PhRMA

Week in Review, July 9, 2014

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CMS makes changes to reporting deadlines and requirements, Canada continues to collect date about the effects of off-label use of drugs, and Medicines Australia updates its Code of Conduct.

You scream, I scream, we all scream for ice cream! And we’ll be doing a lot of screaming because July is National Ice Cream Month. (July – 31 days. Baskin-Robbins – 31 flavors. Coincidence?) Whether on a cone, in a cup or topped with sauces, fruit or confections, July is a great month to enjoy this cold treat. And gone are the days when Tutti Frutti was the outrageous flavor. Now, along with the likes of Cookies & Cream and Rum Raisin, you can have your pick of Chocolate-Chili, Roasted Garlic, or Mushy Green Peas. As you ponder your favorite flavor (bizarre or otherwise) for beating the July heat, we offer our own scoop with this week’s News in Review.

The deadline for submitting Phase 2 data melted away, sort of, last week. CMS sent out an email essentially extending the deadline for submitting Open Payments Phase 2 documents to July 7. In the e-mail, CMS said it wanted to assure accuracy and completeness of the reports and attestations and that penalties would not be enforced for non-compliance until after July 7.

Also melting away could be the CME exclusion in final rule for the Sunshine Act. CMS is planning to propose a change to the exemption for reporting CME payments. The current rule allows an exemption for three reasons: the program is accredited by certain organizations, the physician isn’t paid directly by the manufacturer, or the manufacturer doesn’t influence the selection of speakers. CMS ultimately decided to remove the exclusion due to the redundancies involving indirect payments that occur when the manufacturer is unaware of the recipient. The agency also does not want to appear that it is indicating support of certain accrediting bodies by continuing to specifically name them in the exemption. The proposed changes will appear in the July 11 Federal Register.

And if the CME change isn’t enough, CMS has a few other toppings to add to the final rule sundae. The agency is also proposing that “stock, stock options, and other ownership interests” not be one category, but three. Other changes include the requirement that all manufacturers, including device manufacturers, use the product’s marketed name on reports and the removal of the “definition of a covered device” from the rule.

Canada’s Health Minister, Rona Ambrose, is serving up a scoop or two of new information about serious side effects resulting from off-label drug use. Health Canada has been collecting the information for several years, but technical issues prevented it from making the database of information publicly available. The group is planning a systems upgrade that will allow the regulator to share the database. No timeline for when the public can expect to access the information has been released.

Medicines Australia is looking for approval of its latest flavor. The organization has submitted the 18th edition of its Code of Conduct to the Australian Competition and Consumer Commission for authorization. The new Code includes requirements for the reporting of transfers of value from industry to healthcare professionals. If authorized, the Code will become effective January 2015, with the new transparency requirements going into effect October of 2015. However, not everyone is happy with the result. A provision requiring manufacturers to obtain permission from physicians to allow their name to be published with the payment data, has members of the Greens political party very concerned. A spokesman said the party was considering reintroducing legislation to make the reporting of transfers of value to physicians a legal requirement.

Sunshine and transparency will no doubt continue to be a popular flavor, both here and abroad, for the distant future. That’s why we are adding a global transparency focused module to our growing list of PharmaCertify™ off-the-shelf learning solutions. To learn more about the module or see a content outline, contact Sean Murphy at smurphy@nxlevelsolutions.com.

Have a great rest of the week!

Week in Review, July 1, 2014

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CMS adds two dozen FAQs to the Open Payments website, PhRMA requests an extension to the data submission deadline, and more companies decide to share clinical trial data with researchers through the ClinicalStudyDataRequest.com portal.

Strike up the fife and drums, it’s time for the annual Star Spangled salute to the U.S.A. Independence Day is almost here! In a letter to his wife Abigail, John Adams suggested this day be celebrated with “pomp and parade, with shows, games, sports, guns, bells, bonfires and illuminations from one end of this continent to the other, from this time forward forever more.” The great statesman’s words could not have been more prophetic. As you ponder how to best celebrate our nation’s independence this year, we offer a tradition of our own, this week’s compliance News in Review.

There was an explosion of information on the Open Payments website. CMS recently added over two dozen FAQs to the site. Most of the FAQs deal with Phase 2 data submission and attestation. The questions center on how long it will take CMS to validate submitted data; whether a resubmission of data requires a new attestation; and what the process is for resubmitting corrected data. Other FAQs about data collection, registration, and participation in Open Payments were also added.

