Week in Review, July 22, 2014

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 9, 2014

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

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

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

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

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 27, 2014

CMS prepares for Phase 2 of Open Payments registration, data submission, and attestation; Washington D.C.’s Department of Health announces it will not require the reporting of gift expenses; Roche gets a visit from the State Authority for Industry and Commerce in China; and the FDA evaluates its off-label promotion policies in light of First Amendment cases.

Summer has arrived! Well, not really, but Memorial Day certainly marks the unofficial start of the season. And nothing says summer more than a trip to the beach. Or as our New Jersey staffers like to say, “down the shore.” If you’re struggling to shake the sand off of a memorable weekend at the beach, and refocus on all things compliance, we’ve got just the remedy…this Week’s News in Review.

Break out those beach towels and SPF 70, it’s time to bask in the Sunshine. Phase 2 of Open Payments registration, data submission and attestation will begin on June 1. This phase will occur in two parts, with the first beginning June 1. Applicable manufacturers and GPOs will be able to register in Open Payments; confirm the reporting entity profile; assign roles within the system; and upload test files. Then, beginning June 9, manufacturers will be able to submit final reports and attest to the accuracy of those reports. Companies have until the end of June to complete both parts of Phase 2.

The Sunshine is a little less intense in Washington D.C. The District’s Department of Health will not require pharmaceutical companies to submit gift expenses for physicians and teaching hospitals. For the 2013 reporting year, manufacturers and labelers do need to report physician and teaching hospital gifts provided prior to July 31, 2013. Also, expenses for all other recipients must be reported. Reporting requirements for advertising and aggregate expenses remains the same.

Roche may have found themselves caught up in the wave of bribery investigations in China. The company revealed that China’s State Authority for Industry and Commerce (SAIC) paid a visit to one of its facilities in China. The SAIC is generally the lead agency in bribery cases. Roche said the reasons for the visit were not immediately clear.

Could the FDA be rearranging the beach chairs when it comes to off-label promotion? Recent court decisions have raised issues around the First Amendment and drug promotion, and FDA chief counsel says the agency is taking the “First Amendment concerns very seriously.” The Center for Drug Evaluation and Research chief, Janet Woodcock said, “We are currently carefully evaluating our policies in light of court decisions on First Amendment issues.” While the agency may be revaluating its stance, the DOJ still intends to aggressively pursue off-label cases.

Speaking of the FDA, the agency is planning a study to determine if bargain-hunting consumers weigh price more heavily than other attributes of a drug. The study will show three versions of an ad for a diabetes drug to patients and HCPs. One ad will feature a price comparison between the advertised drug and a competitor, another will feature pricing information only for the advertised drug, and the third version will state the drug’s safety and efficacy profile, and one that will inform the viewers that actual prices may vary. The FDA currently allows manufacturers to include pricing in advertising but very few do.

June 1 not only marks the beginning of Open Payments Phase 2 for manufacturers, it’s also the start date for physicians to register with CMS to access the reported data. This is a critical time for the industry, and keeping your team up to speed on requirements of the Sunshine Act is more important than ever. The PharmaCertify™ module, The Sunshine Act: The Federal Physician Payments Disclosure Law, includes a comprehensive list of the disclosure requirements included in the law and the physician spend information that will be shared with the public.

Have a great week everyone.

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