health

Week in Review, January 7, 2013

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , , , , , ,

The PharmaCertify™ Team

Despite the doom and gloom “allegedly” predicted by the Mayans, 2013 arrived, and we’re all here raring to go for a new year! Well, maybe not raring…quite yet, but there is something rejuvenating about the turn of the year isn’t there – contemplatively looking back on the past year while looking ahead to the new year with hope. So time marches on, and so does the news. Let’s take a look at the happenings between the holidays in this week’s News Week in Review.

Victory Pharma didn’t go out on the happiest of notes in 2012, agreeing to pay $11.4 million to settle criminal and civil allegations surrounding the marketing of several of its products. Of the total settlement, $1.4 million was to resolve criminal allegations of violating the Anti-kickback Statute. The remaining $10 million is to resolve allegations of violating the False Claims Act. The case was brought by a whistleblower who was a former company sales representative.

And speaking of sour notes, 2013 didn’t start happily for a physician who blew the whistle on Amgen. A circuit court has denied the NJ physician’s petition for a court hearing to challenge the government’s recent $612 million dollar civil settlement with the company. The physician claims the government told him to either agree with the settlement or face the possibility of seeing his case dismissed. He declined to sign on, and now the government has asked the court to dismiss the case against Amgen. A lawyer for the physician says his client did not agree to the settlement because government prosecutors would not inform him of his share of the settlement.

A new survey from Ernst and Young shows that mid-market UK companies need to put learning about the UK Bribery Act on their resolution list for 2013. The survey of procurement managers and directors reveals that 64% of mid-market companies do not understand the law. Of those familiar with the law, just over half vet their suppliers for information on how to comply.

As you may know, in December of 2012 Eli Lilly settled allegations of violating the FCPA. In case you haven’t had time to read the enforcement action against Lilly, we have good news for you; Tom Fox has posted a brief video with an overview of the enforcement action, along with the specific internal audit function lapses cited by the government.

The American College of Obstetrics and Gynecology (ACOG) is ringing in the New Year with an update to its policy on professional interactions with the industry. The new policy encourages ACOG members to refrain from taking part in speaker’s bureaus; discourages professionals from accepting gifts (including meals) tied to promotional information; and encourages the provision of  vouchers or samples only to those with a “true need.”  The new policy also encourages physicians to  attend device training conducted by a professional association that has CME accreditation or only attend training focused on the FDA-approved use of the device. The policy also covers ghostwriting and research.

So is the idea of updating your compliance courses on your list of 2013 resolutions? How about investigating mobile technology for expanding the delivery of compliance content? Pharmacertify can help, with custom and off-the-shelf solutions designed to integrate compliance training throughout your company. Check out our course listing and mobile learning options at www.pharmacertify.com.

Happy New Year from all of your friends at the News Week in Review! Have a great start to the year everyone.

Week in Review, December 10

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , , , , , ,

The PharmaCertify™ Team

Tis the season for giving. And if you ask us, “giving” represents the best part of the season. Sure, there’s the stress of coming up with just the right gift for that friend who doesn’t want to offer any hints, or the pressure of deciding whether to pick from the pile or “steal” from your coworker at the company’s yearly White Elephant. So before you’re faced with such daunting decisions as whether a Chia Pet or Pet Rock (how’s that for a dated reference?) makes more sense, we offer our gift to you: the week’s News in Review.

We begin with the week’s big surprise gift. The Second U.S. Court of Appeals overturned the conviction of a former sales representative for promoting a product off-label. The court agreed with the sales rep’s contention that his First Amendment rights were violated and the case was sent back to the lower court for reconsideration. The court also cited the reversal of Vermont’s data mining law by the Supreme Court in support of its decision.

Speaking of First Amendment cases, a former InterMune executive is appealing his conviction for wire fraud, which was based on a press release that touted the use of one of the company’s products for unapproved uses. The executive’s argument is based on his right to express a scientific opinion and the government is arguing that the First Amendment does not protect fraudulent speech, even if it “concerns scientific matters.”

