Description: The Administration's FY2009 budget request of $2.4 billion for the Food and Drug Administration (FDA) would provide a 5.7% increase ($130 million) over FY2008. User fees would make up about 26% of the total amount requested and would account for 61% of the proposed increase. Budget documents indicate that the additional funding would provide for expanded activities to ensure the safety of foods and drugs, as well as to accelerate the availability of new medical products. About half of the requested increase would be used for cost-of-living pay increases, as opposed to new program activities.

Description: The practice of “authorized generics” has recently been the subject of considerable attention by the pharmaceutical industry, regulators, and members of Congress alike. An “authorized generic”–sometimes termed a “branded,” “flanking,” or “pseudo” generic–is a pharmaceutical that is marketed by or on behalf of a brand name drug company, but is sold under a generic name. Although the availability of an additional competitor in the generic drug market would appear to be favorable to consumers, authorized generics have nonetheless proven controversial. Some observers believe that authorized generics potentially discourage independent generic firms both from challenging drug patents and from selling their own products.