"Pay for Delay Settlements" continue...good news for big pharma, but not so good news for consumers...there is proposed legislation to ban such agreements...interesting fact stated here as well...this year the FDA has been to the hill no less than 10 appearances...in 2006 they only appeared 12 times...going to be a busy year at the hill for the FDA...big pharma perhaps looking to buy additional generic firms? How will the FTC and FDA work together may end up having a Congressional review and hearing...BD
The subject of the report are agreements between brand name and generic manufacturers to delay the entry of generics to the market. Quoting the release, "In fiscal year 2007, there were 33 final settlements, nearly half of which (14, or 42%) included both compensation to the generic company and a restriction on the generic’s ability to market its product. Of those 14 settlements, seventy-nine percent involved agreements with first-filer generic companies. Unlike FY 2006, however, most of the FY 2007 agreements involving restrictions on generic entry did not include a side deal involving elements not directly related to the resolution of the patent dispute. Instead, the majority involved compensation to the generic firm through an agreement by the branded firm not to sponsor or compete with an authorized generic product for some period of time. "