Compliance Congress

Week in Review, March 6, 2015

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A potential new law in California calls for greater drug pricing transparency, consumer advocacy groups and industry trade groups in Europe argue over clinical trial data transparency, a Maine law allowing the purchase of pharmaceuticals from foreign pharmacies is overruled, and the issue of off-label speech and free speech is back in the news.

In like a lion and out like a lamb; it’s hard to believe March is here. The really good news…spring is almost here as well (although looking at the seven inches of fresh snow outside the Week in Review windows, we find that hard to believe). Whether you subscribe to the meteorological or astronomical start of spring, one way or another it is/will be here this month, and that alone is reason to celebrate! We are on the downward slope of winter, folks and we couldn’t be happier. Another thing that makes us happing is sharing the news of the week with all of you, so let’s spring in to action and get this week’s Week in Review underway!

Nothing says spring like some sunshine, and nothing says sunshine like transparency laws. A California assemblyman has proposed a law that would require the disclosure of information related to the pricing of drugs. The law would apply to drugs costing $10,000 or more for a course of treatment, and companies would have to report information such as production costs, sales and marketing costs, and financial assistance provided through prescription assistance programs. If the law is passed, companies would submit annual reports to the state, and the information would be made available to the public.

Speaking of transparency and disclosure, there seems to be a kerfuffle blooming in Europe over clinical trial data transparency. Proposed rules by the European Medicines Authority (EMA) have prompted comments from industry trade groups and others regarding the confidentiality of commercial information. Industry groups have said certain data related to clinical trials could reveal trade secrets and compromise patient privacy. Consumer advocacy groups insist the more transparency the better in the name of protecting patients. In a press release, a Germany-based advocacy group accused the EMA of writing such a broad definition of commercial confidential information that the determination of what is confidential is left up the study sponsor. Two bio industry trade groups released a statement saying there should be a “deferral” for the disclosing information from Phase I trials due to the “commercial sensitivity” of the information.

Medical device manufacturer, ev3, had to spring for some past promotional issues allegedly committed by one of its recent acquisitions. The company agreed to pay $1.25 million to settle allegations that it violated the False Claims Act. The government claimed Fox Hollow Technologies, which was acquired by ev3, caused hospitals to improperly bill Medicare and Medicaid for medically unnecessary inpatient stays for patients undergoing atherectomies using a Fox Hollow device. The government alleged the company suggested the inpatient procedures in order to drive sales of the device to hospitals, thereby causing hospitals to be reimbursed more than they were entitled.

There’s been a late freeze on the Maine law that allows individuals to purchase prescription drugs from select foreign pharmacies. A federal judge has ruled the Maine law is overruled by federal law, which prohibits importing drugs from foreign countries. The decision nullifies the Maine law. The state can appeal if it chooses.

The seeds are being planted for another free speech case involving off-label statements. A federal district court in California is considering a whistleblower False Claims Act case against Millennium Pharmaceuticals in which the whistleblower claims that Millennium and Schering-Plough (now Merck) promoted a heart drug for off-label uses. In a motion to dismiss, Merck argued that the False Claims Act cannot be interpreted to prohibit the truthful, non-misleading exchange of scientific information. In making the argument, Merck sited both the Sorrell v. IMS Health and U.S. v. Caronia cases. The DOJ filed a brief with the court saying that truthful speech could be used as a basis for the False Claims Act. PhRMA filed a friend of the court brief in support of Merck’s argument.

With that, we end this “almost spring, we hope” edition of the Week in Review. Have a great week everyone!

 

News Week in Review, February 18, 2015

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Several companies announce settlements of charges related to the False Claims Act, CMS releases new information to help with system registration and data submissions, and the National Coalition on Healthcare holds a lively panel session on the Sunshine Act.

Laissez les bons temps rouler, y’all! The end of the Carnival season is here and yesterday was the big send off…Fat Tuesday! Or as you may know it, Mardi Gras. Yes, a time of frolic, frivolity, and according to Turbo Tax, a number of incidents that can affect the filing of your taxes for the next year. Whether you partied until the wee hours in NOLA, or just enjoyed the simple fun of a pancake dinner at home, we hope it was a great celebration. Now it’s time for our regular look back at some of the “celebrated” compliance news of the week, with this edition of the Compliance News in Review.

