September 29, 2000

The Honorable Jane E. Henney, M.D.
Commissioner
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857

Dear Dr. Henney:

Recently, Committee staff traveled to Laredo, Texas, to meet with U.S. Customs Service and U.S. Food and Drug Administration (FDA) officials, in order to discuss a range of issues relating to U.S. citizens traveling to Mexico to purchase pharmaceuticals. Specifically, staff was interested in knowing (1) the sources and quality of the drugs being purchased at border pharmacies; (2) the types of pharmaceuticals being declared at the U.S.- Mexican border; and (3) what FDA and U.S. Customs’ interpretations are regarding current policies that allow for some drug importation for personal use.

Thousands of U.S. residents cross into Laredo each week and many use such excursions to purchase pharmaceutical products from the numerous conspicuous pharmacies that exist on the Mexican side of the border. During this visit, the U.S. Customs Service provided staff a copy of the most recent policy regarding personal-use reimportation guidance. As outlined in a June 29, 2000, memorandum, this policy allows a U.S. resident to bring into the U.S. potentially significant quantities of controlled substances without any requirement that the citizen possess a valid prescription, or any proof that the citizen is under the care of a licensed practitioner. As taken from the June 29 memorandum, current policy reads as follows:

"In summary, the controlled substances must be declared to Customs upon arrival, be for that individual’s personal use, and be in their original container. If all these conditions are met, a United States resident may import the type and amount of the controlled substance (except those in Schedule I or other prohibited substances) as specified on the prescription.... If the controlled substances are declared, but the United States resident does not possess a valid prescription issued by a practitioner as defined above, the United States resident may bring in only an amount not to exceed 50 dosage units. Remember that the 50 dosage units amount applies to each type of controlled substance being imported. In other words, if the resident is importing 3 different types of controlled substances, the resident may import up to 50 units for each type for a total of 150 dosage units...."

As part of this visit, Committee staff also met with Dr. Marvin Shepherd of the College of Pharmacy at the University of Texas. In 1996, Dr. Shepherd completed a study entitled, "Examination of the Type of Pharmaceutical Products Being Declared by U.S. Residents Upon Returning to the U.S. From Mexico at the Laredo, Texas, Border Crossing." That analysis focused on the types of pharmaceuticals being reimported by U.S. citizens from one specific location on the border by examining declaration forms. Given the apparent laxity of the reimportation policy as applied to potentially dangerous drugs, some of the findings in this study raise troubling questions. Several excerpts from the executive summary of Dr. Shepherd’s analysis are as follows:

"A total of 5,624 declarations were analyzed.... The average age of people who completed the declaration forms was 34.5 years. Males were found to be younger than females (33.2 years versus 34.8 years). The median age for males was 33 years, and for females it was 35 years. People over 50 years of age only represented 9.3 percent of the sample and people under the age of 40 represented over half the people declaring drug products. Thus these findings do NOT support the assumption that the majority of people who purchase pharmaceutical products in Mexico and declare the products at the U.S. Customs port of entry are elderly."

The report then goes on to note following:

"There was an average of 2.48 drug products listed on each claim form. The top 15 drug products listed by number of people declaring a product was as follows: 1. Valium, 2. Rohypnol, 3. Tafil, 4. Tenuate Dospan, 5. Neopercodan, 6. Diminex, 7. Asenlix, 8. Tylex, 9. Darvon, 10. Nubain, 11. Qual, 12. Halcion, 13. Ritalin, 14. Ativan, and 15. Somalgesic. Valium was claimed by 69.8 percent of the people and another benzodiazepine, Rohypnol was declared by 42.6 percent of the people. All the products in the top 15, except Solmalgesic, are classified in the U.S. as "controlled" substances. These results show that the most popular drugs being declared are sedative/hypnotics, antianxiety agents, stimulants and narcotic analgesics."

"Less than two percent of the declared products were for the treatment of cardiovascular problems and only 42 claims out of the 5,624 claims were for an antiulcer agent. Only 96 declaration forms had an antibiotic or antifungal agency listed. Thus, it can be seen that drugs being brought across the border and being declared were not for people who suffer from chronic health conditions such as hypertension, ulcers or cardiovascular problems."

Finally, the report indicates that at least at the time of the study,

"... on average, 11,000 Valium tablets were being declared a day; this extrapolates to approximately four million Valium tablets per year. For Rohypnol, over four thousand tablets were found to be declared each day and this extrapolates to 1.5 million tablets a year coming into the U.S. These two examples point out that large numbers of pharmaceutical products are being allowed into the U.S. And, when one realizes that many of these products have tremendous abuse potential and some are not even approved by the FDA for use in the U.S., the seriousness of the issue becomes more pronounced."

Because this study was published in 1996, certain of the above findings may be different today than when the study was first released. For example, Rohypnol is now a prohibited substance, and thus would not be allowed into the U.S. Nonetheless, as present policy now allows an individual to bring 50 dosage units of many other controlled substances across the border, it is unclear whether the quantity of the controlled substances being transported into the U.S. has fallen, remains the same, or has even increased.

For example, presently, an individual could legally bring in 300 doses of various controlled substances, as long as these were divided into 6 separate drug-types. And as neither the FDA nor the Customs Service appears to track the frequency by which persons are bringing such drugs into the U.S., one could imagine that several trips a week could be made by certain individuals and thus the number could be higher. Most of the controlled substances listed above are available in the U.S. and are relatively inexpensive, so one must question exactly what this policy is designed to achieve. Do individuals really need 50 Valium tablets between the period of when they first reenter the U.S. and the time they see their doctor? What would the logic be for a traveler needing 150 pills of various controlled substances?

