A battle is heating up between House Energy and Commerce Committee Chairman John D. Dingell, D-Mich., and the Food and Drug Administration over the agency’s plan to reorganize its regional laboratories and field operations.

Under a draft bill Dingell released Friday, the FDA would not be able to carry out a plan to close seven of its 13 food and drug safety labs, nor would it be able to close or consolidate any of its 20 regional offices. Although the reorganization is on hold pending an executive branch review, FDA Commissioner Andrew C. von Eschenbach defended the plan at a July 17 hearing as way to save money to fund improved training and technology to better protect against import hazard (See related story, CQ HealthBeat, July 17, 2007).

Along with blocking the reorganization, the draft measure would give the FDA new authority and funding to inspect more shipments of imported food and drug products and order recalls. The measures are needed to strengthen a FDA inspection system overwhelmed by surging imports, particularly of food products, Dingell said in an Aug. 3 letter to House colleagues. “Recent reports of melamine-tainted pet food, diethylene glycol-tainted cough syrup and antibiotic-tainted seafood, predominantly from China, led many to rightly question the strength of our food and drug import safety system,” Dingell said in the letter seeking comments on the draft.

The FDA reorganization plan came under fire from witnesses at the July 17 hearing who said it would shrink FDA’s enforcement presence nationally and allow headquarters to keep field operations on a shorter leash — field offices, at times, pursue enforcement policies that agency headquarters see as too aggressive. Witnesses also said consolidating labs and field offices would lessen laboratory expertise needed to quickly detect and respond to hazards, while in effect reducing the number of cops on the enforcement beat.

The draft legislation lays out a series of steps the FDA would have to take in carrying out a reorganization plan. It would require the Health and Human Services (HHS) secretary to consult with personnel and unions affected by the plan. The secretary would have to report on the plan’s details to the U.S. comptroller general, who oversees the Government Accountability Office (GAO), and to the heads of the Energy and Commerce and the Senate Health, Education, Labor and Pensions committees. The GAO would be required to study the cost and safety impact of the plan, and Congress would have 180 days to turn down the plan after receiving the GAO analysis.

Von Eschenbach said last week that he has suspended plans to close any labs pending a review of import safety ordered by President Bush. A July 18 executive order Bush issued calls for an “Interagency Working Group on Import Safety” headed by HHS Secretary Michael O. Leavitt to report back to Bush within 60 days on recommendations.

The proposal also would give the FDA power to establish user fees on food and drug imports to fund more inspections of products coming into the country and to fund research on tests to detect intentional adulteration or misbranding. The FDA also would get the power to limit food imports to ports of entry located in a city with a FDA laboratory that analyzes products for contamination. Food would have to be labeled to identify its country of origin. HHS would have two years to create a voluntary program for companies to abide by certain safety guidelines in importing food, and in turn, those companies would get speedier inspections.

Under the draft measure, the FDA would have new authority to halt food distribution if it found “a reasonable probability that a food would cause serious, adverse health consequences or death.” Foreign facilities from which food is imported into the United States would have to be certified by HHS as maintaining a program that uses reliable methods to analyze products to ensure compliance with all U.S. standards. The proposal also would allow stiffer penalties on importers who violate U.S. regulations. And foods treated with carbon monoxide to preserve their coloring would have to be labeled to that effect, together with a warning not to rely on color to determine the freshness of a product.

Julie Zawisza, FDA spokeswoman, said FDA’s policy is not to comment on bills or pending legislation. “We will review the bill carefully and respond to any questions or information requests that the Congress may have,” she said.

The drug industry was non-committal about the draft measure, but praised it for calling attention to the dangers of imports. The Pharmaceutical Research and Manufacturers of America said those dangers should serve as a warning to lawmakers not to pass other legislation easing the way for importation of certain pharmaceuticals from abroad, a step urged by many Democrats to give the public relief from high drug prices.

PhRMA Senior Vice President Ken Johnson issued the following statement Monday regarding Dingell's draft proposal: "Although we are still reviewing the details of Congressman Dingell's draft legislation, we share his concerns over the dangers faced by consumers who receive imported fake products," Johnson said.

"Counterfeit toothpaste, tires and dog food are just a few items in the news about the growing prevalence of counterfeits entering the U.S. from foreign countries," he said. "If certain importation schemes pass through Congress, counterfeit medicines could flood into our borders — just as these other products have — and put patients' lives at risk.

"Supporters of importation suggest that it's safe to buy medicines from foreign countries or from purported Canadian internet pharmacies which have been known to sell fake and potentially unsafe medicines to unsuspecting consumers. The facts prove otherwise. Recent high profile reports not only detail the dangers that counterfeit medicines pose to patient health, they also expose the high profit margins that criminal organizations stand to gain from the sale of fake and substandard drugs. In fact, the Center for Medicines in the Public Interest recently stated that counterfeit drug sales will reach $75 billion globally in 2010, an increase of more than 90 percent from 2005."

• Dingell Press Release (pdf)

• Draft Bill Summary (pdf)

• Draft Bill Text (pdf)