While some may consider the FCPA guidance to be a gift that keeps giving throughout the year, the pharmaceutical and medical device industries would be hard pressed to agree. Michael Volkov, partner at the law firm, LeClairRyan, points out that the guidance confirms that life sciences professionals are operating in a high risk environment, where interactions with physicians can be problematic in regard to the FCPA. Volkov cites three takeaways for pharma and med device. First, doctors are foreign officials or instrumentalities and nothing in the guidance indicates that the government intends to back away from that position. Second, companies are liable for their distributors and sub-distributors and due diligence is a must when doing business overseas. Third, companies need to be careful when considering medical conferences, since foreign doctors have significant expectations for company-sponsored attendance.

Healthpoint Ltd. and DBF Pharmaceuticals picked the gift that no one wants; a fine. The companies agreed to a settlement of up to $48 million to deal with False Claims allegations over the product, Xenaderm. The government contends that the active ingredient in Xenaderm was found to be less than effective for its intended use in 1970, making the ointment ineligible for reimbursement by Medicare and Medicaid. Further, the companies were not forthcoming about the regulatory status of the ointment, causing false claims to be submitted to the government. The companies will pay $28 million to resolve the allegations, with another $20 million to be paid if either of the companies experiences a change in ownership over the next three years.

It’s time to tie the last ribbon and bow onto this week’s News in Review. Remember, if iPads are on the gift list for your sales reps this year, PharmaCertify offers the app development and mobile training programs you need to ensure critical compliance information is at their fingertips year round.

Have a great week everyone, and happy giving…and we suggest the Chia Pet.

Week in Review, December 3, 2012

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , , , , ,

The PharmaCertify™ Team

Thanksgiving is behind us and now we move on to other celebrations of the season. As December kicks off, so do the many Christmas parades in towns, cities and theme parks around the country. And who doesn’t love a parade? We can’t wait for the colorful floats, marching bands, and classic cars, while we stand for hours in the cold, breathing in the fumes from the tractors pulling the floats, getting pelted by candy thrown from the floats by overzealous scouts. What’s not to love.

Speaking of causes for celebrations, we begin this week with the big news that the Office of Management and Budget is now in possession of the final rule for the Sunshine Act. CMS says the final rule will be published by the end of the year. (is that the sound of skepticism we hear out there?) Data collection begins January 1, 2013.

The speaker’s bureau parade is coming to an end for faculty at the Oregon Science and Health University. The proposal prohibiting faculty from serving as paid speakers for pharmaceutical companies is expected to be approved in the next couple of months. A petition supporting a ban on participating in speaker’s bureaus was signed by over 100 students at the University earlier in the year. Not everyone is thrilled with the idea. The faculty responsible for the presentations is concerned that the information they share during lectures will be delivered by less qualified physicians.

The OIG has billions of reasons to celebrate this season. In its semi-annual report to Congress, the agency lists expected recoveries totaling $6.9 billion among its accomplishments for the second half of the fiscal year. The OIG identified $8.5 billion in savings for the government, and that they excluded over 3,100 individuals from federal healthcare programs.

The OIG also informed Tennessee that the state’s false claims act needs work. In 2011, the agency notified several states their laws regarding Medicaid false claims were not as stringent as the federal law and they needed to bring the laws up to snuff in order to receive additional recovery money. Tennessee amended its law, but the OIG says the amended law does not offer enough protection for whistleblowers.

On the anti-bribery front, a drilling company located in Scotland became the first company to negotiate a settlement under the UK Bribery Act. The company will pay £5.6 million, the amount of profit gained through the bribes, and will not face further investigation.

In FDA news, the OPDP issued an untitled letter to Cornerstone Therapeutics addressing a pitch letter generated by the company, which allegedly contained false and misleading information and  unsubstantiated superiority claims. It’s rare to see an FDA letter issued against a PR piece, as FDA enforcement tends to focus on non-PR pieces.

That’s all for this News in Review folks. Have a great week and remember, as you map out your 2013 compliance training, PharmaCertify offers the custom, off-the-shelf, and mobile training you need to help ensure your team has the latest in compliance content integrated into their daily work lives.

See you next week!

