IMPORTING DRUGS SAFELY -- HON. JOHN D. DINGELL (Extensions of Remarks - July 11, 2000)

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HON. JOHN D. DINGELL OF MICHIGAN IN THE HOUSE OF REPRESENTATIVES Tuesday, July 11, 2000

Mr. DINGELL. Mr. Speaker, last evening I voted against the prescription drug import amendments offered by my good friends and colleagues Representatives CROWLEY and COBURN. I want my colleagues to know that I
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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.

Equally alarming are the findings of a hearing held just last month by the Subcommittee on Oversight and Investigations on the potential dangers of counterfeit bulk drugs, and the global problems they pose. Chairman UPTON, in his opening statement, said: ``[t]he international community is also increasingly concerned. Just last month, the World Health Organization and international pharmacists and international drug manufacturers publicized their concerns about counterfeit drugs. Some have estimated that 50 to 70 percent of the drugs in some developing countries are counterfeit.'' Why is it that we don't believe these drugs can find their way into countries where U.S. consumers may wish to purchase their medications? This is particularly troubling given the FDA's confirmation later in the hearing to Representative BURR that it has information that there were injuries to American citizens associated with counterfeit products.

Chairman BLILEY has also documented potential serious dangers with drugs from foreign sources. In a lengthy May 8, 2000, letter to FDA Commissioner Henney he suggests that not only have Americans possibly been injured or even killed from foreign-made pharmaceuticals, but that ``[d]evelopments from this investigation require the Committee to intensify its examination and request that the FDA consider taking certain actions to protect the American public.''

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.

Mr. Speaker, I do want to acknowledge beneficial aspects of the amendments to which these comments are addressed. An overwhelming majority of my colleagues from both sides of the aisle are now on record for the proposition that the price Americans pay for prescription drugs is too high. Lack of access to medically necessary prescription drugs is a real problem faced by millions of Americans. Let us do better and give consumers access to lower priced prescription pharmaceuticals that are safe.
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