Hon. Mark B. McClellan
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

September 24, 2003

Dear Commissioner McClellan:

Thank you for your prompt response to my letter from September 17, requesting that the FDA grant Illinois – and all state and local governments – the right to import prescription drugs manufactured and imported in compliance with FDA regulations. I appreciate your detailed explanation as to why some drugs manufactured abroad currently fail to meet FDA guidelines. However, your letter did leave us with some questions.

As you know, the FDA currently permits private health plans, including the AARP, to reimburse participants who purchase prescription drugs from Canada. You briefly note in your letter that the FDA permits private insurance plans to reimburse consumers for drugs purchased while traveling abroad, but then say that reimbursing consumers for drugs manufactured abroad yet purchased in the United States is somehow different. The distinction seems questionable.

Either certain drugs manufactured abroad are safe, and both private health plans and state and local governments should be permitted to reimburse consumers for purchasing them, or they're not safe. If they are safe, why deny less expensive prescription drugs to millions of consumers?

Your letter also says that while many FDA-approved drugs manufactured abroad comply with your regulations, others do not. We all understand that some prescription drugs may currently fail to meet your guidelines. No one is suggesting that we import prescription drugs that aren't safe. But instead of simply saying that certain drugs meet your guidelines and certain drugs do not and leaving it at that, why not work to help more prescription drugs manufactured abroad meet your guidelines, so that more consumers can eventually purchase them and save money? Giving up so easily fails the millions of people in my state – and the tens of millions of people across the nation – who cannot afford the prescription drugs they need.

Finally, you mention in your letter that legislation pending in Congress would allow consumers to leverage their purchasing power to reduce the cost of prescription drugs. Illinois created the nation's first prescription drug buying club this summer, so I am very familiar with the benefits you describe. We believe that our plan can reduce costs by an average of twenty percent. However, stopping there simply isn't good enough.

The FDA has a higher responsibility to the American people than the approach your agency has embraced to date. I hope we can work together to find a way to ensure that prescription drugs manufactured in Canada can meet FDA regulations, so we can pass the savings on to the people who need them most.

Thank you for your consideration.

Sincerely,

Rod R. Blagojevich
Governor