We start today’s parade with settlement news for several industry companies. Medtronic agreed to pay $2.9 million to settle allegations it violated the False Claims Act. The government alleges the company caused claims to be submitted to Medicare and Medicaid for an investigational procedure. Next, AstraZeneca paid $7.9 million to settle charges it violated the False Claims Act. The company is alleged to have paid kickbacks to PBM Medco in exchange for Nexium’s “solely and exclusively” being maintained on Medco’s formulary. The government claims the kickbacks were provided as prices concessions on other AstraZeneca drugs. Finally, a physician has pled guilty to accepting kickbacks from two pharmaceutical companies in exchange for prescribing the drug, Clozapine. The physician received nearly $600,000 in kickbacks and benefits from IVAX and later, Teva. He also agreed to pay over $3 million to settle a parallel civil case.

The Centers for Medicare & Medicaid Services has been busy tossing beads and doubloons to the industry in the form of advice and consultation. Another Open Payments Q&A session was held just this past week, and in advance of the Q&A session, CMS released several new resources covering system registration and data submissions. The agency has also posted the audio from the January Q&A session.

Speaking of the Q&A session, the February session covered a couple of important topics for industry stakeholders. First, it was announced that a fix would occur over the Valentine’s Day/Presidents Day weekend that should resolve most of the problems that companies are having with submission of the 2013 data. On the downside, attendees were notified that the release of the Validated Physician List has been delayed. CMS is hoping to have the list ready by February 20. Those on the call were reminded that this list is only comprised of physicians for whom a 2013 record was submitted. CMS is scheduling a full day to take stakeholder questions. As soon as a date is nailed down, it will be announced on the Open Payments website and via a listserv email.

It wasn’t exactly cause for great celebration, but a recent briefing held by the National Coalition on Healthcare led to the call for expanded requirements under the Sunshine Act. The panel was comprised of individuals from the government, physician groups and the Pew Charitable Trust. A representative from Senator Grassley’s office explained that ultimate goal of the Sunshine Act was to spur an open discussion between patients and their doctors. The founder of PharmedOut, an organization that advocates against pharmaceutical marketing influence in medicine, took the harshest stance, saying the law wasn’t strict enough. She accused companies of seeking out the family and friends of physicians as an avenue for delivering marketing messages, and expressed grave concern about the industry engaging in disease state awareness. Drug samples were a hot topic. A representative from the AMA says there is a gap in transparency where the provision of samples is concerned and he believes providing samples is “misdirected and unsafe.” The founder of PharmedOut agreed, stating that patients should refuse samples and ask for older drugs that have stood the test of time.

That’s about it for the edition of our weekly look back on all the news fit to blog. As we get closer to spring (albeit, slowly for those of us in the Northeast), and the annual POAs are in the rear view mirror, this is as good as time as any to clean up your commercial compliance training. With transparency extending beyond the U.S., shouldn’t your training do the same? The newest addition to our PharmaCertify™ suite of off-the-shelf eLearning modules, Global Transparency: Reporting HCP and HCO Transfers of Value covers the key provisions of the EFPIA Disclosure Code, French Sunshine Act (Loi Bertrand) and the Medicines Australia Code of Conduct. Contact Sean Murphy at smurphy@nxlevelsolutions.com to learn more and see a content outline.

Have a great week everyone!

2014 Year in Review

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2015 is upon us! It seems like only yesterday we were posting our 2014 Compliance Year in Review. Time sure does fly! We here at the Compliance News in Review wish you and yours the best for a happy and healthy 2015. But don’t toss out that warm glass of sparkling cider or noisemaker yet. It’s time to take a look back at a year’s worth of news, with the Compliance News Year in Review – 2014 Edition.