Week in Review…Gobble Gobble Edition

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , , , , ,

The PharmaCertify™ Team

Now is the time to shine up the good silverware, dust off that carving knife and fetch the stretchy pants from the back of closet. Thanksgiving is upon us! Bring on the food, family, friends and football. While we’re not quite ready to  start de-frosting the turkey, we are ready to give you a run down of the week that was. So pull up a chair, tie your napkin round your neck and get ready to feast on this week’s News Week in Review.

We’ll start with a little blurb, or appetizer if you prefer, of a story regarding the future of current HHS Secretary, Kathleen Sebelius. While it’s common for much of the top brass of any administration to move on at the start of a second term, there are no such whispers of a move for Ms. Sebelius. She’s expected to remain at least long enough to see the healthcare law implemented.

Like the Pilgrims, our next stories come to us from Great Britain. GSK was found guilty of three breaches of the ABPI Code. The breaches involve off-label promotion of the company’s platelet drug, Revolade and the revelations were the result of a company whistleblower. GSK was found to have breached multiple clauses, including the promotion of drugs for licensed uses (US only) and the requirement for sales reps to adhere to the ABPI Code.

GSK also agreed to a $90 million settlement with a 38 states over charges that the company illegally promoted Avandia. The states accused the company of inaccurately representing the risks associated with the drug in its marketing materials. A GSK spokesperson said the company chose to settle rather than go through expensive litigation, and the company admits no wrongdoing or liability under the states’ consumer protection laws.

Other side dishes of the week included Pfizer’s settlement of a Wyeth shareholder suit concerning misleading information about the risks associated with use of the antidepressant Pristiq. Plaintiffs claimed that Wyeth caused the price of the stock to be inflated during 2006 and 2007 by failing to release information about adverse events in a timely manner. The company also announced that the Wyeth unit will plead guilty to a misbranding misdemeanor charge as a part of its $491 million settlement with the government over the organ transplant drug, Rapamune. On the other side of the coin though, a whistleblower suit against Pfizer for its promotion of Lipitor was dismissed. A former Pfizer executive had accused the company of using a variety of illegal schemes to boost sales of drug, including kickbacks, misleading doctor education and unlawful sampling.

The main course of the week had to be the release of the long awaited guidance from the DOJ and SEC on the FCPA. If the tryptophan in the turkey doesn’t put you to sleep, you can always take a gander at the 130 page document here.

The day after the release of the document, Lanny Breuer of the DOJ and Robert Khuzmani, SEC Enforcement Division Director, held a press conference to discuss the guidance. Breuer claimed the guidance did not represent a “change in policy.” Khuzmani echoed his sentiments and said the “real value is clarity and transparency.” When asked why a more definitive line was not drawn on just who constitutes a foreign official, Mr. Khuzmani said there were many ways the control of an enterprise could be established, some of which are indirect.

You can find morel thoughts from the FCPA experts here and here, or check out this nice summary from the WSJ law blog.

Every holiday celebration has that one guest you hope doesn’t show, and in the view of one doctor, where the Sunshine Act is concerned, that “guest” is the CMS’ Center for Program Integrity (CPI). CMS has tasked the CPI with collection and dissemination of the spend reports related to the Sunshine Act. What’s the big deal? In an editorial on Amednews.com, the physician says the appointment of the CPI is troubling because it’s the anti-fraud unit of CMS. This gives the impression that any doctor appearing in the public reports will be cast as being involved in unethical behavior. He suggests that the data collection, distribution and appeals be assigned to a different division and compliance with the law be left to CPI.

The Sunshine Act is not the only morsel to come out of the ACA. Section 6004 of the ACA will also affect the industry in 2013. The section requires companies to submit a report of all their sampling activity to the FDA. The report must include: the name and quantity of drug samples requested; the name and quantity of samples distributed; the name, address, signature and professional designation of the person making or receiving the samples; and any other information requested by the Secretary of HHS. The government is likely to use the report to look for healthcare professionals who are abusing the sampling system.

No meal is complete without a really nice dessert, so in that spirit…the Massachusetts Life Sciences Center and the Massachusetts Medical Device Industry Council have teamed up to launch a mentoring program for veterans, aimed at helping returning soldiers return to civilian life. The initiative is part of AdvaMed’s Medical Technology Veterans (MVP) program, and will train 50 Massachusetts veterans for jobs in the med tech workforce. According to the organizations, a number of veterans already have the skills needed to work in the medical technology industry. The groups will hold a free, one day seminar in February.

