18th Annual Pharmaceutical and Medical Device Compliance Congress: A Preview

PCF’s annual Pharmaceutical and Medical Device Compliance Congress kicks off next week. The conference offers attendees the rare opportunity to network with industry leaders and hear their thoughts and suggestions on the bevy of topics and regulations affecting those who work in the pharmaceutical or medical device compliance field. Narrowing the list of impressive panels and sessions down to a manageable schedule may seem overwhelming, but we’ve perused the agenda for what we are looking forward to the most:

Day 1, Monday November 6, 2017

Keynote: OIG Update
Hearing the list of topics that led to settlements and the OIG’s fiscal year 2017 workplan from Mary Riordan, Senior Counsel, Office of Inspector General, Department of Health and Human Services is always valuable for anyone responsible for rolling out compliance training. We are also looking forward to hearing how the agency expects to apply information from the Compliance Program Effectiveness Resource Guide released earlier this year as it conducts investigations.

U.S. Attorney’s Roundtable
While we expect to hear about topics such as off-label promotion, we look forward to hearing what the U.S. Attorneys say about the emerging trend of investigating manufacturer relationships with patient assistance charities. Several companies have been subpoenaed for information about these relationships. One company recently entered into a Deferred Prosecution Agreement, as well as a Corporate Integrity Agreement, after being accused of paying kickbacks to a patient assistance charity.

Chief Compliance Officer Roundtable
For those working in compliance for emerging companies, this session offers an opportunity to learn what risks their brethren from larger companies are facing so they know where to focus their priorities for the upcoming year. With Arjun Rajaratnam, from Smith & Nephew, joining the roundtable, medical device company representatives should also find the information worthwhile and relevant.

Day 2, Tuesday November 7, 2017

HCP Engagement: The Road to Proactive Risk Management

The title is intriguing and we’re curious to know what steps industry professionals like Tom Glavin of Olympus and Michelle Murphy of Regeneron utilize to change their corporate cultures and convince leadership to shift to a more proactive model for addressing risk.

Managed Market Considerations for Hub and Specialty Pharmacy Arrangements

Training and messaging for those who work with specialty pharmacies is a topic not often addressed in these forums, so hearing what industry professionals like Terra Buckley of Celgene and Greg Sherman of Gilead Sciences say should be of value.

Compliance Considerations for Small and Mid-Sized Pharma and Medical Device Companies

Here is a direct opportunity for attendees from emerging companies to evaluate their programs against companies of a comparable size and learn best practices for managing risks with less resources.

Brief Overview of the Policy and Politics of Pharma Pricing

Transparency around drug pricing is a hot topic with state and federal legislators. Learning more about the current laws, as well as what to expect from politicians in an election year, should prove to be valuable when evaluating risk, writing policy, and developing training.

The Exhibit Hall (Especially Booth #112!)

We’re looking forward to catching up with clients and friends (old and new) at the 18th Annual Pharmaceutical and Medical Device Compliance Congress. During the networking breaks, we invite you to stop by the PharmaCertify Booth to see demos of our newest compliance training solutions. Our mission is to help you build a stronger compliance culture and reduce risk, and we welcome the opportunity to show you how we’ve done just that for our clients. While you are there, don’t forget to enter the drawing to win a JBL Flip 4 Waterproof Portable Bluetooth Speaker!

See you in Washington!

Friday the 13th Brings Multiple Settlements for One Unlucky Company

CMS posts new Open Payments thresholds, MedTech Europe revises its Code, California deals with two new pharmaceutical laws, and multiple settlements are announced for one “unlucky” pharmaceutical company…in this Friday the 13th edition of the Compliance News in Review.

Be careful what you wish for, Freaky Friday (a.k.a. Friday the 13th) has arrived. Steer clear of those sidewalk cracks, black cats, and broken mirrors! We prefer to focus more on the “Friday” part of the date stamp rather than the “13th.” Whether you’re working for the weekend, or just counting down the minutes until it officially begins, we offer the latest edition of the Compliance News in Review to help you whittle away the hours until the superstitions have subsided.

Change doesn’t have to always be scary. MedTech Europe, a joint venture of EucoMed and European Diagnostic Manufacturers Association, changed its Code of Ethical Business Practice. Changes include the phasing out of direct sponsorship for HCPs to attend medical conferences; enhanced transparency of educational grants; and new guidelines for demonstration products and samples. In addition, starting in 2018, members will only be able to provide educational grant support for meetings that have been vetted by the organization.

The “lucky” numbers for the Open Payments reporting thresholds for 2018 have been posted by CMS. The small payments, or de minimis threshold, was raised to $10.49, and the annual aggregate threshold was raised to $104.90.