Our countdown begins with what had to be the big story of 2014 – the never ending saga of Open Payments and the Sunshine Act. The year began with a two-phase registration and data submission process for Applicable Manufacturers and GPOs. Phase 1 opened in February and Phase 2 was supposed to start in May. As it turned out, Phase 2 was delayed until June and was deployed in two phases itself, and not without some technical difficulty. So much so that PhRMA petitioned CMS to extend Phase 2 by as much as 30 days.

The registration of physicians and the opening of the review and dispute period represented the next big milestones. That’s when the fireworks really started. Physicians had problems registering, and when they could finally view the data, there were significant problems – confusing “error” messages, missing payments, payments attributed incorrectly. CMS took the system down to correct the problems, and extended the review and dispute period to accommodate for the time the system was down. When Open Payments opened back up for physicians, almost one-third of manufacturer records were “missing.” Eventually, CMS said the records were withheld due to data matching problems. A number of issues were identified that caused the data to disappear. The primary offenders appeared to be state license numbers and NPI numbers submitted by manufacturers and GPOs that did not exactly match what CMS had in its database for those identifiers. Despite all the delays and problems, CMS said the September 30th date for making payment records public would stand, minus the withheld records. Those records would be published by June 30 of the next year.

September 30th came, data was published, and all was right with the world, right? Onward to 2015! Not so fast there dear readers. As we all spent time regretting those unfortunate photos taken at the office Christmas party, CMS elves were busy at work. The agency released 68,000 records that were previously withheld, notified users that Open Payments would be unavailable for most of January to allow time for system maintenance, and announced it will be hosting an Open Payments Q&A in early 2015.

Yes, it was a full year of Open Payments fun, but the news surrounding the data was not all CMS had up its transparency sleeve. The agency notified stakeholders that changes were on the way for Sunshine’s Final Rule. The one change that sparked the most debate was the removal of the exemption for payments to physicians speaking at accredited CME events. Medical societies, physician groups and CME providers were staunchly opposed to the change, but it was still made official in October. The change will take effect in 2016 but it may not be the end of the road for the exemption. A bipartisan bill was proposed to exempt indirect CME payments, as well as the value of medical textbooks and reprints.

Other news of note on the transparency front for 2014 included the passage of a law in Connecticut that requires the reporting of industry payments to nurse practitioners; Minnesota making good on the Board of Pharmacy’s notification that payments to nurse practitioners and others would be required in 2015 reports; and the changes in transparency requirements to the Medicines Australia Code of Conduct.

The cork popped on GSK’s bribery woes in 2014. The company was one of several pharmaceutical companies under investigation by the Chinese government for allegations of bribery. The company announced it was investigating potential bribery in Iraq, Jordan, Lebanon, Poland, and Syria. GSK enhanced its compliance efforts in China and fired several employees over failure to adhere to expenses rules. In the fall, it was able to close the book on the Chinese investigation with a fine of close to $500 million dollars. The head of China operations and four other executives were sentenced in the matter, but all had their jail sentences suspended and avoided actual jail time. The head of China operations, a British national, was deported. The company could still face legal action from the U.S. Department of Justice and the U.K.’s Serious Fraud Office for violating bribery laws.

The FDA resolved it would make the July 2014 deadline for social media guidance, and it actually did! Three draft guidance documents related to social media were published. One document is related to the submission of advertising content, and the other two dealt with actual postings on social media platforms. The guidance on correcting misinformation on social media platforms applies to correcting independent user-generated content, and not content generated by a company, its employees or agents.

The more anticipated document, and the one that drew the most criticism, deals with the posting of information on character-limited platforms, such as Twitter. Some companies feel the FDA has basically restricted them from using character-limited platforms to promote their products due to strict requirements around presenting risk and benefit. The Washington Legal Foundation and the Medical Information Working Group said the guidance infringes upon manufacturers First Amendment rights.

And there you have it, our choices for top stories of 2014. What will be the “big news” of 2015? If we were betting people, we’d put money on Open Payments and Sunshine being the stories that generate the most headlines. With a full year’s worth of spend data hitting the system for the first time, expect more hiccups. Also, a full year’s worth of data is likely to reveal even more issues and have the pundits buzzing. Transparency overseas will likely make news in 2015, as EFPIA member associations and Medicines Australia members begin collecting data for disclosure in 2016.

