Scathing report calls for major changes at FDA, including possibly winding up agency

Scathing report calls for major changes at FDA, including possibly winding up agency


An outside group asked to examine the Food and Drug Administration’s problems following an infant formula crisis this year has delivered a scathing assessment of the agency’s structure and culture. and recommended major restructuring, possibly including disbanding the agency so that oversight of the food system receives more attention.

The FDA has long been accused of neglecting its food program, and it has been criticized by members of Congress and others for failing to avert a formula shortage that has left many parents scrambling to feed their infants. The response to the formula crisis was hampered by flaws in the leadership structure and poor communication within an agency that appeared to be in a state of “constant turmoil”. according to the Reagan-Udall Foundation report for the FDA, which the agency asked to assess its operations.

The report recommends several options for fixing the agency, which is housed within the Department of Health and Human Services and is responsible for overseeing aspects of the country’s food system, as well as tobacco products and pharmaceutical drugs.

The task force’s first and most sweeping suggestion was to create separate food and drug administrations within HHS, which would require congressional approval. The task force acknowledged this was “thinking big” and would be a longer-term solution to solving problems, but said the benefit would be to increase each party’s visibility and separate their budgets.

Other less ambitious options included separating the food and drug arms but keeping them within a single agency, as well as creating a new post of deputy commissioner to oversee food.

In a statement, FDA Commissioner Robert M. Califf said he would review the report and make decisions about the agency’s future with input from inside and outside experts. from the FDA.

The fight to keep unsung bacteria out of powdered baby formula

The report follows heavy criticism of the agency’s handling of a formula shortage earlier this year. Critics said the agency failed to act quickly enough on complaints about sanitation at a major Abbott Nutrition manufacturing plant in Michigan and failed to anticipate the shortage triggered when the plant was shut down. closed to correct deficiencies identified by the FDA.

At least four babies fell ill with a bacterial infection after drinking powdered milk made there. Two of the babies died. FDA investigators were unable to identify the source of the bacteria and the company said it did not come from the factory. But the company recalled 5 million powdered formula units and the five-month shutdown reduced formula stocks. This has left many parents without reliable sources of food for their babies and medically fragile children.

Lawmakers and food safety experts have claimed the agency’s leadership has allowed longstanding structural flaws to deepen.

Food safety experts have long complained that the agency’s food watchdog arm is chronically understaffed and underfunded. Those problems, critics say, have been exacerbated by poor communication between its centers. More generally, experts say, the agency has prioritized the drugs and drugs side, frequently attracting leaders with a medical background and no knowledge of the food industry.

“This report exceeds expectations because it represents a formal acknowledgment of all the food program issues that have occurred over many years,” said Brian Ronholm, director of food policy for Consumer Reports. “It’s actually a very important step.”

Whistleblower report on infant formula didn’t reach top FDA food safety official

A bias towards the medical side, experts say, has led to misunderstandings and failures. A whistleblower report from a former employee alleging safety risks at the Abbott factory took four months to reach the top food safety official. The former employee later dropped a complaint with the Federal Occupational Safety and Health Administration, Abbott chief executive Robert Ford said during a call with investors this fall. Additionally, the coronavirus pandemic has meant that many food manufacturing facilities have not had on-site inspections for most of the year.

Responding to criticism earlier this year during congressional hearings, Califf, a doctor who was named to the top job in February, acknowledged that the response to the formula crisis has taken too long and that “some decisions retrospectives were not optimal”. Califf announced the review of the agency’s organization during a hearing in May, and the Reagan-Udall review was launched on September 8.

Organizations representing consumers, the food industry and state food regulators are pushing to restructure the FDA. In April, the groups sent a letter to Califf, asking it to unify the FDA’s food program under the direction of a deputy food commissioner, responsible to the agency’s commissioner and direct authority over the centers of agency food security.

FDA announces overhaul as infant formula shortage continues

The Reagan-Udall task force suggested the agency establish a new structure with clear leaders and roles, develop a culture in which decision-making is grounded in scientific evidence, and engages improve the transparency, speed and predictability of decision-making.

“What is clear is that the agency’s cultural and structural failures contribute to the communication, organizational and risk management failures that make our food less safe,” said Scott Faber, a security expert. Food from the Environmental Working Group. “Any structural reform options proposed by this task force would improve the current system, provided Congress follows through with the necessary resources.”

The Reagan-Udall Foundation is an independent, nonprofit group created by Congress to help modernize industries and sectors covered by the FDA. It is funded by the FDA and major companies that do business with the agency, including drugmakers Eli Lilly and Pfizer, as well as Nestle USA, which makes infant formula.

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