good promotional practices

Compliance News in Review, July 20, 2015

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The House of Representatives passes the 21st Century Cures Act, two companies settle AMP charges, oral arguments begin in Amarin v. FDA, and CMS updates its Open Payments FAQs.

Diamonds are not only a girl’s best friend…a very special mouse is fond of them as well. The Happiest Place on Earth (or, at least the one in California), is celebrating its diamond anniversary. Happy 60th Disneyland! The place has certainly changed in its 60 years, but fan favorites such as Mr. Toad’s Wild Ride and the Jungle Cruise have stood the test of time. In true Disney fashion, the party isn’t just a one day affair; it actually started back in May and will likely continue through the fall, if not into 2017. Before we cut the cake with the big ears, we have a bit of “magic” of own to administer. Grab a churro and settle in for this edition of the Compliance News in Review.

The House is celebrating the overwhelming passage of the 21st Century Cures Act. The bill is designed to fund research and change the FDA’s drug and device approval process. It includes a change to the rule its provisions are changes to the Sunshine Act which would exclude the reporting of the value of journal reprints and payments for CME.

AstraZeneca and Cephalon may be feeling a bit Grumpy. The two companies reached separate agreements with the government over charges related to underpaid Medicaid rebates. According to a whistleblower, the companies improperly reduced the Average Manufacturers Price (AMP) of their products by subtracting fees paid to wholesalers. The companies paid $46.5 million and $7.5 million respectively to settle the matter.

Oral arguments began in Amarin’s suit against the FDA. The company cited the Caronia decision and the Sorrell v. IMS decision in its argument. Much of the discussion centered on the type of disclaimers need to accompany off-label promotion and not whether Amarin even has a right to do so. The FDA’s lawyer argued the interpretation of the Caronia decision should be very narrow but the judge disagreed. A judicial order is expected in a few weeks.

The whistleblower in a case against Endo may be throwing a Mad Tea Party now that she’s been awarded $33.6 million for her efforts. The case, which was settled with the government in February of last year, involved the off-label promotion of the company’s pain patch. Despite a recommendation from government lawyers that the whistleblower receive 19% of the settlement, the federal judge awarded her 24%, citing her “extraordinary effort” in the case. The whistleblower initially filed suit in 2005, and spent five of the nine years that followed working under the direction of the FBI.

CMS has sprinkled some Pixie Dust over the Open Payments FAQs, and sure enough new FAQs have taken flight. Several of the new FAQs have to do with physicians and teaching hospitals being able to access, review and dispute the data now that the review and dispute period has closed.

If the FAQ updates weren’t enough, CMS was back for a second ride with updated information about the reporting of CME payments on the Law and Policy page of the Open Payments website. Beginning in 2016, manufacturers will have to report indirect payments to CME providers if the manufacturers learn the identity of the physician attendees or speakers within the reporting year, or the first two quarters following the reporting year.

The updates to the Open Payments website remind us that the program is evolving. Your company’s training needs to evolve and grow as well. Affected personnel need to be updated on changes, and reminded of the need to communicate with their physicians. Now is the time to map out your plan for refresher training and refocus your aggregate spend and sales personnel.

That’s a wrap on the compliance news fit to blog for now. Have a great week everyone.

 

 

Compliance News in Review, July 10, 2015

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The government targets Novartis for False Claims violations, pharmaceutical companies map out a plan to keep medication flowing into Greece throughout the crisis, and the industry as a whole ponders the impact of the CMS release of 2014 transparency data.

The days are long and lazy – it’s time for summer vacation! From the beach, to the mountains to foreign destinations, the News in Review staff is finalizing plans for summer R&R. Rest assured though, we are still hard at work keeping up with all the compliance news fit to blog, starting with this sun splashed edition of the Compliance News in Review.

The Justice Department and 11 states are putting a dent in the Novartis vacation account with a $3.4 billion charge for damages and fines in a False Claims Act case involving kickbacks to pharmacies. According to prosecutors, the company offered rebate and discount programs to pharmacies in exchange for increased prescriptions of two drugs. Novartis disputes the allegations and says it will continue to defend itself. A trial has been set for November.

Pharma companies are mapping out a plan to keep medication rolling into Greece. According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), the complexity and fragmented nature of the Greek medicine supply chain makes the flow of medication vulnerable. Pfizer, Roche and Novartis said they have plans to ease any shortages during the crisis, and AstraZeneca and GSK have both said they are drawing up contingency plans to keep medicines in supply.

