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News Week in Review, October 1, 2012

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The PharmaCertify™ Team

The weather has cooled, fall sports are in full swing, and the World Series is just around the corner. Then there’s that one additional reminder of the change of season: a new television season is upon us. Goodbye to the repeats and summer reality, and hello cliffhanger resolutions! We still have more premieres on the way, but for now we’d like to entertain you with  this week’s News Week in Review.

We begin our broadcast day with the news that Stryker has agreed to pay $1.5 million in legal fees to settle two shareholder suits. Stryker admitted no wrongdoing as a part of the settlement, but did agree to install a committee aimed at preventing violations of the FCPA and False Claims Act, and illegal promotional activities.

Lawmakers and the industry are asking the Administration to end the delay and implement the final rule for the Sunshine Act. Senator Herbert Kohl calls the delay unacceptable. Senator Grassley did not mince words, saying efforts to communicate with CMS had been met with resistance, and it was “[as if] Congress passing a law doesn’t make a difference in this town.” Tune in next week for the continuing drama on “Waiting on Sunshine.”

A Modern Family probably has at least one person who owns a smart phone, and a congressional representative from California plans to introduce a bill aimed to smooth the FDA’s evaluation process of apps for those phones. The bill, if passed, would establish an Office of Mobile Health at the FDA to provide recommendations on issues related to mobile apps and to support developers trying to understand regulations related to privacy. IT industry groups and developers are on board with the formation of the new office as an attempt to foster innovation while protecting patients.

A White House advisory group may have been feeling a little Grimm about the rate at which new drugs are being approved, so a plan was drafted to double the rate of approvals. The plan calls for faster approvals of drugs for high risk patients. The advisory group urged the FDA to use its “accelerated approval” process with more frequency to approve drugs for targeted patient populations. Patient and physician group representatives have praised the plan, saying it protects the public health while giving patients in high-risk situations access to medicine.

Once Upon a Time, Assistant Attorney General Lanny Breuer said the DOJ intended to release new, detailed guidance on the FCPA. Now it seems the promised guidance will be delivered in the next few weeks. (Ahem…CMS…take note) The guidance is expected to be released in advance of the October 10 Organization for Economic and Co-operation and Development meeting. In an interview with Compliance Week, the FCPA Professor, Mike Koehler, says he doesn’t expect there to be anything “groundbreaking” in the new guidance, but it is likely to address newer issues that were not addressed in the previous guidance.

Are Board members Persons of Interest in a corporate bribery investigation? A new survey of BOD members reveals one-third believe bribery is their company’s greatest fraud risk, while 63% believe their personal liability has gone up over the last three years. Two-thirds of those surveyed indicated their company did business overseas, with nearly 60% of those indicating they did business with foreign officials. According the Corporate Fraud Index latest quarterly report, reports of corporate fraud, including those concerning violations of the FCPA and UK Bribery Act, represent 23% of all compliance reports.

It’s Elementary that pharmaceutical and medical device industries face risks when it comes to bribery and doing business in other countries and now someone has created a list of the top five corruption risks. Spoiler Alert! The top risks are: state-owned healthcare enterprises, third-party agents, sponsorship of medical conferences, foreign clinical trials, and “anything of value.” As enforcement agencies focus more on the life sciences industry, training on the risks of doing business outside the U.S. has become even more critical. We can help with the customizable Understanding and Preventing Bribery in the Global Life Sciences Marketplace eLearning module.

Well that rounds out this week’s “broadcast.” Before we sign off, there is one more piece of “news” to bring you. While turning thirty is a milestone that is often looked upon with trepidation, that is certainly not the case in central Florida today, as the fine folks at the Walt Disney World Resort celebrate the 30th anniversary of EPCOT. Congratulations to our friends at “Spaceship Earth!”

Have a great week everyone!

Week in Review, September 24, 2012

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The PharmaCertify™ Team

Well, fall officially arrived on Saturday! Bring on the rich colors, cooler weather, outdoor festivals and fairs, and perhaps most importantly, the end of the growing season for lawns most every where.  If none of this inspires you for the turn of season, perhaps last week’s revival of Starbuck’s Pumpkin Latte will do the trick. As you take time to enjoy this beautiful time of year, don’t forget to schedule a few minutes to check in on the compliance news of the past week, with the News in Review.

