Policy and Regulation

45% of Drinking Water Samples in the United States Contain PFAS

by Veronica Salib

An analysis of 716 tap-water samples revealed that 45% of drinking water samples in the United States contained at least one tested per- and poly-fluoroalkyl substance (PFAS), also called forever...

FDA Issues Guidance on Psychedelic Drug Use in Clinical Trials

by Veronica Salib

On June 23, 2023, the United States Food and Drug Administration issued its first draft guidance on using psychedelic drugs in clinical trials. Marking a pivot in the clinical trial landscape, these...

FDA Provides Guidance for Preventing Contamination in Tattoo Ink

by Veronica Salib

On June 12, 2023, United States Food and Drug Administration officials provided guidance for reducing microbial contamination in tattoo ink. The draft recommendation, now open for public commentary,...

Sackler Family Granted Legal Immunity Despite Opioid Epidemic

by Veronica Salib

The Sackler family is getting away with falsely marketing OxyContin, a highly addictive opioid manufactured by their company, Purdue Pharma, as non-addictive. The United States Court of Appeals for the...

FDA Proposes Amendment to Human Prescriptions Drug Labeling Guidelines

by Veronica Salib

On May 30, 2023, the United States Food and Drug Administration (FDA) proposed an additional Patient Medication Information (PMI) section on human prescription drug labels, amending current...

FDA Advisory Panel Favors Over-the-Counter Birth Control Pill: Opill

by Veronica Salib

Echoing the voices of multiple major healthcare organizations and public health leaders, a joint FDA advisory panel favored making a birth control pill available over the counter (OTC). FDA leaders...

WHO Updates HPV Vaccine Guidelines: Shift Toward Single Dose Series

by Veronica Salib

Following the WHO Strategic Advisory Group of Experts on Immunization (SAGE) earlier this year, the organization released an article updating its human papillomavirus (HPV) vaccine guidelines after...

Vertex and CRISPR Submit BLA for Sickle Cell Disease Treatment

by Veronica Salib

On April 3, 2023, Vertex Pharmaceuticals and CRISPR Therapeutics announced that they submitted Biological License Applications (BLAs) for an investigational treatment using exagamglogene autotemcel...

HHS Releases National Cancer Plan to Further Cancer Moonshot

by Veronica Salib

On April 3, 2023, the United States HHS released detailed information for a National Cancer Plan. The plan aims to facilitate the Cancer Moonshot initiative. The Biden administration reignited the...

FDA Details Manufacturing Conditions That Led to Eye Drop Recall

by Hayden Schmidt

After a series of infections that left several blind, an FDA inspector discovered that the manufacturing facility used to create Global Pharma’s artificial tears failed to follow evidence-based...

HHS Relaunched Health Sector Climate Pledge

by Veronica Salib

In March 2023, the United States HHS announced plans to relaunch the Health Sector Climate Pledge, proposed by the White House in 2022. According to the press release, the healthcare sector accounts...

Ohio Attorney General Sues Pharmacy Benefit Managers Due to Collusion

by Veronica Salib

On Monday, March 27, 2023, Ohio Attorney General Dave Yost sued pharmacy benefit managers (PBMs) from multiple organizations for collusion on drug prices. The lawsuit names numerous defendants,...

HRSA Announces Plans to Overhaul Organ Procurement Transplant Network

by Veronica Salib

On March 22, 2023, the United States Health Resources and Services Administration (HRSA), a subset of the HHS, announced plans to overhaul the Organ Procurement and Transplant Network (OPTN). Recently,...

The Policy Problem Behind Adderall’s Pharmaceutical Supply Chain Crisis

by Hayden Schmidt

Attention deficit/hyperactivity disorder (ADHD) is a prevalent mental health condition described as a generalizable inability to pay attention or control impulsive behavior and a tendency to be overactive. The Centers for Disease Control...

California Partners with Civica to Make Affordable Insulin Available

by Veronica Salib

One day into his second term, Governor Gavin Newsom of California has announced a partnership between CalRx, a California Department of Healthcare Services program, and Civica, a healthcare nonprofit,...

FDA Requires Anaphylaxis Warning for All Allergenic Extracts

by Veronica Salib

On March 3, 2023, the FDA issued a safety communication, announcing that it would require and approve changes to prescribing information labels for all allergenic extracts. The new labels should...

Regulating and Authorizing Medicines: A Comparison of the FDA and EMA

by Veronica Salib

Medicine regulation, review, and authorization are critical tools for bringing drugs to market, monitoring patient safety, and ensuring the best health outcomes. While regulatory guidance can vary globally, comparing protocols can help...

Behind Walgreens’ Decision to Forgo Abortion Pill Distribution in Some States

by Hayden Schmidt

Last week, Walgreens announced that it would no longer distribute abortion pills in 20 states across the US following legal warnings made by the attorneys general of those states. Specifically,...

FDA Adds Two Eye Drops to Its Recall List Due to Supply Chain Issues

by Veronica Salib

Last week, the FDA added two more eye drops to its recall list: Apotex Corp Brimonidine Tartrate Ophthalmic Solution (0.15%) and Pharmedica USA LLC Purely Soothing 15% MSM Drops. These recalls follow a...

DEA Proposes Updated Rules to COVID-19 Telemedicine Flexibilities

by Veronica Salib

On February 24, 2023, the United States Drug Enforcement Agency (DEA) issued a press release announcing its proposal for updated telemedicine flexibility rules. At the start of the COVID-19 pandemic...