Texas has faced the problem of drug importation from Mexico for decades but in the last five to ten years the practice has escalated. It is estimated that from 25 to 40 percent of all U.S. residents who travel to Mexico bring back prescription pharmaceutical products. Many people repeatedly visit Mexico to obtain drug products for themselves, family and friends. There are many social, legal and medical issues to address, but the main concerns I have involve patient safety and lack of control.

The main reasons why U.S. residents go to Mexico to obtain their prescription drug products are: 1.) Easy Access, 2.) Lower Prices for Selected Products and 3.) Drug Product Not Available in the U.S. Plus, Mexican farmacias have done well in marketing their products via newspapers, internet, plus there many magazine articles have documented cheaper prices and easy access. The pharmaceutical business in Mexican border towns is a main tourist attraction and generates hundreds of millions of U.S. dollars to the Mexican economy. My concerns revolve the lack of medical supervision, the patient’s lack of understanding on how to use the product correctly and the indiscriminate use of products. Finally, I have a concern about the assurance of product quality. To me, all of these have a potential to harm, severely injure or kill people. The following recommendations are offered.

This option has many political, economic and social concerns. It may not be an option considering political climate and the NAFTA agreement.

The major problem between Mexico and U.S. on the pharmaceutical trade is the vast differences in regulation, education and professional pharmacy practice. Efforts need to be made to bring health care practitioners and officials together from both countries and develop a plan to try to harmonize the medical and pharmaceutical industries.

Try to control the personal import of controlled substances from Mexico. In my research, it was found that the most popular drugs coming across the border from Mexico at the Laredo border crossing were controlled substances and few elderly were the purchasers.

Develop a Public Educational Program on the Risks Associated with Foreign Medications

Currently, the public believes that just because a well-known U.S. based pharmaceutical manufacturers label is on the product the product is FDA approved. Nothing can be further from the truth. I recommend that a public education program needs to be developed warning them that this is not always the case. In addition, the public education program needs to address the risks of counterfeit drug products coming from foreign countries.

Provide assistance to US Customs and the FDA in developing programs to monitor the importation of foreign drug products. Data are lacking on the extent of pharmaceutical products are entering the U.S. from Mexico. They lack the pharmaceutical training, and expertise to identify potentially hazardous prescription drug products. In addition, they lack sophisticated computer technology to collect the needed data to properly monitor the extent of drug importation.

It is pleasure being here today to discuss the issue of the importation of pharmaceutical products. I have been involved with this area for close to a decade, but my involvement has been on the issue of Mexican prescription drugs entering the U.S. I find it striking that before internet pharmacy operations, it was difficult to get anyone’s interest and attention with the problems of importation of pharmaceuticals from Mexico, but now with the growing international pharmaceutical market via the internet concern for all methods of pharmaceutical importation has risen. I applaud you for taking on the task and looking in depth at the issues and problems created by the importation of pharmaceutical products. There are many social, legal and medical issues to address, but the main concerns I have involve patient safety and lack of control. People have been hurt and some have died due to the importation of pharmaceuticals. Unless we can find a better method of controlling the problem, more people will suffer.

As mentioned, Texas has faced the problem of drug importation from Mexico for decades but in the last five to ten years the practice has escalated. It is estimated that from 25 to 40 percent of all U.S. residents who enter Mexico bring back prescription pharmaceutical products. Many people repeatedly visit Mexico to obtain drug products for themselves, family and friends. It has also been documented that from one El Paso, Texas clinic serving US residents, over 80 percent of the patients go to Mexico to obtain their prescription drugs. If you want a full perspective of the size of this importation industry, I invite you to visit anyone of the Mexican border towns of Texas. Rows of farmacias line the streets of Nuevo Laredo, Juarez, Reynosa and Metamoras. Farmacias are a major tourist draw for the Mexican economy, especially border town economies.

