Mr. Speaker, I must oppose this bill. Although there are many very good provisions addressing major agricultural needs, there is also a very dangerous provision that would allow for the reimportation of prescription drugs from foreign sources. That is something I cannot support.

During the 1980's, the House Energy and Commerce Committee conducted a lengthy investigation into the foreign drug market that ultimately led to enactment of the Prescription Drug Marketing Act (PDMA). That investigation discovered a potentially dangerous diversion market that prevented effective control over the true sources of drug products in a significant number of cases. The distribution system was vulnerable to the introduction and eventual retail sale of substandard, ineffective, or even counterfeit pharmaceuticals. As the resulting Committee report stated, "pharmaceuticals which have been mislabeled, misbranded, improperly stored or shipped, have exceeded their expiration dates, or are bald counterfeits are injected into the national distribution system for ultimate sale to consumers."

The PDMA was designed to restore needed integrity and control over the pharmaceutical market, eliminating actual and potential health and safety problems before injury to the consumer could occur. Again, the Committee report was clear on why the PDMA was needed:

"[R]eimported pharmaceuticals threaten the public health in two ways. First, foreign counterfeits, falsely described as reimported U.S. produced drugs, have entered the distribution system. Second, proper storage and handling of legitimate pharmaceuticals cannot be guaranteed by U.S. law once the drugs have left the boundaries of the United States."

I find nothing today that suggests that the problem with misbranded, adulterated, or even counterfeit foreign drugs has been solved, and if anything, the problem may be getting worse. I am thus concerned that in our haste to find a way to bring cheaper drugs to seniors and other needy Americans – a clearly important and laudable goal – we risk making changes to key health and safety laws we may later regret.

On October 3, 2000, the Subcommittee on Oversight and Investigations held a hearing that underscored that the Food and Drug Administration (FDA) is already overwhelmed and underfunded, and thus unable to consistently undertake the many tasks now required to protect the U.S. drug supply. At that hearing, FDA Commissioner Jane Henney testified that FDA has insufficient post-market surveillance resources to keep pace with its current mandate. Consequently, the agency is lagging in conducting inspections of firms that ship drug products to the U.S., and this burden is only going to worsen in the future.

The legislation in question today only exacerbates this already-serious problem. As envisioned by this proposal, FDA will newly be responsible for inspecting the entire custody chain between all parties and processes involved in the shipment of drugs back to the U.S. market This could include repackaging and relabeling facilities, as well as the many storage firms that might be used in this process. This proposal would also ultimately require FDA to oversee the formation of new testing facilities, and develop regulations to address numerous safety concerns ignored by this proposal. In short, the reimport legislation will inundate an already overburdened FDA with new responsibilities. Worse, it will do so without any assurances that the agency will ever see the approximately $92 million it claims it needs to fully implement this plan. Instead, the bill only gives $23 million for a single year, or one-fourth of what the plan will ultimately require. Given the fact that the agency is already significantly underfunded, I see almost no chance it will see this money.

But even if Congress were to provide the additional resources, I remain skeptical that FDA could even construct a global regulatory framework as safe as what is now in place. FDA was unsuccessful in preventing counterfeit and substandard drugs from entering the U.S. before the Prescription Drug Marketing Act (PDMA) went into effect, and so I doubt it will be successful once many of its protections are undermined by this legislation.

Moreover, it is particularly troubling that drug prices may not even be significantly lowered as a result of this proposal. There is nothing that guarantees that in this process of undermining our current regulatory system, lower priced drugs will become available to needy Americans. Wholesalers may not pass on any accrued savings to the public, nor is it clear that they will necessarily be able to access a steady supply for resale. In fact, this bill is riddled with numerous loopholes that will allow manufacturers to label or produce their products in a form that makes them either impossible or cost-prohibitive to reimport The notion that this bill will create an abundance of cheap, properly labeled, and properly repackaged drugs, easily available to reimporters, is simply false.

Finally, Mr. Speaker, this bill makes long-term changes to the Food, Drug and Cosmetic Act, without the benefit of even a single legislative hearing. During the 1980's, the Energy and Commerce Committee conducted a lengthy multi-year investigation resulting in numerous hearings before any related legislation was drafted. There have been no public hearings regarding this legislation, as most of this process has involved closed-door proceedings. With the many implications this legislation will have on public health and safety, this process has ill-served the public and is indefensible.

In conclusion, this provision represents the flawed implementation of a risky concept. Many of the Members supporting this legislation believe they are doing the right thing by helping Americans get access to cheaper medicine, and assume that medicine will, in fact, be safe. I agree that medicine needs to be cheaper, but disagree that reimported medicine will be as safe. We know too much about the kinds of drug manufacturing and distribution shenanigans that take place in other parts of the world to allow our system to be jeopardized by the legislation contained in this spending bill. It is flawed legislation that will, if passed in its present form, result in significant harm to the very persons we are trying to help. Thus, I cannot support this bill.