Philadelphia, February 20, 2003 -- In a statement released today, GlaxoSmithKline encouraged all Americans concerned about affordability of prescription medicines to contact their Member of Congress and urge their support for passage of a Medicare prescription drug benefit.
In its statement, the company said:
We are concerned for the health and safety of our patients. GSK's decision to limit the supply of our medicines to Canadian Internet operators who illegally sell prescription drugs to U.S. residents is an issue of drug safety.
It is also a matter of compliance with U.S. law. Export to the United States of non-FDA-approved drugs violates laws enacted to protect consumers. The Food and Drug Administration has repeatedly stated in testimony before Congress and in official documents that non-FDA approved prescription drugs exported by foreign companies into the U.S. are illegal. Neither the FDA nor the pharmaceutical companies can ensure the safety of medicines purchased over the Internet from another country. With drugs purporting to be foreign versions of FDA-approved medications, the risks of counterfeiting and improper storage/handling are magnified. There are also very real concerns, legal and otherwise, about the extent and quality of doctor/patient and pharmacist/patient interactions involved in cross-border internet drug sales.
Here is what the U.S. Senate found:
The Senate Committee on Aging, July 9, 2002, hearings "Buyer Beware: Public
Health Concerns of Counterfeit Drugs" found that 8% of imported medicines into
the U.S. were counterfeit.
Here's what the FDA has told Congress:
"Consumers are exposed to a number of risks when they purchase drugs from
Internet sites that are not licensed and operating within (U.S.) state pharmacy
laws or (from) sites that dispense foreign drugs."
"Of particular concern are the provisions (in the MEDS Act) for allowing
individuals to import drugs directly from Canadian pharmacies. This would
greatly exacerbate the growing problem of hundreds of websites purporting to
sell legitimate medications that are in fact selling unapproved or otherwise
dangerous drugs to Americans."
"Recent advertisements in U.S. newspapers and magazines claim that Congress
has made the importation of drugs a legal practice. Other advertisements and
certain Internet sites state that personal importation of up to a 90-day supply
of prescription medication is legal. Neither of these claims is true."
"FDA cannot assure the public that re-imported drugs made in the U.S. have
been stored under proper conditions or that they are the real product, because
the Agency does not regulate foreign distributors or pharmacies."
Because of GSK's concern for ensuring appropriate access to affordable medicines, GSK created the Orange Card in 2001 to provide qualifying Medicare-entitled patients savings of up to 40 percent on GSK medicines*. The resulting savings can be in line with those available from Canadian Internet pharmacies. For example, Avandia 4 mg 30 tablets will cost an average of $60.76 with the Orange Card, compared to $57.00 plus shipping from an Internet pharmacy.
GSK is also a founding member of the Together Rx card, which provides seniors with similar savings on 170 medicines from seven pharmaceutical companies. In addition, GSK provides medicines through our Patient Assistance Programs that last year alone gave free medicines valued at $168 million to 400,000 patients with incomes below $24,000 for a household of two.
We understand and share the concerns of the Americans - and seniors in particular - for access to affordable medicines, but it is important not to undermine patient safety or the regulatory laws that Congress has passed to protect the public. To do otherwise would be irresponsible.
GSK believes the appropriate way to resolve the issue of affordability of medicines in the U.S. is for Congress to pass a Medicare prescription drug benefit. The need is urgent. We urge seniors and other U.S. citizens who share our concerns to ask their Member of Congress to pass a Medicare prescription drug benefit. Patients must not be forced to risk their safety by looking to other countries to supply their prescription medicines.
Brian L. Jones (215) 751 7709
(215) 751 3415
* Actual savings will vary depending on pharmacy prices; the Orange Card application should be consulted for important details and limitations.