The customer base for this industry is U.S. residents and it is huge; it is so huge that U.S. Customs struggles with just handling the volume of people. How do check 25,000 to 30,000 people who walk across one bridge and returning the same afternoon? And what about the vehicular traffic? Over a million vehicles cross and return from Nuevo Laredo each month. In 1997, over 7 million U.S. residents used the Laredo border crossing between Mexico and U.S.

The size of the retail pharmacy business enterprise in border communities is huge. For example, the estimated 1997 annual dollar volume for just the top 15 pharmaceutical products entering the U.S. from Nuevo Laredo was $134 million. This is a conservative estimated because it only assumed 25% of the U.S. residents entering Nuevo Laredo purchased pharmaceuticals. To get a better perspective, this $134 million makes up nearly 6 percent of the total Mexican pharmaceutical market and this was just for 15 products from one border city. Another view is to look at the volume of drugs. Our research documented a conservative estimated of over 11,000 Valium® tablets were coming across from Nuevo Laredo per day by U.S. residents in 1995. I have do not believe this number has decreased, in fact I tend to think that it has increased.

Don’t be thinking that this is a Texas problem or a California, Arizona or New Mexico state problem, because my research documents that 41 percent of males and 27 percent of the females who purchased prescription drugs in Nuevo Laredo were NOT from Texas; we found that these U.S. residents were from 37 states; some were as far away as Washington, Maine, Minnesota and Massachusetts. The Mexican pharmaceutical importation practice has been an ongoing problem and affects more than just border states and communities.

There are many reasons why U.S. residents visit Mexico to purchase pharmaceuticals. The main reasons why U.S. residents obtain their pharmaceuticals from Mexico are: 1.) EASY ACCESS TO PHARMACEUTICALS, 2.) LOWER PRICES FOR SELECTED DRUG PRODUCTS and 3.) THE DRUG PRODUCT IS NOT AVAILABLE IN THE U.S.. Also, farmacias have done well marketing their products to tourists. They have internet sites, they have put ads in newspapers papers and there have been many magazine and newspaper articles which describe the process and document the cost savings. Few of these articles describe the legal problems nor do they describe the drug safety problems and risks. Let me take a minute to talk about each of these reasons.

Most prescription drug products in Mexico are sold as over-the-counter products. You can purchase antibiotics, high blood pressure medications, heart medications, gastrointestinal medications, antihistamines, birth control pills, plus many other pharmaceutical products without needing a prescription. These products are sold like candy bars and gum are sold in the U.S. In fact, if you do not know the name of the product you want, many of the farmacias will have a U.S. Physician Desk Reference on the counter for reference. This compendium list all drugs available in the US. So you can look up the drug you want and the farmacia clerk will try to find the Mexican drug equivalent or a similar product. Many times there is no Mexican equivalent available. Also, please note there are no prescription drug labels as we have in the U.S. No drug directions for use are given, all the products are labeled with the manufacturer’s label in Spanish.

Controlled drug substances in Mexico do need a prescription written by a physician practicing in Mexico. However, this requirement is no barrier to purchasers of controlled substances. Some Mexican physicians in border towns have established their practice just to provide prescription for U.S. customers. In fact, they have developed business relationships with neighboring farmacias.

Some Mexican prescription pharmaceuticals do have a lower price with many have a substantial lower price. However, not all Mexican drug products have a lower price and for many products the U.S. prices are very competitive, especially when you compare prices of antibiotic therapies or generic drug prices. For example, the price of Dimetapp® 12 capsules in Juarez Mexico is $16.15 while the price in the U.S is $6.85. Claritin D®, 12 capsules in Juarez is $16.38, in the U.S. it is $19.75. An example, of a major difference in price of Vasotec® 10mg in Juarez is $16.24 and the price in Austin Texas is $47.88. Overall, prices are cheaper in Mexico, but it is product dependent. The perceived major differences in prices do draw many people to Mexico to purchase pharmaceutical products, especially for those people who do not have limited funds such as those on a fixed income, retired or lack prescription drug insurance coverage.

