Week in Review, April 21, 2015

CMS tries to clarify the Open Payments review and dispute process, GSK considers changing its compensation program, and a Florida pharmaceutical manufacturing company is charges with selling unapproved products.

April showers bring May flowers, or so the saying goes. Well if you live in the southeast or northeast corner of the country, it will apparently be an extra flowery May. Rain, rain and more rain has fallen over a good chunk of the country. While that rain is certainly a good thing, the accompanying flooding isn’t. Luckily, sunny weather is on the way according to the pundits and folks can dry out. As we wait for those flowers dry out enough to bloom, we’ll rain some compliance information down on you in this week’s Compliance News in Review.

The Sunshine is back out over the medical community, but the mood is a little gloomy. CMS held a conference call for reportable recipients under the Sunshine Act to discuss the Open Payments review and dispute process. CMS reiterated its stance, that it will not intervene in disputes, but will be monitoring the process. The agency is particularly interested in the number of disputes that are initiated and how many remain unresolved. Reportable recipients expressed frustration that there was not enough context or consistency among manufacturers in how payments are classified under the “nature of payment.” This makes it difficult for reportable recipients to determine whether a payment is correct. CMS said input from all parties would be required before any changes are made.

The winds of change are blowing for GSK and its sales rep compensation structure…again. A task force has been put in place to examine how to simplify the company’s “Patient First” program. The current program establishes bonuses on factors such as product knowledge and understanding the needs of patients and doctors, rather than prescription numbers. A GSK spokesperson says the company remains committed to their commercial model, and while the company has looked for ways to simplify the program in other countries, the fundamentals of the program remain the same.

There’s been no singing in the rain for Florida based Stratus Pharmaceuticals. The distributor had $1.5 million in unapproved drugs seized by U.S. Marshals. The confiscation of the drugs came at the request of the FDA and U.S. Attorney for the Southern Florida District. According to the FDA, Stratus was marketing and distributing a number of unapproved drugs, including an antibiotic skin cleanser, a topical cream to treat psoriasis and eczema, and a topical ointment for treating wounds. The drugs were manufactured by Sonar Products of New Jersey.

With that, we bring this rain-soaked edition of the News in Review to a close. Remember, if the winds of change are long overdue for your compliance training curriculum, the PharmaCertify™ suite of customizable compliance solutions offers the up-to-date training where your learners need it most – in the field and at their fingertips.

Have a safe (and dry) week everyone!

News Week in Review, April 13, 2015

Spain and Malaysia amend their anticorruption laws, researchers from the NIH say the government rules on paperwork and travel are too complex, and India considers dedicated oversight for medical device.

Golf voices and claps only, please. It’s time to celebrate the greenest spectacle in sports – the Masters. The lush fairways, that somewhat disturbing green jacket and we can’t forget the green ($10M total) won by the top players. This year’s event saw the return of Tiger Woods, Jack Nicklaus making a career first hole-in-one at the Par 3 tournament, and the record breaking victory by Jason Spieth. Now that the drama is over and the young man from Texas held off the field, it’s time to tee off on this week’s Compliance News in Review.

A pair of countries legislating compliance programs are the first on the tee this week. At the end of March, the Spanish Congress approved amendments to its Criminal Code, which requires companies to adopt a compliance program. The change is effective as of July 1, 2015. According to the law, compliance programs must be supervised by a group or individual that can exercise a high level of control. The law provides a company protection from criminal prosecution when the company’s compliance program when the individuals responsible for the compliance program did not neglect their duties. It also details six element’s that must be included in order for the company to be protected from prosecution.

Malaysia’s Attorney General wants to amend country’s current anticorruption law to address corporate liability. A deputy with the Malaysian Anticorruption Commission (MACC) said the U.K. Bribery Act and FCPA were being used as guidelines for the Malaysian law.

Medical researchers from the National Institutes of Health (NIH) would like a mulligan, of sorts, on the paperwork required for travel to attend medical conferences. Researchers say the government’s paperwork and travel approval process is time consuming and is hurting science and it can take up to six months to learn whether they’ve been approved to travel to conferences and meetings. The strict rules were put in place following a scandal involving travel at the General Services Administration. One researcher said he had to turn down a speaking request at a popular conference because the agency has to limit how many individuals it sends to any one event, and he is often passed over as a speaker because conference organizers don’t believe he’ll be able to attend. The NIH spent over $14 million in oversight of travel and expenses in 2014, which was nearly a quarter of its total travel budget for the year.

