Experts Call for PBM Transparency During Senate Hearing
Most expert witnesses at a hearing of the Senate Finance Committee on Thursday agreed that pharmacy benefit managers (PBMs) — middlemen between the drug companies and insurers — drive up the prices of prescription drugs, leaving patients with higher out-of-pocket costs, and offered a range of suggestions on how to curb PBM abuses. Historically, PBMs […]
Do Away With ‘Lockout’ Period in iPLEDGE, FDA Advisors Urge
An FDA advisory committee on Wednesday voted 17-4 (with one abstention) to recommend removing a “lockout period” from a risk evaluation and mitigation strategy (REMS) for isotretinoin prescribing that requires patients to wait an extra 19 days — and take an additional pregnancy test — if they miss a 7-day window for picking up their […]
House Lawmakers Squabble Over HHS Budget
Republicans and Democrats on the House Appropriations Committee sparred on Tuesday over provisions in President Biden’s budget request for the Department of Health and Human Services (HHS). Committee chair Robert Aderholt (R-Ala.) said he found it “disappointing” that the proposed budget “continues to double down on out-of-control government spending, which only adds to our already […]
Proposed User Instructions for OTC Narcan Has FDA Concerned
Ahead of an advisory committee meeting, FDA staff highlighted ongoing concerns about labeling for what could possibly be the first naloxone (Narcan) product approved for over-the-counter (OTC) use, labeling it “essential” in the emergency setting of an overdose. At a joint meeting of the Nonprescription Drug Advisory Committee and Anesthetic and Analgesic Drug Products Advisory […]
Thumbs Down for Genetic Test for Opioid Use Disorder, FDA Advisors Say
An FDA advisory committee on Thursday voted strongly against AvertD, a prescription genetic risk assessment tool for opioid use disorder (OUD). In an 11-2 decision, the Clinical Chemistry and Clinical Toxicology Devices Advisory Committee said the probable benefits of the AvertD device did not outweigh its probable risks, taking into account risks and benefits of […]
Genetic Testing for Opioid Use Disorder Heads to FDA Advisors
On Thursday, members of the FDA’s Clinical Chemistry and Clinical Toxicology Devices Advisory Committee will meet to discuss AvertD, a prescription genetic risk assessment tool for opioid use disorder (OUD). AvertD detects the presence or absence of 15 single nucleotide polymorphisms (SNPs) to help identify adults with an increased genetic risk of OUD. It’s intended […]
PI3K Inhibitor Fails to Pass Muster With FDA Advisory Committee
The FDA’s Oncologic Drugs Advisory Committee (ODAC) made a clean sweep of its 2-day meeting, deciding that the PI3K inhibitor duvelisib (Copiktra) does not offer a favorable risk-benefit ratio for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). By an 8-4 vote, the panel came down on the side of the FDA […]
Opinion | ‘I Really Feel We Need the Human Data’: What We Heard This Week
“I really feel we need the human data.” — Pablo Sanchez, MD, of the CDC’s Advisory Committee on Immunization Practices, who cast the only vote against recommending the new bivalent boosters due to the lack of clinical trial data. “It could cause a lot of anxiety in people.” — Sean McGann, MD, an emergency physician […]
CDC Panel Backs Novavax COVID Vaccine for Adults
The CDC Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend Novavax’s COVID-19 vaccine for individuals 18 and up. With a vote of 12-0, the advisory panel endorsed a two-dose primary series of the adjuvanted, protein-based vaccine, which will be administered 3 weeks apart. The recommendation follows FDA’s emergency use authorization last week. Shortly […]
Opinion | Are Omicron-Targeted Boosters Worth It?
The FDA, following the advice of its advisory committee, is advising COVID-19 vaccine manufacturers to reformulate future booster shots to include protection against the BA.4 and BA.5 Omicron variants of SARS-CoV-2. While this decision was not surprising and may have seemed perfunctory to many people, it is worth thinking about the wider context that undergirds […]