CMS and agg spend folks are probably ready for a break in their routine now that the 2014 Open Payments data has been published. The data shows that companies paid physicians almost $6.5 billion for the year, with over 11 million transactions reported. Research payments topped the list with over $3 billion paid, there were $2.5 billion in general payments and $700K was reported on the ownership reports. CMS was able to validate close to 99% of records submitted to the system, which is a vast improvement over the 2013 data. As was the case in 2014, the majority of the reported payments were small. Sixty-six percent were for payments of less than $20. Research and royalty payments represented the largest dollar amounts.

Once the Open Payments data was released, the numbers quickly found their way into the media. The focus on payments to physician and the influence those payments have on prescribing decisions and healthcare at large is at an all-time high. That level of scrutiny highlights the need for training on the Sunshine Act and Open Payments – especially for those interacting with HCPs. While much of the work related to the reporting requirements is a “back office” function, those interacting with HCPs are often the first to hear concerns from the field and they need to be prepared.

In addition, the public release of the data opens companies to examination of their business practices from whistleblowers and enforcement agencies. Critical evaluation of training is important. Are all the appropriate audiences being covered? Is the training up to date? Is a refresher required? Regular audits of training curriculums and plans are key to reducing the risk of questionable payments, and could spare the company expensive costs down the road.

Have a great weekend!

Compliance News in Review, July 2, 2015

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A former medical device CEO is sentence to two years in prison, the House of Representatives moves on the exemption of payments for CME, textbooks and medical literature under Sunshine, a Connecticut APRN finds herself in hot water over kickbacks, and the first full year of physician payments data is officially available for review.

Unfurl the flag and fire up the grill! It’s time to celebrate the good ole U.S.A. Independence Day is almost here! Whether your celebration of the shot heard ‘round the world and 239 years of the great experiment take you to the shining sea, across the fruited plain, or just to your backyard, we hope it’s a safe and joyous weekend. Until the party begins, we’ll dole out a little history less of our own, with this edition of the Compliance News in Review.

Former OtisMed CEO will have his liberty temporarily revoked. The executive was sentenced to two years in prison for intentionally distributing an unapproved medical device in violation of the FDCA. He was also order to pay a $75,000 fine.

The “people’s house” has been busy recently. The House Energy and Commerce Committee announced that over 200 representatives have signed on to the 21st Century Cures Act. The exemption of payments for CME, textbooks and medical literature from the Sunshine Act is included in the bill. The House also approved a bill to repeal the Affordable Care Act’s tax on medical device manufacturers. The bill now moves to the Senate for a vote.

A Connecticut APRN has admitted to accepting $83,000 in kickbacks from the drug maker Insys Therapeutic. The nurse was a top prescriber of the company’s cancer pain drug. Most of the kickbacks were in the form of payments for serving as a speaker and according to prosecutors, more often than not, the nurse and the sales rep were the only people in attendance at the speaker events. On some occasions, the attendees were friends or colleagues of the nurse who were allowed to prescribe drugs. She will be sentenced in September.

We’re waiting for the fireworks to start now that the first full year of physician payments data has been released by CMS. The payments for 2014 totaled nearly $6.5 billion, and represented 11.4 million transactions to over 600,000 physicians and teaching hospitals. Data from the 2013 program year that could not be posted during 2014 is also included in this year’s release. According to a CMS press release, “registered physicians and teaching hospitals reviewed nearly 30% of the total value of the data and the agency plans on continuing its efforts to work with HCPs to increase that review rate.”

While it’s the multi-million dollar corporate settlements that make the headlines, this week’s news shows that in the world of compliance, individuals suffer significant consequences as well. From the Board to the C-suite, across the corporation and even to the contractors, training needs to emphasize that potential violations are not just a “company problem.”

The release of the 2014 Open Payments data highlights the amount of money being spent by industry on physicians, and exposes physicians to potential criticism and scrutiny. HCPs need to be aware of the rules and regulations companies face because as far as the government is concerned, they represent the company just as the employees do. Providing training that respects these contractors as men and women of science, while fully covering product promotion regulations and law, not only protects the company, it enhances the relationship with these valued partners in healthcare as well.

Have a great Independence Day everyone!

Compliance News in Review, June 29, 2015

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The universe has spoken – summer is officially here. (If you’re living in a part of the country that is in the midst of a heatwave, I’m sure you’re thinking “never mind what the calendar says, summer has been here for two weeks!”) Now that we’ve crossed the solstice for another year, let’s take a look back at how spring ended, in this issue of the Compliance News in Review.

