LIVE: Reuters Newsmaker with FDA Commissioner Robert Califf

()

FDA's Regulatory Priorities for Pharmaceuticals in 2024

The FDA aims to address misinformation, improve evidence generation, fix generic drug market failures, and support rare disease treatments.
The agency is enhancing post-market surveillance, collaborating with stakeholders to ensure a smooth transition from pre-market approval to post-market use, and recognizing the importance of real-world evidence in regulatory decision-making.

Gene editing and brain chip implants require careful oversight and regulation.
Obesity drugs show remarkable benefits, but concerns exist about supply issues, manufacturing challenges, and demand exceeding supply.
Clinical trials and data are crucial to ensure safety and efficacy before market release.

Compounding and illicit internet markets pose challenges in enforcing regulations and ensuring drug quality.
Drug shortages occur due to high demand, low prices, and manufacturing issues, which the FDA addresses through collaboration and market failure mitigation.
Counterfeit drugs are a significant problem, especially when purchasing medications online from outside the US.
The US has strict controls over generic drugs, but counterfeit drugs are prevalent in low-income countries.
Data on illicit drug production and importation is limited due to their clandestine nature.

Increased R&D investment is needed for mental health and chronic lung disease, areas with significant unmet medical needs.
The FDA is finalizing the rule on menthol cigarettes and committed to reducing tobacco-related harm.
The agency's role in regulating substances like ketamine, psychedelic drugs, and cannabis is guided by existing laws and regulations, with collaboration with Congress for appropriate legal frameworks.
The FDA enforces regulations against harmful products, regardless of their classification as drugs, dietary supplements, or food.

The FDA investigates cases of drug counterfeiting and illegal sales, such as CBD gummy bears that appeal to children.

The FDA approved Florida's request to import drugs from Canada, but several other requests are pending.
Strict criteria ensure the safety and quality of the supply chain, and Canada must also facilitate drug imports.

A significant portion of generic drugs used in the US is manufactured overseas, mainly in China and India.
The FDA is increasing oversight of manufacturing facilities outside the US to address concerns about shortages and quality issues.
The recent contamination incident involving Indian cough syrup highlights the need for improved oversight and regulation in the generic drug industry.
The FDA collaborates with the Indian government to address problems identified in Indian manufacturing facilities.
The generic drug industry is crucial for public health, serving millions of Americans and billions worldwide with chronic diseases.