William K. Hubbard, Former FDA Associate Commissioner

"FDA remains concerned about the public health implications of personally imported prescription drugs and the introduction of counterfeit drugs into the stream of commerce. In our experience, many drugs obtained from foreign sources that either purport to be or appear to be the same as U.S.-approved prescription drugs are, in fact, of unknown quality.

On The Record:

“We are committed to continuously doing everything possible to show that the drugs and devices that Americans use are safe and effective. And in looking at the import problem, we have been unable to be certain we could assure that, even when they are labeled as having come from, what we would consider a reputable source like Canada, the product itself often is not, and is often coming from places other than Canada that we have absolutely no control or confidence in, or when analyzed are found to either not contain the active ingredient or to contain ingredients that are in effect harmful. We have no way of being able to assure the safety of reimports.”

- Excerpts from January 29, 2008 testimony of Dr. Andrew Von Eschenbach, FDA Commissioner, before the House Energy and Commerce Committee, Subcommittee on Oversight & Investigations.

“The problem of unapproved foreign drugs coming into the United States and being available to U.S. consumers concerns us deeply. These products include not only counterfeits, which are made by people who have concern for profit but not the health of their -- people who are consuming the drugs, but also substandard products which are -- contain the active ingredient in levels that are too low or too high or occasionally not at all, as well as contaminants and bad labeling.”

“I think the products come from all different types of sources, as we've reported in the past. We noted, for example, in intercepts of products coming in from four foreign countries -- India, Costa Rica, Israel and Vanuatu in the Pacific -- nearly half of the products coming in from those countries had documentation indicating that they were in response to orders placed by Americans on websites that purported to be Canadian in some form. And this is an inherently misleading practice. Who knows where the products actually originated from? Almost half again of those products had some documentation indicating that they came from a set of countries all over the world… This is an international market filled by people who are looking for a quick buck in trade of finished pharmaceutical products that have unknown origins, unknown handling, and are intrinsically unsafe, and consumers shouldn't be buying them.”

- Excerpts from September 26, 2007 testimony of Randall W. Lutter, FDA Acting Deputy Commissioner for Policy, before the House Energy & Commerce Committee, Subcommittee on Health.

“The Internet has created an extraordinary, unregulated marketplace for the sale of unapproved drugs, prescription drugs dispensed without a valid prescription, and products marketed with fraudulent health claims. Patients who buy prescription drugs from a rogue website are at risk of suffering adverse events, some of which can be life threatening. These risks include therapeutic failure due to lack of effect because the drug does not contain the correct dose or active ingredient and potential side effects from inappropriately-prescribed medications, dangerous drug interactions or drug contamination. Patients are also at risk because they often don’t know what they are getting when they purchase some of these drugs. Although some patients may receive genuine product, others may unknowingly receive counterfeit copies that contain inert or harmful ingredients, drugs that are expired and have been diverted to illegitimate resellers, or dangerous sub-potent or super-potent products that were improperly manufactured.”

“A survey conducted in January 2007 revealed that of the 462 drug products intercepted and examined at one international mail facility, over half were drugs that are available as FDA-approved generic drug products in the U.S. and are most likely cheaper in the U.S. than abroad."

- Excerpts from March 7, 2007 testimony of Randall W. Lutter, FDA Acting Deputy Commissioner for Policy, before the Senate Commerce Committee, Subcommittee on Interstate Commerce, Trade, and Tourism

“Even if personal importation is limited to Canada, the volume of imported drugs that could result from enactment of the personal importation provisions could overwhelm our already burdened system.”

“Currently, the volume of incoming packages is far beyond the ability of FDA and Customs to properly process. Codification of personal importation would merely exacerbate this problem, as we estimate that tens of millions of small drug parcels will enter the U.S. through international mail facilities and private courier hubs. Neither FDA nor Customs, at current staffing levels, would be able to inspect these packages.”

- Excerpts from May 20, 2004 testimony of John M. Taylor, FDA Associate Commissioner for Regulatory Affairs before the Senate HELP Committee.

“On February 12, the FDA took action against three additional Internet sites associated with sales of the counterfeit contraceptive patches. The FDA obtained the cooperation of the U.S.-based Internet service provider (ISP) in shutting down service to these websites. The counterfeit contraceptive patches were purported to be an FDA-approved product. Instead, customers received packages of patches without the active ingredient necessary to make the patches effective. Moreover, the counterfeits were sent in simple plastic zip-lock bags without identifying materials, lot numbers, expiration dates or any other labeling information needed to safely and effectively use this prescription product.”

On March 9, 2004, Hadi M. Ghandour, owner of Genapharm, Inc. of Austin, Texas, pled guilty to four counts of conspiracy to introduce misbranded and unapproved new drugs into interstate commerce, counterfeiting human growth hormone, and possessing controlled drugs with intent to distribute. Ghandour admitted to engaging in a conspiracy to sell unapproved, misbranded, counterfeit and Schedule I controlled drugs from 1999 to 2001.”

