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Packaging to play a bigger role in the FDA budget

Packaging as a defense against tampering might soon be a higher priority for the U.S. Food & Drug Administration. Though it isn't clear what programs the agency has in mind, packaging has received a prominent mention within FDA's priorities for additional funding in next year's budget.

In government, a budget reflects priorities. There is literally never "enough money" to do everything. So we are left with limited resources and, necessarily, budgets. A government's budget will reflect its priorities in a variety of ways. The recently proposed federal budget tells us that the administration wants to continue to emphasize protection against terrorism directed at the food supply, in particular, and wants to tighten oversight of the safety of drug products in the marketplace.

Packaging, like any other industry, is significantly affected by government priorities. This is particularly so with respect to FDA, the agency that touches so many packaging companies. FDA regulates most of the nation's foods and all of its drugs, dietary supplements, medical devices, cosmetics, animal drugs, and biological and radiological products. It therefore touches not only many elements of the packaging industry, but also the everyday lives of virtually every American.

Ever since September 11, the cloud hanging over every FDA budget process is the threat of terror attacks on the food and drug supply. President Bush's proposed budget, released in early February, requests an increase of $81 million, to a total of $1.9 billion, for FDA overall (this total matches FDA's own proposed budget).

The president's proposal calls for $30 million to be used to "improv[e] the agency's national network of food contamination analysis laboratories and to [support] vital research on technologies that could prevent threats to our food supply," according to new Health and Human Services secretary Mike Leavitt. Laboratories are needed to quickly identify the nature or sources of food contamination incidents. According to an FDA release, this additional funding "will add an estimated 19 FDA-funded state labs."

Upon his departure last December, Leavitt's predecessor, Tommy Thompson, commented that he was surprised that no terrorists had attacked the U.S. food supply, even though, he said, it would have been "easy to do."

So the new budget puts extra money toward helping to protect the food supply. This will include, according to an FDA release, "targeted research in those areas posing the greatest perceived threat to the food supply, based in part on the most recent intelligence. The increase in funding will support research related to prevention/ mitigation technologies, tamper-proof packaging, rapid test methods and/or agent sensor technologies."

While we can forgive the incorrect turn of phrase—tamper-resistant or tamper-evident are the preferred phrases—it isn't clear right now what type of program FDA has in mind by that cryptic reference to tamper-proof packaging. The important point is that the feds may be exploring a far greater role for food packaging that can help thwart tampering or alert consumers to its presence, and that's a wise move.

Since the days of the Tylenol poisonings, many in packaging have worked hard on new technologies to increase package security an dconsumer confidence. It is good to see the recognition that packaging can play an important role in public safety.

Tamper-evident or tamper-resistant packaging is not currently required by federal law for foods, though many companies employ it anyway to reassure buyers, and FDA often advises consumers or manufacturers to look for missing or altered structures as a sign that tampering may have taken place. It remains to be seen just how this new focus will be translated into action. Research is already underway, with FDA's involvement, into technologies for inspecting seal integrity at high speeds and adapting drug-packaging technologies to food packaging. Many useful ideas can be borrowed from the drug-packaging realm, where manufacturers have to contend with a serious counterfeiting problem in addition to concerns about defense against tampering.

Increased funds are also being directed to FDA's Office of Drug Safety, which monitors the safety of drugs after they are on the market. A big part of the pressure on FDA in the wake of recent controversies over the safety of marketed drugs centers on this function, so it makes sense to beef up the agency's capabilities in this area. The agency has already announced that it is focusing new efforts on post-marketing safety trends.

FDA's new food-related efforts are intended to amplify the additional focus on thwarting and limiting the effects of food terror represented by new powers given FDA in the 2002 Bioterror Act. Chief among those new powers are new requirements for food-facility registration and prior notice for imports, and FDA's power to inspect documents and to detain foods if a threat to health is suspected.

Budgeting is always a hard process, but because FDA's role is so broad and multifaceted, it isn't even easy to get agreement on the simplest propositions about its proper role. The natural tension between FDA's police and protection function, and its product approval function, is always present, and affects its priority-setting. These days, there's less debate about the fact that safety is FDA's first job, at least in terms of protecting against terror. But, more and more people are asking whether FDA needs to focus more on protecting public safety within its product approval role, as well.

A budget proposal has a long road to travel until it is made final, full of contentious debates and heavy alterations. As the FDA's slice of the budget wends its way, keep an eye on the reference to packaging—let's see if anyone tampers with it.

Eric F. Greenberg is principal attorney with Eric F. Greenberg, PC, with a practice concentrated in food and drug law, packaging law and commercial litigation. Visit his firm's website at www.ericfgreenbergpc.com. Contact him by e-mail at [email protected], or by phone at 312/977-4647.

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