PetroTiger escaped the heat of an FCPA prosecution. In a highly unusual move, the DOJ announced it would not charge the oil company with violating the FCPA. Three company executives have already pled guilty to the same charges, and typically charges against the company follow. In this case, the DOJ decided otherwise, saying PetroTiger had fully cooperated with the investigation.

The Sunshine Act is never far from the minds of physicians, no matter the season. 100 physician organizations sent a letter to Representatives Richard Michael Burgess and Peter DeFazio expressing support for a bill that would exempt payments for CME and educational materials from the Sunshine Act. The Representatives introduced the bill in an effort to correct the “unintended consequence of over-burdensome reporting requirements that made access to educational materials for physicians difficult to obtain.” The physician groups claim that the dissemination of medical education materials has already slowed as a result of the law.

The sun has set on an off-label marketing case for a former Merck company. The company settled with the government for $5.9 million in an illegal marketing case involving its former Inspire Pharmaceuticals unit. According to prosecutors, Inspire claimed its pink eye drug was effective for treating blepharitis, a condition for which the drug was not approved. According to the government, the promotion of the drug for the off-label use led to false claims being paid by government healthcare programs. Merck claims the activity occurred before it acquired the company. Inspire was sold to Akorn in 2013.

FDA officials shed some light on advertising and promotion enforcement at the 2015 Develop Innovate Advance conference. Deborah Wolf of the Division of Premarketing and Labeling Compliance discussed several promotional issues surrounding devices, including the risk of physicians promoting devices for unapproved uses.

Tom Abrams of the Office of Prescription Drug Promotion said the most common areas of enforcement for his office involved unsubstantiated superiority claims; overstatement of efficacy; and omission and minimization of risk information. Lisa Stockbridge of the CEBR’s Advertising and Labeling branch said that biologics faced many of the same issues as prescription drugs. She referenced an untitled letter sent to a company for claims made by the company’s CEO in a video interview posted on the company website, which included unsubstantiated claims about one of its products.

Obviously, product promotion remains a hot topic, and with good reason. As we continue to see in the news, off-label promotion violates the FDCA and implicates the False Claims Act, and can result in pretty hefty penalties. However, training needs to go beyond on-label promotion, and cover the topics referenced in the stories above. Misleading statements, false efficacy claims, and omission of risk lead to untitled letters from the FDA, and as seen in the 2014 Shire case, can be used by the DOJ in cases against manufacturers.

All facets of promotional speech need to be covered in your compliance training, especially since the FDA has essentially deputized healthcare professionals to be on the lookout for promotional speech missteps through their Bad Ad program. More and more eyes are focused on product promotion, so making sure everyone responsible for making promotional statements, in any form, is aware of the requirements, is more critical than ever.

That’s the news for this edition. Stay cool and have a great week everyone!

Compliance News in Review, June 16, 2015

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Dinosaurs roamed the earth again (at least in the land of movie theaters), over the weekend, with the release of the summer’s first big blockbuster, Jurassic World. You’d think after three films, the characters would have learned not to fool with Mother Nature. Apparently not, and considering the $200+ million the film racked up at the box office, we are not tired of watching them make those same mistakes.

It may not involve death, destruction and extinct creatures, but we have our own epic tale to tell. Break out the popcorn and 3D glasses, and silence your phones please. It’s time for this week’s feature presentation – the Compliance News in Review.

Transparency International is undertaking a project of Giganotosaurus proportions. At the International Pharmaceutical Compliance Congress and Best Practices Forum, Executive Director Robert Barrington spoke to attendees about corruption in the healthcare sector and an initiative underway to evaluate corruption in the pharmaceutical industry specifically. The project will focus on five key areas: procurement and distribution, manufacturing, marketing practices, product registration, and research and development. Barrington noted that the industry should prepare for more scrutiny, with patients demanding to know why increased spending has not led to an improvement in the quality of healthcare.

Public Citizen has accused the FDA of improperly expanding the original approved use of a sleep disorder drug, and has filed a petition with the agency to have the label changed. According to the organization, the drug was initially approved for use in treating the disorder, Non-24, in blind patients, however the drug’s label does not specify the patient population. Public Citizen says this opens the door to the drug being used for other sleep disorders with patients that are not blind. Following the initial approval, the FDA did send the manufacturer a second approval letter which stated a mistake was made and the drug was approved for treatment of Non-24 in general. The second letter notes that the condition is experienced almost exclusively by those who are blind.