Winds of change are blowing slowly in Australia. Medicines Australia’s revised Code of Conduct currently sits with a government regulatory agency awaiting approval. The change under consideration is the reporting of monies paid to physicians for speaking and consulting services, including payments for travel and hospitality while providing those services. If the change is implemented, reports will be published beginning mid-2014. Not everyone is happy. Transparency advocates would like to see individual payments reported, not aggregate payments.

Staying in the South Pacific (where it isn’t fall at all), the Penang Health Department is investigating six pharmaceutical advertising claims involving products for heart and kidney diseases. An enforcement representative said none of the ads received the required regulatory approvals.

Moving on to a cooler climate, a compliance professional in Russia explains what “compliance” means to the Russian pharmaceutical industry. He explains that a successful compliance program is not just about making sure your company is following the “rules” as defined by government agencies, but also involves the proper flow of information. A company needs to have systems that allow the information to flow from the compliance team and back from the organization.

A new study finds that physicians have a skeptical view of clinical trials sponsored by industry. Board certified internists were provided abstracts of results for clinical trials for fake drugs. The physicians were informed that the funding for the studies came from either the industry or the NIH, or there was no disclosure at all. Participants were then asked to offer their confidence in the results of the study and whether they’d prescribe the drug. Products related to those studies identified as funded by industry were less than half as likely to be prescribed as those funded by the NIH.

In corporate fraud cases, whistleblowers can definitely rake in the big cash, but the big dollar awards are rare, according to experts. That’s because most cases involve multiple whistleblowers, and the awards are split among the group. Then the relators’ lawyers and Uncle Sam take their cut. Across all industries, five of the top seven awards went to whistleblowers in healthcare cases. Three of those five are from pharma cases: Pfizer, GSK and Abbott. To keep your team reporting to the compliance office instead of their lawyers’ offices, PharmaCertify’s off-the-shelf compliance modules include topics like open door and anti-retaliation policies and are easily customized to include your hotline and contact information.

A new study finds that 25% of pharmaceutical companies do not have dedicated compliance teams in place. (Color us a bit shocked.) According to the researchers, many of the companies believe that compliance needs to be decentralized in order to be in better contact with the issues “on the ground” so they tasked “function-specific personnel with compliance responsibilities.”   Unfortunately, that approach has resulted in business units being unaware of what other units are doing in terms of compliance polices and processes. The researchers recommend that one individual be assigned to oversee all the company’s compliance efforts, and to draw a line between regulatory and commercial compliance responsibilities.

And with that, we come to the end of this week’s NWR. Enjoy the fall weather everyone and have a great week!

Week in Review, September 17

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The PharmaCertify™ Team

It starts earlier every season, and before long, you’re sick and tired and just ready for all the hype to end. “Christmas sales?” you ask. No. (Although the fact there are trees up and decorated in stores before we’ve even brought out our fall clothes is disturbing.) We’re talking about campaign season. We’ve had enough of all the posturing, the non-answer answers, the ridiculous campaign and PAC ads that run more often than beer ads during a ball game. There should be some sort of rule, law or generally accepted practice that there is to be no campaigning by candidates, or thought provoking messages by PACs, more than six months prior to the first primary! Okay, we’ll step off the soapbox now and move on to news you can actually use: this week’s News Week in Review.

We’ll lead off the NWR with a politician attempting to hold the bureaucracy accountable. Senator Chuck Grassley issued a statement regarding the current status of the Sunshine Act during a roundtable session of the Senate Special Committee on Aging. After some brief background regarding the Act, Senator Grassley expressed his frustration with CMS’s continued delay in releasing the final rule for Sunshine, and their lack of communication regarding the reason for the delay. He even brought up the rumor that CMS has sent the final rule to the Office of Management and Budget (OMB), and the OMB is holding up releasing the rule until after the election. He called on CMS to confirm whether there is any truth to the rumor, and if there is to clear up why the rule is being held. Grassley closed his comments by defending the companies that will have to implement the law by saying companies need the final rule released to assure their systems would allow them to meet the “letter of the law.”

From the halls of the Capitol comes the shocking story that fighting over budget cuts by our elected officials now threatens to hold up the dollars paid in user fees by drug and device makers. In order for the FDA to access the money paid by the industry, it must first receive certain funding from Congress, and the budget stalemate in Congress is delaying that funding.

