[Congressional Record (Bound Edition), Volume 146 (2000), Part 10]
[Extensions of Remarks]
[Page 13844]
[From the U.S. Government Publishing Office, www.gpo.gov]



                         IMPORTING DRUGS SAFELY

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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 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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