 Carrie Jones and Stefanie Tuck co-authored this article. |
In an unprecedented move, judges are assuming a doctor’s responsibilities from the bench, even though they lack medical training or credentials. This development has raised serious concerns about the role the judicial system may have in shaping the government’s regulatory authority, particularly regarding the drug and device approval process.
The quickly shifting landscape has left the biopharma industry unsure of how to proceed and looking to PR professionals to evaluate their comfort level for speaking out and provide guidance on the rapidly changing dynamics across this political issue.
We believe as health communicators, it’s our duty to guide life-sciences companies with grounded and level-headed advice that embodies three foundational pillars: educating the decision-makers, elevating stakeholder voices and managing risk by scenario planning.
While many news stories are focusing on the conflicting federal court rulings on the abortion drug mifepristone and the ongoing appeals process, biopharma companies are grappling with the implications of any judge having the power to change decisions made by the U.S. Food and Drug Administration, both good and bad. They’re also considering how best to insert themselves into this charged conversation.
With careful planning and execution, companies can overcome these hurdles while continuing to bring innovative treatments and therapies to patients who need them.
| This article is featured in O'Dwyer's May '23 PR Firm Rankings Magazine (view PDF version) |
Educating the decision-makers
Decision makers, both internally at biopharma companies and externally at medical associations and advocacy organizations, need succinct, factually-based information before diving into further strategic and tactical planning.
Whether the Texas federal court decision on mifepristone is ultimately upheld or not, the legal implications could have a detrimental impact on the country’s ability to evaluate all medications and treatments.
This is exactly why we must prepare top-level executives who regularly converse with their educated government relations team to better understand the situation, how it impacts the industry and what to expect next. This begins by listening to their audiences and translating what we hear into actionable information that executives can share internally and externally.
Despite the FDA indicating medication is safe via market approval, many biopharma companies that make products some might consider “controversial,” such as vaccines, stem-cell therapeutics and hormone therapy, could find themselves the target of lawsuits—now with a precedent of success.
Being fully informed of all factual aspects and risk factors will be crucial to ensuring that companies do not make any statements or movements that could be seen as damaging with regulatory bodies and the media covering these developments.
Elevating stakeholder voices
Patient groups, medical associations and academics are recognized as advocating for access to new medicines. However, we’re now seeing major biopharma industry organizations join together with companies and key opinion leaders in unwavering support of the FDA’s authority. It seems there’s a first for everything.
The drug discovery community strongly believes in giving every patient a platform to voice their opinions. We can all agree that patients are instrumental in driving progress. Leveraging media channels to amplify the voices of stakeholders is considered a best practice that aids in understanding how a medication or therapy can enhance their health, well-being and overall quality of life.
As PR professionals, it’s our responsibility to advise clients on whom they should prioritize among their stakeholders, when to do so and which channels to use for amplification. While patient perspectives are essential, we must also consider voices such as public health experts, government relations employees, and members of legislative bodies. These stakeholders can play a crucial role in engaging with state and federal representatives to advance policies and legislation that benefit patients.
These stories can be used in multiple ways; we can use targeted op-eds in local or national outlets, visit Capitol Hill to foster positive relationships with Congresspeople, engage with relevant advocacy groups, and use the media to amplify key opinion leaders’ voices and bring broad awareness to different audiences.
As PR professionals, we have a responsibility to help our clients engage with all stakeholders who may be affected by this issue, which will likely play out in the Supreme Court. We must help our clients lift the voices of these unheard advocates.
Managing risk by scenario planning
Crisis and scenario planning tend to be time-consuming, meaning we need to drive home to clients why now is the time to think through key specifics so they feel ready to face any contingency the industry might experience. Identifying best and worst-case scenarios allows us to fully prepare for any eventuality and leads to better business outcomes.
In recent years, our biopharma clients have faced mounting pressure to achieve more with limited resources. Given the swift pace at which the mifepristone case is advancing through the legal system, they must now analyze the situation and chart their next course of action. Yes, some clients may be anxious to act. That’s why we must help them evaluate the pitfalls associated with impulsive communications and help them develop thoughtful crisis plans.
For the majority of clients, the best approach is to assess the situation thoroughly before making any moves. None of us can predict the future or anticipate the outcome of the high court’s ruling.
While the legal battle related to access to medical abortion continues to gain visibility, other related issues persist across the industry. For example, lobbying groups continue to bring lawsuits challenging various portions of federal health involvement—such as questioning the legality of stem cell research and changing what patients have “access” to including cost barriers.
More notably, we’ve already seen these legal challenges infect our system in another recent court ruling addressing the purview of the Preventive Care Task Force. This showcases just how embedded in our health system judges have become and the power they are wielding from the bench. These issues aren’t going away. And it’s all happening at lightning speed.
Recently, we’ve seen a ping-pong of movement faster than we’ve ever seen before in non-emergency situations. We must help our clients stay focused on the core purpose, mission and values, and we must continue to broadcast the good work they’re doing to help patients across the country and the world.
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Carrie Jones is CEO and Stefanie Tuck is Vice President with JPA Health.
Lo Isidro, senior director at Real Chemistry with more than a decade of strategic communications and PA experience, has joined Narrative Strategies.
Nelson Fernandez, former North American chair of APCO Worldwide and managing director of Burson-Marsteller, has joined Volunteers in Medicine Berkshires as director of communications and PA.
Lilit Bargar, who was most recently an EVP in the healthcare practice at Weber Shandwick, comes on board at GCI Health as EVP, corporate practice lead.
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