PhRMA has sent a declaration of sorts to CMS, requesting an extension to the deadline for Open Payments Phase 2 data submission attestation. In its letter, PhRMA cited the technical issues its members were experiencing with the Open Payments website. The organization claims the problems seem to be occurring most with foreign companies and foreign subsidiaries of U.S. based companies and the CMS helpdesk is not operated during hours that would accommodate European or Asian time zones. Since several manufacturers have not even been able to complete the registration process, PhRMA is asking that the deadline be extended by 30 days. Two other concerns are also addressed in the letter. First, manufacturers do not have the ability to indicate when a manufacturer received a refund on a transfer of value. This is a common occurrence with research grants. Also, manufacturers are unable to use characters such as parentheses and mathematical symbols in the text box for assumptions.

Was last year’s Supreme Court decision concerning pay-for-delay deals the shot heard ‘round the pharma world? The Federal Trade Commission (FTC) has opened several new investigations into pay-for-delay deals. In an interview, Markus Meier the head of the FTC’s health-care division, said “Our goal is to bring to an end to this practice by whatever means are available to us.” He did not provide any details regarding the new investigations. The agency is also looking for possible antitrust issues in patent settlements from the last 10 years.

Lilly, Bayer and Boehringer Ingelheim are joining the clinical trial data sharing celebration. The companies joined the list of those sharing of patient level clinical trial data through the ClinicalStudyDataRequest.com website. The site provides a secure Internet portal through which researchers can request patient-level anonymized data.

We wrap up this week’s firecracker report with a story from our friends overseas. The European Federation of Pharmaceutical Industries and Associations (EFPIA) recently launched a website to highlight the disclosure rules associated with the EFPIA Disclosure Code on Transfers of Value to Healthcare Profession and Healthcare Organizations. The agency also released a template for upcoming disclosure reports.

With that, we close out this red, white and blue version of the Week in Review. Have a great week everyone, and an amazing Independence Day!

Week in Review, June 24, 2014

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New social media guidance from the FDA has arrived, a new survey points to the need for reps to be comfortable with the science of what they sell, and PhRMA asks CMS for an extension of the data submission deadline.

We have officially, or astronomically anyway, reached summer! The Summer Solstice occurred over the weekend, giving those of us who live in the northern hemisphere the “longest” day of the year. We hope you found a fun and worthwhile way to enjoyed those extra, precious minutes of daylight. While we may slowly be losing daylight from now until the Winter Solstice in December, that doesn’t the party needs to end. We’ll keep the celebration going as we take a look back at the compliance news of the week, with the News in Review.

Two new social media guidance documents from the FDA have finally seen the light of day. One covers the topic of correcting misinformation posted by third parties on the Internet and social media. The document discusses the situations in which the guidance applies; the information that should be included in a response to misinformation; and the type of communication that is outside the scope of the guidance. The other document covers the presentation of risk and benefit information on social media platforms that restrict the number of character spaces. The guidance features examples of how companies can include risk and benefit information in these platforms.

While the limited character guidance was certainly welcomed, companies still need to proceed cautiously with platforms such as Twitter. The guidance does allow for the use of URL shortening services, as well as the use of common abbreviations to help address the character limitations. However, just providing a link to risk information, or posting a follow-up Tweet, is not sufficient for communicating risk.

A new season has dawned for pharmaceutical sales reps according to a recent survey of healthcare company leaders. More than half of the respondents said selling isn’t the most important skill for reps. Today’s products require sales reps be able to hold in-depth scientific conversations with doctors. Evolving technology was also referenced as being a key factor in the changing role of a sales rep.

A former president of the American Medical Association would like to see physicians and industry companies spending time together in the Sunshine. At a recent conference, former AMA president, Jeremy Lazarus, commented that manufacturers need to work with physicians to develop a mutually beneficial relationship when dealing with the requirements of the Sunshine Act. He said many physicians are still unaware of Sunshine, even though information about their relationships with industry companies will soon be publicly accessible.