California passed two new laws affecting the pharmaceutical industry. First, SB 17 requires health plans and insurers to report information about drug pricing. The information will be compiled into a report showing how drug pricing effects health insurance premiums. The law also requires drug manufacturers to notify purchasers 90 days in advance if a drug’s wholesale acquisition cost (WAC) is going to increase.

AB 265 prohibits prescription drug manufacturers from offering assistance to lower out of pocket costs, if a lower-cost generic equivalent drug is available. Exceptions include the discounts required under an FDA Risk Evaluation and Mitigation Strategy (REMS); single-tablet drug regimens for the treatment of HIV or AIDS that are as effective as a multi-tablet regimen; and completion of step therapy or prior authorization requirements for a branded drug, as mandated by the individual’s health coverage.

Time to start throwing copious amounts of salt over the shoulder at Aegerion. The company pled guilty and pay over $35 million to settle criminal and civil charges that it violated the FDCA, HIPAA, and the False Claims Act. According to the Department of Justice, Aegerion did not follow the proper Risk Evaluation and Mitigation Strategy when educating prescribers about the rare cholesterol condition its drug was approved to treat. The government also claimed the company filed a misleading REMS report and promoted the drug for the general treatment of high cholesterol, all in violation of the FDCA.

Aegerion also resolved civil charges it violated the False Claims Act. The company allegedly shared misleading information about its drug, altered or falsified statements of medical necessity or prior authorization to federal healthcare programs, and defrayed the copay obligations of patients in federal healthcare programs, which is a violation of the Anti-Kickback Statute.

Following the settlement, the patient assistance organization involved, Patient Services, Inc. (PSI), acknowledged it received a subpoena from the DOJ. PSI said it had cooperated with the government in the case. The organization said it operates “under guidelines set by the U.S. Health and Human Services Office of the Inspector General and does not funnel funds for manufacturers.”

Some “strange magic” leads to a $13 million FCPA settlement for Alere to resolve charges it violated the FCPA. The company allegedly paid bribes to meet its revenue targets. According to the SEC, company subsidiaries in India and Colombia used distributors or consultants to make improper payments to foreign officials. The agency said the company failed to maintain adequate internal controls to prevent the payments and recorded the payments incorrectly.

With that, we close out this superstitious edition of the Compliance News in Review. Thanks for reading! Stay safe out there as you navigate the potholes and pitfalls that allegedly lurk in shadows, and no matter what, don’t walk under that ladder!

Compliance News in Review, September 22, 2017

Reprimands in the UK, opioid manufacturers face another investigatory group, and registration processes for Nevada representatives, all in this week’s Compliance News in Review.

Ready or not, Fall is here! Leaves are turning, football is back, the oppressive heat of Summer is fading, and pumpkin spice everything is available. We are certainly fans of Autumn here in the offices of the News in Review and we’re ready to break out the flannel shirts, boots, and maybe a knit cap to enjoy the cooler evenings ahead. We are also fans of compliance! So, grab a pumpkin spice latte and settle in to this edition of the Compliance News in Review.

A nip in the air, and a nip at the marketing practices of several companies by the ABPI. The industry organization reprimanded Pfizer, Novartis, Astellas UK, Astellas Europe, and TOR Generics for breaches of its Code. Pfizer and Novartis were both cited for misleading promotion, and unclear materials used by representatives. Astellas UK and Astellas Europe voluntarily admitted that prescribing information for several of their products omitted references to adverse events. Lastly, TOR Generics was accused of promoting an unlicensed product, which was expected to be a prescription-only product, in a public magazine.

A new team is investigating opioid marketing. 41 state attorneys general formed a coalition to investigate opioid manufacturers and distributors. The group subpoenaed several top manufacturers, and wholesale distributors Amerisource, Cardinal, and McKesson. The AGs want to know if manufacturers deceived healthcare professionals about product efficacy and addictiveness.

Time to turn over a new leaf in Nevada. The state published draft procedures for the registration of pharmaceutical representatives. Individuals who work in Nevada for at least five days a year and communicate with healthcare professionals, or participate in the activities listed below, must register with the state’s Department of Health and Human Services (DHHS):

  • Marketing of prescription drugs to healthcare providers, pharmacists or pharmacy employees, and employees of medical facilities
  • Meeting with healthcare providers to answer questions about product use and benefits, or to provide discussion and product information and resources to those providers or other decision makers while representing the manufacturer or supporting promotional efforts of the manufacturer
  • Distributing FDA regulated product samples and product information

These activities are excluded under the law:

  • Attending a conference in Nevada that is not exclusively marketed to Nevada healthcare professionals
  • Activities related to clinical trials, investigational drugs, or Risk Evaluation and Mitigation Strategies
  • Activities performed by wholesale distributors who do not represent a single manufacturer

Companies are required to notify DHHS as employees are hired and terminated, and employees must be registered with DHHS within 30 days of hire.

