PhRMA

News Week in Review, March 4, 2014

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The FDA updates its good reprint practices guidance, ACCME modifies the accreditation process, one attorney feels the abundance of qui tam cases are slowing the system, and the Solicitor General offers a suggestion to the Supreme Court on a qui tam case.

Laissez les bons temps rouler everyone! It’s the last day of the Carnival season and Mardi Gras is upon us. This is a crazy time of year in the Big Easy for sure, but even if you can’t make it to Bourbon Street, you just need to grab yourself some King Cake, organize an office krewe, and let the good times roll. As you contemplate all of the thematic possibilities for your floats, we’ll kick off our celebration of the week in compliance with this week’s News in Review.

Extravagant designs may work when designing Mardi Gras masques, but not so much for CME accreditation rules. The ACCME’s board of directors has adopted changes to simplify the accreditation process and requirements. Changes include a simplification of the process for first-time applications and the removal of some of the accreditation criteria and policy requirements. The changes apply to all CME providers in the ACCME accreditation system, and are effective immediately.

According to one expert, there are way too many attendees lining up for the qui tam ball. Peter Hutt, a defense lawyer in False Claims cases, points out that nearly 75 percent of cases brought by qui tam plaintiffs don’t result in government intervention or a recovery for the U.S. Treasury. According to Hutt, the cases are a drag on the system and he believes there should be changes to the qui tam provisions of the False Claims Act. Qui tam litigation should be a second line of defense in fighting fraud, says Hutt, and he would like to see incentives in place for companies to self-disclose fraudulent activity.

The U.S. Solicitor General is suggesting that the U.S. Supreme Court not review a qui tam case involving Takeda. The case raises the question of whether a relator has to provide specific instances of false claims in order to meet satisfy rule 9(b) of the Federal Rule of Civil Procedure. Although the circuit courts are split on the case, the Solicitor General believes the split among the circuit courts is not as pronounced as it initially appeared, and as the law evolves, the courts may resolve the issue.

Merck has good reason to celebrate this week. In a securities filing, the company noted the DOJ has closed its FCPA investigation of the company, and no action will be taken.

Any celebrating at the  French train manufacturer, Alstom, will have to wait. The company is expected to face charges of violating the U.K. Bribery Act. The charges are the result of a five year investigation. In 2010, the Serious Fraud Office raided the Alstom offices and the homes of several executives in the U.K., who were arrested under suspicion of paying bribes to win foreign contracts.

The FDA updated its good reprint practices guidance to address the topic of “distributing scientific and medical publications on unapproved new uses.” In the section referencing scientific or medical reference texts, the agency offers guidance on two fronts; providing chapters from a text and providing an entire textbook. Overall, the guidance for medical reference texts and CPGs are largely the same as medical journals.

That about does it for this week’s parade of compliance news. We wish you a joyous Fat Tuesday, and we look forward to bringing you all the compliance news you need to know right back her next week.

Thanks for reading and have a great week!

News Week in Review, February 24, 2014

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A survey shows anti-bribery policies may not be working in Asian-Pacific companies, businesses are again reminded to keep an eye on third party intermediaries in regard to the FCPA, two pharmaceutical companies settle anti-competition charges and West Virginia institutes its own false claims act.

Well, did you set aside any time to indulge in one of the great spectacles in sports over the weekend? We’re not referring to the closing ceremonies of the Olympics, but the 55th running of the Daytona 500…the Super Bowl of racing! While it does seem a little odd to have the big “game” at the beginning of the season, we’ll roll with it anyway. (See what we did there? Roll with it.) Just like in the Olympics, the weather added some stress, but eventually, the race was completed and Dale Earnhart Jr. celebrated his win not by announcing he was going to Disneyworld, but by launching a Twitter account. So with the “Great American Race” as our inspiration, we start our engines on this week’s News in Review.

Sitting in the pole position is an article that raises the question of whether strong anti-corruption policies are actually having an impact on behavior. A recent Ernst & Young survey of employees at Asia-Pacific companies shows that nearly half of those employees believe that corruption is a real problem in their organizations, despite the presence of policies intended to prevent it. Nearly 25% of those surveyed say that the provision of gifts to win business is still commonplace. While 81% of the respondents say they would use an anonymous hotline to report concerns only 32% say their companies had created procedures to do so.