Could this be another “blockbuster” decision by the FDA? The FDA sent a letter to Amarin Pharmaceuticals and the court in response to Amarin’s lawsuit against the agency for violating its free speech rights. The company would like to share study information showing its drug reduces the risk of heart attack when taken in conjunction with a statin, which is not an approved use. In its response to the lawsuit, the FDA says it does not have concerns with most of the information the company wanted to share, and it does not consider the sharing of that information to be false or misleading. The letter also reminded the company that new guidelines for sharing off-label information are forthcoming.

In our opinion, the letter from the FDA to Amarin is certainly not an invitation for pharmaceutical and medical device companies to start sharing information about unapproved uses of their products. Situations like this, as well decisions like the Caronia case, may lead some to think the rules have changed, when in fact they have not. Training and communication efforts need to emphasize that the laws and regulations remain the same. Promotional statements still need to be truthful, accurate, not misleading and balanced.

The message should be clear – only company approved studies and statements may be shared, and done so in the way described by the company. The way in which companies play the game may be evolving, but the rules of the game remain the same. Playing within those rules benefits all stakeholders, including the company, and most importantly, the patient.

Have a great week everyone!

Compliance News in Review, June 5, 2015

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Cephalon settles a generics case with the FTC over its sleep disorder drug and the OIG releases its mid-year update to its 2015 Work Plan, and we offer our take on how it impacts training.

Well, the summer blockbuster season is almost here. Superheroes, Sundance darlings, reboots and rom-coms will all be competing for our attention and discretionary dollars (is that a contradiction in terms?). While it may not carry the cache of the newest Clooney or Cruise release, we proudly offer our own little feature for your entertainment and edification…the latest edition of the Compliance News in Review. On with the show!

It’s finally a wrap on the Federal Trade Commission’s case against Cephalon. The FTC settled its pay for delay case with the company (now part of Teva) for $1.2 billion. The case involved Cephalon’s attempts to delay entry of generics for its sleep disorder drug. The settlement is the largest ever secured by the FTC.

The OIG has premiered its mid-year update to its Fiscal 2015 Work Plan. The update includes several new items, one of which is a review of the financial interests reported via Open Payments.

“We will determine the number and nature of financial interests that were reported to CMS under the Open Payments Program. We will also determine the extent to which CMS oversees manufacturers’ and group purchasing organizations’ (GPOs’) compliance with data reporting requirements and whether the required data for physician and teaching hospital payments is accurately and completely displayed in the publicly available database.”

The OIG’s report on its findings is expected during fiscal year 2016. As Policy and Medicine points out, it will be interesting to see what sort of enforcement follows the OIG’s review, and if the information is used by the agency for its other activities involving fraud and abuse. This potential for enforcement involving this data should not be overlooked.

The first full calendar year of data has not even been released to the public yet, and the OIG is jumping right into a review. The agency’s actions underscore the importance of accurate data and the need for training to ensure that accuracy. From those engaging in transactions with covered entities, to those responsible for the reporting on the back end, understanding data collection and reporting requirements is critical. In addition to in-house staff, third-party vendors and partners that may be involved in reportable transactions on a company’s behalf need training on the basic requirements of the Sunshine Act and Open Payments.

Enjoy the weekend everyone, and we’ll see ya at the movies!

Compliance News in Review, May 27, 2015

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Legislation nullifying the need to report payments associated with CME moves to the House of Representatives for a vote, a new article in the NEJM offers thought proving insight on the relationship between industry and physicians, and OPDP issues untitled letters to two pharmaceutical manufacturers.

The monotonous strains of Pomp and Circumstance fill the air…graduation season is here! From kindergarten to college, students are donning caps, gowns, cords and stoles in celebration of their academic achievement. If you happen to have a student crossing the graduation stage this spring/summer, congratulations! We hope the commencement address is at least as thought provoking as this one. While you’re sitting there waiting for your loved one’s name to be announced, feel free to fill the time with this edition of the Compliance News in Review.

The 21st Century Cures Bill graduates from the House Energy and Commerce Committee and moves on to a vote by the whole House. The legislation aims to improve healthcare through support for research and development and by streamlining regulations. If passed, the law would nullify the requirement for reporting payments associated with CME; require the FDA to provide guidance on the sharing of health economic information; and require the FDA to issue guidance on the sharing of truthful, not misleading scientific information about off-label uses of drugs.

