Will the proposed Preserve Access to Affordable Generics (PGGA) Act actually generate the $4.8 billion savings over 10 years that the Congressional Budget Office suggests it will? How realistic are its assumptions about generic competition or healthcare costs over the next ten years?
The CBO’s savings estimate of a new bill restricting the use of patent settlement agreements which reward generic manufacturers for delaying market entry and avoid litigation under the ANDA approval pathway is exaggerated. It assumes that savings from increasing generic competition would outweigh the savings that would have otherwise been generated from the introduction of innovative pharmaceutical products. In doing so, it makes key assumptions about the behaviour of both the generic and research-based pharmaceutical industries which do not capture the full reality. Therefore, estimates on the savings to healthcare spending as a result of banning so-called “pay for delay” agreements are likely overstated.
For further analysis from Pugatch Consilium on this issue, see: On numbers and access to medicinesShare