Businesses hoping to avoid the black flag for FCPA violations need to keep tabs on their third party intermediaries and resellers. The 2012 FCPA Resource Guide offered clarity on the question of whether companies are responsible for the actions of third parties. In addition, recent cases have reinforced the notion that the government holds companies responsible for the actions of third parties. One case from 2013 involved a company that used a freight forwarder to avoid paying customs duties and tariffs in Nigeria. In another, a company entered into a Non-Prosecution Agreement after the manager of a foreign subsidiary was found to have paid bribes to customs agents.

PhRMA is not happy with the Federal Trade Commission (FTC) over the transfer of patent rights and the organization is headed to court to do something about it. In November, the FTC made a change to the Hart-Scott-Rondino Act over premerger notification rules that applies only to the pharmaceutical industry. PhRMA filed suit to have the change declared unlawful, saying the costs of compliance with the rule will be significant.

On the settlement front, Ranbaxy and Teva have been assigned a couple of penalty laps for restricting competition. The two companies settled charges with the state of New York over an arrangement that would allow Teva to sell the generic form of Lipitor in the U.S. should Ranbaxy’s generic not be approved. Each company agreed to pay $150,000 as a part of the settlement.

The West Virginia House Judiciary Committee has approved a bill that would create a state version of the False Claims Act. The bill provides for whistleblower awards, and if passed, will give the state a larger percentage of federal settlements.

And so ends this week’s race through the world of the compliance news you need to know. Have a great week everyone and we’ll see you back here next week!

 

The 2014 Pharmaceutical Compliance Congress: A Recap and Review

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The 2014 Pharmaceutical Compliance Congress featured many of the same speakers and topics as past conferences, but recent developments in the world of anti-bribery and compliance brought a new twist to the presentations.

Last year’s developments related to the Chinese government’s aggressive pursuit of corruptions was a recurring topic, with John Crisan, Chief Compliance Officer for Johnson & Johnson, stating at the start of the first session, “what happened in China is a major game changer,” and in a later session, Gary Giampetruzzi from Pfizer said, “The fact that China has put people to death for corruption-related offenses certainly gives pause for concern.”

After the opening remarks of Day 1, Tom Abrams from the Office of Prescription Drug Promotion at the FDA took the stage. Of course, Abrams’ presentation this year had the added bonus of the recently announced news regarding the agency’s guidance on social media. Before providing detail on the guidance, particularly in regard to the process for submitting promoting websites, he emphasized that the agency has more work to do in regard to social media and it “will continue to be a high priority.”   Abrams also told the audience that overall, the quality of promotional materials seems to be improving and the agency is very encouraged at the level of voluntary compliance by the industry.

Carmen Ortiz, US Attorney for the District of Massachusetts, followed with a keynote address regarding the trends in healthcare that have followed major settlements with pharmaceutical companies. Ortiz told the audience that there have been no shortage of qui tam referrals and “the publicity around the cases helps her office reach other whistleblowers and bring more issues to light.” She included the establishment of what she called “ethical compensation plans for reps” and on-going training (a topic close to our hearts and minds here at NXLevel Solutions) in her list of critical best practices for life sciences companies.

Anita Griner, from the CMS Center for Program Integrity followed with a review of the ever popular Open Payments program, a.k.a. the Sunshine Act. Griner offered a thorough review of what data needs to be reported under Sunshine and the process for submitting those reports. Her review included the three reporting categories: General Payments, Research Payments and Ownership and Investment Interests, as well as examples of both Direct and Indirect Payments. Griner’s presentation was comprehensive and she suggested anyone with questions contact the agency’s help desk at openpayments@cms.hhs.gov or sign up for the updates at http://go.cms.gov/openpayments.

The US Healthcare Fraud Enforcement Panel was next, with representatives from US attorney’s offices around the country. Ben Singer, from the Department of Justice, highlighted the focus on the healthcare industry by stating that the DOJ has 38 prosecutors fully dedicated to healthcare fraud prosecution.  Zane Memeger, from the Eastern District of Pennsylvania, discussed the cooperative nature of their work, saying the larger offices share resources with the smaller offices in order to boost their efforts throughout the country. Memeger stressed the critical behavior his office looks for when considering the settlements for violators. Key on his list is whether a company trains its employees regularly, since the rules change regularly, and whether the company self-discloses a violation. Bill Nettles, from South Carolina, agreed, saying he and his colleagues discuss whether each case was self-reported when they review. Of course, when the panel was asked whether they ever decided to not prosecute a case because the disclosure was voluntary, the members smiled and said no.