India is bringing medical device oversight on par with how drugs are regulated. A government task force is recommending a separate regulator be put in place to oversee safety and price controls of diagnostic equipment, implants and hospital equipment. Currently, devices are regulated under the same act as drugs, but both industry and public health advocates have argued that devices are different and should be regulated under different rules.

With that, we put a bow on another year of the “tradition unlike any other,” and another edition of the Compliance News in Reviews. Have a great week everyone, and as you hit the greens this year, remember the words of the late, great Paul Harvey, “golf is a game in which you yell ‘fore,’ shoot six, and write down five.”

Week in Review, April 6, 2015

West Virginia repeals its disclosure law, Connecticut modifies its requirements for insurance coverage related to off-label use, two whistleblowers file a suit against Teva, and tighter transparency rules are debated in New Zealand.

Spring has sprung! Woo hoo! Since a number of us “enjoyed” up to 5 inches of snow on the first day official of spring, a break from the drudgery of the bitter temperatures is well-deserved, nay, warranted. The compliance news doesn’t take a break though, so for now, we’ll put our visions of sand castles and sea gulls to the side and focus on all the news fit for blogging, with this week’s Compliance News in Review.

It seems there’s no vacation when it comes to state transparency laws. The governor of West Virginia has approved a bill that will repeal the State’s requirement for pharma companies to report drug advertising and promotion expenses. Expenditures for 2014 are due in April, but the repeal will end the reporting requirement from January 1, 2015 forward. The GOHELP organization has not publicly published advertising expenditures reports since 2010.

Consumers in Connecticut could be getting a break when obtaining medications for off-label uses. A modification to the state’s current law will increase insurance coverage of drugs prescribed for off-label uses. The current law requires off-label coverage if the drug appears in one of three specific medical compendia. Unfortunately, two of the references are no longer published. The revision to the law would require coverage if significant information in peer-reviewed publications support the off-label use.

BioChemics was ordered to pay over $17 million to settle investor fraud charges brought by the SEC. The SEC says the company lied to investors about its research, FDA communications, and status of clinical trials, and provided false valuations for the company. The company collected over $9M from 70 investors. The judgement supplements another judgement against the company’s founder and two promoters from earlier in the month.

Party crashers? A new survey shows securities fraud class action suits against life sciences companies are on the rise. In 2013, there were 19 suits against life science companies. In 2014 that number rose to 39, and represented 23% of all securities fraud cases for the year. Most of the defendants were smaller companies.

Green is the color of spring, and apparently the color of honorarium envelopes at Teva, according to two former sales reps. A whistleblower suit filed against the company claims that Teva engaged in sham consulting arrangements in order to boost prescriptions of Copaxone and Azilect. The two claim that doctors were only allowed to remain speakers for the company if they increased the number of prescriptions written for covered drugs, and that the content of the programs had very little educational value.

The “sunshine” is shining bright in New Zealand, even though they are celebrating the fall season there. In a recent New Zealand Medical Journal article, transparency advocates made an appeal for a U.S. style Sunshine Act. The authors argue that while disclosure requirements are being tightened in other countries, the situation remains “murky” in New Zealand, where doctors receive remuneration for a variety of services, and sponsorship for accommodations and travel to conferences. One of the authors has spoken out about the topic in the past, and has been critical of Medicines New Zealand for its lack of transparency regarding the disclosure of physician payments. While not outright dismissing the idea, Medicines New Zealand has stated that adding disclosure requirements would be complex and require a significant amount of resources.

With that, we close out this spring season edition of the Compliance News in Review. Speaking of sunshine, as transparency requirements grow around the world, the PharmaCertify suite of training solutions offers your learners the content they need to navigate the cloudy world of pharmaceutical compliance reporting regulations.

Have a great week everyone!

Compliance News in Review, March 24, 2015

Oregon considers the idea of requiring pharma companies to disclose pricing information, CMS offers Open Payments updates, Sandoz settles with the OIG over alleged pricing data misrepresentations, the DOJ beefs up its FCPA enforcement team, and Public Citizen petitions the FDA on the issue of companies distributing peer-reviewed articles.

It’s time to dance everyone! March Madness is here. And what a dance it has been so far. As per usual, a couple of Cinderella moments wreaked havoc on brackets far and wide. Now it is onto the Sweet 16. Is your team still in the mix? While there’s a momentary break in the action, let’s take a look at the stories that filled our dance card this past week. Time to tipoff this week’s Compliance News in Review.

