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Congress Preps for Health Debates

Lawmakers Ponder Fix for the FDA

Lawmakers in both parties say the Food and Drug Administration is broken, falling short in its efforts to protect Americans from tainted food and drugs as well as faulty medical devices.

Yet there are substantial disagreements between the two sides about how to fix the problem.

Democrats say the answer is legislation to strengthen the agency’s authority, with an eye toward increasing both domestic and overseas inspections.

The rub, of course, is how to pay for it. A combination of user fees and separate appropriations appear to be the most likely choices — but the most likely areas of disagreement between the parties.

[IMGCAP(1)] Although few observers believe any legislation is likely to pass this year, the possibilities for reform appear much greater in 2009 if there is a Democratic administration.

The Democrats’ main bill is the Food and Drug Administration Globalization Act, which was introduced last month. The legislation, which takes on the safety of imported food, drugs, medical devices and cosmetics, is sponsored by House Energy and Commerce Chairman John Dingell (D-Mich.), Rep. Frank Pallone (D-N.J.), who leads the Subcommittee on Health, and Rep. Bart Stupak (D-Mich.), who runs the Subcommittee on Oversight and Investigations.

This legislation follows numerous high-profile incidents involving tainted food and drugs, both domestic and imported.

The bill is meant to be a “reform mechanism for the FDA,” said Pallone, who has held a series of hearings to obtain feedback from lawmakers and witnesses.

But the consensus is that while Republicans and the administration agree that more needs to be done to ensure safety, they do not necessarily agree with this proposal.

Republicans, for example, question the Democrats’ push to require new user fees to pay for the changes and criticize Democrats for trying to do too much, calling instead for a more limited approach focused on areas considered at highest risk.

Republicans, led by Energy and Commerce Committee ranking member Joe Barton (Texas), have cautioned against new user fees, instead favoring additional appropriations.

Republicans and some Democrats have argued that overuse of user fees could produce an FDA that is beholden to the industry it regulates.

This draft bill “would exacerbate this problem by becoming ever more user-fee-oriented,” Barton said during a recent hearing on the legislation. “I think while we need more assets and resources for the FDA, we should really pay attention to how we give them the resources. It might be better to authorize out of the general revenue as opposed to becoming more and more dependent on user fees.”

Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, also registered concerns about the fees at that hearing. Generally the administration supports user fees, but it will “carefully review” them to ensure they are being assessed only against the parties that benefit from these new federal inspection authorities.

Pallone, however, has dismissed the possibility of excluding user fees. “We have no choice because we have no money” in the budget to pay for these new authorities, he said. Those calling for additional appropriations to pay for these authorities are “just being unrealistic,” he said.

The administration and Republicans are also skeptical of the inspection requirements in the bill, including one that requires that all medical device facilities be inspected before placing a product onto the market and then every two years hence.

Barton called those requirements “overkill and probably not implementable in the real world.” The problem, he said, is that there is no reason to inspect thousands of less complex devices at the same rate as more complicated ones.

That, he said, would “only increase costs to patients with, as far as I can tell, no demonstrable safety benefit and would needlessly delay these therapies getting to patients.”

Industry groups, such as the Advanced Medical Technology Association, agreed, calling for risk-based inspection requirements instead.

But Pallone rejected this approach. “I am very suspicious of [risk-based approaches], and I always have been,” he told Roll Call, adding that such an approach usually means doing more with less money, something that he said is no longer possible.

Under the bill, all importers of drugs, devices, foods and cosmetics would have to register with FDA annually and pay a fee.

Facilities and importers would also be required to have unique identification numbers. In addition, the legislation would establish a corps of foreign inspectors to do on-site inspections of food, drugs, devices and cosmetics that are set to be imported to the United States.

On food safety, the bill would give FDA the authority to issue mandatory recalls of tainted food.

The legislation would also create a food registry for all food facilities within the U.S. and require that these companies pay $2,000 per year to register. This fee would provide the FDA with an estimated $600 million annually for food safety.

All foreign and domestic food facilities would also be required to have safety plans in place that would be subject to a mandatory FDA inspection every four years.

Furthermore, importers would have to get their products certified by FDA-accredited food safety agents or be restricted to only those ports that have federal testing laboratories. Importers would also have the option of meeting security requirements in order to secure fast-track importation into the U.S. market.

The bill also includes numerous provisions regarding importation of drugs, medical devices and cosmetics. These include registries of domestic drug and device facilities and those that are imported into the country; a new user fee to pay for drug and device inspections; mandatory inspection of these facilities every two years; and expanded enforcement tools and country-of-origin labeling.

The Senate is also working on its own bill, but it is not as far along as the House, with no hearings scheduled thus far.

Sponsored by Senate Health, Education, Labor and Pensions Chairman Edward Kennedy (D-Mass.), the bill would include many of the same requirements as the House bill, including mandatory registration and inspection requirements, and new user fees to pay for these new responsibilities.

Some key Republicans, including Sen. Mike Enzi (Wyo.), the committee’s ranking member, are registering concerns with the draft language. An Enzi aide says the Senator believes the bill is too expensive and does not provide targeted efforts to enhance food safety. Adding expensive new requirements could increase food prices even more, at a time when they are already on the rise.

Enzi also believes there should be more focus on preventing contamination, rather than detecting contaminated products, and will seek a better balance between these two issues, the aide said.

A Kennedy aide, in an interview before the Senator’s recent illness, said the draft legislation already focuses on prevention. However, Kennedy is open to adding more prevention provisions to the bill, the aide said, calling the legislation a “major priority.”

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