A panel of defense attorneys closed the morning with suggestions for mitigating risks and preparing for the future. Jennifer Romanski from Porzio reminded the audience that while compliance has to have authority, they have to have buy-in from the entire organization. “You can’t have compliance doing everything,” Romanski stated, “businesses need to play a role.” David Resnicoff of Miller & Chevalier focused on clinical research programs and the need for companies to focus on “what the conversations with the federal government will look sound like, even as they are building their compliance programs.”

For the early afternoon session, I selected the Product Promotional Compliance Track, which kicked off with Lessons Learned from Recent Enforcement Actions Related to Digital Marketing and Social Media. David Vance of Noven offered a comprehensive review of FDA’s position on Internet promotion, and emphasized the need for diligent self-regulation by the industry. During her presentation on Compliant Social Interactions and Engagement, Jennifer Chillas from Bristol-Myers Squibb made a point that those in the industry should not be telling their vendors about the compliance rules, the vendors should be telling them. Do your training vendors know the rules? We do.

During a lively question and answer session, Vance, Sheetal Patel from Johnson & Johnson, and Chillas delved into the challenges of “liking” pages on Facebook.  They agreed that the key is to be aware of what you are “liking” and be careful not to “like” off-label discussions or scientific discussions on sites such as Medscape.

To gain more of a perspective on the global front, I chose the 2:40 session titled FCPA – Key Insights and Enforcement Trends, during which Gary Giampetruzzi from Pfizer made the comment regarding China that I quoted earlier. Giampetruzzi was joined by Richard Konzelmann from Daiichi Sankyo, and the two presented what I considered to be one of the most informative and compelling sessions of the entire conference. After presenting an array of statistics and polls showing that a significant driver of business growth over the next three years will be customers outside the US, the two speakers made a case for the need for increased diligence over interactions, starting with more auditing and investigatory work. Giampetruzzi said he expects FCPA enforcement to accelerate even more quickly, with the 2013 institution of the whistleblower provision in the Dodd-Frank Act. Properly trained management is key to creating an environment in which employees feel comfortable discussing issues internally and feel their concerns are addressed without the need for outside reporting.

I closed Day 1 with the Effective Crisis Management Panel, which featured an impressive list of attorneys and consultants from King & Spalding and more. Wick Sollers, who not long ago represented Joe Paterno at Penn State, pointed out that due to the nature of its business, the pharmaceutical industry is one of the most crisis prone and the need for training on how to respond to a crisis is critical. Seth Lundy agreed, saying “too many of our clients are surprised when someone from the government shows up at the door.” The panel agreed that the Sunshine Act is a risk, particularly with the release of the data scheduled for September and their concern that companies are too focused on the details of the process instead of what the data will reveal.

Day 2

Day 2 started early and the FCPA was once again in focus, as Kathleen Hamann of the law firm, White & Case, again looked at the Act and reminded the bleary-eyed audience to not make their diligence just about the FCPA, but more about eliminating bribery worldwide.

Ilisa B.G. Bernstein, Deputy Director of the Office of Compliance at the FDA, covered the top oversight priorities for the agency. Bernstein focused on the manufacturing problems that occurred because so many facilities were old and out-of-date. But the FDA is encouraged to see the industry policing the problem itself, with firms building new plants, creating better methods and production redundancy.

As the second cup of coffee started to have its desired effect, Patrik Florencio and Samuele Butera, both of Sandoz, and Erik Ramanathan, of Harvard Law School, delivered their Making Compliance Part of Management 101 presentation, which was met with favorable comments throughout the rest of the day. The focus of their comments drilled down to “how often does your manager clearly and specifically reinforce that compliance must never be compromised in order to hit targets?” The three presenters offered a fresh take on the concept of a “culture of compliance” by presenting concrete examples of how internal communication, focused on sales targets, can be seamlessly enhanced with core compliance principles. Compliance targets and goals should not just be theoretical but should be intertwined with financial goals.

