WASHINGTON — A judge’s decision to suspend the Food and Drug Administration’s approval of an abortion pill could have massive impacts for the pharmaceutical industry, but its largest lobbying association is staying on the sidelines.
PhRMA, which is the top-spending lobbying group in the health care sector and is known to be litigious itself, still hasn’t put out a press release on the decision made by a judge in Texas on Friday — despite the possibility that the decision could destabilize the sanctity of the FDA approval process entirely.
Instead, PhRMA is sending a restrained statement to reporters upon request:
“The FDA is the gold standard for determining whether a medicine is safe and effective for people to use. While PhRMA and our members are not a party to this litigation, our focus is on ensuring a policy environment that supports the agency’s ability to regulate and provides access to FDA-approved medicines.”
That statement is identical, word for word, to a statement the group provided to STAT for a story that published in February, before the ruling came down.
Pharmaceutical companies have an enormous amount at stake, as the entire industry is predicated on a reliable regulator, said Josh Sharfstein, a vice dean at Johns Hopkins Bloomberg School of Public Health and former principal deputy commissioner at the FDA.
“If the calculation is, ‘This isn’t a big deal; we don’t have to come right out and say how bad this is,’ I think that’s a mistake,” Sharfstein said.
PhRMA did not respond to a request for further comment on its response to the ruling.
By contrast, the Biotechnology Innovation Organization, which shares many of the same members as PhRMA, took a much more aggressive approach.
A statement from BIO’s interim President and CEO Rachel King on Friday called the ruling “an assault on science,” and a “dangerous precedent” that will have negative effects on drug development. She also made clear that BIO’s preference is that the ruling be overturned.
“The reason that we got on this as quickly as we did, and why we got a statement out over the weekend, was because we felt so strongly that that authority really needs to be maintained,” King said in a Monday interview with STAT.
BIO’s activities on the issue may not stop at a press release, King alluded, as she said that the organization will be “aggressive and deliberate in looking at how we can defend the FDA’s authority.”
PhRMA’s board of directors and BIO’s executive committee share several of the large pharmaceutical companies, including Takeda, Genentech, Bristol Myers Squibb, Novartis, Pfizer, and Sanofi.
One pharmaceutical industry lobbyist said the difference may be due to the fact that PhRMA generally has better relationships with Republican lawmakers, who have largely been silent on the lawsuit. BIO, on the other hand, has a more liberal board and has taken steps in recent years to appeal more to Democrats. Another suggested that PhRMA may not want to get involved with a lawsuit over one product.
Out of PhRMA’s 30 members of its board of directors, just three are women. BIO’s 19-person executive committee of its board of directors has four women.
In the absence of a pointed statement from PhRMA itself, some board members have decided to sign on to a letter from various executives of biotechnology and pharmaceutical companies. The letter calls the ruling “judicial interference” that creates regulatory uncertainty for companies developing new medicines.
Paul Hastings, the CEO of Nkarta and the chair of BIO’s board’s executive committee, said having individual conversations with individual companies allowed the grassroots letter to move faster than larger organizations that have multiple levels of approval.
PhRMA board treasurer and Pfizer CEO Albert Bourla signed on, as did Lundbeck CEO Deborah Dunsire, who is one of the PhRMA board’s female members. Merck executive Christopher Tan, Bayer executive Imran Nasrullah, and Biogen President Alisha Alaimo signed the letter as well.
“If BIO or PhRMA decides they’re not going to support a certain issue, we’re OK with that. We’re going to support the issue,” Hastings said.