Mr. Speaker, last evening I voted against the prescription drug import amendments offered by my good friends and colleagues Reps. Crowley and Coburn. I want my colleagues to know that I wish to work with them to craft legislation that achieves the goals they seek, while ensuring that the prescription drugs that Americans consume are as safe as possible. I see no reason why the Commerce Committee cannot roll up its sleeves and mark up good legislation for presentation on the House floor shortly after the August recess.

Mr. Speaker, the Crowley and Coburn Amendments block a key provision of the Prescription Drug Marketing Act (PDMA). This law came into being after an investigation revealed serious irregularities with respect to imported drugs. As stated in the April 1987 report of the Commerce Committee, "[t]he purpose of the legislation is to protect American consumers from mislabeled, subpotent, adulterated, expired, or counterfeit pharmaceuticals..."

Recent investigations of Internet web sites indicate there is still cause for concern. In fact, the U.S. Customs Service recently reported a more than 400 percent increase in the amount of pharmaceuticals being shipped into this country via the U.S. mail, and that in many cases, the origin, purity, or history of the drugs being shipped is indeterminable. These are drugs with major health implications. A May 22 letter from Commissioner Kelly addressed to me and Representative Klink noted the following: "[a]mong the most common types of pharmaceuticals seized by Customs are Diazepam; Tylenol with Codeine; Mathandienone; Alprozolam; Xanax; Valium; Codigesic; Lorazepam; Fenfleuramine; Thyroid tabs; Panzatazocine; Cetabon; Andriol; Premarin; and Rohypnol, a powerful sedative sometimes described as a ‘date rape’ drug." Commissioner Kelly said that "[i]n most of the mail seizures that Customs encounters, the brand name and manufacturer of the products are not identifiable because the original packaging has been removed and repacked into containers that bear no marks or identification." These are the same sorts of mislabeling and repackaging shenanigans that the Subcommittee first identified when it investigated this issue more than a decade ago, and led to the PDMA.

First and foremost, the PDMA is a public health and safety law. We should therefore tread carefully before changing it. I am greatly concerned that the amendments adopted by the House lack the care and craftsmanship needed to ensure both access to less expensive prescription drugs and assurance of safety for the consumer.

The investigation that led to the PDMA discovered a "diversion market" that prevented effective control over the true sources of merchandise in a significant number of cases. The integrity of the distribution system was insufficient to prevent the introduction and eventual retail sale of substandard, ineffective, or even counterfeit pharmaceuticals. As the 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 the integrity and control over the pharmaceutical market necessary to eliminate actual and potential health and safety problems before serious consumer injury results." The Committee report specifically outlined the concerns PDMA was intended to address: "Reimported pharmaceuticals threaten the American 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." The PDMA is not perfect. But I dare say that the PDMA has saved a lot of lives.

Now let us note why legislation to modify the PDMA in a responsible fashion is an idea whose time has come. Foreign drugs are often less expensive than domestically available products. Notwithstanding the range of safety risks they pose, many Americans seek them out because of outrageously high domestic prices that make drugs unaffordable for many Americans, particularly the elderly. I am open to a careful review and revision of PDMA for the purpose of creating a paradigm for drug importation that is safe for our consumers while facilitating access to the international market prices at which many commonly prescribed prescription drugs are available.