The FDA is at a crucial juncture because of important gains in science-based medical treatment.
The FDA is at a “key moment” for the nation’s public health and global well-being because of the potential to make important gains in science-based medical treatment, Commissioner Robert Calif told the Washington Legal and Regulatory Community in June 2022 at the June 2022 annual meeting. of the Institute of Food and Drug Law (FDLI). It aims to address these challenges by improving the FDA’s supply chain management in all areas, with digitally integrated systems that support preventive action and allow for a rapid response to product shortages. Another priority is to counter widespread misinformation about vaccines and medical products by focusing on science-based decision-making in the agency and to advance the development of medical products based on appropriate communication between the agency’s experts and those in the regulated industry.
Caliph stressed the importance of improved information and data management systems in all FDA operations to support the agency’s oversight and decisions about medical therapies. Priority is given to the FDA’s food program, which will require sufficient funding from Congress to support something like a 21st Century Treatment Initiative for Food, similar to the one introduced to modernize and improve the agency’s oversight of medical devices. in 2016. Under the current system, Caliph noted that food manufacturers should not even tell the FDA if they find contaminants in products waiting to be shipped, limiting the agency’s ability to anticipate serious supply problems such as the ongoing infant crisis.
At the same time, Caliph defended the agency’s “appropriate” commitment to regulated companies as valuable in assessing the “promise and risk” of new products and technologies. The FDA staff’s extensive knowledge of the full range of products under development – including many failures – can help developers guide effective pathways and prevent wasted and duplication of effort – including clinical trials that could harm humans.
Similarly, Deputy Commissioner Janet Woodcock called for a better understanding of the challenges and difficulties surrounding the many regulatory and scientific decisions made by FDA officials and leaders at another FDLI address who acknowledged the agency’s serious mistake in approving opioids. sustained release for the market. Woodcock noted that a science-based regulatory process, as in the FDA, must issue regulations and policies that enforce laws, a process that involves interpretation and inevitably generates disagreement. Although science aims to assess the facts, many decisions are “surrounded by a cloud of uncertainty,” she said. Therefore, the FDA’s critical approval for sustained-release opioids in 1995 was based on far-reaching predictions of harm and prescribing behavior at the time, Woodcock acknowledged. However, she acknowledged that she was pessimistic about improving this situation in the near future, unless scientists and politicians failed to communicate more widely about the “big picture” of uncertainty that inevitably bypasses agency decisions.
Caliph expressed similar concerns about the “growing dissemination of misinformation and misinformation about science, medicine and the FDA that puts patients and consumers at risk” at the FDLI conference, as well as at the BIO International Convention in San Diego. Disinformation, he told biotech leaders, is the leading cause of death in the United States, noting that almost all COVID-19 deaths are now preventable if patients are fully vaccinated and reinforced. Misinformation, moreover, hinders the appropriate use of effective treatments for chronic diseases. It is paradoxical, Calif noted in BIO, that although America is an “innovation for the world”, life expectancy in the United States is low, especially compared to other rich nations.
Caliph noted in the FDLI that he agreed to return to the FDA last year after a previous stay as agency leader, hoping to help modernize the agency’s operations to prevent future critical delays and product shortages. This is a “key moment” for the agency’s future effectiveness, he said, stressing that changes are needed to “stay ahead of the industries we regulate and the technology, science and communications that those industries use.”
About the author
Jill Wexler is the editor of Washington BioPharm International.