Our first story takes us to the home of the Oregon Ducks. Perhaps taking a cue from its neighbor to the south, a bill has been introduced in the Oregon legislature to require pharmaceutical companies to disclose information related to drug pricing. California introduced similar legislation recently, and like the California proposal, Oregon’s proposal would apply to drugs with an annual wholesale acquisition cost of $10,000. Companies would be required to file an annual report with the State, detailing information such as the manufacturer’s costs related to R&D, and costs paid for distributing the drug. Representatives from industry groups, PhRMA and BIO, testified before a committee, saying that the proposed law would harm patients and industry companies.

The clock is running down for 2014 data submission to Open Payments. With that in mind, CMS recently held a Q&A session to deal with any burning questions from Applicable Manufacturers and GPOs. During the call, CMS suggested that companies that have United States spelled out in their files deleted their records, change to “U.S.” and resubmit. So far the work around has proved largely successful. The agency also noted that it can trace deleted manufacturer records and said in order for companies to avoid audit issues and possible penalties, companies should separate rejected records from accepted records.

Sandoz was called for a costly foul when the company agreed to settle with OIG for $12.6 million over allegations it misrepresented drug pricing data. According to the OIG, between 2010 and 2012, Sandoz misrepresented the Average Sales Price (ASP) to CMS. As part of the settlement, Sandoz had to certify that it has established a government pricing compliance program.

The DOJ is adding quite a few new players to its FCPA enforcement team. The agency has confirmed it is adding 30 new agents specifically to deal with FCPA violations. More hands on the DOJ deck raise the stakes for companies in their compliance efforts. Legal experts say companies need to take a look at their internal and external anticorruption programs, and conduct reviews of internal controls, risk assessment, and third-party due diligence.

The SEC plans on beefing up its FCPA enforcement schedule. At the Corporate Counsel Institute conference, the SEC’s enforcement director, Andrew Ceresney, said that the agency’s regulatory focus would be on internal controls, and more FCPA enforcement actions. He pointed out that the SEC has already brought more FCPA cases in the five months of the 2015 fiscal year, than it did in all of 2014.

Public Citizen is asking the FDA to withdraw a proposal that would allow pharmaceutical companies to distribute peer-reviewed articles containing data stating a drug is not as risky as indicated on the label. The group sent a letter to Health and Human Services, saying the proposal would allow drug companies to “sell more drugs by making them appear safer than the FDA judged them to be.” Public Citizen has obtained and published all the comments the FDA has received on the proposal. Most of them are in opposition to the idea.

That about wraps it up for this edition of the Compliance Week in Review. Here’s hoping your favorite college squad is still in the hunt for a Final Four – we’ll be here wondering what exactly happened to our Villanova Wildcats (there’s always next year…again).

Have a great week everyone!

The 2015 Pharmaceutical Compliance Congress: A Review and Recap

The 12th Annual Pharmaceutical Compliance Congress provided an overflow crowd of rapt attendees with two days of best practices and updates on critical compliance-related topics. While the usual array of content was covered, the focus often turned to two key topics – Speaker Programs and the FCPA.

Day 1

The conference kicked off with a keynote speech from Michael Shaw, Vice President and Chief Compliance Officer for GlaxoSmithKline. Shaw’s presentation was focused on the idea that instilling a culture of compliance is not enough in today’s regulatory environment. He emphasized the importance of ‘explaining the why’ behind the values, and the need to hold individuals accountable for compliance. As an example, at GSK, while Compliance is responsible for facilitating the process, Brand Directors are held accountable for managing the risk. As Shaw says, “compliance programs are important, but they’re not enough. The elements of the programs need to have traction.”

Otsuka ‘s Regina Gore Cavaliere and Brian Miller showcased their use of humor as a core tool for compliance training. Cavaliere and Miller have integrated a variety of creative elements, including a mock mini-series called The Pharm, comic books, and live talk shows, into their curriculum to keep the training fresh and appealing. Much of what was presented was indeed witty and engaging, and it showed that comedy can clearly be an effective tool when developed professionally and integrated carefully into a blended campaign.

In the Chief Compliance Officer Panel titled, Working with the Business – Ensure Compliance Adds Value to Operational Success, Jeffrey Rosenbaum from Vertex, Sujata Dayal from J&J, and Sumita Ray from Pharmacyclics, offered their perspectives on the keys to an effective program. With limited resources and time, Rosenbaum starts with his company’s business objectives while managing the issues with the highest risks. Ray agreed, saying she evaluates what risks she has to address on a daily basis, making training her first priority. As part of a large global company, Dayal begins with a formal risk assessment and conducts testing on a regular basis to ensure that mitigation is working. Rosenbaum also emphasized the importance of recruiting allies in the company when resources are stretched, as with Sunshine Act reporting, while Ray echoed Michael Shaw’s points about the importance of holding businesses accountable for their actions and results.