There was a noticeable lack of big dollar enforcement cases in healthcare fraud and FCPA cases last year. While the DOJ could boast upwards to $2 billion in healthcare fraud recoveries for the 2014 fiscal year, there were no billion or multibillion dollar settlements with life sciences companies. The crystal ball is a little cloudy on that front. Was 2014 the calm before the next storm, or has the season of the multimillion to billion dollar settlements with pharma and med device companies come to an end?

FCPA enforcement actions were in a bit of a lull through at least the first half of 2014 compared to years past. The DOJ ended the year on a big note though, with its Alstom settlement. As far as we’re concerned, it’s been a little too quiet lately where FCPA enforcement is concerned, so we wouldn’t be surprised to see more activity in 2015. Don’t be surprised if we see actions against the handful of pharma companies that were accused of passing bribes in China in 2013.

Whatever 2015 brings, we’ll be writing about it through our weekly Compliance News in Review. Have a great year everyone and as always, thanks for reading!

Week in Review, December 10, 2014

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The Serious Fraud Office gains its first conviction under the U.K. Bribery Act, Sanofi is charged with kickback violations, and CMS unveils new tools and user guides in the Open Payments system.

Well, we’re smack dab in the middle of it now. There’s no escaping the mire, so just give in and go with the flow. The Christmas shopping season is in full swing. Daily Doorbuster specials, circling the mall parking lot repeatedly looking for a space to park…yes, the joys of the season are upon us. As you lick your wounds from another weekend of retail madness and mayhem, we offer a brief respite, with this week’s Compliance News in Review.

Gift giving is certainly a joy of this season, but you don’t want it to land you on the naughty list during an FCPA investigation. This list of ten tips to consider when giving business gifts can help keep a company on the nice list. Tips include making sure the gift is permitted under the local law where the recipients is based and recording gifts routinely in company books and records.

The Serious Fraud Office (SFO) has tied a bow around its first conviction under the U.K. Bribery Act. Two individuals were found guilty in a case that involved the sale of biofuel investment interests to U.K. investors. The defendants were found to have created fake invoices that allowed them to collect large commissions from the investors. Legal experts say the case makes it clear that the SFO will pursue individuals for private sector bribery.

Sanofi, its former CEO, and several other executives have been accused of overfilling the stockings of doctors, pharmacists and hospitals. A whistleblower suit, filed by a former Sanofi paralegal, claims she was fired when she raised concerns over several contracts that paid consultants to pass along kickbacks to doctors, pharmacies and hospitals. The kickbacks were allegedly offered in return for prescribing or purchasing the company’s diabetes drug. Former CEO, Chris Viehbacher said the accusations are “entirely baseless and are categorically false.” The company says it will vigorously defend the suit.

AstraZeneca and Ranbaxy won’t need to return the present they received in a pay-for-delay case. A jury decided that a deal between the two companies, which delayed a generic version of Nexium, was large and unjustified, but was not anticompetitive. A Ranbaxy spokesperson stated “the jury understood the facts of the case and was not swayed by wishful thinking on the part of the plaintiffs.”

CMS donned the Santa cap as it handed out several “gifts” last week for Open Payments users. The agency released an improved physician and manufacturer search tool, updated physician lists and revised user guides. CMS also announced it would soon provide reference information for the 2014 program year, including an overview of the timeline and updates on system enhancements.

If new commercial compliance training is on your holiday wish list, PharmaCertify™ from NXLevel Solutions, offers updated training on critical topics like global transparency, the Anti-kickback Statute, on-label promotion, and the False Claims Act. To see a demo of our eLearning modules and mobile apps, contact Sean Murphy at smurphy@nxlevelsolutions.com

That’s all for this week folks. Stay safe out there, and we’ll see you back here next week!

Week in Review, November 5, 2014

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The OECD questions Japan’s bribery law, OIG releases its 2015 Work Plan, CMS hopes to clarify the issues with data mingling, and Biomet settles False Claims Act charges against one of its subsidiaries.