The Chief Compliance Officer Panel included the CCOs from AstraZeneca, Daiichi-Sankyo, Aegerion, and Sunovion. Following an introduction by the moderator, which ran a little too long for a number of attendees I later spoke to, the panel also discussed the rules-based vs. values-based approach to compliance. Balance seems to be the key, with Sarah Whipple from Aegerion noting that in “our business, you can’t get away from a rules-based approach. People are used to rules, but people need to be rewarded for doing the right thing.” Jeff Fleming from AstraZeneca pointed out that his company is evolving from a rules-based approach to a values-based one, which does present challenges. “If you’re not going to have rules, tremendous accountability is required,” said Fleming. Matthew D’Ambrosio from Sunovion touched on the handling of mistakes, “Mistakes can be addressed with training, except of course for catastrophic mistakes.” he said. The panelists also agreed that communications and effective awareness campaigns are critical.

The Compliance Program Structure and Effectiveness track was my next stop. Representatives from large and small pharma companies presented suggestions on topics from the challenges of multinational compliance programs to the importance of business in compliance decisions. Jessica Kwon of Forest Laboratories talked about the need to be aware of what is going on in a specific country, politically and culturally, when establishing a compliance program there. “That helps move the conversation along,” Kwon said, “bring yourself out of a US focus.”

Christine Fiore and Bob Doyle of Boehringer-Ingelheim centered their presentation on integrating the business into compliance and it proved to be one of the most dynamic sessions of the day. The pair explained how the compliance department at BI is made up of professionals from different backgrounds who bring a valuable range of experience to the table. Fiore stressed the need to make compliance training fun and engaging and shared tools and tips for doing so with the audience. She even demonstrated an internally-developed iPad app that features video clips and policy documents in a creative and organized framework. This was great material and certainly cutting-edge in terms of how critical compliance content is delivered.

For final session of the conference, I chose the discussion on Compliance Considerations for Small to Mid-Sized Companies, mostly because so many of my clients fit this description and I’m always looking for more knowledge to share with them. The session didn’t disappoint. The discussion began with the topic of resources and whether the participants utilize others, outside of compliance, to accomplish their objectives. “You have to,” said David Stollman from Incyte, “but you have to ask permission to do so. Don’t set yourself up for failure.” Jeff Rosenbaum from Vertex said he turns to his colleagues in accounting for help with auditing. He also pointed out that for small companies with a global presence, compliance can be difficult and again, a focus on the biggest areas of risk is necessary.

On the subject of budgets, the panel agreed that decisions have to be made on what is really needed and what is wanted. How much of that can be done in-house? A good risk assessment will lead to the budget and that assessment needs to be the first step. For Elizabeth Jobes from Auxilum, prioritization is critical. “The highest risk has to be addressed first.”

The session closed with a word of warning from a number of the panelist – no matter how limited your resources, don’t conduct investigations alone. One-on-one meetings in those situations present too many opportunities for facts to be recorded improperly and distorted later.

The 2014 Pharmaceutical Compliance Congress, along with PCF’s Pharmaceutical Regulatory and Compliance Congress both offer excellent opportunities for industry professionals to stay abreast of the best practices and strategies needed in a complex and evolving regulatory world. As a vendor partner, the conferences provide me the chance to not only network with clients and colleagues, but also distribute critical ideas through my social outlets, such as this blog.

If you attended the 2014 PCC, I welcome your comments and feedback. Thanks for reading!

Sean Murphy, NXLevel Solutions

Week in Review, January 21, 2014

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The Serious Fraud Office adds Deferred Prosecution Agreements to its arsenal, doctors in the UK are looking for more transparency and one generic drug manufacturer gives up on China.

The teams for Super Bowl XLVII are set! The Seattle Seahawks and the Denver Broncos will do battle in New Jersey in February. Hmm, New Jersey…in February. Nothing against the Garden State (for many of us, it is home), but wouldn’t a warmer climate be more inviting for those with a ticket? Barring any blizzards, the game should be exciting as the top offense and top defense in the NFL face off. We know we’ll be tuned in, but until then there’s other news to address. Let’s kickoff this week’s News in Review.

February is shaping up to be a big month for the Serious Fraud office as well. Beginning next month, the SFO will be able to utilize Deferred Prosecution Agreements as a tool to deal with corporate bribery. The advantage to the SFO and to corporations is that agreements can be negotiated without prolonged court cases or the eventual debarment for corporations if they were found guilty through a trial. Implementing DPAs will bring its own set of challenges though. Judges in certain jurisdictions in the UK prefer justice to be doled out in court and not in advance. Consultation with judges prior to an agreement being signed should help, but the judges are not bound to accept the agreements. That leads to an issue of consistency in the process. If companies can’t rely on agreements being ratified by judges, they will be less likely to engage in the negotiations.

British doctors and academics teamed up to ask for more transparency in physician conflicts of interest. In an open letter appearing in the British Medical Journal, the group called on the General Medical Council to set up a general registry for physicians’ conflicts of interest. The letter cited an ABPI estimate that nearly 40 million pounds are paid to physicians by the pharmaceutical industry, and that the recipients of those payments are largely unknown. The letter said transparency into just who is receiving those payments “can only be good for medical practice.” A spokesperson from the GMC said that it could not require doctors to disclose payments without a change in law.

Generic drug maker Activis is scrapping its China playbook. The company announced it would cease operations in China. It’s CEO said China was not a “business friendly environment,” and there is too much risk in doing business there. The company has a small profile in China, and while it has not run into the issues some other pharmaceutical companies have of late, the CEO said he wasn’t confident that if anything did happen, the company would get a fair hearing.

2013 was another record setting year for False Claims Act recoveries, according to the DOJ. The DOJ collected $3.8 billion during the 2013 fiscal year. Of the $3.8 billion, $2.6 billion was from healthcare fraud recoveries. The majority of that $2.6 billion was from settlements with pharmaceutical industry companies.

Congress is calling for a review following CMS’ explanation for why payments for textbooks and journal reprints are not excluded from Sunshine reporting. The explanation provided by CMS did not sit well with members of Congress, and some are exploring options for changing the requirement. An aide to Maryland Representative Andrew Harris said the Congressman plans to add language to an appropriations bill to halt the collection of the data.

The fourth quarter’s here and it’s time to wrap this thing up. Before we dump the bucket of virtual sports drink over the head of this week’s Review though, we have to ask if you feel confident with your compliance training lineup for 2014. Do you need to add a new player or get back to training on the basics? The PharmaCertify™ suite of compliance training solutions includes two key players – Good Promotional Practices offers a comprehensive review of compliant product promotion practices and concepts for your sales team, and Commercial Compliance Overview is a comprehensive review of commercial compliance for your entire staff.

Have a great week everyone!

Week in Review, January 14, 2014

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The University of Minnesota adds a medical device degree to its curriculum, Microsoft requires its partners to take anti-corruption training, Aegerion receives a subpoena from the Department of Justice and CMS clarifies its stance on textbooks and journal reprints under Sunshine.

If you weren’t watching television Sunday, you missed a night of glittering stars, flowing wine and cutting one-liners. Even with Meryl Streep pronouncing awards season as ridiculous, millions tuned into the Golden Globes to see if their favorite movie, TV show, or actor took home the trophy. Okay…let’s face it, some of us watch just to marvel at the ridiculousness of the fashion choices, which is often far more interesting than the acceptance speeches (with the exception this year of Jacqueline Bisset’s confused rambling – what was that!?). We have winners and losers of our own (of the compliance kind) to cover in this week’s News Week in Review.

The University of Minnesota plans to award individuals a medical device master’s degree in the near future. The University is currently recruiting students for a master’s level program in medical device innovation. The program will be part of the school’s College of Science and Engineering and the first class is expected to be enrolled this June.

The question at Microsoft isn’t “who are you wearing?” it’s “who has taken anti-corruption training?” The company launched a global initiative requiring all its partners to provide anti-corruption training to “all employees who resell, distribute, or market Microsoft products or services.” Media reports claim the DOJ and SEC are investigating allegations of bribery involving Microsoft partners in several countries.

In a settlement that almost rivals the value of the jewels on the stars walking the red carpet Sunday night, Alcoa has agreed to pay $348 million to settle charges it violated the FCPA. The settlement is a joint effort between the SEC and DOJ. SEC officials said Alcoa subsidiaries repeatedly bribed officials in Bahrain and Alba in order to obtain government contracts. The company agreed to plead guilty to one count of violating the FCPA.

