Opinion: The Opioid Crisis: Where Does Pharma Go From Here?


After the Oklahoma case ruling, Johnson & Johnson stocks rallied, but the ruling is a warning to industry leaders that change is necessary.

A Missouri chapter of FED UP, a nationwide coalition to end the opioid epidemic, recently rallied to make sure voices of the victims were heard in 1 of the largest legal cases to impact the pharmaceutical industry and the public at large.

The Oklahoma case against Johnson & Johnson claims that the company used nonpromotional campaigns to mislead health care providers (HCPs). Similarly, other companies such as Allergan, Purdue and Endo, have all been accused of misleading marketing practices that ultimately contributed to the opioid epidemic.

However, as a senior pharmaceutical executive who worked in the industry for almost 2 decades, as well as a former management consultant executive who served the industry, I believe that it is vital to understand that the pharmaceutical industry is not the sole player involved in contributing to the current crisis today.

After the Oklahoma case ruling, Johnson & Johnson stocks rallied, but the ruling is a warning to industry leaders that change is necessary.

But, what type of change? What can the industry do differently vs. current practices that could perhaps discourage unethical behavior or ensure that there is a uniform understanding of what are considered ‘best practices’ in the industry?

I believe for our industry, it is has to start with accredited education, training and certification. This is why I truly believe in what the Accreditation Council for Medical Affairs (ACMA) is doing. We focus primarily on the education and certification of medical affairs professionals, which includes medical science liaisons (MSLs).

The medical affairs space has grown over 300% in the last decade and will continue to grow because HCPs want to get their information from what they consider to be their ‘peers.’ Namely, MD, PharmD, PhD, NP/PA professionals who have deep clinical and scientific backgrounds. And this makes perfect sense.

The reality is that medical affairs is a newbie in pharma. With only about 25 years as a formal function among most companies, the field lacks uniform standards and competencies across regions and job functions. The Board Certified Medical Affairs Specialist Program (BCMAS) ensures that companies are accrediting their medical affairs/MSL professionals so that there is a minimum level of mastery or competence met, and that it is uniform across the entire organization.

This notion is not unlike what happened in the financial industry after the 2008 crash. We need regulations and accreditation in place to ensure that if an individual cannot demonstrate competency then they should not be involved in developing clinical trials or speaking to HCPs.

The same holds true for ethical violations. If a BCMAS professional willfully or negligently acts in a manner that is not aligned to a company’s code of ethics, that individual would not be eligible for continued credentialing and would be unable to pursue future job openings at other companies without the credential.

This could certainly discourage individuals from participating in unethical behavior that would ultimately cause harm to patients. While accreditation by itself is not a complete solution, it is certainly 1 important factor. Imagine if many of the individuals involved in the deceitful marketing practices at these companies had lost their ability to work in the industry.

Today’s pharmaceutical industry CEOs need to take stock and get ahead of the curve. Be proactive and demonstrate to the public, including patient advocates that they will take tangible steps to do the right thing for patients, providers, and their organization.

Most pharmaceutical industry CEOs want to do the right thing. They got into this business because they’re passionate about health care. Let’s not let this crisis cause us to lose sight of it.

Uniform standards of excellence for 1 of the fastest growing areas in the pharmaceutical industry, namely medical affairs, is the future of our industry. Today we stand on the cusp of a new era in the industry, what we do next will define the pharmaceutical industry for years to come.

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