Ordering prescription drugs from non-FDA approved foreign sources is a dangerous path, opposed by all of the previous heads of the United States Food and Drug Administration (FDA), United States Department of Health and Human Services (HHS) since 2000.
When asked for their professional opinions on drug importation, every single head of the FDA and the HHS for the past 17 years has said the benefits that might be gained are far outweighed by the many dangers.
In 2000, Dr. Donna Shalala, secretary of the HHS, told President Clinton, Dr. Shalala said the flaws in a foreign drug importation bill “could pose unnecessary public health risks.”
In February 2002, Tommy Thompson, Secretary of the HHS was asked by the Senate Budget Committee to certify safety of foreign non-FDA approved medicines and said, “The law requires us to certify that we know that these drugs are safe. It’s impossible for us to certify that these drugs are safe.”
While testifying in front of the Senate Committee on Commerce, Science and Transportation on November 20, 2003, John M. Taylor, III, Associate Commissioner for Regulatory Affairs at the FDA said, “At a time when FDA faces more challenges than ever in keeping America’s supply of prescription drugs safe and secure, legislation to liberalize drug importation could cause additional drug safety concerns. …By choosing affordability over safety rather than taking new steps to address both, such legislation is a dangerous solution to the twin challenges of safety and affordability.”
Dr. Andrew Von Eschenbach, former FDA Commissioner, was testifying before the House Energy and Commerce Committee, Subcommittee on Oversight & Investigations on January 29, 2008. Rep. Greg Walden (R-02) asked him if the FDA was able to certify that prescription drugs that people were either purchasing on the internet or that were imported into the US would be safe and what people thought they were purchasing. Dr. Von Eschenbach said, “we have been unable to be certain we could ensure that, even when they are labeled as having come from what we could consider a reputable source like Canada, the product itself often is not and they are often coming from places other than Canada that we have absolutely no control or confidence in or when analyzed found to either not contain the active ingredient or to contain ingredients that are in fact harmful. We have no way of being able to ensure the safety of re-imports.”
In November 2009, the FDA sent out warning letters to rogue internet pharmacies that were engaged in the illegal sale of unapproved or misbranded drugs to U.S. consumers. In a press release concerning the letters, FDA Commissioner Margaret A. Hamburg, M.D. said, “Many U.S. consumers are being misled in the hopes of saving money by purchasing prescription drugs over the Internet from illegal pharmacies. Unfortunately, these drugs are often counterfeit, contaminated, or unapproved products, or contain an inconsistent amount of the active ingredient. Taking these drugs can pose a danger to consumers.”
While testifying at his nomination for FDA Commissioner before the Senate HELP Committee, Robert Califf, M.D. said the, “FDA would not be able to make safety and quality determinations for prescription drugs offered for import into the United States that have not gone through the U.S. regulatory process. … FDA evaluation of non-FDA-approved imported drugs revealed that while nearly half of imported drugs claimed to be Canadian or from Canadian pharmacies, 85 percent of such drugs were actually from different countries.”