In news from the FDA, the Office of Prescription Drug Promotion (OPDP) issued an untitled letter to Eli Lilly questioning the use of color on an image of a brain that appeared  on a product website and on promotional materials. The OPDO said Lilly was misbranding the product, a radioactive agent used for PET Scans, because the color images suggest that scans can be displayed and reviewed in color. The prescribing information specifically calls for the use of black and white scale and gives several examples of how to read scans in black and white.

On the political history front, the DOJ has re-released the original FCPA document signed by President Carter and Speaker of the House, Tip O’Neal. A nice slice of history, but what isn’t history is the DOJ’s focus on investigating healthcare companies for potential violations of the law. The medical device industry has found itself squarely in that bull’s eye. An article in Compliance Week examines recent settlements and the risks that make the industry vulnerable to potential violations. The author says the top factor regulators take into consideration during investigations and settlements is a strong culture of compliance within an organization. Robust training is an important part of building a culture of compliance, and we can help with our Understanding and Preventing Bribery in the Global Life Sciences Marketplace module.

Hey, look who’s jumping on the Pinterest bandwagon; it’s pharma! A handful of companies are embracing this rapidly expanding social media platform. Bayer was the first to “pin it,” and now, they’ve been joined by Boehringer Ingelheim and GE Healthcare.

BI also upped the social media game for the industry with the beta launch of its Facebook game, Syrum. The game allows players to run their own pharmaceutical company and develop drugs for a variety of diseases. The company also has a YouTube channel, Twitter feed, and blog focused on the game. The game is in public beta in Europe, with a global launch expected in 2013. We can’t wait to see the FB requests for lab equipment appear in our news feed.

For an executive at a pharma or med device company, being excluded from federal healthcare programs is never a good career move. So the former CEO of InterMune is fighting his five-year exclusion handed down last year. The CEO claims that since his wire fraud conviction had nothing to do with delivering a health care item or service, the OIG had no basis for exclusion. He claims the OIG based the exclusion an unproven allegation of misbranding, for which he was acquitted. The OIG says the CEO is misinterpreting the law, and that a direct correlation between the conviction and the provision of a health care item or service is not required.

That certainly was a big week for political mudslinging, but we’ve hosed off and we’re hoping to evade the muck this week. Oh well, that’s what they make volume buttons for, right? On the bright side, we are one week closer to the election, so it will all be over soon. We can take some comfort in the fact that this sort of craziness has been around since well, since a political system existed in this country. If you think political races of modern times are harsh, take a look at some old school mudslinging.

Have a great week everyone!

Week in Review, September 4, 2012

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The PharmaCertify™ Team

At last, this past weekend was the time to dust off the pompoms and break out the stadium seats! Fall “officially” arrived with the start of the college football season! This is truly the most wonderful time of the year! Decorating the car with magnets and flags, preparing a game day feast for family and friends, and let us not forget the ever important ritual of face and body painting. Good times, good times. After such festivities and a long holiday weekend, it’s hard to focus and get back to work, but we’re here to help kick off this first work week of fall with the News Week in Review.

We’ll kickoff this week’s review with a story of kickbacks. Omincare has struck an agreement in principle in a whistleblower suit that accuses the company, and its owner, of paying kickbacks when it purchased a pharmacy services company. The government declined to join the suit. Omincare has agreed to settle the suit, but the company’s owner has not, and that case continues.

Pharmaceutical sales reps in India haven’t exactly been cheerleaders for their industry, as made obvious by the day-long strike by the Federation of Medical and Sales Representatives’ Associations of India. The group protested against threats to job security, high prices of drugs and corporate corruption in the industry. In a letter, the FMRAI said the effort to shift responsibility for corporate corruption onto sales representatives has led to reps being banned from hospitals and medical institutions. The group says the true corruption is occurring at the corporate level and it is demanding that a statutory code of ethics be enacted.

And now for the halftime show! Taking the field is the American College of Informatimusicology with their salute to obtaining your medical information. Sit back, relax and enjoy the show!

The California Assembly passed a bill that will amend the state’s False Claims Act. The amendment will more closely align California’s law with the federal statute. Changes in the California law include increased protections for whistleblowers, provisions for awards to relators even if those relators were involved in the action that led to a violation, increased penalties for violations, and broadening of the definition of what constitutes a claim. The bill has been sent to the governor for signature.

