The House of Representatives unanimously passed a pair of bills aimed at increasing the accuracy and transparency of the FDA’s Orange Book and its Purple Book databases.

In a joint statement released this week by Energy and Commerce Chairman Frank Pallone Jr. (D-NJ) and Health Subcommittee Chairwoman Anna G. Eshoo (D-CA) following the House approval of the the Orange Book Transparency Act of 2019, and the Purple Book Continuity Act of 2019, the lawmakers said the generic and biosimilar manufacturers depend on the 2 databases to bring more affordable medications to the market.

“Ensuring these databases are up-to-date will help prevent patent listing errors that delay more affordable alternative medications from coming to market sooner,” said Pallone and Eshoo, in their statement. “Research has shown that 1 of the most effective ways to reduce prices at the pharmacy counter is to ensure generics come to market promptly after patent and exclusivity periods end.”

H.R. 1503, or the Orange Book Transparency Act of 2019, was introduced by Rep. Robin Kelly (D-IL). The goal is to help to ensure that the Orange Book is accurate and up-to-date by requiring manufacturers to share complete and timely information with FDA, as well as ensuring that patents listed in the Orange Book are relevant to the approved drug product. Patents found to be invalid through a court decision or a decision by the Patent Trial and Appeal Board would be required to be removed promptly.

H.R. 1520, or the Purple Book Continuity Act of 2019, introduced by Eshoo, would codify publication of the patents of approved biological products in the Purple Book in a similar format and with similar requirements to the Orange Book, specify that the Purple Book should be published electronically on FDA’s website and updated routinely, and direct FDA to consider the types of patents that should be listed in the Purple Book.

In their statement, Pallone and Eshoo vowed that legislators would continue working to lower the cost of prescription drugs in the United States. “We will continue to work on delivering a better deal on drug prices for all Americans,” they noted.

The bills were passed in the House by bipartisan votes of 422-0 and 421-0, respectively. 


PALLONE & ESHOO ON HOUSE PASSAGE OF BILLS INCREASING THE ACCURACY & TRANSPARENCY OF FDA’S PRESCRIPTION DRUG DATABASES [news release]. Washington, DC; May 8, 2019: House Committe on Energy & Commerce. Accessed May 2019.