PhRMA would like to see the Sunshine “extended.” Last week PhRMA sent a letter to CMS suggesting that the June 30 Phase 2 data submission deadline be extended. In the letter, PhRMA said its members are reporting technical problems with the registration process in Open Payments. Companies have also encountered numerous problems when uploading data. The problems are particularly troublesome for foreign entities, and those entities are having issues getting help because the CMS helpdesk does not accommodate European or Asian time zones. PhRMA would like CMS to extend the deadline 30 days once the agency confirms that the glitches have been corrected and the system is operating correctly.

The release of the latest social media guidance by the FDA is a timely reminder that promotional statements must meet certain requirements, regardless of the communication platform. That’s why we are updating the PharmaCertify™ Good Promotional Practices module to include the new information. The module is targeted to sales and marketing staff and topics include gifts, meals and entertainment; promotional statements; advisory boards; and the handling off-label inquiries.

Have a great week everyone!

Compliance Week in Review, June 18, 2014

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Comments to CMS show physicians and the pharmaceutical industry are wary about the Sunshine dispute resolution process, the American Medical Association passes a resolution to modify the Act, and Minnesota makes changes to its aggregate spend law.

Well, that was a big weekend. First we had a Friday the 13th to escape and/or celebrate (your choice), and then the big day, Father’s Day. Hopefully, you avoided any unfortunate incidents or questionable neckties. So now here we are on just another plain ol’ day in June. We’ll keep the “party” rolling by taking a look back at some of the big news stories of the past week. Time to for this week’s Compliance News in Review.

Comments received by CMS regarding the Sunshine dispute resolution process show physicians and the industry alike are feeling a bit wary about the future. Physician groups commented that the 60 days to resolution period is too short. It was pointed out that even if a physician submitted a dispute to CMS when the window opens, there is no guarantee CMS will forward the dispute in a timely manner to the manufacturer. In addition, teaching hospitals will need more time to complete their review of the data than an individual physician. The CME Coalition suggested that data publication be delayed until March of 2015. The group said physicians should be allowed more time to deal with discrepancies. On the industry side, PhRMA noted that CMS was correct in allowing manufacturers the ability to determine what disputes will be investigated and resolved.

The “lucky” number for the AMA House of Delegates is 100. During a recent meeting, the House of Delegates passed a resolution to lobby Congress to enact two significant changes to the Sunshine Act. First, the Medical Society of New Jersey (MSNJ) suggested the minimum threshold for reportable transfers of value be raised to $100. The MSNJ said the current threshold is too difficult for the industry and physicians to track. The second change involved the inclusion of medical textbooks and journal articles in the educational items exclusion. The change was suggested by the American Medical Group Association. The passage of the resolution is considered to be a message to the Washington D.C. office of the AMA to work with Congress to institute the changes to the Act.

A new article disputes the argument that conflicts of interest between the industry and physicians result in decisions that are harmful to patients. The authors of the article say the “conflict of interest campaign” has directed resources away from worthwhile medical care and research issues. The authors claim the huge settlements in off-label cases give the impression that patients were in harm’s way, however there is very little evidence that was actually the case. Where publication biases are concerned, the article’s authors say the conflict of interest detractors are asking the wrong question. Detractors focus on whether there are differences in industry-funded studies and studies conducted by non-profits, rather than focusing on whether the studies are scientifically unsound. Removing the assumption that positive results from industry studies are the result of misconduct, no reason exists to assume the studies are scientifically flawed.

Changes have been made to the granddaddy of aggregate spend laws. The Minnesota legislature passed a bill that expands the definition of a practitioner to include APRNs, Medical Assistants and Dental Assistants who are authorized to prescribe, dispense or administer medication. The expansion means these professionals now fall under the state’s gift ban and reporting laws. The Board of Pharmacy suggested companies begin tracking spend related to these professionals since reporting would likely be required in 2015.

To no one’s surprise, the Sunshine Act is still dominating the news. During a recent webinar aimed at physicians and teaching hospitals, CMS said that the dispute resolution period would be in the August/September time frame, but the agency did not offer specific dates. CMS still appears committed to a public release of the data by September 30. However, one of the callers on the webinar pointed out that the September 30th date was not included in the Final Rule and the Rule only states that 2013 data reports will be published in 2014. If CMS pushes the public release back, this would address one of the issues raised in the comments about the dispute resolution process. CMS also said it would not be expanding covered recipients to include mid-level practitioners. That sort of change would have to come from Congress.