The much anticipated FCPA guidance from the government appears to be advancing down the field ahead of schedule. Assistant Attorney General Lanny Breuer had said the guidance would be released in November, but now sources say the government will release the guidance in advance of the OECD meeting in October. The release could come this month with the officials from the Justice Department scheduled to speak about the guidance at the National Conference on the FCPA.

Some Georgia men may find themselves wearing a black and white striped uniform, but it won’t be as referees. The Securities and Exchange Commission charged eight men with insider trading related to Sanofi-Aventis buying publically traded Chattem, a pharmaceutical products company. The SEC says one of the men, an accountant, learned of the pending sale from a client who had come to him to discuss the tax implications the Chattem purchase would have on his stock options. The accountant then shared the information with four friends and as the cliché goes, “they told two friends, and they told two friends, and so on, and so on.”  The SEC said the group made just over $500,000 in trades. Four of the accused have agreed to settlements with the government without admitting wrongdoing. Cases against the other four men are moving forward.

Well folks, the clock has run down on this game, and all that’s left is to tune up the band and sing the Alma Mater before we head out of the stadium. We hope your team, high school or college, emerged victorious over the holiday weekend! Have a great, short, work week everyone.

Week in Review, August 27, 2012

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The PharmaCertify™ Team

Time is a ticking on summer with Labor Day just around the corner and now is the time to squeeze in those final cookouts and road trips. Of course, any proper barbecue or cross country trip wouldn’t be complete without a list of great summer tunes. Remember that great anthem that you heard all summer long and brought back great memories when you heard it years later? Well, as you start building this year’s Labor Day weekend playlist of guilty pleasures, we have a bit of “list” to tune up ourselves, the News Week in Review.

There’s been a British invasion over at Shire as the company joins the Association of the British Pharmaceutical Industry (ABPI) as a full member. Regarding the decision, company representatives said, “we seek to play a role in the development and growth of our industry, so joining the ABPI will be one way of contributing to this.”  Shire will also have a representative joining the ABPI Board of Management.

Two congressmen are not singing the praises of the current 510(k) approval process for medical devices. In a letter to the head of the FDA’s Center for Devices and Radiological Health, the pair expressed concern that faulty medical devices are able to reach the market through a loophole in the 510(k) approval process. The congressmen would like to see the FDA’s authority extended to deny approval for devices with designs that are based on devices that have previously been recalled.

On the legal front, former baseball star, Eddie Murray, and Abbott executive, James Mazzo, were indicted by the SEC on charges of insider trading related to the purchase of Advance Medical Optics by Abbott. Mr. Mazzo, former CEO of Advance Medical Optics, is alleged to have shared non-public information regarding the sale with one of Murray’s teammates. Murray learned of the sale from the teammate and profited from the inside information. Mr. Mazzo denies the allegations while Mr. Murray has agreed to a settlement with the SEC, but has denied any wrongdoing.

A former employee at Abbott is whistling an interesting tune about the company’s marketing practices for its cholesterol drug, TriCor. A new whistleblower case has been filed alleging the company used misleading and off-label marketing practices and provided kickbacks to doctors, which all led to Medicare and Medicaid paying for unnecessary prescriptions.

The definition of a foreign official under the FCPA, an oldie but goodie, was making the rounds on the anti-bribery playlist last week. This time, the case involves a Haitian telecommunications company. One of challenges to the defendants’ conviction centers on whether Haiti Teleco could be considered an instrumentality of the government simply because Haiti’s national bank owned a majority of shares in the company. In its brief, the government said 97% of the telecom company is owned by the bank, thereby making it an instrumentality of the government. The government also said the defendants could have requested an opinion from the DOJ as to whether the telecom company counted as an instrumentality.

Boehringer Ingelheim wants to “blind you with science,” but not in the typical fashion. Rather than announcing a breakthrough drug, the company announced they launch a social game that lets players run their own lab. The game, Syrum, is scheduled for beta trial in September. The company says they developed the game to educate “players about the pharmaceutical industry in a fun and engaging way.”  Game on!

And so we’ve reached the end of our playlist. If you’re like us, you’ll soon be breaking out the seersucker suit and white shoes for one final spin as you relish the memories of another summer season? Have a great week everyone. Enjoy the Labor Day festivities!