With that, we wrap up this edition of the Compliance News in Review and head outback to roast marshmallows and make smores! If you can’t join us by the fire pit, we’ll catch you back here for our next issue.

Thanks for reading!

Compliance News in Review, September 8, 2017

Attention students! This week in the news: an opioid marketing Warning Letter; more state level transparency requirementss; and Novo Nordisk learns a tough lesson about product marketing.

The wheels on the bus are going ‘round and ‘round for children all over the country. School is back in session. Time to sharpen those pencils (do kids still use pencils?) and organize that Trapper Keeper. Sorry kids, but we kind of like this time of the year. After all, the deals on office supplies can’t be beat! Can one ever have enough index cards and three prong folders? While we go bask in the glow of our school supply haul, we’ll leave you with a little reading assignment: the latest edition of the Compliance News in Review.

Opioid manufacturer, Cipher Pharmaceuticals, didn’t have a letter sent home by the teacher, but it was issued a Warning Letter by the Office of Prescription Drug Promotion for misbranding its drug, ConZip. The company licenses the drug to Vertical Pharmaceuticals for sales. The letter references a sales aid that failed to disclose the risks associated with use of the product.

Don’t offer the teacher too many of those apples…at least in New Jersey. In the Garden State, Governor Christie wants to place restrictions on transfers of value to HCPs. The regulation limits compensation for “bona fide” arrangements up to $10,000 per year. It requires the arrangements to be in writing, with the HCP’s qualifications clearly stated in the agreement. The regulation also prohibits receipt of lavish meals, gift cards, and other items of a personal benefit to HCPs. Exclusions are made for payments for speaking at CME events and provision of items for patient education. The regulation will be published to the New Jersey Register in early October and a public hearing is scheduled for October 19.

Two industry trade associations are putting their civics education to work. PhRMA and BIO have filed suit against Nevada over the state’s transparency law. The groups claim the law is unconstitutional, and is preempted by federal law, and they have asked the court to put a halt to the implementation or enforcement of what they consider to be the problematic parts of the law. A representative from BIO said the law effectively establishes price controls on diabetes medication, which in turn will reduce private investment in biomedical innovation. A PhRMA representative said the law is unconstitutional because it conflicts with federal and state laws that protect intellectual property and trade secrets.

The city of Chicago is jumping onboard the drug pricing transparency bus. An ordinance has been proposed that will require manufacturers to report price increases 90 days in advance of sales. The ordinance also proposes the establishment of a Prescription Drug Price Review Board to monitor prices, and a hotline for the public to report information about price increases.

Novo Nordisk agreed to pay over $58 million to settle allegations it violated the Food, Drug, and Cosmetic Act (FDCA) and the False Claims Act. According to the DOJ, sales representatives downplayed or mislead HCPs about the risk of a rare cancer associated with the use of Victoza when detailing the drug to healthcare professionals. The company will pay $12.5 million in disgorgement for violating the FDCA, and $48.5 million for violating the False Claims Act.

With that, the final bell rings on this edition of the News in Review. We hope the return to the post-Summer school routine is a smooth and seamless one for all involved. We’ll see you around the schoolyard during recess with another edition of the Compliance News in Review.

Compliance News in Review, July 31, 2017

A whistleblower settlement, the effect of a recent cyberattack on one company’s drug supply, transparency in Ontario, and the growth of CME, all served for your approval in this edition of the Compliance News in Review.

It is the quintessential American food, even if it didn’t originate here; it’s the hamburger. Nothing beats a good burger, even during the hot dog days of summer (see what we did there?). The tasty entrée even inspired the bard of gulf and western music, Jimmy Buffet, to write a song extoling its virtues. So, how do you like your burger? With slaw? Kraut? Chili? Our mouths are watering just pondering the possibilities! Before we fire up the grill here at the News in Review World Headquarters, we’ll serve a tasty treat of a different flavor – the latest edition of the Compliance News in Review.

This is hardly minced meat. Celgene has agreed to pay $280 million to settle claims in a whistleblower suit that accused the company of promoting two of its cancer products for off-label purposes. The whistleblower, a former employee, claims the company directly marketed the drugs for the off-label uses and hid risks of blood clots from physicians. Celgene did not admit to wrongdoing in the settlement.

Still in a bit of pickle following the Petya cyberattack, Merck has warned that some drug supplies may be disrupted as it continues to rebound from the attack. The company’s R&D and manufacturing operations have not yet fully recovered and there may be temporary delays in filling orders for some products.