- Excerpts from March 18, 2004 testimony of William K. Hubbard, FDA Associate Commissioner for Policy and Planning before the House Government Reform Committee.

“FDA remains concerned about the public health implications of personally imported prescription drugs and the introduction of counterfeit drugs into the stream of commerce. In our experience, many drugs obtained from foreign sources that either purport to be or appear to be the same as U.S.-approved prescription drugs are, in fact, of unknown quality. FDA cannot assure the American public that drugs imported from foreign countries are the same as products approved by FDA.”

“FDA has long taken the position that consumers are exposed to a number of potential risks when they purchase drugs from foreign sources or from sources that are not operated by pharmacies properly licensed under state pharmacy laws. These outlets may dispense expired, subpotent, contaminated or counterfeit product, the wrong or a contraindicated product, an incorrect dose, or medication unaccompanied by adequate directions for use. The labeling of the drug may not be in English and therefore important information regarding dosage and side effects may not be available to the consumer. The drugs may not have been packaged and stored under appropriate conditions to prevent against degradation, and there is no assurance that these products were manufactured under current good manufacturing practice (cGMP) standards. When consumers take such medications, they face risks of dangerous drug interactions and/or of suffering adverse events, some of which can be life threatening. These risks could include potential side effects from inappropriately prescribed medications or side effects due to drug contamination.”

- Excerpts from June 24, 2003 testimony of William K. Hubbard, FDA Associate Commissioner for Policy and Planning before the House Energy and Commerce, Subcommittee on Oversight and Investigations.

“The FDA has serious concerns about proposals that would open America’s borders to a stream of imported prescription drugs for which FDA cannot assure safety, effectiveness or quality.”

“In the FDA’s experience, many drugs obtained from foreign sources that either purport to be or appear to be the same as U.S.-approved prescription drugs are, in fact, of unknown quality.”

“…Canadian health officials have made clear in public statements that they can provide no assurance as to the safety and authenticity of drug products shipped to Canada for resale in other countries. In fact, the Agency has concrete examples of drugs purchased from Canadian pharmacists that violate safety provisions established by FDA and by state pharmacy authorities, and we have seen instances of internet sites that offer to sell FDA-approved drugs, but upon further investigation we have determined that the drugs they sell are adulterated, sub-potent, or counterfeit.”

“The relatively “closed” regulatory system that we have in this country has been very successful in preventing unapproved or otherwise unsafe drug products from entering the U.S. stream of commerce. Legislation that would establish other distribution routes for prescription drugs, particularly where those routes traverse a U.S. border, creates a wide inlet for counterfeit drugs and other dangerous products that are potentially injurious to the public health and that pose a threat to the security of our nation’s drug supply.”

“…I remain concerned that provisions to legalize importation of prescription drug products would greatly erode the ability of the FDA to ensure the safety and efficacy of the drug supply. At this time, the Agency simply cannot assure the American public that drugs imported from foreign countries are the same as products approved by FDA, or that they are safe and effective.”

- Excerpts from June 19, 2003 letter to Senator Thad Cochran from FDA Commissioner Mark McClellan.

“We are very concerned that a system, if designed to be a different system than the current system, poses risks and we can not be assured that we could successfully implement such a system and bring in safe drugs because we do not have the same level of confidence about where it was manufactured, and how it was manufactured, and by whom it was manufactured, that we have under the current system.”

“From a public health standpoint, importing prescription drugs for personal use is a potentially dangerous practice. FDA and the public do not have any assurance that unapproved products are effective or safe, or have been produced under U.S. good manufacturing practices.”

- Excerpts from June 7, 2001 testimony of William K. Hubbard, FDA Senior Associate Commissioner for Policy, Planning and Legislation, testimony before the House Energy and Commerce Committee, Subcommittee on Oversight and Investigations.

Dr. Andrew Von Eschenbach, FDA Commissioner " In looking at the import problem, we have been unable to be certain we could assure that, even when they are labeled as having come from, what we would consider a reputable source like Canada, the product itself often is not, and is often coming from places other than Canada that we have absolutely no control or confidence in ... We have no way of being able to assure the safety of reimports."

“I think as we have listened to our Canadian counterparts—and it had already been a concern of our own—there is this whole issue driving Canada to somehow be used as a front port, if you will, for counterfeit or, in many ways, contaminated product becoming available. So…one has to be concerned about a safety issue here.” “The trackability of a pedigree of a drug is more than in question. Where did the bulk product come from? How was it manufactured? One is just put at increased risk when you do not know all of those things.” - Excerpts from March 7, 2000 testimony of President Bill Clinton’s FDA Commissioner Jane Henney before the Senate Agriculture Appropriations Subcommittee on March 7, 2000. Read More Here.