The FDA's most polarizing official may be leaving, but that's no guarantee that the agency is about to undergo what its critics say is a needed course-correction.

Why it matters: The agency's drug approval standards and its ability to avoid more upheaval are both in question.

The big picture: The FDA's high-profile rejections of a series of rare disease drugs and its reversal on Moderna's mRNA vaccine may have dominated headlines over the past few weeks. But they followed concerns about the agency's political independence and the stability of its leadership.

• And while Vinay Prasad, the agency's top regulator of vaccines and biologics, is departing next month, his exit doesn't necessarily signal a mindset shift.
• Prasad took much of the blame for the agency's controversial recent decisions. But regardless of whether that was fair, he didn't operate in a vacuum.

Where it stands: Prasad's departure is being cast as a positive for companies that develop cell and gene therapies and other rare disease treatments, despite speculation in some circles that not much will actually change.

• FDA commissioner Marty Makary vocally defended Prasad shortly before announcing his departure, and it's no secret that Health Secretary Robert F. Kennedy Jr. has long been skeptical of pharmaceutical companies.
• What's more, Tracy Beth Høeg, who played a leading role in the push to adopt Denmark's slimmed-down childhood vaccination schedule, remains the FDA's top drug regulator — the fifth person to hold that position in a little over a year.
• Prasad "was one voice within a broader agency, and the lasting ramifications of the departure will depend on who follows and whether we see a stabilization within the organization," Leerink analysts wrote in an investor note.

What they're saying: "The underlying leadership dysfunction and staffing issues remain under the leadership of Commissioner Makary and HHS Secretary Kennedy," Capital Alpha Partners' Rob Smith wrote in a note this week.

• White House spokesman Kush Desai said: "Under Commissioner Marty Makary's leadership, the FDA has focused on restoring Gold Standard Science and streamlining the development of promising new therapies for rare diseases."

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Tens of millions of Americans have delayed surgeries, vacation plans, career moves and other big life decisions because of the cost of health care, a new West Health-Gallup survey found.

Why it matters: Affordability concerns are hanging over the midterm election cycle, with just over half of all Americans believing basic medical care is affordable and accessible.

• As groceries, housing and utilities also become more costly, those pressures are forcing difficult trade-offs in nearly every aspect of life — even for those who have insurance.

The survey of nearly 20,000 adults found that medical cost concerns didn't just force people to borrow money or stretch out prescriptions. They also led people to delay major events like having or adopting a child, retirement and going back to school.

• One in three said they've made a financial trade-off like taking out a loan in the last 12 months to pay for health care or medicine.
• About half of those in households earning between $48,000 and $180,000 a year reported putting off at least one major life decision in the past four years due to health costs.
• Even higher earners were affected. West Health-Gallup estimated that almost 70 million Americans delayed surgery or another medical treatment over the period studied.

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Speaking of budget pain, a new analysis finds some Medicare beneficiaries may need to save almost $500,000 to cover their health expenses in retirement.

Why it matters: As more large employers drop retiree health benefits, individuals are having to factor the future cost of insurance premiums, drugs and medical services.

• That's despite the Inflation Reduction Act's new $2,000 cap on Medicare out-of-pocket spending for prescription drugs.

What they found: The Employee Benefit Research Institute simulation found a couple with especially high prescription drug expenses would have to save $469,000 to have a 90% chance of covering their health care costs in retirement.

• A 65-year-old man enrolled in a Medigap plan with average premiums would need to save $120,000 to have a 50% chance of covering premiums and median prescription drug expenditures. A 65-year-old woman would need $146,000.
• Enrollees in Medicare Advantage plans generally would have lower savings targets, though there's significant variation by plan.

Sen. Josh Hawley (R-Mo.) yesterday introduced a bill to ban the use of the widely used abortion pill mifepristone, ensuring that abortion access will remain a talking point as the midterm elections approach.

Why it matters: Hawley has been pressuring the FDA to tighten dispensing requirements for the drug, which is widely available through telehealth. His new move, while highly unlikely to pass, shows a willingness to keep pressure on his colleagues.

What they're saying: Hawley said Wednesday that the Supreme Court opinion overturning Roe v. Wade "is basically a dead letter so long as these abortion drugs can be mailed into every state."

• "Only Congress" can make a permanent move that cannot be reversed by a future FDA, he added.

Between the lines: FDA officials have said the agency is conducting a safety review of mifepristone, though the timeline for completion is not clear.

• Any administrative action to restrict access to abortion drugs would be politically perilous ahead of the elections.

What we're watching: Whether Hawley's effort gains any traction — and whether GOP leaders are willing to hold votes that could potentially divide their caucus.

💉 Independent vaccine advisers to the FDA will meet today for the first time since the Biden administration to recommend strains for fall flu shots. (CIDRAP)

💵 Providing therapy to children with autism has surged in recent years, fueled by taxpayer-funded Medicaid payments. But auditors have found irregularities. (WSJ)

📊 The FDA merged its adverse drug events trackers into a single database, including vaccine side effects. (Endpoints News)