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Pallone & Eshoo on House Passage of Bills Increasing the Accuracy & Transparency of FDA’s Prescription Drug Databases

May 8, 2019
Press Release
“The passage of these two bills is a first step in Democrats’ ongoing commitment to lower the soaring cost of prescription drugs for Americans.”

Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) and Health Subcommittee Chairwoman Anna G. Eshoo (D-CA) released the following joint statement today after the House of Representatives passed H.R. 1503, the Orange Book Transparency Act of 2019, and H.R. 1520, the Purple Book Continuity Act of 2019:

“These two bipartisan bills will increase the accuracy and transparency of the Food and Drug Administration databases that generic and biosimilar manufacturers depend on to bring more affordable prescription drugs to 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.  Research has shown that one 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.

“The passage of these two bills is a first step in Democrats’ ongoing commitment to lower the soaring cost of prescription drugs for Americans. We will continue to work on delivering a better deal on drug prices for all Americans.”

H.R. 1520, the "Purple Book Continuity Act of 2019," introduced by Chairwoman 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. The bill was passed by a vote of 421-0.

H.R. 1503, the "Orange Book Transparency Act of 2019," introduced by Rep. Robin Kelly (D-IL), would 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. The bill was passed by a vote of 422-0.

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