And while we’re on the subject of the MVP program, AdvaMed announced that they will launch a website for returning veterans interested in joining the medical device industry. The site was initially offered to 25 veterans back in the summer, but now the market has been expanded to any veteran interested in a med tech job.

That’s all the tasty offerings for this week. We hope you’re geared up for a great time with family and friends on Thanksgiving. We’d like to take a moment and tell you all how thankful we are that you stop by each week and reading our little tome. We enjoy bringing it to you. Happy Thanksgiving everyone!

Week in Review, November 12, 2012

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , , , ,

The PharmaCertify™ Team

It’s been a wild couple of weeks. Hurricane Sandy followed a nor’easter that the Weather Channel named Athena (really, TWC?), and that was followed up by “Brutus” (again, really?), which socked western states with snow. And somewhere in the middle of all of it, we had an election. We hope all of you affected by this weather are safe and life is getting somewhat back to normal. Time for a look a back to see what made news, other than the weather. Here’s this week’s News Week in Review.

The 6th Circuit Court of Appeals ruled last week that when the False Claims Act was amended in 2009, Congress essentially used the terms “claims” and “cases” interchangeably. (Interesting bit of trivia on the ruling; it came on the same whistleblower case that prompted the 2009 amendment to the law.) In a nutshell, when the change in the law came about, Congress said it applied to pending “claims” back to June of 2008 as well as all pending “cases” at the time the law was enacted. The 2009 amended law changed the definition of a “claim,” so enter the wild litigation. A federal district court said the new standard for a claim could not be applied to cases pending in June of 2008. The courts said if Congress had intended for that to happen they would not have used the word “claim” to refer to those cases. Enter the 6th Circuit, which upon examination of the statute, said Congress used the terms interchangeably.

In other legal news, an examination of the Boehringer Ingelheim settlement and CIA begs the question, are the feds really “done” with stepped up enforcement of off-label promotion cases? The BI settlement cited two types of false claims stemming from off-label promotion not generally seen in these cases. One involved promotion of products for higher dosage than what was on the label, but the false claim only applied to Medicaid and Federal healthcare programs other than Medicare – sending a signal that state Medicaid may play an increasing role in fraud investigations. The other involved claims of superiority, which are rare in False Claims cases.

Coincidentally, during her speech at the Pharmaceutical Regulatory and Compliance Forum, Mary Riordan, of the OIG, mentioned that the agency would be focusing on less traditional promotional issues in 2013, such as superiority claims. Her remarks also focused on the results of a February roundtable with compliance officers from pharmaceutical companies who were under CIAs. The session revealed that many of the participants wanted more direction from the government regarding promotion over social media.

Dierdre Connelly’s keynote address at PCF was focused on trust. Ms. Connelly said, “Trust is a two way street” and that GSK has changed as company, and that those who hold them accountable need to understand that. She went on to discuss the change in GSK’s sales representative compensation program. The change began with a discussion with New York sales reps, during which the reps pointed out their sales metrics did not align with their customers’ goals for their patients. This was preventing the reps from building a sufficient level of trust with their customer. The company has since changed how it compensates all sales representatives, and that change appears to be helping the company regain the trust of physicians.

During Ms. Connelly’s address she said, “fines and settlements do matter.”  The SEC and DOJ agree with her when it comes to fines levied against the industry in FCPA cases. The industry has come under fire in recent years for promotional activities outside the U.S. Millions in fines have been doled out against a handful of companies but some question if the fines are much of deterrent. A fine in the tens of millions of dollars against a company that brings in billions of dollars a year is not much of hit to the bottom line. A representative at the SEC said she believes the fines are making a difference. She adds, however, that if the SEC learned companies simply view fines as a cost of doing business, the amount of the fines would certainly rise.

That brings us to the end of this week’s News Week in Review. This week, we learned new ways enforcement agencies are viewing the impact of promotional activities on federal healthcare programs, in particular promotion for unapproved uses of product. As you keep this in mind when planning your 2013 training, Pharmacertify can help with custom and off-the-shelf training focused on on-label promotion and good promotional practices.