There sure was plenty of Sunshine in this week’s news and there are bound to be plenty of Sunshine-related questions from healthcare professionals. The PharmaCertify™ eLearning module, The Sunshine Act: The Federal Physician Spend Disclosure Law, provides your sales representatives to up-to-date training on the Act, and includes a comprehensive list of the disclosure requirements included in the law.

Have a great week everyone!

Week in Review, June 09, 2014

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France publishes its first public reports related to physician payments, several companies pay out millions in settlement fines,  medical affairs professionals discuss their changing role in compliance, and Massachusetts releases a notice regarding the reporting of the same spend information required under the Sunshine Act.

Break out the mortarboard and fire up Pomp and Circumstance, it’s that time of year again. has arrived. There’s nothing quite like watching the graduates cross that stage, receive their diploma and bask in the achievement. Here’s hoping they enjoy the moment before they have to face the harsh realities of the next phase of life. (Remember that moment when we realized that “nap time” in first grade did not include a mat? Welcome to the real world!) With that in mind, we proudly present this week’s graduating class…and this week’s compliance News in Review.

A transfer story from France leads our parade of worthy stories. France has published the first public reports of industry transfers of value (TOVs) to healthcare professionals, as required by the French Sunshine Act. To manipulate this database you’ll need to dust off your old French text book, or quickly invest in a Rosetta Stone course, because there is no option to switch to an English (or any other language for that matter) translation. The company information is all .txt files that are practically impossible to read, but if you know some HCPs in France you’d like to search for, that information is slightly more reader friendly…except for the whole being in French thing. Oh well, the information is there for the linguistic and inquisitive among us. According to the folks at Policy and Medicine, there has been little press coverage of the release of the data.

Don’t get to comfortable with the French Sunshine Act though, it appears there may be a major change coming soon. Recently, the Ministry of Social Affairs of Healthcare issued a draft order that would modify some of the regulations. One modification will simplify the details reported about HCP arrangements. Another will lessen the level to which companies need to protect HCP information. Finally, a change to the schedule initially set up to declare the benefits and the conventions has been proposed.

Several industry companies are facing unexpected fees and fines. Medtronic will pay $9.9 million to settle allegations under the False Claims Act. According to the government, the company used a variety of payment schemes to induce physicians to use its pacemakers and defibrillators. The company is alleged to have paid physicians to speak at events to increase referral business, created marketing/business development plans for physicians at no cost, and provided sporting event tickets to physicians.

Boehringer Ingleheim has agreed to pay $650 million to settle 4,000 lawsuits involving the drug, Pradaxa. According to a BI spokesperson, the average payout per settlement will be $162,500. Plaintiffs claim the company didn’t adequately warn patients of the risks associated with use of the blood thinner. The company says the drug’s safety has been repeatedly demonstrated, and the settlement does not change the drug plays in patients’ lives.

GSK has agreed to pay $105 million to 44 states and the District of Columbia to settle claims they illegally promoted two antidepressants and an asthma drug. In the agreement with the states, the company agreed to changes in its incentives to sales people, not use paid physicians to promote products, and to refrain from making deceptive or misleading statements in its advertising.

Chicago is throwing its cap in the ring and has filed suit against five manufacturers of highly addictive painkillers. In a suit similar to one filed by several California counties, Chicago is claiming the companies overstated the benefits and downplayed the risks associated with the use of the pain drugs. The suit says the companies violated laws related to consumer fraud, misleading advertising and false claims. In addition to the civil penalties and punitive damages, the city is seeking to reclaim profits associated with the illegal marketing activity.

As the regulatory landscape changes, medical affairs personnel are becoming more important in conversations with HCPs and more involved with health economic and outcomes research (HEOR). Within these two areas, concerns regarding off-label use of products are becoming a hot issue. Speakers at last week’s World Congress said their companies have evolved their policies on responding to unsolicited requests for off-label information. Compliance issues related to HEOR include the nature of the studies used and whether or not the company is providing payers with balanced information regarding the safety and efficacy of products.

Massachusetts has finally moved the tassel on some of its HCP spend reporting requirements. The state recently released a Notice of Federal Preemption, which stated that the Department of Public Health could not require pharmaceutical and med device companies to report the same spend information that is required by the Sunshine Act.