Well, it certainly was a spooktacular weekend full of ghosts, goblins, and sugary goodies. November is upon us and Thanksgiving is just around the corner. But before we start the annual debates over canned or real cranberry sauce, or apple pie vs. coconut custard (a particular favorite at the Week in Review home offices), we have one more treat; this week’s News in Review.

The Organization for Economic Cooperation and Development (OECD) is taking issue with Japan’s ghost-like anti-bribery enforcement efforts. Japan does have a law prohibiting bribery of foreign officials, but it has done little in the way of enforcing that law. Under pressure from the OECD, the Japanese government developed a plan to increase enforcement, but the organization claims the law doesn’t address key issues, such as facilitation payment. The government plans to make more changes, but businesses are not waiting. According to Transparency International, a number of businesses are seeking guidance on how to develop effective anticorruption programs.

If you’re looking for a little something to help you take advantage of that extra hour of sleep we picked up over the weekend, the OIG has released its 2015 Work Plan. Sweet dreams.

CMS provided a few treats for applicable manufacturers and GPOs caught up in the data mingling issue that occurred during the inaugural submission of physician payments records. The agency has returned the report records to those affected and has given manufacturers and GPOs until March 31, 2015 to re-submit corrected records. A webinar for organizations with a returned record report is scheduled for November 13th and CMS is also providing a Validated Physician List in the Open Payments portal.

It wouldn’t be Halloween without a few surprises and CMS was happy to oblige. The agency announced several changes to the Sunshine Act Final Rule. The changes include the removal of the CME exemption; the deletion of the “covered device” definition; a requirement to report the marketed name and therapeutic area of a covered drug, device or biologic; and a requirement that stocks, stock options and any other ownership interest be reported as separate categories. The changes are effective immediately, but due to comments from industry CMS and the time needed to make changes to manufacturer systems, the changes will be implemented in the 2016 collection year.

On the settlement front, Biomet agreed to pay $6 million to settle charges it violated the False Claims Act. According to prosecutors, EBI, Inc., a Biomet subsidiary, provided kickbacks to encourage physician office staffers to use its bone growth stimulating product. The lawsuit was filed under the False Claims Act by a former product manager.

We close this week’s Review with a reminder that as you look to expand, supplement, or revamp your compliance curriculum, PharmaCertify™, from NXLevel Solutions, offers the off-the-shelf and custom training solutions you need to continually deliver critical compliance content where your staff needs it most – in the field and at their fingertips.

Have a great weekend everyone.

Week in Review, September 17, 2014

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A new study reveals surprising information about FDA panelists and their ties to manufacturers seeking regulatory approval, the DOJ files a False Claims suit against a neurosurgeon and a spinal implant company, the FTC accuses two companies of trying to stymie generic competition for Androgel, and a collection of advocacy groups ask CMS for an indirect payments exemption.

Ahoy there mateys! Stand fast, secure the rigging, and let us hear your best “arrr.” Yes, “Talk Like a Pirate Day” is on the horizon. As you prepare to weigh anchor and hoist the mizzen, we strongly recommend you avoid the parrot on the shoulder idea – that didn’t end well for one of the old salts here at the Week in Review offices last year. The big day isn’t until Friday, so we’ll fill the time with this week’s Compliance News in Review.

It’s not the amount of treasure involved, but rather the type of treasure, that may be more influential in the decisions made by FDA panel members when they decide which drugs to recommend for regulatory approval. A recent study found that panelists who have financial ties only to the drug manufacturer seeking approval are 1.5 times more likely to vote favorably for the company than members with no ties. However panelists who have ties to the company seeking approval and its competitors are no more likely to recommend for approval than those panelists who have no ties. Panelists with multiple relationship may not have a sense of loyalty to any one particular manufacturer. In addition, panelists who serve on advisory boards are more likely to approve a drug than panelists who have research or consulting relationships with the manufacturer.