Have a safe and dry week everyone!

Week in Review- October 22, 2012

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , , ,

The PharmaCertify™ Team

Now that it is mid-October, the time has come for glitter, glamour, kings and queens. Homecoming! The one game you have to win, and for ladies, the second most important dress you’ll buy that year (it isn’t the prom after all!). Oh, and let’s not forget, everyone loves a parade- except of course the people that are stuck behind the slow moving leviathan clogging up the streets of your town. For many of us it is a time to go back to our alma mater and see old friends, and remember the “good old days.” Let’s begin our own walk down memory lane with some of the news nuggets of yester-week. Now taking the field, this week’s News Week in Review.

Leading off the parade we have a story regarding the FCPA and the life sciences industry. Federal prosecutors and regulators have widened their expectations in third-party due diligence and the oversight that companies need to have over third-parties. The expectation is that companies not only do an initial due diligence, but also look at whether the third-party is capable of conducting business in a manner that measures up to the company’s own FCPA standards. For life sciences companies the sheer number of third-party relationships is staggering, and this need to review third-parties applies not only to new partnerships, but also to already established relationships. Implementing a sound assessment process that encompasses both new relationships as well as ones that are currently active is vitally important.

No more mum corsages for doctors in India from Abbott sales reps. Abbott has implemented a policy temporarily suspending the giving of gifts to doctors in that country. An internal memo says only clinical or scientific literature may be given. The ban even includes minimal value “therapy reminder” items such as pens. Indian law prohibits doctors from accepting gifts or travel, however the law is not consistently enforced. No comment from Abbott as to the reasoning for the decision. In other Abbott news, its $1.5 billion settlement agreement for off-label promotion of an anti-seizure medication was accepted by a judge in federal court.

Are doctors not showing enough spirit for the results of studies funded by the industry? According to one doctor, the skepticism pendulum may have swung too far.  Physicians have become skeptical of the results reported in pharma funded studies as pointed out in a study published in the NEJM. Some skepticism is warranted, but as the doctor points out, physicians have gotten so skeptical that they could be overlooking important safety data by discounting pharma sponsored studies. He suggests that there needs to be more transparency in clinical studies, and suggests greater third-party statistical review and more use of public access sites like clinicaltrials.gov.

The Sunshine Act: the industry’s current homecoming queen. She sure is taking her time putting on her crown and sash to meet the public. While we all wait on the final rule, take a listen to this podcast (written transcript here) from Medsider that discusses the law and its impact on medical device manufacturers. (Much of what is discussed is applicable to those outside of med device as well.) In the podcast the Medsider host and his guest expert discuss a variety of issues including: the purpose of the law, the costs associated with preparing to implement the law, are there any loopholes in the law and what companies need to be doing now to get ready to implement the law. An important point made by the guest is that if companies do not have front-end policies and procedures in place regarding physician consulting agreements, they should seize the opportunity to do this now before their data is publically available. While Sunshine does not require any of this, he says both the government and private attorneys will likely be pouring over the information in the public database. He likens just having your back-end systems and processes in place without addressing this front-end issue to driving a car without car insurance. Nice.

Massachusetts med students want the governor to revisit the past in regards to the provision of meals. A group of med students and consumer advocates, carrying trays of champagne and lobster tails (seriously?), delivered a petition asking the governor to bring back the ban on providing meals at educational presentations outside of a practitioner’s office. The group believes the definition of a “modest meal” is vague, and that these meals do nothing to benefit patients. The group would like to see Massachusetts’ Department of Health set a dollar limit on these meals, ban the serving of alcohol and obtain information about how money for these meals is allocated.

That brings us to the end of this week’s review, but before we put away the crepe paper and streamers we’d like to float one more thing by you: mobile learning. Access is everything, so why not make sure your ethics and compliance training accessible for your learners on their terms? PharmaCertify has a variety of mobile learning solutions to help you put compliance knowledge in the hands of people when and where they need it.

That brings us to the end of the homecoming celebration. We hope you had a good time reminiscing with us. Have a great week and we’ll see you back here next week!

News Week in Review, October 1, 2012

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , , ,

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

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , , ,

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

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , ,

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.