Pharmaceutical Companies promoting drugs ‘off-label’ – Implications for Medical Affairs Professionals

Several studies conducted by the National Institutes of Health (NIH) have demonstrated that a vast majority of drugs prescribed by physicians are for off-label uses (from 30-70%).

In 2017, Arizona became the first state to allow pharmaceutical companies to speak with doctors about drugs off-label uses as long as it was truthful promotion. In 2016, Amarin was successful in a case against the Food and Drug Administration (FDA), claiming free speech based on first amendment rights to allow off-label promotion of its drug VASCEPA, used to treat hypertriglyceridemia.

Few months ago, the Missouri house committee heard a bill that would allow pharmaceutical companies to promote drugs, devices and other products for uses which were not specifically approved by the FDA.

For pharmaceutical industry professionals working in the medical affairs function, these changes may have important consequences. Medical affairs, which encompasses the medical science liaison (MSL) role, are relied on by companies to both generate data and communicate data to health care providers (HCPs). Medical affairs is playing an increasingly important role in the pharmaceutical industry. Estimates are that it has grown over 300% in the last decade, with MSLs driving the majority of that growth.  Although MSLs cannot speak to doctors proactively on off-label uses of drugs, they are relied on by companies to provide off-label information when there is an unsolicited request for the information from the HCP.

Some believe that the recent legislation in Arizona, and proposed bill in Missouri, blur the lines between MSLs and sales. It also further highlights the importance of providing adequate and independent training of pharmaceutical industry professionals which are in a position of providing off-label information to physicians.

Indeed, the issue of certification for Medical affairs professionals (including MSLs) has gotten a lot of attention in the last few years. The Board Certified Medical Affairs Specialist Program (BCMAS) offered by the Accreditation Council for Medical Affairs is a self-directed, online program comprised of 20 modules covering everything from health economics outcomes research (HEOR) to clinical trial designs and even presentation & communication skills training. The program has grown to include over 3500 registrants worldwide and was recently featured in The Pharmaceutical Executive, ABC News, and the Pharmacy Podcast.

Most will agree that providing continued training and professional development for medical affairs professionals, such as the BCMAS program, has tremendous value and benefits to both the individual and the company.  However, the concept of certification of medical affairs professionals provides more than simple training. It offers a measure and standard of minimal competencies needed to be an effective medical affairs professional.  Something that can help set a medical affairs professional apart and protect the integrity of the role which may become more and more blurred with sales as boundaries around ‘off-label’ are less clear.

With pharmaceutical companies paying more than 1 billion dollars a year into continuing medical education (CME) for physicians, one cannot deny that they play an important role in educating doctors. Given their influence, it further supports the importance of credentialing and certifying pharmaceutical industry professionals with a program like BCMAS.

Whatever the future holds, medical affairs is becoming front and center and will continue to play an important role in the evolving healthcare saga.

 

Written by William Soliman, PhD, BCMAS

President, CEO, Accreditation Council for Medical Affairs

Email: [email protected]

Pharmaceutical Companies promoting drugs ‘off-label’ – Implications for Medical Affairs Professionals last edit: 2018-06-02T16:47:10+00:00 da wasoliman1

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