The House Energy and Commerce Health Subcommittee today held a hearing to discuss seven bills aimed at increasing competition in the prescription drug market to lower prices, including the AHA-supported Creating and Restoring Equal Access to Equivalent Samples Act (H.R. 965). The CREATES Act would allow generic drug manufacturers facing certain anticompetitive delay tactics to bring an action in federal court for injunctive relief.
Witness Anthony Barrueta, senior vice president of government relations for Kaiser Permanente, said anticompetitive practices “significantly delay generic and biosimilar availability, hampering our ability to provide more affordable options to our members.”
Other bills discussed at the hearing would:
- allow the Food and Drug Administration to approve a subsequent generic drug application before the first generic applicant goes to market if certain conditions are met (H.R. 938);
- establish an authorization process for generic manufacturers to gain access to samples of approved drug products (H.R. 985);
- make it illegal for brand name and generic drug makers to enter agreements to keep a generic equivalent off the market (H.R. 1499);
- require manufacturers to share complete and timely information to ensure that the FDA’s Orange Book of approved drug products is accurate, up to date and lists only valid patents relevant to the approved drug product (H.R. 1503);
- allow generic filers who win a patent challenge in court to share in the 180-day exclusivity period of first applicants who enter patent settlements that delay entry (H.R. 1506); and
- codify publication of the Purple Book of licensed biological products in a format similar to the Orange Book, and direct FDA to consider what types of patents the book should list (H.R. 1520).
Also testifying at the hearing were officials from generic drug maker Nephron Pharmaceuticals, the Association for Accessible Medicines and National Health Council, and several experts on antitrust, patent and drug law.