A series of court rulings has the potential to shake the entire pharmaceutical industry. But the organizations that manufacture prescription medications are waging battles in both the courtroom and the court of public opinion to fight for clarity and consistency how drugs are approved for public consumption.
The case is vastly complicated and moving quickly. In brief, a court ruling by a judge in Texas would have halted the Food and Drug Administration’s approval of mifepristone, an abortion-inducing drug that has been on the market for more than 20 years.
The Supreme Court stepped in Friday to temporarily stay the order, the New York Times reported, and keep the pill available pending a final decision from the high court.
According to reporting from USA Today, this marks the first time a federal judge has attempted to revoke FDA approval of a medication. The precedent has raised deep concerns from the pharmaceutical industry that judges could outlaw drugs with the stroke of a pen, taking away the stability and scientific rigor the FDA has offered for decades.
Dozens of pharmaceutical and biotech companies, including giant Pfizer, came together to sign an open letter decrying the action and defending their regulatory agency.
“As an industry we count on the FDA’s autonomy and authority to bring new medicines to patients under a reliable regulatory process for drug evaluation and approval,” the letter reads. “Adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives for investment, endangering the innovation that characterizes our industry.”
The letter also condemns Judge Matthew Kacsmaryk by name, calls his ruling “judicial activism” and makes their position crystal clear.
“In the face of laws and rulings that aim to undermine the evidence-based and legislatively sanctioned authority of federally mandated institutions such as FDA to protect public interests, and by putting an entire industry focused on medical innovation at risk, we cannot stay quiet. We call for the reversal of this decision to disregard science, and the appropriate restitution of the mandate for the safety and efficacy of medicines for all with the FDA, the agency entrusted to do so in the first place.”
While Carrie Jones, CEO of PR agency JPA Health, wasn’t directly involved in drafting the letter, many of her clients were signatories. And she applauds the move.
“Rock solid PR move,” she told PR Daily in an interview. “Awesome. It was fast. It was to the point. It was forceful and clear.”
Jones is counseling her clients through this unsettled, uncertain environment. Her best advice? Pay attention and be ready.
“Watch carefully, be consistent in your position, but don’t overreact. There’s going to be a lot of movement,” Jones advised.
Indeed, the case is moving at “dizzying” speed by most judicial standards, Jones said. It’s hard to keep up with the sometimes-hourly changes. That is why she recommended being prepared with draft statements ready to go, especially if the companies work in the women’s and reproductive health space.
And above all, Jones emphasized the importance of communicating with all stakeholders, from legislative leaders to internal government relations staff.
“And, of course, point to patients, connect, connect, connect with the media and connect with their stakeholders,” she said. “Connect them to patients who can talk about why access to various medications, whether it be the abortion medicine or any other medicine that could potentially be at risk,is super valuable and important for them.”
This court case revolves around abortion, one of the most politically fraught subjects in American life over the last 60 years. And speaking up is not without risk as some politicians begin to use their power to punish companies who speak up about policies.
Jones’ advice is to focus on science over politics.
“We try to take a step back from the political side of things and focus on science and research and following the letter of the law through the FDA approval process,” she said “If you just use that as your north star, it’s amazing how much you can avoid getting into the political discussion.”
No one knows how this case will shake out yet. But good preparation and a focus on what matters most is always the right move.
“We have to stay the course and not get too distracted by what we hope will be ultimately a positive outcome,” said Jones. “And for us, that means access to FDA approved medicines.”.
By Allison Carter
Source: PRDaily
