Pfizer CEO Ian Read has ample reason to be disgruntled with The Man: That Pfizer-Allergan mega-deal was, after all, axed earlier this year by the US government.
But his distaste with regulatory bodies stretches deeper still. Yesterday, at the Cleveland Clinic Medical Innovation Summit, Read took to the stage and spoke plainly of the failings in the US healthcare system, including his frustrations with regulatory policy — ranging from the Sunshine Act to generic drug oversight at the FDA. Some excerpts:
On research and development
One big reason that drug development timelines are so long? Red tape. Or, as Read put it: “Most of the time is wasted in interaction with the FDA.”
From the earliest investigative stage, “there are long discussions about meeting regulators' needs, which may or may not be valid,” he said. He is more inclined to trust the drug developers to do what's right: “Good scientific organizations... [will want to] bring forward good trials," he said.
On the EpiPen
The costliness of the EpiPen, too, is a “failure of regulation,” Read said.
One reason the EpiPen (which is manufactured by Pfizer) is so costly is that the FDA has laws in place that standardize how these life-saving devices work. That's meant to ensure reliability, but it also makes it tough for competitors to jump in and create alternatives.
“You want an FDA that’s strong. You want them to bring safe medicines to you,” Read said. “And right now, the fallout of that is — you have to pay more for generic products, because you were so focused on having this pristine, totally independent, totally-focused-on-safety FDA that you don’t get the regulations right.”
On medication non-adherence
Even issues like medication adherence are out of the hands of drugmakers, Read said — because kickback laws limit the amount of contact between pharma and physicians. So while helping patients regularly take their meds would certainly help Pfizer's bottom line, and presumably help patients, too, the company can't do much about it.
“The kickback provisions stop us from working with [physicians] on that,” Read said. “Basically it’s the laws that stop us.”