And with that, we bring this week’s ceremony to a resounding close. We wish all of the graduates out there good luck with whatever life holds for them next. Toss those caps in the air everyone and have a great week! We’ll see you right back here next week.

Week in Review, May 13, 2014

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CMS posts help for applicable manufacturers to prepare for Phase 2, Maine’s Pharmacy Board questions the validity of an Internet pharmacy, the OIG asks Boston Scientific about two of its products, and Brazil fines Eli Lilly for manufacturing violations.

We’re not sure how it happened, but somehow, nearly half the month of May has passed with us not realizing that this is Barbeque (or Barbecue if you prefer) Month. And if you thought (insert your favorite sports rivalry here) was a topic that could fire up a heated conversation, just mention proper barbecuing techniques. Pork versus beef, sauce versus no sauce (we won’t even open up the type of sauce can of worms), dry rub versus wet rub…it’s all a point of contention and fierce debate. So break out the brisket and make your plans to celebrate Barbecue/Barbeque Month while we fire up this week’s Compliance News in Review.

CMS is getting the coals all nice and hot for Phase 2 of the Open Payments data submission process. The agency announced that it will post a series of tutorials to help applicable manufacturers and GPOs prepare for Phase 2. The first of three tutorials is available now on the Open Payments website. CMS also announced that physicians and teaching hospitals will be able to register in CMS’ Enterprise Portal beginning June 1. Registration is not necessarily required for physicians or teaching hospitals, but it is needed if anyone from those institutions wants to see their Open Payments data.

The Maine Pharmacy Board is asking the Attorney General to apply some direct heat to an Internet pharmacy that has been advertising inexpensive drugs in the state. The president of Maine Pharmacy Association filed a complaint with the Board, saying the online drug seller wasn’t a licensed pharmacy. He says he ordered three medications from the company and all were made outside of Canada.

Is there a secret sauce for determining fair market value (FMV) rates in emerging markets? It certainly can get complicated in a constantly changing global economy. In an article for Policy and Medicine, Mario Prohasky, of Polaris, suggests companies should update their FMV rates when macroeconomic changes occur. For example, when an annual inflation rate exceeds 10% to 15%, or a local currency experiences a devaluation of 20% or more, a company should re-evaluate its FMV rates.

HHS is asking Boston Scientific to carve out a little information related to one of its products. In a regulatory filing, the company revealed that the OIG has asked for information regarding the 2008 launch of two of its defibrillators.

On the physician spend front, the total cost of payments to physicians and hospitals in Massachusetts dropped between 2011 and 2012. While recently released data shows a 12% drop in the total amount of payments, the number of payments actually increased. This can be credited to the change in the Massachusetts law that allows companies to provide modest meals. Spending on food (barbecue and otherwise) was up 65%.

Eli Lilly is disputing the ingredients it’s been accused of using at one of its manufacturing plants. The company was fined $450 million by a Brazilian court for allegedly exposing employees to hazardous materials at the plant. Lilly is appealing the decision, saying the chemicals to which the plaintiffs claim they were exposed were not used in manufacturing. Lilly also claims the court’s ruling is based on bad math and “inaccurate scientific claims.”

And with that, we bring this week’s feast of compliance news to a close. If you’re wondering if your compliance training curriculum offers the right list of ingredients, the PharmaCertify™ suite of eLearning modules and mobile apps offers comprehensive and up-to-date training on the regulations and policies your learners need to understand as they interact with healthcare professionals.

Have a great week everyone!

Week in Review, April 29, 2014

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Pakistan joins the transparency parade, Arkansas’ Supreme Court won’t reverse the Risperdal decision, one Google executive wonders why pharmaceutical companies aren’t using YouTube more, and the DOJ offers a reminder about the need for a proactive approach to compliance.

California Chrome. Vicar’s in Trouble. Wicked Strong. Titles to obscure B movies? Nope, they’re just some of the participants in the “greatest two minutes in sports.” The countdown is on to the Kentucky Derby! We have less than a week to polish up those mint julep cups and shop for that perfectly obnoxious large hat. In the meantime, sound the call to the post, it’s time for the News Week in Review.

