Congress debates whether FDA can discuss fees with pharma companies amid concerns over influence

The program was implemented in 1992 under the pressure of AIDS activists who wanted drugs to be approved more quickly.

Updated: September 18, 2022 - 6:01pm

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Congress is debating whether the Food and Drug Administration can meet with pharmaceutical company officials as scheduled in order to negotiate the "user fee" program that composes nearly half of the agency's budget. 

Every five years, FDA officials hold a private meeting with pharmaceutical giants to negotiate the user fee program, which is when companies pay the federal agency in order to seek approval of products. The program brought in $1.1 billion last year for the FDA's drug division budget and fees have soared since the program was created three decades ago, The New York Times reported Thursday.

Congress must decide by Sept. 30 whether to reauthorize the FDA's power to collect user fees. The pharmaceutical lobbyists argue that the funding gives the FDA the ability to quickly approve life-saving drugs. Opponents say the user fee program weakens the process meant to guarantee that medicine is safe and effective.

"Philosophically, I wish the taxpayer paid for all the F.D.A. and there weren't user fees," FDA Commissioner Dr. Robert Califf said earlier in the summer. 

The program was implemented in 1992 under the pressure of AIDS activists who wanted drugs to be approved more quickly. A decade later, the timeline for medicine approval leaped from about 19 months to 10 months on average, the Times reported.

The application fees for a new drug can range from $1.5 million to more than $3 million. 

Sen. Richard Burr (R-N.C.) has been working on what he says is a "clean" reauthorization of the user fee program that would cut out extra provisions proposed from senators on both sides of the aisle. For example, Sen. Rand Paul (R-Ky.), Sen. Cory Booker (D-N.J.) and others are seeking to end mandatory animal testing in favor of alternative methods when possible.