Food-borne illness is a public health crisis: Congress must act (The Hill)

THE HILL | On Jan. 31, the Food and Drug Administration proposed a redesign of its human food program in response to several ongoing food crises impacting public safety and the health of millions of Americans.

The redesign attempts to solve leadership and funding problems identified by an expert panel in December. 

Unfortunately, the proposal does little to fix the most urgent or fundamental problems within the agency and the safety of our food. Only Congress has the necessary tools to do that.

The festering food leadership failures at FDA were brought to public attention in part by the recent shortage of infant formula. In response to criticism over their role in the shortage, FDA appointed an expert panel to investigate the root causes of the problems and to recommend solutions, sparking a broader conversation about the various ways FDA’s food programs have recently fallen short. 

Read more at The Hill:

Commissioner Califf needs to put the F back in FDA (Stat)

STAT | Robert Califf is taking the reins as commissioner of the Food and Drug Administration with the nation in a nutrition crisis. Americans are living shorter, less-healthy lives due to the foods they are being sold. The new commissioner can meet this challenge by harnessing the FDA’s effective but underused food-related regulatory powers, which were created with FDA itself for a similar food crisis more than 100 years ago.

At the turn of the 20th century, food was making Americans sick. Illnesses due to chemical and microbiological contaminants were among the top 10 causes of death. Food producers, eager to meet consumer demand for cheap, quick, appealing, and tasty food, were adding harmful ingredients without concern for people’s safety and were intentionally mislabeling food. Milk contained chalk and formaldehyde; canned foods had salicylic acid, borax, and copper sulfate; corn syrup was sold as honey; and colored animal fat from pig stomachs sold as butter. Food manufacturers were unchecked by government regulation, basic food safety, or labelling requirements.

Under the leadership of President Theodore Roosevelt and Harvey Wiley, a chemist working for the U.S. Department of Agriculture, the federal government was able to make the country’s food supply safer through research and policy. Wiley conducted groundbreaking research on food additives by testing them on a group of men that came to be known as “the poison guard.” This research culminated in sweeping food safety laws — and the founding of the FDA — through the 1906 Pure Food and Drug Act.

Read the full article here:

FDA Draft Guidance on Real-World Data (Forbes)

FORBES | In a document issued this week, the Food & Drug Administration laid out for comment its draft guidance of how real-world evidence could support regulatory decision-making for medical devices. This is a positive step forward for improving the medical product development process. At the Bipartisan Policy Center, Representative Bart Gordon and I have been urging FDA to advance medical innovation with real-world evidence. FDA has limited this guidance to how real-world evidence may be used for regulatory review of medical devices. But the FDA is to be applauded for taking this step, and acknowledging the increasingly vital role real-world data (RWD) will have in healthcare.

Read more at Forbes.