US FDA and pharmaceutical companies agree on increased fees for faster approvals

Inpharma 1333 - 13 Apr 2002

■ US pharmaceutical companies and the FDA havetentatively agreed to a fee increase in return for fasterprocessing of applications for drug reviews andapprovals, reports the BMJ. Currently, the PrescriptionDrug User Fee Act requires pharmaceutical companiesto pay a fee of $US200 000 upon application forreview and approval of a new drug. If the latest feeincreases are approved by Congress, pharmaceuticalcompanies will end up paying over 50% of the cost ofreviews and approvals of new drugs. Such fundingmay be a conflict of interest, say consumer groups.Instead, they advocate adequate public funding as theideal solution, and they also note that speedier drugapproval processing may have compromised patientsafety. For instance, rapid approvals of several drugs inrecent years have been followed soon afterwards bytheir withdrawal from the market (e.g. troglitazone fordiabetes mellitus and mibefradil for hypertension).Josefson D. US drug companies will meet more than half the cost of drugapproval. BMJ 324: 808, 6 Apr 2002 800896705

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Inpharma 13 Apr 2002 No. 13331173-8324/10/1333-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved