Life Science Compliance Update

January 15, 2018

Maine Updates Their Gift to Physicians Law Online


Maine has posted a revised version of their gifts to physicians law which bans cash payments from pharmaceutical manufacturers, wholesalers agents for research, consulting, promotional speaking related payments but exempts educational materials, modest meals, prescription drug samples, honorarium at educational events and education-related funding to institutions.

We have previously written about the Maine Legislature passing a new law to prohibit gifts from industry to health care practitioners.

On November 1, 2017, the law went into effect and can now be found online for reference.

For a refresher, the law amends the Maine Pharmacy Act to prohibit a person engaged in the manufacture of prescription drugs or a person who buys prescription drugs for resale and distribution to persons other than consumers from giving a gift to an individual who is licensed, registered or otherwise authorized in the appropriate jurisdiction to prescribe and administer drugs in the course of that individual's professional practice.

However, some significant changes seem to be made to the version listed on the Maine legislative site. Whereas previously there was a list of seven items specifically excluded from the bill, the final legislation does not include that same list.  Instead, the law prohibits manufacturers or wholesalers from offering or giving cash gifts in any amount of a gift for which reciprocity is expected or implied to a health care practitioner.

Further, the list of exceptions has shrunk to a handful. The exceptions include:

  • Giving noncash items of minimal value that will directly benefit the practitioner’s patients including:
    • Prescription drug samples for distribution to patients,
    • Educational materials
  • Modest meals and refreshments that are provided in connection with a meeting or presentation about the benefits, risks and appropriate uses of prescription drugs or medical devices, as long as the meeting or presentation occurs in a venue and manner conducive to informational communications;
  • Giving funding to an academic institution, residency program, or and fellowship program to support the participation of medical, nursing, physician assistant, veterinarian and pharmacy students, residents and fellows in professional meetings, including educational meetings, as long as the program identifies such funding recipients based on independent institutional criteria and the funds are distributed to recipients without specific attribution to sponsors;
  • Giving reasonable honoraria to a practitioner and making payment of reasonable expenses of a practitioner at a professional or educational conference or meeting.

We also recently reviewed the Maine Office of Professional and Occupational Regulation (OPOR) Regulatory Agenda to get a status update. The agenda notes that the Maine Board of Pharmacy expects to get involved in rule-making activity on the topic in 2017-2018.

From the Agenda,

Rulemaking activity is currently under consideration for purposes of implementing 2017 Public Law Chapter 249 to establish procedures and standards to Board-certify a pharmacist to prescribe naloxone hydrochloride and procedures and standards on the dispense naloxone hydrochloride (see chapter 40 below). The Board may consider rulemaking for purposes of implementing 2017 Public Law Chapter 267 on appropriateness of certain gifts extended by manufacturers or wholesale distributors to health care practitioners for which is major substantive rulemaking. In addition, the Board is expected to review rules overall streamlining, to ensure compliance with current laws, and to update rules by addressing outdated references, providing clarification of certain rules as necessary, and setting licensing requirements and operating standards for newly identified types of retail pharmacies.

While most of us like to be prepared and work hard to ensure full compliance with all laws, with no guidance or rule adoption of these laws, companies cannot be found in violation of the laws. Therefore, you still have time to comply while preparing your company for the laws once they take effect.

This change of language has no exemption for research or consulting. We encourage you to review the rules in their entirety to determine what changes if any, your company needs to take.

A Compliance New Year’s Resolution – Assess the Company’s Culture


The topic of ‘company culture’ is certainly not new, but it continually emerges as a hot topic within regulatory circles. An organization’s culture is recognized to exert a powerful influence on how a company and its people conduct business. Although there is an inherent understanding that by continually enhancing company culture, ethical aspects of the organization will follow suit, why isn’t culture reviewed with the same rigor and principles that are required for compliance programs? This article will discuss the importance to evaluate an organization’s culture of compliance, and will introduce some considerations on how this can be done.

At the start of every New Year, we hear people discussing, exchanging, making and breaking New Year’s resolutions. Why should the company compliance program be any different? Frankly, we do not think it should. Therefore, for 2018, we propose that assessing the company’s culture top the compliance New Year’s resolution list.

Here are a couple of reasons why culture assessment should top the list.

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January 12, 2018

Media Has it Out for Pharma…Still


Many would say that the media is no friend to the pharmaceutical industry. However, CNN has recently started to (seemingly) build a case against Avanir Pharmaceuticals for its promotion and marketing of its pseudobulbar affect (PBA) drug, Nuedexta.

In October 2017, CNN published its first article on the subject, where it was noted that the company “aggressively targets frail and elderly nursing home residents for whom the drug may be unnecessary or even unsafe.” While PBA afflicts less than 1% of Americans, it is most commonly associated with patients who have multiple sclerosis (MS) or ALS.

Then, in December 2017, CNN published another article on the company, once again dinging them for payments made to physicians and alleging that physicians had criminal convictions in their history for illegal prescribing.

According to CNN, Nuedexta's financial success is being propelled by a sales force focused on expanding the drug's use among elderly patients suffering from dementia and Alzheimer's disease, and high-volume prescribing and advocacy efforts by doctors receiving payments from the company.

Avanir Pharmaceuticals paid nearly 500 doctors to speak or consult on its drug, Nuedexta, between 2013 and 2016, according to government data. Through a review of the top prescribers and top paid physicians in this group, CNN identified a dozen who have been disciplined by state medical boards. These offenses included the harmful treatment of nursing home residents and "grossly negligent acts" involving the inappropriate prescribing of dangerous and addictive drugs -- resulting in probation, suspension, fines and revoked licenses.

Between 2013 and 2016, Avanir and its parent company, Otsuka, paid doctors nearly $14 million for Nuedexta-related consulting, promotional speaking and other services, according to government data. Paying doctors for promotional speaking is legal and is defended as a way for experts in their fields to share important experience and information about medications, but it's long been a controversial practice.  

Since 2012, more than half of all Nuedexta pills have gone to long-term care facilities. The number of pills rose to roughly 14 million in 2016, a jump of nearly 400% in just four years, according to data obtained from QuintilesIMS, which tracks pharmaceutical sales. Total sales of Nuedexta reached almost $300 million that year.

CNN noted that between 2013 and 2016, Avanir and its parent company, Otsuka, paid doctors nearly $14 million for Nuedexta-related consulting, promotional speaking and other services, according to government data. Paying doctors for promotional speaking is legal and is defended as a way for experts in their fields to share important experience and information about medications, but it's long been a controversial practice.  

In an emailed statement, the company said PBA is often "misunderstood" and that the condition can affect people with dementia and other neurological disorders, which are common among residents in long-term care facilities. A company website states PBA can afflict up to roughly 40% of dementia patients -- a figure that is based on an Avanir-funded survey and was repeatedly disputed by medical experts interviewed by CNN, including some of those paid by Avanir.

Avanir said it "vehemently oppose(s) any mischaracterization" of its interactions with physicians and other members of the medical community, explaining that these relationships are ethical and are used as a way to share important information and raise awareness of medical conditions and treatments that could help patients.

In response to the articles, the Pharmaceutical Research and Manufacturers of America, which represents drug makers across the country, said companies should strive to work with speakers who meet ethical and professional standards. "In the rare instance where there is an outlier," the group said on its website, "companies take corrective action."

This is one example of the way the media can use Open Payments to support cases against pharma companies. The ease with which Open Payments can be found highlights the need for companies to vet to whom they give money.


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