timetable when the draft guidance will be ready. Mr. Berwick said the delay was due to an executive order which requires federal agencies to reduce regulatory burden (please, try not to laugh), and the agency was still actively working with stakeholders to that end.  Senator Grassley was not pleased saying nothing new had been revealed and that the response was inadequate.

Speaking of executive orders, the President signed an executive order this week requiring the FDA to take certain steps to help deal with drug shortages. In the order, the FDA is to broaden its reporting of potential shortages; speed up approval of applications to change production of drugs headed for shortage; and inform the DOJ of suspected price gouging or collusion.

At the Pharma Congress Mary Riordan said the OIG would not be “falling back” on holding individuals accountable when it comes to healthcare fraud. The same holds true for FCPA investigations. More investigations of individuals for books and records violations of the FCPA are on the horizon.

Also at the Pharma Congress, Assistant Attorney General Tony West discussed healthcare fraud enforcement. In his remarks he cited a number of cases and settlements of healthcare fraud covering several facets of the healthcare industry with the final focus being on cases from the pharmaceutical industry.  As for the future, he indicated there would be a continued focus on individual accountability through use of the Park doctrine. He acknowledged that they know most companies and individuals want “to do the right thing”, and encouraged companies to come forward and self-disclose when problems are discovered.  You can read his full remarks here.

We’ll wrap up this week’s review with the big eye-opener of the week. GSK announced it will pay the U.S. $3 billion to settle criminal and civil investigations which included allegations of illegal marketing and Medicaid fraud. The investigations have been carried out over an eight year period and concern several products.

That does it for the review for this week, but before you run out to buy a Snuggy in preparation for the return to standard time, may we suggest that you stop by the PharmaCertify website first. With healthcare fraud and corruption overseas top priorities of enforcement agencies, we can help you get your teams the information they need with our library of compliance courseware and mobile apps focused specifically on the pharmaceutical and medical device industries.

For all of you in the Northeast, we hope life is back to normal after this past weekend’s snow storm. Now, go get that Snuggy and enjoy your weekend!

The PharmaCertify™ Team

“Did you hear that?” “Sounds like it came from the dark, scary basement that has only one way in or out.” “I think I’ll go down there and check it out – unarmed of course. What could go wrong?”

Ah, the famous last words of more than one victim from horror movies. It is that time of year, when Halloween (insert sequel number here) and Friday the 13^th run practically non-stop on a variety of channels, and we anxiously await the return of the Great Pumpkin. Rest assured, there are no ghosts, goblins or chainsaw wielding psychopaths here at the PC News; just some of this week’s top news items from the world of pharma, bio and med device compliance. So read on good people….if you dare! <click for maniacal laughter>

Let’s start this week’s review with something lurking in the darkness…of physician’s cell phones.

Text messages! Not your average, run of the mill text message, but ones that are sent to other physicians about patients. According to a provider of a secure text messaging platform, around 70% of physicians use text messaging to communicate with other physicians about patients. If PHI is communicated in a text, the physician could be in violation of HIPAA’s security and privacy rules if proper safeguards are not in place.

On to the frightening financial relationship between the industry and physicians. Oklahoma doctors are the latest on the media hot seat based on analysis of Pro Publica’s data. One physician interviewed by Tulsa World said the relationship between the industry and his profession has changed over his 30 years of practice. While he has no problem with information about the financial relationship between doctors and industry being made public, he is concerned the data will be misinterpreted. To that point, the Sunshine Act raises communication concerns for stakeholders affected by the Act.

The former president of a telecom company was handed a blood curdling 15 year prison sentence this week for bribing Haitian government officials. The sentence is the longest one ever handed down in an FCPA case.

A privately held med device company also received a “treat” from the government this week in the form of a nearly $2.4 million settlement over False Claims Act and Anti-kickback violations. The government alleged the company paid physicians for each patient who completed a survey called a User Preference Evaluation. Completion of survey necessitated that the physician use one of the company’s devices, and the majority of the patients involved were Medicare beneficiaries. The government also alleged physicians were provided improper remuneration in the form of travel, expensive meals and entertainment. And if that didn’t give you chills, this just might: healthcare fraud enforcement in 2011 is on track to outpace 2010 by 85%. <click for blood curdling scream >

Next we travel across the dark, murky, foggy waters of the Atlantic to the U.K. where the first individual charged under the U.K. Bribery Act was found guilty this week. The former court clerk could face up to 10 years in prison when he is sentenced in November.

We wrap this up with a word of warning from the FDA: the black licorice which may show up in the trick-or-treat bag can come back to haunt you in a most unpleasant way…especially if you are over 40 (which let’s face it being over 40 is scary enough!). According to the FDA, eating two ounces of black licorice a day for two weeks can lead to irregular heart rhythm. The sweetener used in the licorice, glycyrrhizin, (um…wasn’t that one of Superman’s nemeses?) leads to drops in potassium levels which then leads to arrhythmia, high blood pressure and edema. Medical journals have linked black licorice to health problems in people over 40.

Well that’s the end of this spooktacular edition of the PC News week in review. If you’ll be attending the Pharmaceutical Compliance Congress next week be sure to stop by the PharmaCertify booth (#216) to enter our contest to give this wonderful publication a more fitting name. There just might be something in it for you, plus you get to meet us! We don’t bite…we promise. Seriously, we look forward to meeting many of you next week, and to discussing how we can help you meet your compliance challenges.

This is Halloween time so stay out of the woods, the basement and most importantly, stay away from black licorice as you go about your weekend!