Compliance News in Review, June 13, 2017

States with new laws, lawsuits and more; HHS says drug pricing is a top issue; the AMA takes aim at DTC ads again; and transparency efforts and more from Europe…all in this edition of the Compliance News in Review.

The magic, mystery, and “monstering” of the summer movies season is in full swing! From super-heroes to lush gothic tales, there’s something for everyone this summer. There’s nothing like escaping to the theater on a rainy summer day. Can’t you just smell the popcorn and taste the Milk Duds? Before you head off to take in the latest blockbuster or art house feature, silence your cell phone and enjoy this screening of the latest edition of the Compliance News in Review.

We begin with a trilogy of compelling releases. The Nevada legislature passed a bill that would have required makers of diabetes drugs to report drug pricing information to the State. The bill was forwarded to the governor, who promptly vetoed it. Undaunted, State senators revised the bill; removing the requirements to which the governor objected and adding provisions that apply to all drug manufacturers. It was passed, and in an ending fit for Hollywood, the governor has said he is “proud to sign” the new bill. The law will require manufacturers to report pricing for diabetes drugs, and all manufacturers must now supply a list of sales representatives who work in the State. Additionally, all transfers of value from Nevada sales representative to HCPs must be reported each year, including those to mid-level practitioners and office staff.

It’s a wrap on a new law concerning generic drug pricing in Maryland. Generic drug makers will now be fined when a price increase causes a product’s wholesale acquisition price (WAC) to increase by more than 50% in one year, or if the drug’s WAC is greater than $80. Maryland’s expressed concern that the bill did not address the cost of patented drugs and devices, and that it may result in citizens not having access to some generic drugs. Concerns aside, the governor did not veto the bill. The law will go into effect October 1.

The Washington D.C. Department of Health has posted several FAQs related to AccessRx. The FAQs cover a variety of issues including reporting timelines, advertising expenses, and gift reporting.

HHS Secretary, Dr. Tom Price, says drug pricing is a coming attraction for the agency. In testimony before the senate budget committee, Price said the president has directed him to develop proposals to lower drug costs. He also said meetings with stakeholders have already taken place.

This attraction is rated “P” for pricing. At the AMA’s annual meeting, the group will consider a proposal urging drug manufacturers to list drug prices in DTC ads. The proposal was introduced by several New England medical societies, and advocates who have been pushing federal agencies, such as the Federal Trade Commission and the FDA, to compel drug companies to include retail pricing information in DTC ads. The proposal will need to be approved by the American Medical Association’s House of Delegates before being presented to the larger body.

From the foreign film division, a story of transparency. German doctors will be able to voluntarily disclose payments they receive from drug companies in a database managed by the non-profit journalism group, Correctiv. According to a study conducted by Correctiv, 71,000 German doctors received 575 million Euros worth of payments from the industry last year. The study also found that only 29% of doctors were willing to have their payment information published.

Two companies have been publicly reprimanded for breaches of the ABPI Code of Practice. In one case, a media agency published the work it did for the company to promote the agency’s creative capabilities. The work was out-of-date and no longer accurate. Even though the company did not give the agency permission to publish the work, and voluntarily reported the incident, it was found to have violated Clause 2 of the Code of Practice; bringing discredit upon and reducing confidence in the industry. In the other breach, another company was reprimanded for distributing a patient support leaflet with inaccurate and misleading information. The company was asked to issue a corrective statement to the healthcare providers who had already received the leaflet.

The last story is a good reminder of the importance of making sure your compliance training extends to vendors and other third parties. In bribery cases, we see the damage that can be caused when third parties run afoul of laws and regulations. Vendors and other third parties need to be evaluated for the risk associated with their services and targeted training should be provided based on that risk.

With that, we roll the closing credits on this edition of the Compliance News in the Review. Thanks for reading. We’ll see you at the movies!

