Recent Postings

The “from the editor” column discusses the problems with FDA user fees and why Congress should end user-fee-based funding of the agency and restore full funding with public funds. You may be surprised to learn that 48% of the FDA budget in fiscal year 2024 was provided by $3.3 billion in industry user fees.

Dupilumab (DUPIXENT) is a recently approved add-on maintenance treatment for adults with inadequately controlled eosinophilic chronic obstructive pulmonary disease (COPD), a form of the lung disease involving an inflammatory response from a type of white blood cell. The drug is a monoclonal antibody that is injected subcutaneously (under the skin). It should only be considered by patients with eosinophilic COPD and for whom other treatments have failed to adequately control flare-ups.

Granted accelerated approval by the Food and Drug Administration (FDA) in 2016, obeticholic acid (OCALIVA) is an expensive oral drug that is a second-line treatment for adults with a liver disease known as primary biliary cholangitis. Learn about the lack of benefit of obeticholic acid, the drug’s safety concerns, and why the FDA should immediately rescind its accelerated approval.

A 2024 study published in the BMJ compared the efficacy and tolerability of several oral migraine drugs. The study found that some older drugs performed as well or better than newer, more expensive drugs.

The FDA recently provided an update on marijuana (cannabis) use, including the clinical implications of the medical and recreational use of marijuana-related products. In 2024 the Drug Enforcement Administration proposed a rule that would move marijuana to Schedule III, a classification for drugs and other substances with an intermediate potential for physical or psychological dependence. There are two FDA-approved drugs derived from marijuana with narrow indications.

A recent report highlights how up to 45% of dementia cases could be prevented or delayed by attention to 14 potentially modifiable factors. The factors are untreated vision loss, high LDL cholesterol, physical inactivity, smoking, excessive alcohol consumption, hypertension, diabetes, obesity, hearing loss, depression, traumatic brain injury, social isolation, less education, and air pollution.

The editor’s column discusses a disturbing failure of informed consent during clinical trials of two recently approved drugs for Alzheimer’s disease; participants were not told whether their genetic profiles increased their risks of brain injuries from receiving the drugs. Investigators and institutional review boards should learn from the informed consent failure and ensure that research subjects are fully informed about their risks.

Learn how the Food and Drug Administration reviews drugs and medical devices before they can be marketed in the United States, and the similarities and differences between the drug approval process and the medical device approval and clearance process.

In February 2024 the FDA finally responded to a 2011 petition from Public Citizen’s Health Research Group to require additional safety warnings on the labels of glucocorticosteroids. The FDA granted the petition in part, prompting belated safety labeling changes.

Some prescription and over-the-counter medications are associated with symptoms of cognitive impairment in older adults, such as confusion, memory loss, problems paying attention or difficulty thinking. Drugs to be aware of include anticholinergic drugs, benzodiazepines and Z-drugs, proton pump inhibitors, and certain combinations of drugs.

The editor’s column discusses a Viewpoint article in JAMA about the origins of “confidential commercial information” at the Food and Drug Administration (FDA). The article makes the case for a “long overdue” and “more balanced” approach to the public disclosure of company information. Dating from 1974, the FDA’s approach to information sharing should be revised.

Learn about compounded injectable semaglutide (OZEMPIC, WEGOVY) and tirzepatide (MOUNJARO, ZEPBOUND) products that are widely marketed for type 2 diabetes and weight loss. Compounded drug products are subject to a lower regulatory standard than FDA-approved drug products and are not approved by the agency. Public Citizen’s Health Research Group recommends that you do not use compounded injectable semaglutide or tirzepatide products or any such products that are purchased without a prescription.

In August 2024 the FDA approved an epinephrine nasal spray (NEFFY) for the immediate treatment of certain life-threatening allergic reactions, including anaphylaxis. Learn about the epinephrine nasal spray, which Public Citizen’s Health Research Group has classified as Do Not Use for Seven Years because of the limited clinical data available.