As mentioned, some Mexican pharmaceutical products are NOT available in the U.S. Either the manufacturer decided not to market the product or in some cases the product does not have FDA approval. Examples of Mexican products not available in the U.S. are Asenlix® (clobenzorex a stimulant product),Chloromycetin® (Chloramphenicol®, antibiotic), Ponderex® (fenfluramine, weight reduction), and Rohypnol® (flunitrazepam, sedative hypnotic). Also, some Mexican products are combination products which are not available in the U.S. For example, the product Qual® contains acetaminophen 200mg, Valium® 2mg, and Darvon® 50mg. Except for products banned from the U.S., Customs officials do allow people to bring into the U.S. pharmaceutical products which are not available in the U.S. as long as the patient has proper documentation for using the product. In addition, if people begin a drug therapy in Mexico, they are allowed to import the continuation of such therapies to the U.S.

As mentioned earlier, I have some grave concerns about patient safety and the use of Mexican pharmaceuticals. My concerns revolve the lack of medical supervision of the patient’s therapy, the patient’s lack of understanding on how to use the product correctly and the indiscriminate use of products. Finally, I have a concern about the assurance of product quality. To me, all of these have a potential to harm, severely injure or kill people.

First, the vast majority of Mexican drug products are NOT FDA approved. There are only a handful of products made in Mexico which have an FDA approval and most of these are bulk products and not finished goods. Based on this fact alone, the vast majority of people who enter the U.S. from Mexico with a prescription pharmaceutical product are in violation of U.S. law. The key point I want to make here, is that U.S. customers of Mexican pharmaceuticals need to be informed that foreign made versions of U.S. approved drugs may not have been manufactured in accordance and pursuant to FDA. In other words, the products may not be the same.

The health concern I have is when a U.S. resident, who is successfully being treated and is stabilized on a U.S. manufactured drug product, goes to Mexico obtains what he/she considers to be the identical product, but it is not. The potential harm is great depending on the therapeutic agent and the clinical outcome. Switching back and forth from U.S. made product to Mexican product may be dangerous, especially for those products which have a narrow therapeutic index.

My second concern is the indiscriminate use of prescription products, especially antibiotic products, but other therapeutic agents are also affected. The indiscriminate and self-medication use of antibiotics increase the problem of antibiotic resistance. This has already been documented with the high antibiotic resistance rates for tuberculosis in Mexican border cities. Some U.S. residents visiting Mexico purchase tetracycline, penicillin and erythromycin like candy bars. They save the products and self-treat themselves, family members and friends. Also, with self-treatment, medication compliance is usually lower which contributes to the antibiotic resistance problem. The lack of understanding and the poor use of pharmaceutical products has the potential of seriously affecting the health of many.

As mentioned earlier, when U.S. customers purchase Mexican drugs little if any information is given to the customer as to how to use the product. There are no drug labels giving directions for use and the labels are written in Spanish which may be of no value to some. Thus, the opportunity to learn about the Mexican product is limited. This can be very dangerous for those who want to "try-out"a new product. Final note, few farmacias have a college educated pharmacists on there staff. In fact, farmacias which do not sell controlled substances are not required to have a college educated pharmacists on their staffs. Most farmacias are staffed with clerks, thus limiting the customer’s opportunity to get competent help and information about the medication. Even if the farmacias does provide controlled drugs, there is no requirement that a college educated pharmacist must be present. As a side note, upon returning to the U.S., many Mexican drug purchasers visit U.S. pharmacists and inquire as to how to use the products purchased in Mexico.

The recommendation I want to make is to ban the import of all non-FDA approved pharmaceuticals from foreign countries. Basically, this recommendation is asking for the enforcement of the current written law (Federal Food Drug and Cosmetic, 21U.S.C. Section 331). I realize that this is a difficult political decision, especially with the elderly contingent and those who do not have the financial resources to purchase therapeutic remedies. It would also cause international political problems, especially with Mexico and the NAFTA agreement.

