My Home About Me

by Mark S. Senak
Eye On FDA



While the FDA has not yet posted any of Dr. von Eschenbach's testimony before Congress, that of Randall W. Lutter, Ph.D., Acting Deputy Commissioner for Policy, Food and Drug Administration has been put up on the FDA Web site. He testified on matters related to the importation of drugs before Subcommittee on Interstate Commerce, Trade, and Tourism Committee on Commerce, Science, and Transportation just two days ago on March 7.

There was not much news. He quoted a four year old study performed in 2003 by the Department of Health and Human Services on issues related to drug importation.

There are significant risks associated with the way individuals are currently importing drugs that violate the FD&C Act.

The integrity of the distribution system must be ensured.

It would be extraordinarily difficult and costly for "personal" importation to be implemented in a way that ensures the safety and effectiveness of the imported drugs. Regulating personal importation could be extraordinarily costly, on the order of $3 billion a year based on 2003 estimates of the volume of packages entering the U.S.

Overall national savings from legalized commercial importation will likely be a small percentage of total drug spending, and developing and implementing such a program would incur significant costs and require significant additional authority.

The public expectation that most imported drugs are less expensive than American drugs is not generally true, especially in the case of generic drugs marketed in the U.S.

Legalized importation of now-unapproved drugs will likely adversely affect the future development of new drugs for American consumers.

The effects of legalized importation on intellectual property rights are uncertain but likely to be significant.
Legalized importation raises liability concerns for consumers, manufacturers, distributors, pharmacies, and other entities.

It would seem that the FDA today would have more to say on the subject than from old reports. Nothing in the testimony addressed the counterfeit problem of drugs inside the U.S. In my mind, the two issues are linked, but no one ever seems to link them.


Source: EyeOnFDA.com



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