It’s been a big year for big pharma and its federal regulator, the FDA. There’s the race to develop a Zika vaccine, an outcry over the punishingly high price of EpiPens, the public meltdown of blood-testing company Theranos, and, simmering beneath it all, the never-ending and increasingly brutal opioid epidemic, which many claim is a direct result of profit-seeking pill companies and lax FDA policies.
In response to the more recent scandals, the FDA has taken action to effectively shut down Theranos and (possibly) undercut the EpiPen monopoly by approving a competing device. But the FDA approval process itself lies at the crux of these questions of accountability and enforcement, the place where the stories that end up making headlines years later begin, as the government approves or denies pharma companies access to the American public.
Unsurprisingly, given how much money is on the line for the pharma companies, there’s a whole industry of regulatory consultants that help guide companies toward getting an official thumbs-up from the feds. These consultants whip up professional PowerPoints, proofread all the paperwork and make sure the science meets the FDA’s criteria, but they also offer services that seem a little less… data-driven. They profile FDA committee members, so that presentations can be geared toward the individual judges, role-play long Q&A sessions and then go back and review the tape, and perhaps most interestingly, help the researchers and other presenters perfect their public speaking skills.
An FDA spokesperson told MEL that “decisions are made on the scientific evidence presented,” and that the committee hearings are only useful for helping the agency “clarify questions,” but that doesn’t stop big pharma from bringing in (expensive) outside help to polish their presentations.
So we got in touch with Joyce Newman, a 30-year veteran of the FDA presentation coaching industry and the founder of The Newman Group, to learn a little more about whipping scientists into shape for their big day with the FDA.