First out of the gate is the news that Pakistan is considering physician-industry interaction transparency requirements. The Drug Regulatory Authority of Pakistan is driving the increased transparency initiative and Pharma Bureau, a trade group of multinational industry companies operating in Pakistan, welcomes the move. The Bureau sees consistent guidelines and enforcement as a step toward better patient care and an improvement in the industry’s image.

According to a new study, doctors who don’t accept drug samples are a long shot to prescribe branded drugs. The study, published in JAMA Dermatology, compared offices in an academic medical center, where samples are not permitted, to private practice offices that do accept samples. Only 17% of the prescriptions written for adult acne drugs in the academic centers were for branded drugs, compared to 79% of the scripts being written for branded drugs in the private offices.

No Big Bazinga from the Arkansas Supreme Court regarding its reversal of the Risperdal verdict. In a 4-3 decision, the court said it would not reconsider its March decision to overturn the verdict. The verdict was overturned when the court said the state’s Medical Fraud False Claims Act did not apply to the Risperdal manufacturer because the law was codified in way that conflicted with the intent of the law. Arkansas Attorney General Dustin McDaniel asked for the ruling to be reconsidered because the issue of how the law was codified was not raised but the state or the drug manufacturer.

The folks at Google think pharmaceutical companies could benefit from a little more Social Inclusion. The head of Google’s healthcare-focused digital marketing team, David Blair, says the industry could utilize YouTube more effectively. Online viewership has now eclipsed television, and according to Blair, one-third of You Tube users share what they watch. YouTube is also the second largest search engine behind Google and Blair believes pharmaceutical companies are missing an opportunity to make an emotional connection through a disease awareness video or wellness campaign.

According to experts speaking at the Dow Jones Global Compliance Symposium, companies should set an aggressive pace when scrutinizing their own compliance programs. A deputy attorney general from the DOJ told attendees at the Symposium that companies are too quick to claim the problem only involved a few employees and that’s one of the first signs of a weak compliance department. Attendees also learned that the U.K., Canada and Germany have all set up units similar to the DOJ’s FCPA unit.

That’s going to bring us to the finish line for this week’s News in Review. We’ll see you right back here next week with another summary of the news from the world of life sciences compliance. As always, thank you for reading and have a great week!

Week in Review, April 21, 2014

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The European Federation of Pharmaceutical Industries and Associations increases its education efforts, GSK conducts internal bribery investigations, FCPA experts warn of increasing scrutiny and some restaurants look for creative solutions to changing pharmaceutical company requirements.

May is almost upon us, and you know what that means…so is the summer movie season! It’s a time marked by seemingly endless blockbusters and family movies, released on a weekly basis. Captain America: The Winter Soldier “sort of” represented the unofficial start of the season, and in a matter of weeks, the parade of superhero, wacky comedies, sci-fi thrillers and animated family films will begin in earnest. Hollywood’s big blockbuster may be still be a week or two away, but we have a little entertainment of our own to share, with this week’s News in Review.

Coming soon to a global theater near you: physician payment disclosure. The European Federation of Pharmaceutical Industries and Associations (EFPIA) is rolling out an education program to help companies prepare for its financial disclosure requirements. In January, companies will have to collect, and subsequently disclose, payments made to healthcare professionals and healthcare organizations. The education program, which will include webinars, leaflets and videos, will focus on current best practices and highlight how companies across Europe are preparing for the disclosures.

Look for sequels to be a popular choice for audiences this summer (How to Train Your Dragon 2, 22 Jump Street), but don’t expect GSK to be excited about another sequel on the anti-bribery front. Polish authorities are accusing the company of bribery, and the company has launched an investigation into bribery allegations in Jordan and Lebanon. In Poland, the company is accused of paying doctors for prescriptions, and disguising the payments as speaker fees. According to Polish authorities, a dozen doctors were paid fees for presentations they never delivered. GSK conducted its own investigation, saying the payments seem to be linked to one employee and that employee has been disciplined.

In Jordan and Lebanon, GSK began investigating allegations of bribery after a whistleblower contacted the company. The investigation is focused on allegations that bogus speaker fees were paid to physicians; free product was offered for the physicians to sell to patients; and a physician was allowed to exchange a business class plane ticket economy class tickets so his family could accompany him to a medical conference.

