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Abortion-pill rulings could break the FDA, drug companies say

ByTeam BB

Apr 18, 2023

Pharmaceutical companies, among the most powerful interests in Washington, have mobilized against a pair of lower-court rulings restricting access to abortion pills that they contend go far beyond issues of reproductive health and pose a threat to the regulatory foundations of the U.S. drug industry.

The warnings — contained in friend-of-the-court advisory briefs filed Friday with the U.S. Supreme Court — are harshly critical of rulings this month by a U.S. District Court judge in Texas and a three-judge panel of the 5th Circuit Court of Appeals.

District Court Judge Matthew Kacsmaryk ruled on April 7 that the Food and Drug Administration should not have approved the abortion pill mifepristone in 2000, deciding that the FDA rushed the process and that the pill was unsafe. The 5th Circuit stayed part of Kacsymark’s decision on Wednesday but agreed to overturn looser prescribing rules that the FDA adopted beginning in 2016.

The industry contends that by nullifying years of evidence-based regulations by the Food and Drug Administration, the two rulings would eviscerate FDA authority more broadly and undermine the legal underpinnings of U.S. pharmaceutical research and development.

The Biden administration, members of Congress, abortion rights groups, doctors, former FDA and Department of Justice officials and industry interests are urging the Supreme Court to block the lower-court rulings as an unacceptable interference in FDA approvals.

Investments in cutting-edge biotechnology fields aimed at cancer and other serious diseases could be subject to attacks in the courts if FDA’s rulemaking is thrown open to court challenges, said executives who are urging the Supreme Court to put the orders on hold.

The Justice Department asked the Supreme Court to temporarily allow full access to a key abortion medication on April 14. (Video: The Washington Post)

“While we may be talking about mifepristone today, we must understand that political motives could similarly attack many innovative and lifesaving biotherapeutics such as genetic medicines, cell therapies and even today’s major advancements in mRNA vaccine technology,” Reid Huber, a partner at Third Rock Ventures, a health care venture capital firm with offices in Boston and San Francisco, said in an email.

Huber is among scores of industry executives and business leaders who signed onto an amicus curiae brief before the Supreme Court. Former FDA and Department of Justice officials warned of widespread disruptions in separate briefs.

“Once you go down this road, you never know where it will lead,” said Stephen Ostroff, an industry consultant who is a former acting commissioner and chief scientist at the FDA, said in an interview. “Once the courts make a decision that they understand the science better than the FDA does, we could see similar attempts to either get drugs onto the market or take drugs off the market that for some reasons someone doesn’t like.”

The leading industry group, the Pharmaceutical Research and Manufacturers of America, said in its brief to the court that drug companies and investors rely heavily on the FDA to guide how they bring drugs to market. It called Kacsmaryk’s ruling that overturned the FDA’s 2000 approval of mifepristone “an unprecedented assault on FDA’s approval decisions.”

The dire warnings illustrate the degree to which the U.S. health care industry is dependent on federal rules for its survival. The industry has spent decades lobbying White House administrations and Congress to shape the rules that govern FDA’s approvals. The industry even pays for about 45 percent of the FDA annual budget via a system of user fees.

Without confidence that FDA’s actions can withstand attacks from people dissatisfied with the outcome, tens of billions of dollars of investments a year could be in jeopardy, the industry said.

“Biopharmaceutical companies make enormous investments in drug development based on the reasonable expectation that once a drug product is approved finally by FDA under the statutory standards, barring emerging scientific data, it will be lawful and profitable to sell that product for an extended period in the United States,” PhRMA said in its filing.

The Supreme Court is expected to decide as soon as Wednesday if it will put a temporary stay on the 5th Circuit decision until the full 5th Circuit decides the issue.

Danco, the manufacturer of brand-name mifepristone, in asking the Supreme Court for a stay, said the lower court rulings could require it to suspend distribution while it updated the label for its drug to reflect new, court-imposed restrictions.

GenBioPro, a generic producer of mifepristone that won approval in 2019, said in a friend-of-the-court brief the impact on its operations would be catastrophic. It said that would be forced to cease sale of mifepristone unless the 5th District ruling is stayed. The company said its pills account for about two thirds of the 500,000 annual medication abortions in the United States.

A brief filed Friday by the Biotechnology Innovation Organization, Washington’s other major industry trade group, and dozens of companies and executives harshly criticized Kacsmaryk’s decision to overturn the FDA’s mifepristone approval.

“The court cast aside not only the voluminous scientific evidence FDA considered at the time of approval, but also nearly a quarter-century of subsequent data that FDA determined showed safe and effective use of mifepristone,” they said. “In its place, the court relied on personal stories told by plaintiffs and cherry-picked, unreliable publications (including anonymous blog posts), many of which were not even submitted to FDA. The court then ruled that FDA was required to refuse to approve the [new drug application] based on the court’s own nonscientific assessment of this alternative, incomplete record.”

Attacking the FDA’s actions was just one strategy of the antiabortion plaintiffs in the lower-court case. Another was citing the Comstock Act, an 1873 law that banned shipment in the mail of obscene materials as well as birth control products and items that could induce an abortion.

Kacsmaryk and the 5th Circuit panel agreed that the plain language of the Comstock Act, still on the books but not enforced in many decades, prohibits shipment of abortion pills.

A group of former Department of Justice officials — most of them former U.S. attorneys during the Clinton and Obama years in the White House — said in a brief before the Supreme Court the lower courts’ reasoning was flawed. Decades of deliberations and interpretations by the courts, Congress and the executive confirms that Congress intended the Comstock Act to outlaw shipment of items that could induce an illegal abortion, not a legal one, the former officials said.

A group that opposes abortion, the American Center for Law and Justice, represented by lawyer Jay Sekulow, filed a brief disputing a DOJ Office of Legal Counsel opinion that said the Comstock Act only banned shipment of abortion pills if the abortion were illegal. The center contended the justices should look to the plain text of the Comstock’s ban and not rely on court precedents and analysis cited by the Office of Legal Council.

The Office of Legal Council analysis, the center said in its brief, “rewrites the statute in the service of a pro-abortion agenda.”

Laurie McGinley contributed reporting.

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