Ontario doctors may be flipping over a recent judicial decision that will allow the payments they receive from the government insurance program to be published. The Toronto Star filed a Freedom of Information Act request to obtain the names of the top 100 billers. The Ontario Health Ministry refused to provide the names, saying it would be an invasion of privacy. Two doctor groups and the Ontario Medical Association also fought the release of names, arguing that doing so “accomplishes nothing other than naming and shaming.” The judges disagreed, saying the “public is entitled to information in the possession of their governments so that the public may, among other things, hold their governments accountable.”

The Accreditation Council of Continuing Medical Education (ACCME) 2016 report on the growth of CME finds an increase in the number of events (7%), as well as an increase in the number of instructional hours (9%). The study also shows the number of activities and interactions has increased steadily since 2010. ACCME President and CEO, Dr. Graham McMahon, noted that there are currently more than 3,000 hours of CME available to healthcare providers.

That brings us to the end of another “well done” edition of the Compliance News in Review. We’ll see you right back here for the next summertime treatise, and in the meantime, we leave you with a few tips for barbecuing the perfect burger (olive oil…who knew?).

Have a great week!

Compliance News in Review, July 7, 2017

Canadians, Californians, and Mainers are all on the hunt for transparency. Will they find “gold” they seek? Find out in this week’s News in Review.

There’s gold in them thar hills! Seriously. A number of years ago, a man hid an estimated $2 million treasure of gold and jewels somewhere in the Rocky Mountains, leaving only a cryptic poem to guide treasure hunters to the stash. At the time, he said he hoped it would inspire folk to get up off their couches and explore nature. Many have, and unfortunately, a couple of them met an untimely end during that search. As far as anyone knows, the treasure is still out there for the taking, but before we break out our atlases and sharpen our pickaxes, let’s dig into the news of the day in this edition of the Compliance News in Review.

Pharma companies will be able to hold on to their doubloons if an amendment to the California bill prohibiting gifts and restricting payments to doctors stands. Legislators eliminated the penalties associated with the bill, but added a provision that prohibits doctors from receiving payments for speaking or serving as faculty at events that are not accredited by the ACCME or a similar organization.

A pair of Canadian doctors are on the hunt for transparency with a program intended to gain support for more industry/physician transparency. According to one of the doctors, “interaction with industry is everywhere and a lot of progress has come from collaborating,” but he worries that trust will be eroded if they continue to “keep relationships in the dark.”

Providing some clues to the transparency hunt, ten of the largest pharmaceutical companies in Canada released information on transfers of value they provided to healthcare professionals and organizations. The effort was headed by GSK, and included AbbVie, Merck, and Eli Lilly. Total payments for all the companies came in just under $50 million and covered the 2016 calendar year. Critics complained the data provided little real transparency because the figures represented the companies’ aggregate payments to all doctors or healthcare organizations, rather than individual practitioners or organizations.

The release of this data prompted one treasure hunter, Ontario’s health minister, to announce he will investigate the concept of requiring pharmaceutical companies to disclose physician payment data (a la the U.S. Sunshine Act). He said the voluntary release of recent spend data by certain pharmaceutical companies was a good start, and that the government is “committed to strengthening transparency across the healthcare sector.” Consultations into the matter are scheduled for this summer.

Trekking across the Canadian border to Maine, we discover the legislature has passed a bill that will curtail payments from pharmaceutical companies to doctors. The bill prohibits the provision of “cash gifts” but allows non-monetary gifts of “minimal value.” It also allows doctors to receive payments for speaking about research at “legitimate educational conferences.”

For those wishing to do a little prospecting, the Open Payments data for the 2016 is now available. Nearly 1,500 companies reported transactions totaling $8.1 billion. Just over half of the $8 billion went toward research. A billion dollars was paid in ownership interest, and just under $3 billion fell in the general payments categories. Nearly 12 million records were published this year, covering 631,000 physicians and 1,146 teaching hospitals.

There’s a certain theme running through this week’s news bites. Transparency. Governments, academia, and special interest groups, all extol the need for transparency in the relationships between life science companies and healthcare professionals. Although most of the heavy lifting regarding data is typically handled by a small group of dedicated data hounds, others in the organization need to be aware of the laws and their restrictions.

Those who interact with healthcare professionals need to know the types of information that is reported and understand their role in assuring the accurate and timely collection of the data. As the saying goes, “garbage in: garbage out,” and considering that many of these laws carry financial penalties for reporting errant data, companies certainly want to take steps to reduce the “garbage.”

Well, we’ve reached the end of the trail on this edition of the Compliance News in Review. We’ll see you right back here for the next edition.

Thanks for reading!

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!