A new article in the New England Journal of Medicine explores the relationship between physicians and the industry. The article suggests the need for a reasoned approach when addressing conflicts of interest. The author acknowledges that conflicts exist, but that there are benefits to the physician industry relationship that shouldn’t be discarded simply because such relationships with industry are perceived as a negative.

Over a period of five days, the Office of Prescription Drug Promotion (OPDP) issued two untitled letters. Until this point, the agency had issued only four letters this year. The first letter, issued to Oak Pharmaceuticals, dealt with misleading statements on an exhibit banner. The statements did not include information about risks or material information about the approved indication of the product. According to OPDP, the only reference to prescribing and safety information on the banner was a directive to talk to a representative at the company’s booth.

The second letter was issued to Actavis over misleading statements on a Watson Pharmaceutical product webpage. The OPDP said the webpage was misleading because it contained unsubstantiated claims. The agency cited a specific marketing statement indicating the drug would help with conditions (sleep disturbance and work productivity) for which there was no evidence in the clinical studies.

When training about promotional speech, life sciences companies often focus on off-label statements, and with good reason. Off-label promotion continues to be a dominant issue in False Claims Act cases. However, other promotional speech issues should not be ignored or forgotten. The OPDP has least one letter every month so far in 2015. Additionally, the agency continues to dedicate considerable resources to educate healthcare providers about its Bad Ad program. That’s why promotional speech training needs to go beyond off-label, and address the need for company representatives to present the benefits and the risks of the products they promote.

Enjoy the week everyone!

Week in Review, May 13, 2015

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European Medicines Agency changes its conflicts of interest policy, ACCME updates its requirements related to the disclosure of commercial support, Siemens may be facing corruption charges in China, Bio-Rad tries to block access to FCPA settlement documents, the FDA schedules a summer session with stakeholders to discuss the topic of off-label, and another pharmaceutical company adopts the First Amendment argument in a fight to promote off-label.

Well, the world welcomed a new royal at the beginning of May, and last week, we even learned the name of the latest little princess, Charlotte Elizabeth Diana. A lovely name for a lovely little girl, and a touching tribute to the proud papa’s mother. Of course, if you’re not an Anglophile, you undoubtedly couldn’t care less, so we’ll quickly move on to our own little bundle of joy…the latest version of the Compliance News in Review.

In other news from across the sea, the European Medicines Agency (EMA) has made changes to its conflicts of interest policy. The agency will no longer allow individuals with connections to the pharmaceutical industry, or those who know they will be working for the industry, to sit on drug review panels. The previous policy left that decision up to the individual.

The ACCME has issued a royal proclamation updating its requirements for disclosure of commercial support. CME providers will now be allowed to use tabs, hyperlinks, or other electronic means to communicate commercial support to attendees. The ACCME says the move is an effort to “simplify compliance expectations and make them consistent across activity types.” The organization expects learners, as they always have, to receive disclosure information prior to the start of a CME session.

Siemens announced that its healthcare unit’s marketing and business practices are being investigated by Chinese regulators. The company denies media reports that the investigation deals with corruption, and says that it is working with regulators to resolve the matter. A Chinese government website stated that regulators were not investigating the company over bribery concerns. Siemens sells medical equipment and biochemical tests in China.

Bio-Rad raised the drawbridge on a records request from an investor. That investor has now filed a petition to have access to records related to Bio-Rad’s FCPA settlement. In 2014, the company entered into a non-prosecution agreement with the DOJ and accepted an Order issued by the SEC to resolve the matter. The investor made a request for records that related to the bribery allegations, but the company said there was no proper purpose for the records and the request did meet certain legal requirements.

The FDA will hold audience with the public during the summer to discuss off-label promotion. The agency says the meeting is being called to discuss the issue with a variety of stakeholders. The industry has been vocal about how the regulations infringe on First Amendment rights and have called on the FDA to relax its regulations. Critics worry that allowing companies to promote off-label will lead to less clinical trials and risks to patient safety.

One drug maker has decided to not wait for that summer meeting to take action. Amarin Pharma has filed suit against the FDA over its ability to share off-label information with physicians. Lawyers representing the company say the company is within its First Amendment Rights to share the information, as long as it is truthful and not misleading. The lawyers believe Amarin is the first company to pre-emptively sue the FDA over the issue. At the center of the suit is the company’s ability to share company-sponsored clinical trial information with doctors. The information indicated that the drug may be helpful for a wider patient population than what was approved. Lawyers for the company say the company knows physicians are already prescribing the drug off-label for a wider patient population, and more information, not less, should be shared with the physicians. A director with the health advocacy group, Public Citizen, says if the suit succeeds, it will undermine the FDA’s drug approval process. The FDA had no comment.