Compliance News in Review: the 2016 Year-End Summary

Here we are again. Another 584 million-mile (940 million km for our metric friends) trip around the sun is nearly complete. It seems like just yesterday we were celebrating the beginning of 2016 and now we’re picking out our favorite brand of champagne to celebrate its end. Before we break out the noisemakers and party favors, let’s take one last nostalgic look back at some of the life sciences compliance-related developments of 2016.

A new milestone was reached regarding HCP spend disclosure. The first disclosure reports under the EFPIA Disclosure Code were released in 2016. Gaining disclosure authorization from individual HCPs proved to be a challenge for the industry and the numbers of doctors who granted authorization ranged widely between countries. According to Britain’s pharmaceutical trade association, ABPI, 70% of their HCPs granted authorization and in Ireland, just over half of HCPs did so. In other transparency developments, ten of Canada’s top drug firms announced plans to voluntarily disclose aggregate physician and healthcare organization payment data. The movement was started by GSK Canada, and other multinational firms including Abbvie, Purdue, BMS, and Lilly followed.

Drug pricing was a big story in 2016. Former CEOs from Turing and Valeant were called to testify before Congress about drug price hikes, and Mylan’s CEO was called to testify over dramatic increases in the cost of an EpiPen. Laws that would require drug companies to disclose information about their pricing decisions were proposed in several states, and a bill was introduced at the federal level with similar requirements. Even with those high profile stories making headlines, only one pricing disclosure law successfully passed this year – Vermont. That law requires a select group of manufacturers to provide information about the factors related to price increases.

A handful of former Insys employees had an eventful year. A former sales representative entered a guilty plea to charges of fraud, and a district sales manager and a several of top executives were all arrested on charges they paid kickbacks to doctors. The drug at the center of the charges is the opioid painkiller, fentanyl. Prosecutors and enforcement agencies claim the individuals offered a variety of kickbacks to doctors to increase prescriptions and encouraged them to prescribe it for unapproved uses.

2016 was an active year for settlements related to bribery cases. GSK, AstraZeneca, SciClone, and Novartis all entered into settlements with the SEC over activities conducted by subsidiaries in China. Orthofix and Teva both set aside cash in anticipation of resolving the FCPA-related charges. Olympus entered into a $22.8 million settlement with the DOJ to resolve charges that a subsidiary covering Latin America paid bribes to healthcare professionals working in government facilities in order to increase sales of product.

We saw a couple of legal “victories” for the industry in the debate over sharing truthful off-label information. In the Amarin case, the FDA decided not to appeal a judge’s decision that allowed the company to share truthful off-label information about its fish oil product. In addition, in proposed jury instructions for a medical device case, the DOJ indicated that it is “not a crime for a device company or its representatives to give doctors wholly truthful and non-misleading information about the unapproved use of a device.”

With a string of legal decisions favoring the industry, the FDA held a public forum in November concerning the ability of drug and device makers to share off-label information. The primary topic was whether the agency needs to revise its regulations considering recent legal decisions and the forum was attended by various stakeholders representing both sides of the argument.

With that, we complete our look back at 2016 and the stories that made headlines in the world of life science compliance. It was an eventful year, and everyone at the Compliance News in Review is excited to see what the new year holds. Thanks for joining us throughout the year and best wishes for a happy, healthy, and compliant 2017!

Week in Review, December 16, 2014

Otismed pleads guilty to selling knee replacement cutting guides that had been rejected by the FDA, Senators Hatch and Bennett introduce bill to exempt low risk software from the definition of a medical device, and the oversight group for the APBI Code of Conduct chastises Galderma over the requirements for attending a presentation.

They litter the landscape of the Christmas season, and have become so iconic that an entire day is dedicated to celebrating the infamous ugly Christmas sweater. It’s as much a fixture of the season as Santa hats and reindeer antler headbands. In fact, a number of on-line retail outlets have jumped on the bandwagon for this haute mess couture. Before we get dive into a debate over the categorization of light-up sweaters as “ugly” or just a “whole separate item,” we’ll dive into something a little less controversial, this week’s Compliance News in Review.

