WASHINGTON, DC - Energy and Commerce Committee Republican Leader Greg Walden (R-OR) and Subcommittee on Health Republican Leader Michael C. Burgess, M.D. (R-TX) issued the following joint statement after the House passed two bills that make updates to the Orange and Purple Books at the Food and Drug Administration (FDA) by increasing accuracy and transparency of the two databases that guide development decisions for generic and biosimilar manufacturers.
Passing the House today was:
H.R. 1503, the Orange Book Transparency Act of 2019, from Rep. Robin L. Kelly (D-IL) and Oversight and Investigations Subcommittee Republican Leader Brett Guthrie (R-KY), codifies the current requirement to list drug substance patents, drug product patents, and method-of-use patents; and allows the listing of other patents at agency discretion. It further requires manufacturers to notify FDA of any court decision finding a patent invalid and requires that FDA remove those patents from the Orange Book to ensure the database is up to date.
H.R. 1520, the Purple Book Continuity Act of 2019, from Health Subcommittee Chair Anna G. Eshoo (D-CA) and Rep. Burgess, codifies the requirement to list: name of biologic; date of licensing; studies necessary for biosimilar applications; updates every 30 days; patents disclosed during “patent dance"; and withdrawal or suspension of licensure. In addition, the bill requires FDA to report recommendations of what patents should be listed in the Purple Book going forward. The legislation also increases the utility of the Purple Book by requiring it to be made public in a more usable format.
“Both Republicans and Democrats can agree that the cost of prescription drugs in America have skyrocketed," Walden and Burgess said. “These two bills passing the House will make a difference - increasing access to lower the cost of generic drugs and bolstering competition in the marketplace. We urge the Senate to swiftly pass these bills so we can ensure generic and biosimilar products can come to market as soon as possible."
