300 drug makers including Pfizer say move to freeze access to abortion pills ‘disregards science’

Pharmaceutical industry leaders slammed a Texas judge’s decision on Friday to suspend access to the abortion-inducing drug mifepristone. 

Over 300 biotech and pharma industry executives, including Pfizer CEO Albert Bourla signed a blistering letter on Monday in which they said Judge Matthew Kacsmaryk’s ruling amounted to ‘judicial interference’ that imperils to future of prescription drug approvals. 

Other high-profile signatories include those from biotech giant Biogen as well as Merck &Co, the company behind such blockbusters as Keytruda for various cancers, the Gardasil HPV vaccine, and contraceptives such as NuvaRing and Nexplanon. 

The industry leaders are calling for Judge Kacsmaryk to reverse his decision, which has set off a wave of uncertainty and questions about the legal landscape of abortion access. 

They said in their letter: ‘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.’

Mifepristone, unlike its counterpart misoprostol, is only approved for abortion healthcare, as well as, for some miscarriages. It was approved in 2000. Roughly one-half of abortions are completed using the two-pill system

The letter was written by ReCode Therapeutics CEO Shehnaaz Suliman, Blackfynn co-founder Amanda Banks, and Ovid Therapeutics CEO Jeremy Levin, who is also a former chairman of biotech industry lobbying group BIO. 

It was a rare show of unity from biotech companies large and small in response to Friday evening’s surprise ruling

They add in the letter: ‘The decision ignores decades of scientific evidence and legal precedent. Judge Kacsmaryk’s act of judicial interference has set a precedent for diminishing FDA’s authority over drug approvals, and in doing so, creates uncertainty for the entire biopharma industry.’

Ever since Congress gave the FDA overarching jurisdiction to determine whether drugs are safe and effective as part of the Food, Drug and Cosmetic Act of 1938, courts have typically deferred to the agency’s scientific expertise. 

But the Texas ruling errodes the legitimacy of the FDA as the arbiter of good medical and scientific regulatory judgement and opens the door for more polititical rifts over medications that have been deemed overwhelmingly safe. 

The judge’s decision, they fear, could send a chilling effect across the field of medicine development, an already risky and expensive endeavor. 

The pharma execs added: ‘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. 

‘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.’ 

Court challenges such as the one mounted in Texas could open the door for other parties to challenge the FDA’s approval of other new or existing drugs deemed controversial and caught in culture war crosshairs. 

In response to the Texas judge last week, President Joe Biden said: ‘If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks.’

Believing that a ruling to invalidate mifepristone’s FDA approval was imminent, several states have already begun stockpiling mifepristone as well as misoprostol, the second in a two-drug medication abortion regimen. 

Misoprostol is approved for stomach ulcers but can be used off-label to induce an abortion on its own without mifepristone, though the efficacy is slightly lower. 

California Gov Gavin Newsom announced on Monday that his office made plans to secure an emergency stockpile of up to 2 million pills of misoprostol in the wake of the ‘extremist’ judge’s ruling. 

Gov Newsom said: ‘We will not cave to extremists who are trying to outlaw these critical abortion services. Medication abortion remains legal in California.’ 

In Washington, the Department of Corrections has bought up tens of thousands of doses of mifepristone that it will soon become authorized to dispense.

Gov Inslee said at a press conference last Tuesday: ‘Washington is a pro-choice state and no Texas judge will order us otherwise.’

And Whole Women’s Health, an independent medication abortion provider in New York City, said Friday: ‘[W]e follow directives from the FDA, and not anti-abortion judges in Texas who lack any formal medical training.

‘Whole Woman’s Health will continue to dispense [mifepristone] in our clinics and our Pills by Mail program for the next week as we monitor both decisions.’