Corporations should expect even more focus on FCPA enforcement this summer and in coming years, especially now that global agencies are pooling enforcement resources. Speaking at a conference of the New York City Bar Association, two former government fraud officials, one formerly with the SEC and one formerly with the DOJ, warned that the two agencies are adding to the penalties if companies don’t cooperate with the investigations or try to obstruct the process.

Senator Grassley is planning a new whistleblower production and he is turning to his colleagues for help. The Senator announced he intends to form a Senate Whistleblower Protection Caucus to help ensure whistleblower protection laws are enforced. The plan is to recruit colleagues for the caucus throughout the year, with the goal of launching the new production at the start of the new Congress.

The rules on providing food for pharmaceutical and medical device company meetings have changed, but rather than walk away from the business, some restaurants, like Fogo de Chao, are taking a more creative approach. Leo Jakobson, editor for Successful Meetings, says the Brazilian steakhouse keeps the menus modest and informal by focusing on meals served on skewers, and all of the locations offer private dining rooms for up to 120 participants.

And that’s almost a wrap…at least for this version of the News in Review. The summer season is a great time to reconsider the impact your compliance training has had on your audience. Compliance rules, guidance and best practices are evolving, and we’re expanding the PharmaCertify™ list of mobile training solutions to keep pace with those changes. Through the release of new titles, like Understanding Global Physician Spend Transparency, and updates to existing modules like The Sunshine Act: The Federal Physician Spend Disclosure Law, PharmaCeritfy™ offers the training where your reps need it most – in the field and at their fingertips.

Have a great week everyone! We’ll see you at the movies.

News Week in Review, April 8, 2014

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China shifts its focus to medical device, the Arkansas Attorney General petitions the state’s Supreme Court to reconsider its reversal of the Risperdal verdict, GSK dismisses employees for violating expense rules, and a new study raises questions about conflicts of interests for medical school leaders sitting on the boards of pharmaceutical companies.

Ah yes, the glittering dresses, the suave tuxes, the perfectly coifed hair. No, we’re not talking about the Academy Awards or the Golden Globes, this is much more important than all that. It’s almost prom season!

If your Facebook, Twitter or Instagram isn’t littered with pictures of your kids and their cronies in their formal finery yet, it’s just a matter of weeks. You can take some small amount of solace knowing all those happy smiling faces will one day be questioning their choice of fashion or hairstyle. C’mon, you know you did. (Let’s just say there were some very unfortunate prom fashion choices made in the 70’s and 80’s by members of the News Week in Review staff.) As we wax poetic about proms of yore, let’s also look back at the compliance week that was, in this week’s News Week in Review.

First on the dance floor is news that China intends to toughen penalties for corporate malpractice against medical device companies. The country will segment devices into three categories based on their potential risk to consumers. The new rules are set to take effect in June, and the top fine for selling illegal medical devices will increase to 20 times the value of the device.

Not wanting to feel like a wallflower, the Attorney General of Arkansas is asking the state’s Supreme Court to reconsider its reversal of the $1.2 billion verdict in the Risperdal case. The court ruled the state had misapplied the state Medicaid fraud law when it tossed the verdict, and even said the law was codified incorrectly. The Arkansas Code Revision Commission voted to provide the AG with an analysis comparing the law as written to how it was written into Code. The AG says the analysis may be helpful in obtaining a new hearing.

The chaperones seem to be working hard at GSK. The company has dismissed several individuals for violating company expense rules. The company did not comment on the number of individuals involved, but did say monitoring efforts in China have increased, and that irregularities are always investigated. Emails reviewed by the Wall Street Journal indicate the company is also investigating allegations of bribery in the Middle East. The emails focus on activities occurring in Iraq, including the hiring of state employed doctors as medical representatives while those doctors were still working for the government.

A former GSK sales representative in China tells the Financial Times that kickbacks to doctors there were widespread. According to the former rep, domestic and foreign firms routinely paid kickbacks to doctors to achieve their sales targets, and the sales model at GSK was no different than those of its competitors. GSK called the behavior “completely unacceptable,” but as AstraZeneca’s CEO pointed out, even a tough compliance program can’t stop an employee determined to stray.