I believe the major problem between Mexico and U.S. on the pharmaceutical trade is the vast differences in regulation, education and professional pharmacy practice. Efforts need to be made to bring health care practitioners and officials together from both countries and develop a plan to try to harmonize the medical and pharmaceutical industries. U.S. residents have been using the Mexican health care system for decades. However, currently, more U.S. residents are taking advantage of and abusing the Mexican health care system for personal gain. Medical and pharmaceutical regulations and practice behaviors within the border communities need to be examined and perhaps modified on both sides to better provide patient care. This is a long term approach and will take a lot of effort, but it is a positive step forward.

While waiting for the long term approach in addressing the professional and regulatory climate between the two countries, my recommendation would be to try to control the personal import of controlled substances from Mexico. In my research, it was found that the most popular drugs coming across the border from Mexico at the Laredo border crossing were controlled substances. All of the15 most frequently declared products entering the U.S. were controlled substances. These included narcotic analgesics (Neopercodan, Nuban Tylex), tranquilizers (Valium), sedative/hypnotics (Rohypnol, Qual, Halcion), stimulants (Ritalin, Tenuate Dospan, Diminix, Aselix) antipsychotic/antianxiety (Antivan), and muscle relaxant (Somalgesic). What alarmed me the most was that the vast majority of these products were imported by people under 35 years of age. If you are worried about the impact such a recommendation would have on the elderly, I can say that few elderly purchase controlled substances in Mexico. My study found that only 0.6 percent of all controlled substances entering the U.S. were carried by someone over 65 years of age.

Although I have not compared the prices of controlled substances between the U.S. and Mexico, it is my belief that the cost differences are small, mainly because most controlled substances in the U.S. are available in generic form. My personal feeling is that much of the controlled substances entering the U.S. are for recreational use and sold on the streets, but I have no data to support the belief. I just question why so many youths travel to Mexico and bring back so many stimulants, tranquilizers and narcotics. Basically, this recommendation calls for a cost-benefit analysis. Does the benefit of allowing the legitimate use of controlled substances from Mexico outweigh the black market and detrimental and addiction effects of recreational drug use? Personally, I do not think so.

Last month I spent a Saturday in Laredo assisting the FDA in collecting data on the type and amount of pharmaceuticals coming across from Nuevo Laredo. I really did not see many changes, of course I saw no Rohypnol®, but I did see tranquilizers (Valium®) and narcotic analgesics( Neopercodan® and Oxycotin®) and most of these were being carried by males in their 20s or 30s.

My second recommendation is for the development of a major public educational program informing the public about the potential problems which may result with the use of Mexican pharmaceuticals or foreign made non-approved drug products. Currently, the public believes that just because a well-known U.S. based pharmaceutical manufacturers label is on the product the product is FDA approved. Nothing can be further from the truth. Drug labels in Mexico are similar in size, type, color and style with the U.S. and when the consumer sees Eli Lilly, Pfizer, or any other manufacturer’s label they assume it is a FDA approved product. I recommend that a public education program needs to be developed warning them that this is not always the case.

In this recommended educational program, the threat of counterfeit medications from Mexico needs to be highlighted. Recent reports have documented the increasing risk and threat of counterfeit medications coming into the U.S. from Mexico. The public needs to be aware of the problem and the potential risk. In my opinion, I think the threat of counterfeit medications will continue to increase with the high prices of pharmaceuticals. We need to develop better and cost-effective surveillance techniques.

My last recommendation is to provide assistance to US Customs and the FDA in developing programs to monitor the importation of foreign drug products. Data are lacking on the extent of pharmaceutical products are entering the U.S. from Mexico. I have worked with Customs agents in Laredo and they are overburdened with this problem. The number of people crossing the border is tremendous. In fact, in my opinion they are begging for assistance. They lack the pharmaceutical training, and expertise to identify potentially hazardous prescription drug products. In addition, they lack sophisticated computer technology to collect the needed data to properly monitor the extent of drug importation. They are still using the handwritten form method. New computerized methods need to developed to improve the efficiency and effectiveness of their enforcement for prescription drug products.

Thanks for asking my input. I’ll be glad to work with you and other governmental officials to explore our opportunities to assure quality care and patient safety on the procuring and use of pharmaceutical products. Thanks for this opportunity.