Critical ruling for abortion pill

From: POLITICO Pulse - Thursday Aug 17,2023 02:02 pm

Aug 17, 2023

Driving the Day

Packages of Mifepristone tablets are displayed.

An appellate court dealt a blow Wednesday to easy access to the abortion pill mifepristone. | Anna Moneymaker/Getty Images

NEW ABORTION PILL RULING — The 5th U.S. Circuit Court of Appeals ruled Wednesday that access to mifepristone should be significantly curbed, escalating the legal threat to what is now the most common abortion method, POLITICO’s Alice Miranda Ollstein reports.

If the Supreme Court allows the decision to take effect, it would rescind the federal government’s efforts since 2016 to make the abortion pills more accessible, including through online ordering, mail and pharmacy dispensing.

Still, nothing is changing yet. The status quo will remain until the Supreme Court revisits the issue, likely next year. But with bans in force in many states, the current patchwork of availability will continue.

The details: Judge James Ho, a Trump appointee, wanted to end FDA approval of the drugs but was overruled by two colleagues, who argued it’s too late for anti-abortion groups to challenge the original approval. The agency declared the drugs safe and effective more than two decades ago.

The Alliance for Hippocratic Medicine — a coalition of anti-abortion medical groups that formed in Texas last year — challenged both the FDA’s original 2000 approval of mifepristone, arguing the agency didn’t adequately consider the drug’s safety risks, and later agency actions that loosened restrictions on the pills.

The Biden administration and the Danco, mifepristone’s drugmaker, are defending federal regulation of the pills, pointing to their decadeslong safety record.

Why it matters: Even though the decision doesn’t immediately affect access to the pills, the court’s endorsement of conservatives’ attempts to curtail pill access puts it in greater peril and could impact the Supreme Court’s decision.

The DOJ said it’s seeking a Supreme Court review of the decision, and HHS Secretary Xavier Becerra slammed it.

“Today’s decision undermines our nation’s entire system of drug approval by overriding the scientific, evidence-based decision-making of the FDA,” Becerra said in a statement. “This decision … if it stands, would have a devastating impact on women’s health by restricting their access to reproductive health care.”

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In Congress

House Speaker Kevin McCarthy speaks with reporters at the U.S. Capitol.

When Congress returns, House Speaker Kevin McCarthy will likely have to deal with the conservative wing of his party to pass a stopgap spending bill or a continuing resolution to fund the government. | Francis Chung/POLITICO

CONGRESS FACING TALL SEPTEMBER ORDER — A reminder: Just over six weeks remain until government funding and several major health care provisions expire.

Congress returns Sept. 5, and lawmakers have few legislative days left to come together and avoid a government shutdown. House Speaker Kevin McCarthy will likely have to deal with the conservative wing of his caucus to pass a stopgap spending bill or continuing resolution to fund the government temporarily, likely through early December as of now, as he’s indicated.

The stakes are high: Under the terms of the debt-ceiling deal, federal funding will automatically fall by 1 percent in January if Congress resorts to a stopgap spending bill to keep the government open for a short time. Whether or not that happens, cuts appear to be in store for major health care programs due to the deal and inflation. If spending talks derail, committees will likely have to make alternative plans.

Among the programs and funding that Congress must reauthorize by Sept. 30 are:

— The SUPPORT Act, which would continue several programs related to the opioid epidemic, including funding for comprehensive opioid recovery centers

— The Pandemic and All-Hazards Preparedness Act , the nation’s main pandemic preparedness law

— A community health center grant program that makes up 70 percent of the federal funds for health centers

— The Children’s Hospitals Graduate Medical Education program, which funds training for pediatricians

PALLONE PROBES MEDICAID PRIOR AUTH — House Energy and Commerce Committee ranking member Frank Pallone(D-N.J.) said Thursday that he’s launching an inquiry into Medicaid managed care plans over their use of prior authorization.

Pallone pointed to an HHS Office of Inspector General report from last month that found the plans denied 1 in 8 treatment requests, more than twice the rate of Medicare Advantage plans.

“I will be contacting each of these health insurance companies directly for additional information and questions regarding their prior authorization practices,” Pallone said in a statement.

The watchdog report called on CMS to do more to ensure proper oversight of prior authorization denials. The report said CMS concurred with the watchdog’s recommendation that it work with states to address inappropriate denials but didn't say if it agreed with others.

An HHS spokesperson didn’t respond to a request for comment.

Zooming out: Pallone’s concern comes as lawmakers on Capitol Hill are also pushing Medicare Advantage prior authorization reforms to make the process more efficient and facilitate access to care.

Sen. Ron Wyden (D-Ore.), chair of the Finance Committee, has raised concerns about AI being used in prior authorization.

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IN THE STATES

PUSH TO KILL CA DATA BROKER REGS — The advertising industry has kicked off a campaign to kill a California bill that would make it easier for residents to request that data brokers delete their personal information, POLITICO’s Alfred Ng reports.

A person who works in the California Legislature told POLITICO that multiple lawmakers received printouts credited to the Association of National Advertisers this week titled “10 Reasons SB 362 Will Harm California” and “Negative Real-World Impacts of California SB 362.” The handouts warned that letting people delete their data en masse would hurt the government’s ability to stop fraud and prevent hospitals from providing services.

The person, who also received the documents and was granted anonymity because he wasn’t authorized to discuss the matter on the record, said at least one legislator received the documents in an email Monday.

The legislation would allow California residents to make a single request to delete their data that goes to multiple companies.

Why it matters: The push comes amid increasing concern about privacy as more data — and health-related data — moves online.

Opioids

FIRST IN PULSE: TOP DEMS PRESS FDA ON OPIOID DISPOSAL — Sens. Martin Heinrich (D-N.M.), Jon Tester (D-Mont.) and Patty Murray (D-Wash.) led a group of 10 Democrats pushing the FDA to go further with its prescription opioid disposal policy in a letter obtained by Pulse.

The lawmakers — including Sens. Elizabeth Warren (D-Mass.) and Ron Wyden (D-Ore.) — call for the FDA to go beyond its April proposal, which would require that patients be given mail-back envelopes and safe-disposal education come when prescribed opioids in outpatient settings. The lawmakers want FDA to add an at-home disposal option.

“Our constituents in rural areas do not always have regular mail access and any policy that focuses solely on mail-only disposal creates an undue burden for those individuals to safely remove opioids from their homes,” the lawmakers said in the letter.

An FDA spokesperson didn’t respond to a request for comment.

Why it matters: The FDA policy aims to avert abuse of and accidental exposure to unused prescription opioids. Prescription opioids are involved in thousands of overdose deaths each year.

In April, the FDA called for comments on the proposal. Comments close Aug. 28.

The SUPPORT Act, which tackles the opioid epidemic, gave the FDA the authority to create a safe-disposal system. Congress is working to reauthorize the act before it expires on Sept. 30.

Names in the News

Former Rep. Patrick Kennedy (D-R.I.) is joining behavioral health firm Holmusk as a strategic adviser.

What We're Reading

The Wall Street Journal reports that scientists are warning cutting ties with China on scientific research could slow progress.

The Associated Press reports on a study showing ties between fracking and asthma and lymphoma in kids.

STAT reports on a Philips ventilator recall revealing at least one death and two injuries.

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