Here’s one envelope you don’t want to see your name on: a DOJ subpoena. Aegerion confirms it has received a subpoena from the DOJ for information related to the sale and marketing of its cholesterol drug, Juxtapid. The company’s CEO recently received a warning letter for misleading statements he made about the drug during a television interview. Aegerion says it is fully cooperating with the investigation.

As far as two clinical research professionals are concerned, the Sunshine Act should be nominated for the “Law Having the Most Negative Impact on Clinical Research” award. Gary A. Shangold, M.D., chairman of the Association of Clinical Research Professionals Board of Trustees, and Michael J. Koren, M.D., former president of the Academy of Physicians in Clinical Research, authored an article outlining how the Sunshine Act will negatively impact clinical research and medical innovation. They are concerned that the reports on payments related to research are not reflective of what the physicians are actually paid; the cost of complying with the law will divert money from research; and overall quality of care will ultimately be affected by the diminished investment in research. The two also call on lawmakers to change the legislation in order to provide a more accurate picture of the financial transactions between research physicians and the industry.

CMS Administrator Marilyn Tavenner recently responded to an inquiry from Congress about textbooks and journal reprints not being considered educational items under the Sunshine Act. Educational items are described as those that are intended for patient use or have a direct benefit for the patient and are therefore excluded from reporting. In her letter, Ms. Tavenner said textbooks or journal reprints do not have a direct benefit for patients the way an anatomical model does. Rather, the textbooks and reprints provide a “downstream benefit” for patients so CMS believes the items should be reported as gifts or education.

With that, the band is signaling us that it’s time to wrap up the News in Review for this week, so we’ll leave you with one last note. If you’re looking for additions to your 2014 compliance training cast, PharmaCertify™ offers up-to-date modules and apps on critical topics like Adverse Events, On-label Promotion and Good Promotional Practices.

Have a great week everyone!

Week in Review, December 16, 2013

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The Serious Fraud Office hits another bump in the road, Brazil expands its anti-corruption efforts, and the Pew Charitable Trusts and the CME Coalition disagree on suggested changes for the industry’s interaction with medical schools.

As the song goes, “the weather outside is frightful.” The string of winter storms over the last week has brought snow for some, ice for others, and a lovely cold rain over much of the country. Welcome to early winter! Yes, we know, the calendar still says we’re in the fall. If you’re one of the unfortunate ones scraping snow and ice off your windshields and sidewalks already, we can’t offer much in the way of help with that shovel, but we can help you catch up on the compliance news you need to know, with this week’s News in Review.

The Serious Fraud Office is facing more stormy weather. The agency abruptly called off the high-profile bribery case against businessman Victor Dahdaleh. Dahdaleh was accused of paying millions in bribes to managers at Aluminum Bahrain (Alba) over a period of eight years.  The trial began in early November, and the SFO had to call an end to their prosecution when two U.S. lawyers who had helped with case refused to testify and a third witness changed his testimony. The two U.S. lawyers also represent Alba in a civil case, which raises questions about whether they should be used in the British criminal case. The case is the latest in a string of embarrassing and expensive missteps for the SFO.

New legislation has been introduced in Canada that would require doctors and pharmaceutical companies to reveal more information about the adverse effects associated with pharmaceutical products. The law would require doctors to notify Health Canada when patients have an adverse drug experience, and pharmaceutical companies would then be required to make immediate changes to a drug’s label to reflect the new safety concerns.

A change in the anti-corruption weather is on the horizon in Brazil. The Clean Companies Act (CCA) will go in effect January 29, 2014. The anti-bribery law shares a number of similarities with the FCPA and U.K. Bribery Act. The law applies to any company or legal entity doing business in Brazil, and applies to the bribery of both domestic and foreign government officials at any level. It also prohibits facilitation payments and implements strict liability for legal entities involved in corruption.

The courtroom had to be frosty when Boehringer Ingelheim was handed a $931,000 fine for losing documents related its Praxada drug. The judge said the company allowed the documents to be destroyed, and that attempts to create back up versions were even thwarted. Further, the company disabled programs that would have preserved voicemail and text messages. The loss of the documents affects 1,700 patient lawsuits.

