What reason does the FDA give for it not ensuring the safety of foreign drugs

[Wesley_Clark]

I know the main argument of the FDA against pharmaceutical importation is that it cannot ensure the safety of imported drugs. The main counterargument to this is that all the FDA needs to do is check out and certify a handful of pharmacies in Canada/France/UK/India/etc to prove they are capable of distributing quality drugs which are up to FDA standards and americans will be able to import safe drugs with impunity from these certified pharmacies. What reason does the FDA give as to why it doesn’t do this because I can’t remember if i’ve ever heard any FDA spokespersons answer this question.

[astro]

@Wesley Clark

I know the main argument of the FDA against pharmaceutical importation is that it cannot ensure the safety of imported drugs. The main counterargument to this is that all the FDA needs to do is check out and certify a handful of pharmacies in Canada/France/UK/India/etc to prove they are capable of distributing quality drugs which are up to FDA standards and americans will be able to import safe drugs with impunity from these certified pharmacies. What reason does the FDA give as to why it doesn’t do this because I can’t remember if i’ve ever heard any FDA spokespersons answer this question.

I think their main point is not that they can’t “check”, but that they have limited regulatory authority over re insuring the quality of the supply at the source.

[mks57]

I thought that the FDA had the authority to regulate drugs that were marketed in the United States. Importing a prescription from Canada or Mexico is not the same thing as importing and wholesaling a drug to the United States market.

[Squink]

It is axiomatic in the quality assurance literature that quality cannot be “tested into” a product but must be “built into” the product from beginning to end.

PROCESS CONTROL

Here’s some of the things that must be built into pharmaceutical processes: Current Good Manufacturing Practices (cGMP) regulations.

[mike1dog]

How about this.

The FDA does not have the legal authority or resources to assure the safety and efficacy of drugs purchased from other countries outside this legal drug distribution system, or from unregulated Internet sites that are not run by pharmacies licensed and regulated by states.

From this web page.

[Dr.Lao]

@Wesley Clark

I know the main argument of the FDA against pharmaceutical importation is that it cannot ensure the safety of imported drugs. The main counterargument to this is that all the FDA needs to do is check out and certify a handful of pharmacies in Canada/France/UK/India/etc to prove they are capable of distributing quality drugs which are up to FDA standards and americans will be able to import safe drugs with impunity from these certified pharmacies. What reason does the FDA give as to why it doesn’t do this because I can’t remember if i’ve ever heard any FDA spokespersons answer this question.

Because it isn’t the FDA’s job to ensure the safety of drugs. It is the job of drug manufacturers to prove their drugs are safe and effective to the FDA before the FDA will allow the drugs to be held for sale in interstate commerce. Drugs sold in foreign markets have not been approved and therefore are unapproved new drugs in the United States. They must, by law, go through the approval process in order for them to be sold in this country. Of course, there is no reason for drug companies to seek approval for the drugs they sell in foreign markets because they almost always have approved versions that they are already selling in the US at 10 times the price.