FTC Report on Generic Settlements Released
The FTC report outlines the calendar year 2005 experience as reported to FTC of US “Brand”-Generic and Generic-Generic settlements, the former referring to patent disputes involving the innovator’s brand drug. As you might know, FTC has lost a number of its challenges to innovator-generic settlements recently, which appears to have emboldened some dealmakers to craft agreements that haven’t been seen since 1999–those that both restrict generic entry and provide direct or indirect compensation to the generic company (see the left side of figure 3 and text for a description). Unfortunately, for firms that are cutting deals, no deal term details are provided by FTC for benchmarking purposes. Based on personal experience and the experiences of my colleagues, I can tell you that these deals are all over the map. FTC promises to take a close look at these deals, but if recent history is predictive of trial outcome, FTC is likely to challenge only the most egregious examples of apparent anti-competitive behavior in court. Clearly, FTC’s hope is that Congress will use these data to guide policy when they re-visit Hatch-Waxman (when exactly that will occur remains unclear).
On an unrelated topic, I’ll be tackling NICE and its recent evaluation of Exubera in May’s Pharma’s Cutting Edge story. The focus will be on the reasons provided by NICE for their conclusion that Exubera is unlikely to be cost-effective. I will not try to play Monday morning quarterback. Rather, I’m interested in exploring the weight of evidence required for cost-effectiveness demonstrations with a chronic-use, incrementally innovative, NME like Exubera and whether it is feasible for pharma R&D programs to demonstrate cost-effectiveness for such products prior to first launch. Look for it or sign up to receive the PCE RSS feed on the main page.
Remember, FDA’s Approvables and Related NDA/BLA Actions is now available from Pharma Growth Strategies. It is required reading for any manager responsible for planning or reacting to FDA approval for an NME or novel protein therapeutic. Discounts are available for multi-user orders.