A physician and spinal implant company have found themselves on the wrong end of a hornswaggle claim by the Department of Justice. The agency has filed a False Claims Act suit against a Michigan neurosurgeon, as well as spinal implant company, Reliance Medical Systems, and two of its distributorships. The company is accused of paying kickbacks through physician-owned distributorships (PODs). The government alleges that the company set up the PODs to induce physicians to use its spinal implants. The physician involved received payments through a POD in which he had an ownership stake. He is also accused of performing unnecessary procedures on patients who did not need spinal implants.

The Federal Trade Commission (FTC) is suing Abbvie and Besins Healthcare for running a rig and trying to prevent generic competition for the product Androgel. The agency claims the companies filed baseless patent infringement lawsuits in an effort to prevent potential generic competitors from entering the market. While the lawsuits were pending, Abbvie then entered into a pay-for-delay deal with Teva in order to postpone the launch of its generic version of the product. The FTC is asking the court to declare that Abbvie and Besins Healthcare violated the Federal Trade Act, and is seeking disgorgement of profits.

The mutiny against indirect payment disclosures under Sunshine continues to grow. A collection of 64 patient advocacy groups sent a letter to CMS requesting an exemption for indirect payments to the groups. The letter claims drug and device manufacturers have no discretion on how funds provided to patient advocacy groups are directed. It also suggests that the process of determining how a manufacturer’s funds are allocated places an unnecessary administrative burden on the groups.

As we heave to on this week’s journey into the world of compliance, we end with a question: arrr your sales representatives prepared with the up-to-date content on topics like the Sunshine Act, HIPAA, and Good Promotional Practices? The PharmaCertify™ suite of solutions offers your team compliance-focused information where and when they need it most – in the field and at their fingertips.

Have a great rest of the week everyone.

News Week in Review, July 29, 2014

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Physicians find confusion instead of data on Open Payments, a judge refuses to dismiss the false claims case involving Thalomid, FedEx is facing arraignment this week for shipping illegal drugs, and the SFO is teaming with the Chinese government on the GSK case.

Time to deck the halls and break out the It’s a Wonderful Life DVD. It’s Christmas in July! While the dog days of summer may seem an odd time for sugar plum fairies to be dancing through our heads, we can at least crank the air conditioning, don a really ugly reindeer sweater, and let our imaginations run wild. It’s time to rip the paper and ribbons off this week’s Compliance News in Review.

Some doctors unwrapped a confusing error message when they tried to access information in the Open Payment system last week. July 14th marked the first day physicians and teaching hospitals could access the information that has been reported about them in the system. A number of physicians reported that it took them up to an hour just to log on. Once logged in, some saw a rather ambiguous error message; “You have the following errors on the page. There are no results that match the specified criteria.” Although the physicians were unsure whether this was a bug in the system, or it really meant no payments were in the system, CMS said the message is clear and anyone with questions should call their helpdesk.

The sleigh ride isn’t over yet for Celgene. A federal judge refused to dismiss a false claims case brought against the company by a former salesperson. The case has drawn interest because it raises questions about when manufacturers can discuss the off-label use of products with physicians. According the whistleblower, initial marketing efforts for the drug Thalomid were focused on off-label uses. The company asked for a dismissal, saying the plaintiff failed to state a plausible claim. The judge disagreed, saying the plaintiff’s claims did lay out a sufficient case of wrong doing and that Celgene was “belied by its own evidence.”

The director in the charge of the lab where employees were potentially exposed to anthrax has resigned. Lax adherence to safety protocols in the lab led to the possible exposure. Luckily no one fell ill. An investigation into the incident has found that several other labs, some dealing with dangerous germs, were also not following proper safety protocols. CDC chief, Tom Frieden, said disciplinary action will be taken against those intentionally breaching safety protocol, or those who know of safety breaches but do not report them.

One of Santa’s helpers, FedEx, will be arraigned in federal court this week. The company was indicted for shipping drugs for illegal pharmacies. The government claims it repeatedly warned FedEx about shipping drugs for the pharmacies. FedEx says it ships millions of packages and cannot be responsible for policing the contents of each one. The company says it repeatedly asked for a list of shippers involved in shipping illegal prescription drugs, but was never provided one. United Parcel Service signed a non-prosecution agreement last year over similar charges.

