Trump DOJ stings conservatives with positions on abortion pill regulation, vaccine trial integrity

The Trump Justice Department is continuing its predecessor's legal arguments against lawsuits by red states against abortion pills by mail and a whistleblower's case against the drugmaker Pfizer, creating two unexpected setbacks for causes championed by conservatives.

The Food and Drug Administration is at the center of both disputes.

Idaho, Missouri and Kansas argue the FDA's deregulation of the abortion pill mifepristone violated those states' abortion restrictions. Meanwhile, the clinical trial whistleblower Brook Jackson's lawsuit alleges fraudulent data was used to grant emergency use authorization to Pfizer's COVID-19 vaccine.

The government first stayed out of the False Claims Act case filed four years ago by Jackson, who oversaw Pfizer's outsourced Phase 3 trials in Texas, even though it had the power to dismiss because Jackson is a "relator" suing on the federal government's behalf.

It then supported Pfizer's motion to dismiss, arguing the FDA would have approved the vaccine even if 3% of data were fraudulent, as Jackson claims from her test sites.

The FDA unsuccessfully asked a court for 55 years to fully release its Pfizer vaccine approval documents. The Centers for Disease Control and Prevention admitted three years ago hiding the vast majority of its COVID data in part to protect the reputation of vaccines.

"We're simply asking DOJ to step aside and let us handle Pfizer," Jackson wrote on X in explaining the Trump DOJ's continuation of its predecessor's posture. "We don't need their help—we just need them out of the way."

Waited too long to challenge FDA free-for-all on abortion pill

FDA Commissioner Marty Makary said last month he has "no plans" to restrict mifepristone, which the FDA made permanently available by mail in 2021 after years of regulatory relaxations including telehealth prescribing and a 10-week gestation window. A new study claims mifepristone's complication rate is north of 10%, most commonly emergency room visits.

But Health and Human Services Secretary Robert F. Kennedy promised last week that Makary would do a "top-to-bottom" mifepristone review under grilling by Sen. Josh Hawley, R-Mo., whose wife, Erin Hawley, argued the original mifepristone challenge before SCOTUS.

In a barebones motion to dismiss between those statements, DOJ argued that Idaho, Missouri and Kansas have "no connection" to the federal court in Texas where the case was first filed by the Alliance for Hippocratic Medicine, whose legal standing was rejected by SCOTUS after oral argument suggested some wariness of insulating the FDA from judicial scrutiny.

The red states have also exceeded the six-year time limit for challenging the FDA's expansion of the gestation window to 10 weeks in 2016, and nothing stopped them from bringing Administrative Procedure Act claims "challenging the scope of FDA’s authority or its decisionmaking" before the Dobbs ruling devolved abortion to the states, DOJ said.

The continuation has put pro-life groups in an awkward position, with few openly blaming the Trump administration, much less the president whose 2024 campaign overhauled the pro-life plank in the GOP's platform. 

One big exception is the American Life League, which told Just the News Trump is "not the pro-life hero people want him to be" because he has consistently supported the abortion pill, even saying he would never block it" in the first presidential debate, "and supports the states regulating killing however they see fit."

"Pro-life Americans need to know the facts before they jump to awarding him a title that doesn't fit and doesn't match his actions" up to now, "when the pill is up for debate again."

"Pro-lifers were taken aback" by the DOJ motion to dismiss, Focus on the Family's Daily Citizen wrote, but emphasized that Trump nominated U.S. District Judge Matthew Kacsmaryk, who is hearing the case and used pro-life language such as "abortionists" and "unborn child" in suspending mifepristone's FDA approval before SCOTUS overturned him.

"If previous action is indicative of future behavior, pro-lifers should be able to trust that the current administration will act in a way consistent with efforts to protect preborn life," the Daily Citizen wrote.

Susan B. Anthony Pro-Life America clarified its President Marjorie Dannenfelser's comments to Catholic News Agency, that the DOJ motion is "about who has the right to sue, not whether abortion drugs are safe," when asked by Just the News whether it accepted DOJ's legal-standing argument.

"These cases are far from over," Vice President of Communications Emily Davis wrote in an email, reiterating its stance that "the FDA needs to review the safety of these drugs because we know if they do a full and accurate review they will see the drugs are harmful, not healthcare."

It blamed Biden's FDA, "under the guise of COVID-19," for making mifepristone "permanently available through a doctorless, faceless online process so anyone (not just women) could purchase them for any reason," and cheered Kennedy's promise to Sen. Hawley.