A report from the Pew Charitable Trusts suggests industry-physician interactions at the nation’s medical schools need to be put in the deep freeze. The recommendations from Pew include the typical ban on rep visits, meals, gifts, etc., as well as a suggestion that school staff not accept speaking fees from pharmaceutical companies.

The CME Coalition would like to put the Pew recommendations on ice though. Senior advisor to the CME Coalition, Adam Rosenberg, says the recommendations in the report are “irresponsible,” and “they are nothing short of dangerous to America’s health.” For example, even though Pew recommends that CME should be free of industry funding, the organization cites no studies or evidence showing that funding is leading to poor patient outcomes, or is unduly influencing prescribing decisions.

And so we come to the end of this chilly edition of the News Week in Review. If adverse events reporting is at the top of your holiday and new year wish list, the newest off-the-shelf module from PharmaCertify™, Adverse Events and Product Complaints, covers the definitions and sources of events and complaints, as well as the information needed to ensure accurate reports are filed. As with all of the PharmaCertify™ solutions, the module is easily customized with your  organization’s procedures and policies.

Stay warm everyone, and have a great week!

New Week in Review, November 18, 2013

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The APBI amends its Code of Practice, a doctor in Scotland looks for Sunshine, PhRMA sues the state of Maine over drug importation, and a congressman from New Jersey seeks clarification on how food provided to CME program speakers and attendees is reported.

The big day is almost here…if you have a tween or teenager, you are probably well aware that the long-awaited opening of the film, The Hunger Games: Catching Fire, is this Friday! With a number of theaters premiering the film a day early, we’re left with precious few hours to practice our skills for the archery tournament and best braid contest. But before we prepare for our time in the Arena, we pause to present you with a week’s worth of compliance news, with the News in Review.

Our first “tribute” comes courtesy of the ABPI, whose members have agreed to amend the Code of Practice to include greater transparency on payments made to HCPs and healthcare organizations. APBI’s chief executive views the changes to the Code as an important first step in correcting the public’s misconception of the relationship between the industry and HCPs. According to a recent British Medical Journal article, he may be onto something. The article reported the results of a recent survey, which found 90% of the nearly 1,055 respondents felt that payments to HCPs should be made public.

As the ABPI moves on with determining the details of its transparency program, a Scottish doctor is hoping a Sunshine Act style law will “catch fire” in his country. The physician has petitioned the government to create a Sunshine Act of Scotland, which would publicly disclose payments to NHS healthcare professionals.

A compliance uprising has been started in Maine as PhRMA and several Maine pharmacy associations are suing the state over its drug importation law. The law allows Maine’s citizens to obtain prescription drugs pharmacies in Canada and from licensed retail pharmacies in the U.K., Australia and New Zealand. PhRMA, and the other plaintiffs, say the law violates the U.S. Constitution and federal laws that control the sale of drugs.

If you’re looking for more information on Open Payments and data submission, CMS has announced a series of webinars, designed to introduce features of the Open Payments system, on November 19. While the webinars are targeted to manufacturers and individuals responsible for creating data submission files for manufacturers, anyone is welcome to attend. A follow up question and answer session will be held December 3.

Speaking of “hunger games,” the language regarding meals at CME events continues to cause confusion. So much so that New Jersey Congressman Robert Andrews sent a letter to CMS requesting that the cost of food provided to speakers, faculty AND attendees of CME events be exempt from individual reporting requirements.

The rule already exempts the speakers and faculty as long as three requirements are met: the program is accredited by one of five designated organizations; payments or transfers of value are not made by the manufacturer directly to speakers or attendees; and the selection of faculty and speakers is not influenced by the manufacturer.

In his letter, Congressman Andrews points out that CMS has already acknowledged that accreditation bodies and industry standards create safeguards against sponsor involvement in educational content. He says the same logic should be applied to the meals provided to attendees.

Well, that’s the news for this week. We leave you this week with a recommendation for a different type of trilogy – one that weaves a compelling and engaging tale of compliance best practices and risk reduction across a broad array of topics. PharmaCertify’s Compliance Overview, Good Promotional Practices and On-label Promotion eLearning modules offer the regulatory and practical content your sales representatives and office staff need to understand the compliance rules and promotional policies that affect their daily activities. They’ve been met with rave reviews by learners of all ages!

Have a great week and, “may the odds be ever in your favor.”