Michael Carrier
Rutgers Law School
Abstract:
My testimony to the Health Subcommittee of the House Energy & Commerce Committee supports legislation being considered to lower high drug prices.
First, I support the CREATES Act and FAST Generics Act, which would ensure that generic companies receive the samples they need to enter the market.
Second, I support the FAIR Generics Act, which would ensure that the 180-day exclusivity period is serving the purpose it was intended to by rewarding not just the first generic filer (who could settle with the brand by agreeing to delay entering for years) but also the first generic to win in court, demonstrating that the patent is invalid. I also favor the Protecting Consumer Access to Generic Drugs Act of 2019, which would make clear that pay-for-delay settlements are illegal.
Finally, I support legislation that would bring the Purple Book into the 21st century by making it searchable. And I favor amendments to the Orange Book that would (1) incorporate appellate court and PTAB decisions finding patents invalid and (2) not list patents in the Orange Book on drug delivery devices such as the EpiPen.
Full testimony available on SSRN: https://ssrn.com/abstract=3352629
