Generic medications for hepatitis C.
The recent development and approval of expensive but highly effective oral agents against hepatitis C has led to restrictions and access limitations in many countries with limited healthcare budgets. Generic formulations of many of these agents are available at a fraction of the retail price in several countries because of generic licensure agreements. The discounted alternatives are only accessible in developing countries and require manufacturing and distribution regulations to ensure the quality and bioequivalence of the new drug formulations. The continued medication access limitations have driven great interest in the practice of personal drug importation of the generic formulations. This review and debate will address the medical and legal issues involved in the purchase and importation of these medicines.
Section of Hepatology, Department of Medicine, RUSH Medical Center, Chicago, IL, USA.
Donald M
DM
Jensen
Section of Hepatology, Department of Medicine, RUSH Medical Center, Chicago, IL, USA.
Phoebe
P
Sebhatu
Section of Hepatology, Department of Medicine, RUSH Medical Center, Chicago, IL, USA.
Nancy S
NS
Reau
D000998:Antiviral Agents / Q000191:economics* / Q000627:therapeutic use; D002170:Canada; D003132:Commerce / Q000331:legislation & jurisprudence; D058110:Counterfeit Drugs; D017277:Drug Approval; D004335:Drug and Narcotic Control; D016568:Drugs, Generic / Q000191:economics* / Q000627:therapeutic use; D005607:Fraud; D006526:Hepatitis C / Q000188:drug therapy*; D006801:Humans; D011786:Quality Control; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration
D000998:Antiviral Agents; D058110:Counterfeit Drugs; D016568:Drugs, Generic
counterfeit; generic; hepatitis C; regulations