Speech by U.S. Rep. James C. Greenwood:

Over the last five years, several factors, including the advent of Internet pharmacies and the globalization of the pharmaceutical market, have led to a dramatic surge in drug imports (especially personal imports) that have overwhelmed the FDA. These factors have made FDA’s system of import controls, more and more untenable. Two years ago, at the same hearing with the Rode’s, FDA testified that approximately 2 million packages containing drugs were imported into the U.S. every year. FDA complained that they simply did not have enough staff to inspect those packages. In 2001, FDA could not tell the Subcommittee what percentage of those packages contained legitimate vs. counterfeit product, determine the country of origin or describe the conditions under which the drugs were manufactured. In short, FDA could tell us very little about the 2 million packages of drugs that were being imported. Very little has changed since our hearing in 2001 other than the volume of drugs.

According to a senior supervisory Customs inspector, the mail facility in Miami, Florida, routinely receives about 30,000 pharmaceutical shipments weekly, often from South and Central America, Canada, Europe, the Bahamas, and Mexico. Packages containing pharmaceutical products account for nearly one-third of the total volume of packages. Thus, under this estimate, Miami would receive approximately 150,000 packages containing pharmaceuticals weekly, 600,000 monthly, and approximately 7 million packages containing drugs annually.

According to data provided by Customs, every month approximately 5 million packages enter the commerce of the U.S. or 60 million packages annually. If the estimate from Miami is extrapolated nationally, 20 million packages containing pharmaceutical products are imported into the U.S every year. This is an increase of over 1000% in 2 only years.

As this Subcommittee has heard ad naseum, drugs procured outside the United States regulatory system can be dangerous for numerous reasons. FDA acknowledges that it cannot monitor or guarantee the safety and effectiveness of drugs purchased outside the closed U.S. distribution system. FDA has warned the public that drugs purchased from foreign countries could be counterfeit, cheap foreign imitations of FDA-approved drugs that could be sub-potent or super-potent, expired drugs, contaminated drugs or drugs stored under unsafe conditions. At this Subcommittee’s June 7, 2001, hearing, which highlighted the public health concerns that these drugs pose to the American people, FDA proposed to the Department of Health and Human Services that it eliminate its personal use policy for mail imports, allowing FDA and Customs to deny entry of all these illegal drugs into the U.S. and return them to sender. No action has been taken on the proposal. This is perhaps understandable given the apparent split in public and political opinion on personal reimportation policy.

Why are U.S. consumers playing Russian roulette with their medications by purchasing them over the Internet from unknown sources? The fact is that the skyrocketing prices of medications are increasingly out of the reach for too many of our seniors and nearly all those on fixed incomes. Some of the seniors, who testified at our Oversight hearing in Mr. Deutsch’s District in March, stated that they often forgo other essentials in order to purchase their necessary medications. In a country as wealthy as ours, we must do better. It is my sincere belief that the Medicare reform bill that this Committee passed last week will ensure full access to and the affordability of pharmaceuticals. However, the fact remains that when consumers purchase drugs over the Internet for whatever reason, they are taking a leap of faith with their health because there is no guarantee that the drugs they are purchasing are legitimate.

We are also concerned that FDA may be aggravating a deteriorating drug import problem with some instances of poor judgment and ineffective policies. On October 21, 2002, FDA requested that Customs detain at least 1,233 packages of generic drug for Viagra imported into the U.S. through Miami, Florida, which appeared to be violative of the Food, Drug, and Cosmetic Act. On May 5, 2003, FDA knowingly authorized the release of the 1,233 packages of unapproved generic Viagra. On May 20, 2003, FDA informed the public that it was taking steps to respond to irregularities related to its handling of a large shipment of unapproved Viagra. The Committee is continuing to investigate whether the problems identified in Miami, Florida, represent wide-spread issues surrounding FDA’s approach nation-wide to preventing the dissemination of imported counterfeit or unapproved pharmaceuticals.

Unfortunately, the problem of counterfeit drugs, drugs with no active ingredient, or drugs stored in unsafe conditions rendering them useless, is no longer restricted to the Internet. Counterfeit drugs and drugs of unknown origin are appearing with greater regularity at U.S. drug stores. Recently, we have seen counterfeit versions of Lipitor, Serostim, Procrit, Epogen, and Combivir. On our second panel today, you will hear that because of unscrupulous wholesalers, consumers in Florida cannot know if the pharmaceuticals they purchase are legitimate. However, with vigorous law enforcement actions and new criminal penalties and tough regulations, the State of Florida is at the forefront of ensuring a safe and effective pharmaceutical supply.

At the end of the day, FDA is responsible, to the greatest extent possible, for ensuring that Americans have a safe and effective supply of drugs. Given the exponential increase in the volume of drugs being imported into the U.S., FDA’s current approach must be substantially altered to address this new reality. First, FDA must procure real data on the type and volume of drugs being imported into the U.S. Further, FDA must also discern from where these drugs are being imported and whether they contain legitimate product, are counterfeits, are stored in unsafe conditions or are sub-potent or super-potent. FDA must also engage in aggressive enforcement actions aimed at the importers of bogus and harmful drugs. Lastly, FDA must predicate all of its current regulatory and enforcement action on a risk-based assessment of threats to our drug supply. I can think of fewer more important or challenging tasks.