First-term Trump administration DOJ lawyer Hilary Perkins, who first argued for in-person visit requirements for mifepristone and then switched positions under Biden's DOJ, abruptly quit her new job as FDA chief counsel in March under pressure from Hawley as it became clear she could sink Makary's confirmation, The New York Times reported.

"Marty Makary was attempting to sneak a Biden abortion lawyer into top leadership at FDA," leading Hawley's staff to unearth that "this Biden lawyer has argued FOR Biden’s outrageous pro-abortion rules in *many* cases," Hawley wrote March 12, later saying he voted for Makary because Perkins had quit.

"I am a Christian who is both conservative and pro-life and who simply followed my oath as a Department of Justice career attorney," Perkins told the Times in response to Hawley's characterization, while his office simply pointed to Hawley's social media statements.

Big beautiful bailout?

Just as they have been unable or unwilling to tackle the nation's debt since the Tea Party movement's birth, congressional Republicans who control both chambers may stumble on abortion-rights holdouts in their long-running quest to defund the nation's largest abortion provider.

Planned Parenthood Action Fund cheered reports that Senate GOP abortion-rights supporters are fighting to strip a funding ban on the provider from the "Big Beautiful" budget reconciliation bill that squeaked through the GOP-controlled House early Thursday, which prompted cheers from pro-life groups, before it reaches Trump's desk.

American Life League National Director Katie Brown Xavios trashed the House-passed bill for still funding Planned Parenthood abortions based on rape, incest or threats to the mother's health. 

"If the exceptions are the only way Planned Parenthood will get paid, you had better believe that every abortion will now become a life-or-death situation so that Planned Parenthood ensures that it will get its money," she said in a press release Thursday.

Planned Parenthood's most recent annual report says it performed more than 400,000 abortions in 2022-2023, an increase of about 10,000 from the prior report, and received $100 million more in federal funding than it did in the prior period, despite performing fewer cancer screenings and preventive services.

It had tried to appeal to GOP budget hawks by touting a Congressional Budget Office report that estimates cutting PP's federal funding – by blocking its Medicaid reimbursements – will in fact increase the deficit by $300 million. Democratic senators touted the same report in a press conference with PPFA last week.

The abortion provider faces a comparable problem from California Democratic Gov. Gavin Newsom, who recently proposed using Proposition 35 revenue to pay down the Golden State's $12 billion deficit and directing $500 million from the tobacco tax into the general fund. 

Planned Parenthood Affiliates of California CEO Jodi Hicks, who was co-chair of the Yes on Prop. 35 campaign, told CalMatters a third of its budget would disappear if the Legislature approves Newsom's "shocking" and "plan cruel" proposals.

DOJ doesn't tolerate clinical trial fraud, unless...

Wisconsin GOP Sen. Ron Johnson's Permanent Subcommittee on Investigations threw a harsh glare on former President Joe Biden's FDA and CDC in an interim report Wednesday, finding they waited months to disclose post-COVID mRNA vaccination myocarditis, a deadly heart disease, after being alerted by Israeli officials and the feds' own vaccine surveillance systems.

Pfizer trial whistle-blower Jackson's opening brief at the 5th U.S. Circuit Court of Appeals was filed less than a month into President Trump's second term, accusing U.S. District Judge Michael Truncale of several errors by letting DOJ make a "later date" intervention to dismiss, two years after it declined to get involved.

The Biden administration's "threadbare motion provided no evidence of investigation into the merits, analysis of discovery burdens, changed circumstances since declining intervention, or legitimate government purpose served by dismissal," Jackson's brief said.

Truncale didn't require DOJ to show good cause, he "improperly collapsed the distinct analyses for intervention and dismissal" and "failed to consider how terminating Jackson's meritorious action would chill future whistle-blowers from exposing fraud."

Trump's DOJ told the 5th Circuit last month "the FDA was aware of the protocol violations allegedly witnessed by" Jackson, it had "continued access" to the trial data and still believes the vaccine is effective, and "discovery and litigation obligations" are too much for the feds.

The motion was filed by acting Assistant Attorney General Yaakov Roth, whom Jackson accused of hypocrisy on X for prosecuting clinical research facility owners for asthma trial fraud. Roth said DOJ will keep working with the FDA to "investigate and prosecute those who illegally undermine the integrity of the clinical trial process to facilitate fraudulent payments.”

"Commit Fraud in a Clinical Trial? You Will Go to Jail...unless you are Pfizer!" Jackson fumed. The asthma trial case bears uncanny similarities to her own case, but "unlike the small fish who get charged, Pfizer walks away untouched—again."