This isn’t a warm and cozy situation for Otismed and its former CEO. The company pleaded guilty to criminal and civil charges that it sold knee replacement surgery cutting guides despite it being rejected by the FDA. According to prosecutors, the former executive directed that over 200 of units be shipped despite the product not receiving FDA clearance and the company’s board voting to cease shipments of the product. Otismed was purchased by Stryker, which was unaware of the incident at the time of purchase. The company will pay $80 million to resolve the charges and the former CEO will be sentenced in March of 2015.

There are no ugly feelings from med tech innovators about a bill recently introduced in the U.S. Senate. Senators Orin Hatch and Michael Bennett have introduced a bill that will exempt low-risk medical software and apps from the definition of a medical device under the FDCA. The senators say the bill will provide clarity over which devices should be regulated. The bill, called the MEDTECH Act, removes five categories of innovation from the definition of a covered device.

Could the Prescriptions Medicines Code of Practice Authority (PMCPA) be unraveling its ties with Galderma? PMCPA, the oversight group for the Association of the British Pharmaceutical Industry’s Code of Practice, and Galderma are at an impasse over a public reprimand issued against the company by the organization. The reprimand stems from a complaint lodged by a nurse attending an educational meeting sponsored by Galderma. The complaint alleges that attendees had to prove they had purchased the company’s filler in order to attend the presentation. In addition, the PMCPA says attendees received financial incentive to attend in the form of free product. Galderma says it was not uncommon to require attendees to purchase product in order to attend, and the filler is a medical devices so any related activities do not fall under the Code. Galderma appealed the decision, and the PMCPA has removed the company from its list of companies agreeing to abide by the Code.

With that, we put a wrap on this week’s edition of the News in Review. Good luck with those ugly sweater contests this weekend everyone, and remember, light-up reindeer noses always seem to catch the judge’s eyes.

Have a great week!

Week in Review, August 19, 2014

The widespread use of DPAs and NPAs in bribery cases raises legal concerns, CMS shuts down Open Payments to correct data problems and subsequently announces it will actually withhold one third of the data until June 2015.

Can you feel it? The air is heavy with despair. It may be faint, but the smell of newly sharpened pencils and mimeograph ink (remember that stuff?) is in the air. It’s back to school time! If you need help figuring out what to buy for Junior’s backpack this year, the trusty editors at Good Housekeeping have created a series of school shopping lists divided by grade level. You may be surprised to see tissues and hand sanitizers on there, along with the staples like pencils and glue sticks. Don’t forget the hand sanitizer and tissues!

To go this year started, we begin with a little reading assignment of our own. Put your thinking caps on class, it’s time for this week’s News Week in Review (and most of this will be on the test).

Corporate Bribery + Prosecution Agreement = End to Case. According to a recent Forbes article, the widespread use of Deferred Prosecution Agreements and Non-Prosecution Agreements in bribery cases is troubling from a legal standpoint. Using DPAs and NPAs leads to the charges being untested in court and self-reporting can do more harm than good. The authors argue that companies or individuals are better off fighting untrue or exaggerated claims, rather than opting for the settlement route.

No school year would be complete without a little drama, and thanks to Open Payments we have quite the soap opera to tell. Days after physicians and teaching hospitals were able to access Open Payments to review the data reported about them, at least one physician found that payments from another physician with the same name were showing up on his report. CMS subsequently shutdown the Open Payments portal for physicians and teaching hospitals. The shutdown dragged on for eleven days before the portal was reopened, and so far, so good. CMS extended the review and dispute period for physicians and teaching hospitals to September 8. The public website will still be available on September 30th.

All’s Well that Ends Well, right? No so quicketh, faire reader. The malady was resolved, but hark, hear now cometh a report that all information will be revealed not! (okay, we apologize for the rough attempt at Shakespearean English) CMS has announced that due to data inconsistencies, it will withhold one-third of Sunshine data from the public website. The records are being returned to the submitters to address issues of data intermingling. The data will be released in the June 2015 publication. In addition to clearing up the errant records, CMS replaced a confusing error that appeared when a search yielded no payments for a physician or teaching hospital.

