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House Democrats Thursday unveiled legislation to make broad regulatory changes to the Food and Drug Administration, including the creation of a special force of inspectors to monitor overseas production of food, drugs and cosmetics.

The draft legislation by John D. Dingell of Michigan, chairman of the House Energy and Commerce Committee, would create a registry of all companies producing drugs, food and medical devices for American use. It would also require country-of-origin labeling for food and drug products.

Dingell and Rep. Bart Stupak, also a Michigan Democrat, have for months used oversight hearings to draw attention to what they say are the FDA’s failings and to build a case for an agency overhaul.

While Dingell’s influence can help propel the bill through the House, its prospects in the Senate will depend on the ability of FDA critics such as Edward M. Kennedy, D-Mass., and Charles E. Grassley, R-Iowa, to find bipartisan consensus for an overhaul.

It will also depend on proponents’ ability to persuade lawmakers to embrace a major regulatory overhaul in an election year, especially considering the lobbying that such a measure is expected to provoke from the pharmaceutical industry.

 

Funded by Fees

Under Dingell’s bill, each producer would pay fees to fund FDA inspection and safety activities. Food-producing facilities would pay $2,000, generating $600 million annually for agency activities. The secretary of Health and Human Services would be able to determine the fees for drugs.

The bill also would require the FDA to inspect foreign drug facilities every two years, just as is done for domestic facilities.

In addition, drug and food products would be required to be labeled with the country that produced it. The FDA also would get mandatory recall powers for tainted food and tainted or dangerous drugs and medical devices.

In a statement, Dingell, Stupak and Frank Pallone Jr., D-N.J., chairman of the Health Subcommittee, said they would hold hearings “in the next few weeks” and mark up the bill soon after that. Pallone has scheduled a hearing for April 24.

Dingell said in the statement that he hoped Joe L. Barton of Texas, the committee’s ranking Republican, would join him in moving the bill. Committee Republicans have in the past questioned the FDA’s safety powers but have not called for the new powers Dingell is pushing.

Several drug and food safety scares have put the issue in the headlines and driven the case for legislation. Most recently, the blood-thinning drug heparin — produced in China — was found to be contaminated, resulting in 62 deaths. Other domestic and foreign food and drug scares have left lawmakers and consumers wondering about the FDA’s ability to do its job.

A Combination of Bills

The bill is a combination of several, built around other bills (HR 3610) by Dingell. Legislation by Pallone (HR 3624), Stupak (HR 3115) and Diana DeGette, D-Colo., (HR 3484) was incorporated into the bill.

The FDA has been reluctant to take on broad new powers. On April 16, FDA Commissioner Andrew C. von Eschenbach said he was unsure the agency could absorb a major increase in funding in just one year. Von Eschenbach also said that having inspectors in China would not have prevented the patient deaths from the contaminated heparin.

The agency is currently opening offices in five overseas regions: India, South America, the Middle East, Europe and China. There will be three offices in China, said von Eschenbach, the first of which he hopes will begin operations in May.

Asked about Dingell’s bill, FDA spokesman Brad Swezey said, “We look forward to reviewing the draft legislation and responding to Congress about it.” The agency has previously asked for several new food authorities included in Dingell’s legislation, but has not asked for new drug or device regulatory powers.