I also remain somewhat confused by how the FDA’s personal use policy can operate simultaneously with the U.S. Customs Service directive. Which policy actually governs? Under the Food, Drug, and Cosmetic Act, individuals are not allowed to re-import pharmaceuticals into the U.S., unless certain strict conditions are met. That guidance, as posted on FDA’s Website, states that FDA should not consider taking enforcement actions against importation for personal use,

"when 1) the intended use [of the drug] is unapproved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means; 2) there is no known commercialization or promotion to persons residing in the U.S. by those involved in the distribution of the product at issue; 3) the product is considered not to represent an unreasonable risk; and 4) the individual seeking to import the product affirms in writing that it is for the patient’s own use (generally not more than a three month supply) and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product or provides evidence that the product is for the continuation of a treatment begun in a foreign country."

Because virtually all of the drugs cited in the above study have "approved" versions of their formulation available in the U.S., it is unclear how an individual can transport such controlled substances into the U.S. under FDA’s own policy. Does the guidance, as issued by the U.S. Customs Service, simply nullify FDA’s guidance? If so, how does the U.S. Customs Service take into consideration the fact that many of these substances are apparently arriving at the border in misbranded or mislabled containers, which makes such drugs in violation of the FD&C Act? Also, does the U.S. Customs guidance consider the fact that the agency has no evidence or guarantee that many of the above products are made in facilities that meet current good manufacturing practices? What is also unclear is why one directive, issued by the Customs Service, allows a traveler to bring in potentially dangerous substances without a prescription, and yet the other policy, as outlined by FDA, requires that some proof be given that the importer is under the care of a licensed practitioner or provides evidence that the product is for the continuation of a treatment begun in a foreign country. Why the difference? Which agency’s policy takes precedence at the U.S. - Mexican border?

I am concerned that, in their present form, these practices may be facilitating the easy entry of substances that cause serious harm when not taken under the supervision of a licensed practitioner. Moreover, I am troubled by the general confusion and differing interpretations staff has found in the implementation of U.S. policy on the importation of pharmaceuticals for personal use. I would therefore ask you to address the following questions:

(1) Please explain the personal use guidance policy that is now being followed at the Mexico-U.S. border. It is unclear whether FDA’s policy is the standard or whether the policy as outlined in the June 29 Customs Service memorandum (or a combination of the two) is the policy now in place at the border. Please also explain the origin of this policy (whichever one is used) and how it comports with the various import prohibitions under the Food, Drug and Cosmetic Act. Also, does FDA believe the June 29 Customs Service guidance is consistent with the original intent of FDA’s personal use import guidance? Please explain.

(2) Has FDA conducted a study similar to that of Dr. Shepherd’s that attempts to determine (1) the average age of persons visiting Mexico to purchase prescription drugs, and (2) types of drugs being declared at the U.S. border for reentry under the above-cited U.S. Customs policy? If so, please provide such findings.

(3) Of the 15 drugs outlined in Dr. Shepherd’s study, please provide a brief description of (a) the drug’s typical pharmacological use (for what conditions it is generally prescribed); (b) whether a generic version of the drug exists today; (c) the average cost of the drug in the U.S. (please provide the average brand name price and the price for the generic version if one exists); and (d) whether 50 dosage units of the drug would be considered a "three month supply" under FDA’s application of its own personal use guidance policy.

(4) Does FDA believe that the present policy, as outlined by the June 29, 2000, memorandum, creates a significant opportunity for controlled substance abuse by U.S. residents? Has FDA conducted any analysis to attempt to measure the abuse potential of this policy? Please discuss any analysis FDA has undertaken in this regard.

(5) Does FDA believe that the findings of Dr. Shepherd’s study, which focuses on the Laredo, Texas, border crossing, have application to other border communities in Texas, or in other border states such as California, Arizona, and New Mexico? Does FDA have any basis to make such a judgment?

(6) Are there any age restrictions on those individuals allowed to bring controlled substances into the U.S. without a prescription? Under the June 29 memorandum cited above, there does not appear to be a specific age limitation involving importation. Committee staff was told that many college students travel to Mexico to purchase drugs for "recreational use." Please indicate what the policy is regarding age limits and in which guidance documents this is set forth.

(7) It is my understanding that, under Texas law, controlled substances cannot be brought into the State without a valid prescription. Nevertheless, Customs’ guidance policy says that, as a general rule, Customs Officers "will not initiate reports of violations to state authorities." Does FDA have any formal effort to coordinate such policies with Texas officials? If so, please describe them.

(8) What is the quality of the drugs being purchased in Mexico and brought back into the United States? Are they of the same quality drugs manufactured in the United States? Do they pose any risks to the U.S. consumer? If so, please explain any analysis FDA may have undertaken in this regard and what risks, if any, may be posed.

(9) It does not appear that FDA or the Customs Service has any formal mechanism to track the frequency or the volume of drugs being imported by any individual. Please explain how the Customs Service and FDA assess whether present personal use guidance policies are being abused by the frequency in which drugs are being imported by U.S. residents.

Thank you for your cooperation with this request. I ask for your response to these questions by no later than Monday, October 30, 2000. If you need any further information, please have your staff contact Mr. Christopher Knauer of the Commerce Committee Democratic staff at (202) 226-3400.

Sincerely,

JOHN D. DINGELL
RANKING MEMBER

cc: The Honorable Tom Bliley
Chairman, Committee on Commerce