Life Science Compliance Update

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December 01, 2015

Study Explores Lack of Sunshine Act Guidance From Professional Medical Associations

  Unclear

As with any large piece of legislation, the Sunshine Act (Open Payments) has conjured up a wide variety of reactions, including concerns about the accuracy of the published data, possible misinterpretations of the published data, and downstream effects on innovative drug development. More fundamentally, given the complexity of the Sunshine Act, simply figuring out what the rules are has proven challenging. A recent research article published in Postgraduate Medicine, has concluded that a lack of professional guidance on how to interpret elements of Sunshine Act may be having a "chilling effect" on physician investigators' participation in clinical trials and publish results. 

A group of researchers delved into various guidances from professional medical associations to get a better understanding of how physicians are views the requirements, and what, if any advice they provide to their members on how to best comply. The article focuses on guidance on how-"nonmonetary assistance" provided by the pharmaceutical industry to those who write medical publications on licensed drugs. Industry often provides this support to authors "to assist with the development of medical publications (including peer-reviewed journal articles and reviews, congress abstracts and oral and poster presentations)," the authors write. "The support often is in the form of medical writing, copyediting and creating artwork for the publications, under the direction of the authors.

Researchers’ Methods

The researchers explored both peer-reviewed and “grey” literature to get the best compilation of industry viewpoints. Grey literature is defined as “articles, in print or electronic form, not published in easily accessible journals and which may not be indexed in formal academic databases” and can be found in search engines such as Google and Google Scholar.

The researchers pored through many articles and publications, placing them into six categories: industry-supported/sponsored publications, industry–author relationships, industry–investigator relationships, guidance and/or recommendations related to industry– HCP relationships, ethical considerations around the Act, and industry-sponsored research. If an article or publication did not fit into one of the six criteria, it was excluded. If an article fit into multiple categories, the researchers placed it in the category that was most prominent within the article.

Once a publication was deemed to meet the criteria, the researchers collected its publication type (peer reviewed, “grey,” industry, or academic), the year the article was published, the content type, and created a structured summary of three significant findings/conclusions per publication.

Results

In total, the researchers reviewed fifty-nine articles and concluded that there is limited guidance out there on how to best follow the Sunshine Act mandate. Professional associations tended to focus on clarifying the reporting requirements to their subscribers and readers. While the professional associations websites and articles “contained broad guidance, there was insufficient consistence or consensus from associations around specific concerns, including [transfers of value] for research grants, trial participation and medical publications.”

Most of the publications and articles focused on reiterating the Rules to their readership, ensuring that at the very least, their readers would know that the new Rules existed. Whether the readers would know how to implement those Rules, however, is another question. Most publications tried to provide an outline for covered recipients and healthcare providers, showing them how to prepare themselves and check the data reported.

The arena of medical publications and payments remains murky, at best. The researchers found that the Rules contain no clear direction on how to report industry support of authors. One group found that even when guidance is sought and clarifications were requested, it was tough to discern the real answers and requirements.

Additionally, the authors of the study came to realize that key opinion leaders in the field may be overrepresented in the clinical literature relative to other experts, regardless of their financial relationships, because of the frequency with which they appear in publications and articles offering their expertise. This has the potential to limit the value of disclosures made under the Act.

Conclusion

The researchers determined that while there is some guidance that has been written on the most effective, efficient, and responsible way to implement and follow the Sunshine Act mandate, there is no expert interpretation of the Final Rules. As such, there are not only many gaps in guidance, but also a lack of complete confidence in the guidance that has been written.

The researchers do recognize that a lack of expert interpretation can be due to many reasons, one of which is publications are expecting the law to evolve a bit before it reaches its final form, and contracting an expert opinion at this point in time is a bit too early.

The authors warn that without the expert interpretation of the Final Rules, “the process of assigning a monetary value to publication support may continue to vary across companies. One consequence may be confusion among authors, particularly those working with several different companies, and the risk of disputed Open Payments records.” They believe that education is one of the most important components to ensure that the relationships between the pharmaceutical industry and physicians, and the data published in the Open Payments system, are placed and understood in the proper context. 

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