The presentations shifted to a governmental and regulator’s perspective with Doug Brown from CMS updating the audience on the state of Open Payments, a panel of US Attorneys addressing trends and top priorities in healthcare enforcement, and Andrew Ceresney, Director of Enforcement at the SEC covering disclosure issues relevant to the pharmaceutical industry.

What stood out during the enforcement panel was the increased amount of cases the regulators are seeing involving small to mid-size companies. Greg Shapiro, from the District of Massachusetts added that the audience should expect to see more criminal liability with those cases. Jacob Elberg, from the District of New Jersey encouraged those who identify a problem to self-report since “it sends the right message to employees and regulators.” More than one panel member delved into the risks of Speaker Programs, with Shapiro calling them “areas prone for abuse” and William Killian from Tennessee reminding the audience that Speaker Programs must not be tied to any promotion of business.

Ceresney covered the FCPA and the risks particular to the pharmaceutical industry. According to Ceresney, the SEC is focusing on three enforcement areas: pay to prescribe, pay to get on formularies, and charitable contributions. He emphasized the need for risk assessments and training, and the need to take measures when issues are identified.

After lunch, the sessions were divided into smaller groups, and I opted to stay with the FCPA theme in the session titled, Strengthen your FCPA Compliance through Smarter Training. David Nicoli, former VP, Corporate Affairs, AstraZeneca, and a panel of vendors walked through the steps they consider to be crucial when training on the FCPA. Collaboration is key, Nicoli claimed, and during his tenure at AZ he partnered on training initiatives with key allies, such as the Heads of Human Resources and Social Responsibility, who truly understand the work environment. The panel stressed the need for short, quick hits in FCPA training, and the fact that bad decisions make for good stories that stick in learners’ minds.

After the FCPA session, I jumped into the track dedicated to Product Promotional Compliance. Paul Silver from Huron presented statistics from a recent industry survey on company interactions with HCPs. For example, 86% of companies reimburse for HCP travel time and 1/3 of the companies surveyed have a limit on hotel expenses. Overall, the statistics presented a strong baseline for how the industry handles HCP travel time and I highly recommend the data for those interested in knowing what their peers are doing.

The session on overseeing the relationships between Sales, MSLs, and Managed Care Reps, was highlighted by one powerful statement from Kevin Stark, Director of GHH Compliance, at Merck, which could be considered a compelling theme for the entire conference, build a culture where it’s okay for people to admit when they made a mistake.”

Day 2

The second day opened with Tom Abrams of the FDA and his annual update on enforcement trends at the Office of Prescription Drug Marketing. In the area of policy and guidance development, OPDP has released six draft documents since January 2014, and three draft guidance documents on social media.

Abrams’ agency continues to allocate resources and priorities based on potential threats to public health. The most common violations over the past year were related to omission and minimization of risks, and unsubstantiated superiority claims.

Day 2’s enforcement panel, titled, A View from the Outside —Mitigate Risk and Prepare for the Future featured a panel of defense attorneys well-versed in the areas of risk for small and large pharmaceutical companies. Scott Lieberman of Loeb and Loeb stressed the need for sales representatives to know exactly how to handle off-label questions when dealing with HCPs. Matthew O’Connor, of Covington & Burling warned smaller companies to allocate enough resources to monitoring, an area often neglected. When asked about the relationship between Compliance and Legal, Allison Shuren from Arnold & Porter said Compliance should be the “boots on the ground, moving issues up the food chain,” and John Richter, from King & Spalding, noted that Compliance should be ‘setting the policy and evaluating the balance between costs and risks.’

I was particularly interested in the Life After a CIA — Impact on Internal Team Structures and Resource Allocation panel, so I attended the breakout session: Compliance Program Structure and Effectiveness.

Sujata Dayal, from J&J, stressed the need to continue the conversation between the businesses and Compliance but that dialogue needs to change as the role of the business shifts from one in which the businesses mandates company priorities to one in which they influence actions and decisions. Gregory Beeman, from Eli Lilly, said the first step was to see what can be streamlined and continued post-CIA. In other words, what was under OIG oversight that could be eliminated now that the CIA has expired?