With that news of the on-going battle over off-label, we proclaim this issue of the Compliance News in Review as complete. Clearly, the focus on off-label isn’t going away anytime soon. That’s why we continually update our PharmaCertify eLearning module, On-label Promotion, with the content your representatives need to stay in compliance as they interact with HCPs.

Have a great week everyone!

Week in Review, April 27, 2015

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Teva settles a pay-for-delay case, the FDA migrates toward electronic submission of promotional materials, a circuit court rejects off-label claims against Medtronic, and several states introduce legislation requiring drug makers to release the costs associated with expensive drugs.

Lordy, lordy, King Arthur is Forty! Monty Python’s version of King Arthur that is. The comedy classic, Monty Python and the Holy Grail, is celebrating its 40th anniversary. If you’re not familiar with the film, forget what you think you know about King Arthur’s quest for the Holy Grail. This version certainly reveals a side to Arthur, his Knights and life in medieval Britain that has never been explored. Whilst we consider the merits of this classic comedic cinematic achievement, we’ll leave you with an epic tale of our own. To horse fine people…it is time for the Compliance News in Review.

Now this is a lot of coconuts. Teva has agreed to pay $512 million to settle a pay-for-delay case involving its Cephalon subsidiary. Drug wholesalers and retailers accused the company of paying generic drug makers to delay marketing a generic version of Provigil. The settlement is the largest in a pay-for-delay case.

The FDA has released new guidance that will make it easier for drug companies to submit promotional materials to the Office of Prescription Drug Promotion (OPDP). Currently, companies are required to submit promotional pieces through a paper-based process, using form FDA-2253. The new guidance offers instructions for submitting promotional materials using the FDA’s electronic common technical document (eCTD). The use of eCTD was mandated in the Food and Drug Administration Safety and Innovation Act. According to the guidance, in two years, all promotional materials must be submitted electronically.

They don’t have a shrubbery, but they would still like safe harbor. The National Infusion Care Association (NICA) has issued a paper arguing that OIG’s position stating that co-payment coupons and other financial assistance runs afoul of the Anti-kickback Statute (AKS) should not apply to specialty biologics for which there is no generic available. The OIG issued a report saying the coupons could be problematic under the AKS if they entice a patient to purchase a drug that is paid for by the government. NICA says while well intentioned, the position is really only valid if there is a generic alternative available for a specific drug. The organization claims that for many specialty biologics, no such alternative exists, and they worry that patients on government programs could be left with few treatment options if they are not able to accept co-payment coupons offered by manufacturers. NICA would like to see CMS, HHS, OIG and others in the government create a safe harbor allowing those on government programs to participate in co-payment programs if there is no generic alternative.

It may not have had the same drama as the process for determining if someone is a witch, but a circuit court has rejected claims against Medtronic over its off-label promotion of a medical device. The company was sued by an Oklahoma woman who said her physician implanted the product, Infuse, in a manner that was different than the FDA-approved approach. The woman said her doctor was urged to by a Medtronic representative to use the particular approach, and that the company had violated state tort laws. The court said her claims either did not have sufficient proof or were pre-empted by federal law.

Several states will soon be asking drug companies to bring out their drug costs. Massachusetts, North Carolina and Pennsylvania are the latest states to introduce legislation requiring manufacturers to disclose the costs and pricing information associated with expensive drugs. The Massachusetts’s bill will impose a limit on what a company can charge if the state determines the price of a drug is “significantly high.” If that bill is passed, the state will develop a list of drugs for which reporting is required. Companies will have to report costs related to production, research and development, and marketing. North Carolina’s law will require disclosure reports on all drugs sold in the state, and like Massachusetts, the production, research and marketing costs will have to be reported. Pennsylvania’s law will require disclosure reports for drugs with an average wholesale price of $5,000.00 or more, annually or per treatment. The Pennsylvania bill allows insurance companies and state programs to not cover a drug if the manufacturer has not filed a transparency report with the state.

With that, our tale for this week has nearly ended dear readers. We leave you with the reminder that many knights prefer accessing up-to-date compliance training whilst jousting about on horseback rather than hoping for a strong wireless connection over a mug of mead at the local tavern. The PharmaCertify™ suite of compliance-focused training solutions offers that training where your knights need it most – beyond the round table and at their fingertips.

Farewell for now dear friends.

Week in Review, April 21, 2015

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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!