A new study finds that the leaders of medical schools and hospitals are being paid handsomely for sitting on the boards of pharmaceutical companies. The study found that of the 50 largest companies, 40% had at least one board member who was in a position of leadership at an academic medical facility. The average total compensation for these individuals was over $300k per year. The study raises the potential for a conflict of interest. For example, the president of Yale’s medical school receives nearly $300k from Abbott, but a spokesperson from Yale says the doctor would not make decisions about formularies, clinical trials, or drug samples, when Abbott is involved. Several other medical schools made similar comments regarding leaders of their medical facilities who receive compensation from pharmaceutical companies.

As we cue the last song on this week’s playlist, we’ll take this opportunity to let you know the PharmaCertify™ list of compliance modules and mobile apps is expanding. If global transparency, including the EFPIA Code and French Sunshine Act, is on your radar, we’ve added Understanding Global Physician Spend Transparency to our curriculum of customizable eLearning modules. To learn more about the module, or any of topics, contact Sean Murphy at (609) 466-2828, ext. 25.

Have a great week everyone.

Week in Review, March 17, 2014

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

In this issue…a look back on Caronia and its impact (if any), China cracks down on medical device websites, Teva settles improper allegations involving one of its subsidiaries and the FDA chastises one company for its product claims on Facebook.

Top o’ the morning, afternoon and evening to you! This may be the Ides of March, but we’ll put that aside and focus on the fun of St. Patrick’s Day instead. If this is March 17th, spring must be right around the corner and this must be Lá Fhéile Pádraig! Hopefully, you wore enough green today to avoid the pinch of those dastardly leprechauns. Pass the corned beef and cabbage, cue the bagpipes and straighten your kilts…it’s time for this week’s O’News in Review!

More than a year has passed since the Caronia decision, but it hasn’t exactly been the lucky charm some thought it would be for the industry. The decision supported the argument that truthful, non-misleading statements regarding off-label uses were protected by the First Amendment. However, the government distinguishes the application of the decision as it applies to the Food, Drug, and Cosmetics Act from how it applies to the False Claims Act (FCA). The government has argued that Caronia has no bearing on cases brought under the FCA because the Act applies to any conduct, including off-label promotion, that results in the submission of a false claim being submitted. For the foreseeable future at least, the government is as committed as always to pursue cases involving off-label promotion.

The Chinese government thinks that some medical device websites have taken the gift of gab a bit too far. The country’s State Food and Drug Authority has reported ten websites to the authorities for publishing false information about medical devices. The discovery is particularly concerning to the global med tech industry since several of the sites have allegedly forged the names of medical device manufacturers and posted fake equipment.

Teva Pharmaceuticals, Ltd. has agreed to part with a wee bit o’ green ($27.6 million) to settle allegations that one of their subsidiaries made improper payments to a physician.  According to the government, the Teva subsidiary, IVAX, funded vacations to Miami for the doctor, his family, friends and staff. The doctor is facing civil charges in Illinois federal court.

Closing the discrepancy between what medical device manufacturers report for physician spend and what those physicians disclosed may take more than just a little luck, according to a new study by Yale. The study compared the spend disclosures posted on the Medtronic and DePuy websites against what the physicians had disclosed. More than half of the information on Medtronic’s website was not in line with what the physicians reported and the discrepancy rate at DePuy was 30%. The study’s director says the errors go both ways, and he is concerned the public will assume that physicians are trying to hide something when that is not the case.

The International Society of Medical Publication Professionals has reevaluated its recommendations regarding support for medical publications and Sunshine reporting. In its previous recommendation, the organization suggested that all support from an applicable manufacturer was reportable. Now it recommends members consider who would benefit from the publication. For example, if the support provided by the manufacturer helps an author publish a study that the manufacturer would have an ethical obligation to publish anyway, then that support is not reportable.

The FDA has issued an Untitled Letter to a pharmaceutical manufacturer over content on the company’s Facebook page. According to the letter, statements on the page touted the benefits of the drug without revealing any of the risks. In addition to failing to report potential risks, the company omitted important “approved use” information from the product label.

With that, we end this emerald edition of the News in Review. While the celebration of St. Patrick may be filled with talk of good luck and the proverbial pot of gold, compliance training is not something you want to leave to chance. That’s why our PharmaCertify™ suite of off-the-shelf modules cover the critical topics, like on-label promotion and the Sunshine Act, your colleagues need to integrate good promotional practices into their daily activities.

Have a great week everyone!