WASHINGTON, D.C. — The following statement was issued by David Mitchell, a cancer patient and founder of Patients For Affordable Drugs Now, in response to the Senate Health, Education, Labor, and Pensions Committee’s passage of a package that includes three amendments that would crack down on Big Pharma’s abuses of the drug pricing system:
“We applaud Chairwoman Murray, ranking member Burr, and members of the Senate HELP Committee for advancing S. 4348, which reauthorizes the FDA user fees and includes three key amendments to improve the U.S. drug pricing system to boost competition by easing the process for generic competition to come to market and drive down drug prices for patients. The bipartisan citizen petition provision, offered by Senator Baldwin (D-WI) and championed by Senators Shaheen (D-NH), Cassidy (R-LA), Bennet (D-CO), and Rubio (R-FL), will help restore integrity to the FDA citizen petition process by closing a loophole manipulated and abused by brand-name drug makers to slow the approval of lower-priced generics and keep prices high for patients.
“For years, the P4ADNow patient community has been calling on Congress to pass legislation to prevent Big Pharma from using the citizen petition process to delay or block more affordable generic drugs from coming to market. On behalf of patients across the country, we thank Senators Baldwin, Shaheen, Cassidy, Bennet, and Rubio for their work fighting for patients.
“We urge the Senate to quickly pass the FDA user fee package with the citizen petition, orphan drug, and generic drug approval transparency reforms intact.
“The committee’s approval of these provisions adds important momentum to the work being done in the Senate to pass a reconciliation package that includes the comprehensive drug price reforms, including Medicare negotiation, already passed by the House of Representatives. The Senate must advance the reconciliation package to deliver relief to all American patients.”
- P4ADNow has been advocating tirelessly since 2018, urging the federal government and Congress to address pharmaceutical companies’ abuse of the Food and Drug Administration’s citizen petition process.
- The amendment, introduced by Senator Baldwin (D-WI) to crack down on abuse of the citizen petition process, has been previously introduced in the Senate as S. 562, the Ensuring Timely Access to Generics Act, which was sponsored by Senators Shaheen (D-NH), Cassidy (R-LA), Bennet (D-CO), and Rubio (R-FL).
- The FDA’s 505(q) citizen petition process is intended to provide a forum for patients, consumer groups, and other entities to raise concerns about pending generic drug approvals under consideration by the FDA.
- Currently, the citizen petition process is often misused by brand-name drug manufacturers that submit sham petitions in an effort to delay or block generic approval and market entry.
- Brand-name drug makers were behind 92 percent of all 505(q) citizen petitions filed between 2011 and 2015.
- The FDA threw out 9 of every 10 petitions from 2011 to 2015.
- This bill would strengthen the citizen petition process, more effectively weeding out petitions that are filed with the intent to delay the approval of generics or biosimilars.
- The Senate HELP committee also included in S. 4348 the RARE Act (S. 4185), offered as an amendment by Senator Baldwin and sponsored by Senators Baldwin and Cassidy. The bill codifies FDA’s longstanding interpretation of the Orphan Drug Act and prevents drug makers from taking advantage of a 2021 circuit court decision that would enable them to block competitors. The House passed a similar provision in the chamber’s user fee package last week.
- The Senate HELP committee also advanced a bipartisan amendment, led by Senators Hassan (D-NH) and Paul (R-KY), that would speed more affordable generic drugs to market by giving the FDA the authority to provide specific information on inactive ingredients and drug concentration levels to generic applicants working to come to market. The House passed a similar provision in the chamber’s user fee package last week.