Drugs have to go through years of laboratory testing and clinical trials before they can be approved by the FDA. During this process, they must be shown to be safe and effective. Getting through this process takes at least three years on average. However, drug companies and global regulators are under pressure to speed up the process of identifying and developing vaccine candidates and new medicines.
Upheaval at the FDA is affecting specific junctures in the drug approval process, including a delay in decision dates for drugs from Verastem Oncology and Stealth BioTherapeutics. It also may be limiting the ability to issue product-specific guidance documents, which are used to explain how the agency will evaluate a given medicine.
In addition to this week’s announcement of a voucher program, the FDA is changing its policy on how it reviews and approves vaccines. It is reverting to a more traditional approach, meaning that all vaccines must be compared to placebo to win approval. The move marks a departure from the approach taken by Makary and his boss, Health Secretary Robert F. Kennedy Jr., who pledged a return to “gold-standard science.”
As we look ahead to 2025, there is great excitement among investors and pharmaceutical companies for the promise of neuroscience medicines that could treat Alzheimer’s, ALS and depression. These new treatments are expected to generate billions in sales. They are just one reason that many of the largest pharmaceutical companies are expanding their research and development budgets.