As the bell rings on this edition of the Compliance News Week in Review, we dismiss you with the reminder that the PharmaCertify™ suite of eLearning modules and mobile apps offer the up-to-date information your staff when and where they need it most – in the field and at their fingertips.

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, May 5, 2014

UCLA settles with a surgeon over conflicts of interest, CMS announces a timeframe for Phase 2 of Open Payments data submission, qui tam lawyers pour through the recently released Medicare payment data and PhRMA weighs in on simplifying product warning information.

Not so long ago in a galaxy…well, right here…the greatest achievement in cinema was celebrated (yes, we’ll admit it, we’re often given to hyperbole). With all due respect to Bogie and Bacall and Orson Welles, we’re of course referring to this past weekend when the Fourth of May was with us, and we celebrated Star Wars Day. Then, on Monday we had to deal with the Revenge of the Fifth. Rather fitting don’t you think? If Star Wars isn’t your particular cup of blue milk, feel free to jump right to the earthly compliance news of the week with this issue of the News in Review.

10,000 credits in advance may get you a ride on the Millennium Falcon, but it took 10 million dollars to settle a retaliation suit between a UCLA surgeon and the University of California Board of Regents. The surgeon, who was head of the orthopedic surgery department, raised concerns about physicians’ financial relationships with medical device companies. He claims his complaints were ignored and he was then denied patient referrals and prevented from participating in grants. In settling, UCLA claims it chose “to end a prolonged conflict and permit UCLA Health Sciences to refocus on its primary missions of teaching, research, patient care and community engagement.”

Open Payments: Episode 2, coming soon to an industry company near you. CMS has announced that applicable manufacturers can expect Phase 2 of Open Payments data submission to be open late May or early June. During Phase 2, applicable manufacturers and GPOs should:

  • Register any authorized officials not registered during Phase 1
  • Complete the registration for entity and the authorized official (supplemental information is required)
  • Verify entity profile information is correct
  • Upload, verify and attest to accuracy of payment data

Additional roles within the Open Payments system may also be assigned during Phase 2. CMS is preparing tutorial videos to assist applicable manufacturers and GPOs with implementation.

Qui tam lawyers have been mining the recently released Medicare payment data almost as aggressively as the Empire mined the Tibanna gas mines at Bespin (wow, we went full out geek there). The organization known as Taxpayers Against Fraud has lawyers pouring through the data looking for physicians who prescribe high numbers of a particular product. Obtaining this type of data previously required a subpoena. Is this a foreshadowing of what to expect once Sunshine data is released? Sunshine data might be used to demonstrate alleged instances of kickbacks, or infer that a company is involved in off-label marketing when a physician’s specialty doesn’t align with the approved use of a product.

They may not be well-liked by the hard core fans, but the Ewoks certainly proved the power of “keeping it simple.” Seriously, a bunch of teddy bears held off the Empire with rocks and logs! PhRMA appears to share this simplicity sentiment when it comes to the warnings in DTC ads. When the FDA asked for comments regarding a study focused on whether simplified warning information would help patients better understand the risks, PhRMA didn’t hesitate to voice its opinion. The organization believes shorter or less-complex warnings would help patients understanding the risks and motivate patients and healthcare providers to seek additional information about the drug.

With Phase 2 of Open Payments registration and data submission about to begin and the data publication expected not too far in the distant future, the Sunshine Act is burning brighter than the two suns of Tatooine. Make sure your team understands the nuances of the law The Sunshine Act: The Federal Physician Spend and Disclosure Law from the PharmaCertify™ suite of off-the-shelf eLearning modules.

Well folks that brings us to the end of this episode. Have a great week, and may the Force be with you!

Week in Review, April 29, 2014

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!