In Successful Promotional Programs — How to Use Data Analysis & Market Research to Drive Compliant, Effective Results, Mark Dizon from Actelion, and David Gilman from Huron led a spirited discussion on the use of data and analytics to assess risks and results of Speaker Programs. The idea of whether Speaker Programs should be evaluated against Return on Investment was of particular interest as audience members and the panel members debated the merits and risks associated with acknowledgement of the ROI.

The final session I attended was focused on the challenges faced by small to mid-size businesses as they struggle to allocate compliance resources. The panel, consisting of Timothy Ayers of Porzio, Bromberg & Newman, Katrina Church of Merz North America, Jeff Rosenbaum from Vertex, Sarah Whipple from Aegerion, and Greg Moss from Kadmon, offered a diverse set of best practices based on their experiences with limited resources and time. The perspective offered by those who are literally ‘departments of one,’ and those, like Church from Merz, whose departments are growing rapidly, had enough content, suggestions, and tips to fill a conference unto itself. As one example, the panel and audience debated the benefits and challenges of live training versus eLearning. While live training offers the opportunity to work face-to-face with each trainee, which is easily achieved in very small companies, Church was quick to point out that as Merz grew, a shift to more eLearning, with its streamlined tracking, became a necessity. And, like their colleagues from larger companies, these participants emphasized the need to include the Board of Directors and the C-Suite in the importance of compliance training; and in getting buy-in at all levels of the company.

To sum up, the details brought forth over two days by many well thought out presentations and panel sessions in this year’s Pharmaceutical Compliance Congress offered veteran attendees and new comers alike a wealth of practical and impactful information, making attendance not only a good idea, but crucially important to staying abreast of new developments and best practices in life sciences compliance.

Compliance Week in Review, March 15, 2015

A French court overturns the fee for service exclusion from Loi Bertrand, a dental company settles with the Vermont AG’s office over failure to report charges, an internal investigation at Teva reveals potential FCPA violations, and a representative from the SEC discusses the FCPA with a group of life sciences compliance professionals.

Well, we’ve survived another shift to Daylight Saving Time and we’ve had a few days to adjust and reset our internal clocks…yeah right. There isn’t enough caffeine in the world, is there? That spring forward thing certainly leaves us here at the Week in Review offices feeling anything but springy! As it is, we’re in Daylight Saving Time now, like it or not (unless of course you live in AZ, or a handful of U.S. Territories that have the good sense not to jump on this bandwagon), and while the clock may shift, the news waits for no one. So sit back, relax, but not too much, as we spring into this week’s News Week in Review.

The times they are a changing, and so is the French Sunshine Act. The top French administrative court reversed the decision by the Ministry of Social and Health Affairs to exclude the amount paid to healthcare professionals and organizations for fee for service contracts from manufacturer reports. Currently, manufacturers only need to report the existence of the contract. The court said that Ministry overstepped its bounds with the decision. The Ministry is evaluating the implications of court’s decision, and will issue new regulations at some point in the future.

Better make time to send in those disclosure reports to Vermont! A dental company settled a case with the Vermont Attorney General’s office for $45,000 over its alleged failure to submit disclosure reports. This is the second settlement in a month involving the disclosure law.

Through a securities filing, TEVA revealed it had uncovered information that some of its actions may have violated the FCPA. The company’s investigation began after it received subpoenas from the DOJ and SEC. The investigation centered on business practices is in Russia, Eastern Europe and Latin America.

A representative from the Securities and Exchange Commission (SEC) shed some light on the subject of FCPA risks for life sciences companies at the recent Pharmaceutical Compliance Congress. Andrew Ceresney, Director of Enforcement athem nt the SEC, focused on three key areas of risks, pay-to-prescribe arrangements, (rewarding doctors for writing prescriptions), payment of bribes in exchange for being placed on a formulary, and the payments of bribes disguised as charitable donations.

Ceresney also pointed out the importance of establishing internal controls specific to the business, and updating the internal controls when the business changes or grows. He referred to dealings with the FDA as the “lifeblood” of the industry, and emphasized the importance of investors having accurate information when making critical decisions.

And that brings us to the end of this Daylight Saving Time edition of the Compliance Week in Review. Remember, if you’re compliance training curriculum is in need of a wakeup call, the PharmaCertify™ suite of solutions offers up-to-date compliance training and reference content where your team needs its most – in the field and at their fingertips.

Have a great week everyone, and don’t forget that extra cup of coffee.

Week in Review, March 6, 2015

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!



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