scholarly journals Drug importation: limitations of current proposals and opportunities for improvement

2021 ◽  
Vol 11 (7) ◽  
Author(s):  
Caleb J. Scheckel ◽  
S. Vincent Rajkumar

AbstractDrug importation is a policy proposal to help alleviate rising pharmaceutical prices. Restrictions on drug importation stem from the Federal Food, Drug, and Cosmetic Act but authorization of importation can be made by the Health and Human Services (HHS) Secretary. During the Trump administration a number of states passed laws to develop a drug importation programs, however, none have been authorized by HHS. Limitations of these importation programs include sole reliance on Canada, exclusion of high-cost drugs like biologics, and persistent legal hazard of the Personal Importation Program. Potential revisions to current law include expansion of countries approved for importation, inclusion of biologics, and codifying protection for personal importation. Drug importation policies are not a panacea to address rising pharmaceutical prices but may blunt prices while more permanent solutions are pursued.

1995 ◽  
Vol 58 (2) ◽  
pp. 209-212 ◽  
Author(s):  
G. H. PAULI ◽  
L. M. TARANTINO

The Federal Food, Drug, and Cosmetic Act requires that a food that has been irradiated may not be sold in the United States unless the Department of Health and Human Services finds that the food is safe and issues a regulation specifying safe conditions of irradiation. This presentation briefly outlines the types of information needed to issue an authorizing regulation, describes the conditions under which food may currently be irradiated, and discusses the basis for current regulations.


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