The Serious Fraud Office (SFO) and the Chinese are caroling together in the GSK investigation. SFO chief, David Green, says this is the first cooperative case between the agency and the Chinese government. Green visited China earlier in the year, and said the Chinese government has a desire to deal with bribery and corruption. The SFO’s interest in GSK has expanded beyond the company’s business in China, and the agency is seeking help from whistleblowers regarding reports of bribery in the Middle East and Europe. GSK chief Andrew Witty says he remains “very concerned” about bribery allegations in China.

Even if you didn’t bother to break out the decorations for Christmas in July, planning for the actual, year-end festivities will be here soon after summer ends. And so will, the need to make your 2015 compliance training plans. The PharmaCertify™ suite of commercial compliance training solutions offers the up-to-date modules and mobile apps your staff needs to help them integrate good compliance practices into their daily activities.

Have a great week everyone, and happy holidays!

Week in Review, July 22, 2014

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The Minnesota Board of Pharmacy confirms that payments to nurse practitioners and PAs must be reported, the FDA issues more Warning Letters, a grand jury indicts FedEx for shipping drugs for illegal pharmacies, and industry funding for CME continues to decline.

With summer in full swing, Major League Baseball took a break from the pennant races for its annual showcase of the best and brightest stars from both leagues…and the ratings were up. In what seems to be the trend lately, the American League came out on top and National League fans were left lamenting the fact that should their team make it to their World Series, they will once again be denied the coveted home field advantage (strange rule indeed). Now, as trade talks heat up and races tighten, we step up to the plate with this week’s News in Review.

First up, we have news from the state that hosted the All Star Game, Minnesota. The Minnesota Board of Pharmacy released a memo confirming that 2014 payments to nurse practitioners, physician assistants, veterinarians and dental technicians must be reported in May 2015. The Board advised manufacturers to begin tracking data for these professionals since it expected the legislature to require companies to report those payments.

Batting second this week is the always confusing topic of social media. The FDA recently issued an Untitled Letter to Gilead and a Warning Letter to Zarbee’s Naturals regarding the company’s use of social media for product promotion. In its letter to the company, the FDA cited an ad that used Google’s AdWords. The ad neglected to provide risk information, and the drug was misbranded. The ad also did not include the generic name of the product and only featured the brand name in a couple of URLs listed in the ad. Zarbee’s Warning Letter focused on the use of Facebook “likes.” The FDA equates “likes” top promotions and the company “liked” several customer testimonials on its page.

Companies that manufacture products for human use aren’t the only ones running afoul of the FDA’s promotion regulations. A Warning Letter was issued recently to the French pharmaceutical facturer, AB Science, for the off-label marketing of a veterinary drug. The letter cited several off-label statements on a product website. The FDA also noted that the company neglected to list important safety information on the product website and other promotional material.

The federal government took a swing at FedEx recently when a federal grand jury indicted FedEx for shipping drugs for illegal pharmacies. According to prosecutors, the company was warned for over a decade that they were shipping drugs for illegal pharmacies, but that those warnings went unheeded. Rather, the company “departed from its usual business practices” to continue shipping the drugs. According to prosecutors top managers at FedEx approved the continued shipping to known illegal pharmacies. A senior vice president for FedEx said the company was innocent of the charges levied against it, and would plead not guilty.

It’s a single for industry support of CME…a single digit decline in funding that is. According to the ACCME’s Annual Report, industry funding of accredited CME dropped by 1.9% in 2013. Support from industry represents 27% of all CME income. This is a far cry from 2008, when industry funding represented almost half of CME funding. Physician attendance at CME events was down in 2013 by just over 4%, but attendance by non-physicians was up by 5%.

As we wind down this week’s version of the Week in Review, we offer one last pitch about the importance of reviewing your Sunshine Act training needs – particularly in light of the ongoing activities around Open Payments registration and data review. The PharmaCertify™ eLearning module, The Sunshine Act: The Federal Physician Spend Disclosure Law, is designed to bring your team up to speed on reportable and excluded expenditures, and the information required for submission to CMS.

Have a great week everyone!

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

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

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!