Robin Kelly

The U.S. House Energy and Commerce Committee has advanced the Orange Book Transparency Act of U.S. Rep. Robin Kelly (D-2^nd District) to the full House of Representatives for consideration.

House Resolution 1503, introduced in March, would increase access to lower cost generic drugs and bolster competition in the marketplace to drive down prescription drug costs for American families, Kelly said.

“No one should be forced to choose between lifesaving medicine and putting food on the table. Sadly, this is the everyday reality of too many people,” said Kelly, chair of the Congressional Black Caucus Health Braintrust, “There is more that we can and should do to lower drug costs for American families. This bill will increase access to and competition from generic drugs. The result will be lower out-of-pocket costs for families — a major promise of Democrats’ For the People agenda.”

Congresswoman Kelly’s legislation would make several technical changes to the U.S. Food and Drug Administration’s drug product listing, the Orange Book, and its submission process to create greater clarity for doctors, pharmacists and generic drug manufacturers. Experts, medical professionals and advocates have been requesting changes for years, Kelly said.

Doctors and pharmacists use the Orange Book for information on generic drug approvals and availability. Generic-drug manufacturers also use it to make research and development decisions as it provides information on the exclusivity period of novel, name-brand drugs.

The legislation was favorably reported by the health subcommittee, on which Representative Kelly serves, on March 27.

The House Energy and Commerce Committee is the oldest continuously standing committee in Congress; it was established in 1795. Today, the committee serves as Congress’ chief policymaking body with jurisdiction over health care, energy, environmental, consumer safety and electronic communication policy.