FDA presses for key rules, to sort out the chaff New FDA commissioner initiates efforts to audit agency's list of proposed regulations.


WASHINGTON -- With the goal of restoring credibility after a decade of budget cuts and deregulation, the Food and Drug Administration is about to begin a sweeping review of hundreds of food and drug safety measures it has proposed in the last 30 years but never acted on.

The review is the second phase of efforts by the FDA's new commissioner, Dr. David Kessler, to rebuild the agency. The first phase, which began several months ago, was increased

enforcement actions against food and drug manufacturers.

The idea, Kessler said in interviews over the weekend, is to first get rid of misleading labels and then to give manufacturers guidance on what the labels should say and how to keep their products safe.

Kessler said that even before he officially took office he discovered, in trying to answer a routine question from Congress, that the agency could not say how many regulations it had proposed in recent years or what had happened to them.

After agency staff members searched card files, the Federal Register, which publishes government regulations, and the memories of senior staff members, Kessler was told that the FDA had proposed, but never issued, about 400 regulations. They ranged from the size of type required on drug packages to standards for lifesaving heart defibrillators.

Peter Hutt, a former FDA general counsel, reflecting on the state of the agency when Kessler arrived, said: "I am absolutely astonished. How can you manage an agency if you don't even know what regulations you have proposed?"

While food and drug manufacturers have not been happy with every enforcement action taken by the FDA in recent months, industry representatives as well as members of Congress have been greatly relieved to see that the agency will have more consistent and predictable regulations and, perhaps, speedier approvals of manufacturers' applications.

Kessler said that for the first time in at least a decade the FDA would review all its pending regulations to press ahead with

those it considers important and scrap the others.

"This says volumes about the sorry state of affairs at the FDA, and the challenge that Dr. Kessler faces there," said Rep. Henry A. Waxman, D-Calif., chairman of the House Subcommittee on Health and the Environment. "In order to restore the FDA's credibility and to protect the public health, it is critical that Dr. Kessler move quickly to insure that the FDA has the ability to issue regulations in a timely manner."

Kessler is moving quickly. Appointed last fall by Louis W. Sullivan, the secretary of health and human services, the 39-year-old former chief of medicine at Albert Einstein Hospital in the Bronx moved within two months to add 100 criminal investigators to the agency.

In weeks since, he has announced enforcement actions against food and drug manufacturers intended to regain the agency's credibility -- from eliminating the word "fresh" from products that are actually processed, like some brands of orange juice, to a ban on the use of misleading fat percentage claims on foods like ice cream and yogurt.

On Friday, Sullivan gave Kessler the go-ahead to carry out another step in the rebuilding of the agency, a major reorganization intended to streamline management by reducing to five senior officials the dozens of people who report to the commissioner.

The move will give more authority to lower-level officials and will include new procedures to monitor the agency's performance.

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