The problem with AstraZeneca’s Farxiga TV ad; Americans are unsure about Mifepristone; new alternative HPV test endorsed by ACS – Morning Medical Update

FDA flags Farxiga TV ad for ‘misleading impression’

AstraZeneca is under scrutiny from the Food and Drug Administration (FDA) after regulators said a recent 45-second Farxiga television commercial misrepresented the drug’s approved indications for chronic kidney disease and heart failure. The Office of Prescription Drug Promotion (OPDP) noted the ad highlighted only a reduction in cardiovascular death, omitting additional outcomes — including slowing chronic kidney disease (CKD) progression, reducing end-stage disease and lowering heart-failure hospitalizations — that formed the composite endpoints supporting approval.

The FDA said the selective messaging could lead patients to believe Farxiga is indicated solely for CV mortality reduction, concluding the spot “creates a misleading impression” of the drug’s full capabilities. Fierce Pharma has more.

Americans are unsure about Mifepristone’s safety

A new KFF poll shows many Americans are still fuzzy on the basics of mifepristone. Fewer than half now say the abortion pill is safe when used as directed — a noticeable drop from two years ago. A large share of people simply aren’t sure what to think. That uncertainty extends even to women of reproductive age, whose views largely match the public’s.

When it comes to policy, the picture is clearer. About two-thirds of adults say they don’t support laws that would ban the abortion medication nationwide, criminalize providers for mailing pills to patients in states with bans or block clinics like Planned Parenthood from receiving Medicaid funds for the other care they deliver. The poll also finds that very few people have heard about the FDA’s new review of mifepristone announced this fall.

New alternative to pap smear endorsed by ACS

The American Cancer Society (ACS) has endorsed self-collected human papillomavirus (HPV) testing as an acceptable option for cervical cancer screening, following federal approval of the first at-home self-swab earlier this year. The new guidelines reflect more than a decade of evidence showing that self-collection is accurate, easy for patients and can help reach those who face barriers to in-clinic exams.

Screening rates in the U.S. have stalled — and have fallen sharply among recent immigrants and uninsured women — while cervical cancer rates in women ages 30 to 44 have begun to rise. By allowing patients to collect a sample at home or in a clinic without a pelvic exam, ACS leaders say self-testing could boost screening uptake and move the country closer to the long-term goal of eliminating cervical cancer.

The guidelines recommend starting HPV-based screening at age 25 and continuing through age 65 with appropriate follow-up for positive tests. Contemporary OB/GYN has more,