FDA authority is the focus at SCOTUS

Mar 26, 2024

With Megan R. Wilson

Driving The Day

Three women hold signs.

The Supreme Court will hear oral arguments today on a medication abortion case that could affect the FDA's authority to make regulatory decisions. | David Erickson/AP

FDA AUTHORITY IN THE BALANCE — Supreme Court arguments today over access to the abortion pill mifepristone aren’t just about access to the procedure — it’s a debate over the FDA’s authority to decide whether and how drugs can be sold and used.

While the FDA’s initial 2000 approval of the drug is not under the microscope, justices will consider whether the agency’s 2016 and 2021 decisions to relax certain requirements to access mifepristone were based on science and not politics.

The drug industry and former FDA commissioners oppose hamstringing the agency’s power to make regulatory decisions based on scientific data.

Industry concerns: PhRMA, the main lobbying group for branded drugs, warned in a Jan. 30 friend-of-the-court brief that a high court ruling upholding the 5th U.S. Circuit’s opinion would upend the industry. That ruling unraveled FDA decisions about the timeframe in which patients can take mifepristone and how the pills can be prescribed, though its effects are stayed until the Supreme Court rules.

Such a decision would scramble the regulatory framework drugmakers rely on to make business planning decisions and would establish a precedent for opponents of other drugs to test in court, PhRMA said.

“FDA’s drug approval decisions implicate enormous reliance interests on the part of patients, healthcare providers, biopharmaceutical companies, and other stakeholders,” the group said in its brief. “The stakes could not be higher when a medication is on the market one day and off the market the next.”

The group also said that existing law outlines how the FDA and drugmakers can withdraw drugs from the market and the appeals court’s opinion undermines that process.

Past regulators fret: Ex-commissioners and acting commissioners — including some who worked for GOP administrations — agreed in a Feb. 1 brief that a ruling in favor of anti-abortion groups would allow judges to substitute their own evaluations for the agency’s expertise, even if drugs have been approved and available for decades.

“The resulting uncertainty would threaten the incentives for drug companies to undertake the time-consuming and costly investment required to develop new drugs and ultimately hinder patients’ access to critical remedies that prevent suffering and save lives,” the former officials wrote.

IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Bird flu has been found in cows at three dairies in Texas and one in Kansas.

Send news and tips to Lauren Gardner (lgardner@politico.com or @Gardner_LM) or David Lim (dlim@politico.com or @davidalim).

Eye on the FDA

A sign for the Food And Drug Administration.

A new reports says the FDA needs to revamp the wording it uses when approving new drugs so as not to confuse consumers. | Sarah Silbiger/Getty Images

TRANSPARENCY CALL — A new report by a group critical of the pharma industry’s regulatory influence calls on the FDA to revamp its disclosure practices, change its vocabulary when approving new drugs and demand stricter pre- and postmarketing requirements.

The report by PharmedOut, a Georgetown University project, takes issue with the (congressionally directed) industry user fees that fund about half of the agency’s work. But it also critiques work that falls in the agency’s purview, such as the number of advisory committee meetings it holds and the extent to which patient advocates disclose whether drugmakers support them.

Patient influence: Dr. Adriane Fugh-Berman, who edited the report, said the group has become increasingly concerned with how patient advocates have influenced the agency’s standards for approving drugs, arguing the FDA is in some cases relying too heavily on real-world evidence of how a product works once it’s on the market.

The report says the FDA’s verbiage around certain processes — like “accelerated approval” and “breakthrough therapy” — can mislead consumers about the level of evidence supporting a drug’s safety and efficacy.

The FDA should “celebrate rejections as much as approvals,” Fugh-Berman said. “Their job isn’t to approve as many drugs as possible. But they should be proud of the ones they’ve rejected.”

The agency didn’t respond to a request for comment about the report.

BAN ON SOME ELECTRO DEVICE USES — Equipped with new powers from Congress, the FDA is again attempting to ban use of electrical stimulation devices for the controversial treatment of aggressive or self-harming behaviors.

The D.C. Circuit ruled in July 2021 that the agency did not have that authority when it first finalized plans to ban those uses of the devices in 2020. The Judge Rotenberg Educational Center — the sole facility using the devices for this practice — said it would again pursue litigation if needed to preserve its use of the treatment.

“FDA has determined these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling,” the proposed rule says. The FDA estimates that 50 patients “currently have a treatment plan that includes the use, or potential use, of an ESD.”

PLAN B LABEL CHANGE — The FDA has approved an updated label for the emergency contraception pill Plan B.

The change removes language suggesting that the drug “may also prevent fertilization of a released egg” and implantation in the uterus. The FDA said in December 2022 that current evidence shows the pill has no effect on those processes, which anti-abortion groups have long cited when arguing the medication ends pregnancies instead of preventing them.

Coronavirus

FDA GREEN-LIGHTS NEW ANTIBODY — The FDA has authorized a new long-acting, prophylactic monoclonal antibody for teens and adults with weakened immune systems. Invivyd’s Pemgarda is the only Covid-19 preventive treatment available for this population, which often can’t mount a sufficient immune response from vaccination alone.

Pharma Moves

Complete Genomics, a California-based company in Congress' crosshairs, hired CLS Strategies to meet with lawmakers and their staff to "[clarify] inaccurate information about the company's ownership and business to ensure company is not misplaced in legislation," Megan found in newly filed disclosures.

The issue: Chinese biotech company MGI Tech is the parent of Complete Genomics. The hire comes as Congress moves to crack down on China-owned firms, claiming they are a threat to U.S. national security. The legislation, which advanced out of a Senate panel earlier this month, would prohibit the federal government from inking contracts with Complete Genomics and three other biotech companies: BGI, MGI and WuXi Apptec.

WHAT WE'RE READING

Chick-fil-A is modifying its policy that bars serving chicken treated with antibiotics because of difficulties obtaining enough antibiotic-free chicken, The New York Times’ Victor Mather reports.

Medicare spending on GLP-1 drugs — often used for weight loss — is spiking despite current law prohibiting the program from covering them for that purpose, a new KFF report by Juliette Cubanski and Tricia Neuman found.

Document Drawer

The Government Accountability Office recommended that the FDA “evaluate its recruitment and retention” efforts for its investigator workforce.

The FDA said it is opening a new Quantitative Medicine Center of Excellence in its Center for Drug Evaluation and Research to coordinate use of that type of modeling across the organization.

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