Imported Pharmaceuticals May Be Hazardous to Your Health

By Joseph J. Wang
JWang@central.uh.edu

A study here, a statistic there, and a concern everywhere exist regarding the rising cost of prescription drugs.  Particularly for elderly Americans, this trend spells big trouble.  Many elderly are on fixed incomes and struggle to pay for medicines out-of-pocket.  As drug prices rise, some could be forced to make such a precarious or potentially life-threatening choice as deciding whether to buy food or to buy prescription drugs.  And insurance coverage may be inadequate or non-existent.  Congress continues to struggle with adding a prescription drug benefit to Medicare.  Consequently, many Americans are turning to other countries to satisfy their pharmaceutical needs.

The Internet, mail order, and border pharmacies are the primary means by which American consumers secure pharmaceuticals from abroad.  Particularly with the increasing number of online pharmacies based in foreign countries, imported drugs are readily available and relatively cheap.  A USA TODAY survey found that the most popular drugs often cost two, three, even four times as much in the United States as in other industrialized nations. See http://www.usatoday.com/life/health/drugs/lhdru066.htm.

Although to allow Americans to purchase drugs at a cheaper price from a foreign market may appear harmless, personal importation of foreign drugs may be a threat to public health and safety.  Imported drugs may be contaminated, counterfeit, mislabeled, out-of-date, or the wrong dosage.  To illustrate the real-life dangers potentially associated with imported pharmaceuticals, the Honorable Billy Tauzin, chairman of the Committee on Energy and Commerce in the U.S. House of Representative, in his statement before his committee on July 7, 2001, provided several examples of the threat foreign drugs pose (See http://energycommerce.house.gov/107/news/06072001_270.htm):

The Federal Food, Drug, and Cosmetic Act prohibits the importation of pharmaceuticals not approved by the Food and Drug Administration (FDA) (21 U.S.C. § 381 et seq.).  The only exception is for drugs that are used to treat life-threatening conditions and are unavailable in the U.S.  The purpose of this law is to keep dangerous drugs out of the U.S.  Another purpose is to avoid the significant risks associated with taking many of these drugs without the continued oversight of a physician.  Unfortunately, these purposes are frustrated by the inability of federal agencies to enforce the law.  Although many packages are eligible for inspection, only a small fraction of packages ever gets inspected by the FDA or Customs Service.  Thousands of parcels are never examined and simply pass through.

Even the FDA acknowledges its inability to control the flux of imported drugs.  In its FY2000 Annual Performance Plan, the FDA reported that the FDA's ability to guarantee the quality and safety of all regulated products from domestic and foreign sources is declining in 1997 over $10 billion in pharmaceuticals and medical devices were imported into the United States from the European Union (EU). By the year 2000, FDA may be equipped to handle less than one inspection per $100 million in EU pharmaceutical exports.  See http://www.fda.gov/ope/FY00plan/intro00.htm#product%20safety%20initiative.

To address the ineffective drug inspection process for imported pharmaceuticals, the FDA recently proposed to block all drugs mailed from foreign addresses to the U.S.  The only exceptions are to allow drugs for life-threatening conditions not available in the U.S. and, under Controlled Substances Act (21 USCS §§951 et seq.), to permit U.S. residents to carry a limited amount of imported pharmaceuticals across the border for their personal medical use. See http://www.ama-assn.org/sci-pubs/amnews/pick_01/hlsa0625.htm.

Although its intentions are good, the FDA proposal may not be a viable option.  It would inevitably prevent many financially disadvantaged Americans from obtaining much needed prescription drugs.  Imported pharmaceuticals via mail may be the only way many Americans are able to pay for drugs.  And with the elderly population disproportionately affected by such a proposal, implementation may not be politically feasible.

All the problems associated with the importation of foreign pharmaceuticals could be avoided if we could provide cheaper pharmaceuticals at home.  No matter how hard we try, we may never be able to screen all pharmaceuticals coming into this country.  The demand for cheap drugs is overwhelmingly high.

The best solution in curbing the demand for foreign drugs is to develop strategies to make domestic drug pricing more affordable for Americans.  At the federal level, Congress could make drugs more affordable for the elderly by adding prescription-drug coverage to the Medicare program.  States can take the initiative as well.  For example, this year, the Texas Legislature passed H.B. 915, a law that would create an interagency council to coordinate and oversee the bulk purchase of pharmaceuticals by participating state agencies thereby driving down costs.

Obviously, finding ways to make pharmaceuticals more affordable may be as elusive as keeping foreign pharmaceuticals out.  Nevertheless, before we chose to put our health and lives in the hands of foreign border and cyber pharmacies, it behooves us to first look for a solution in our own backyard.

08/17/01