Stephanie Kennan Quoted in FDAnews on Medicare Drug Pricing Rollback, FDA’s User Fee Program Reauthorization

On October 11, 2022, McGuireWoods Consulting senior vice president Stephanie Kennan was quoted in the FDAnews article “Republicans Introduce Bill Rolling Back Drug Pricing Reforms,” on Senate Republican efforts to repeal the provisions of the Inflation Reduction Act that allows Medicare to negotiate drug prices, as well as caps annual drug expenses.

Kennan noted that the move to roll back the law passed by the Democrats was expected, with the Republicans opposed to the actions. "Given the long historical opposition to drug price controls many Republican members have, it is not surprising they would introduce this legislation now. It serves as a marker for their efforts should they take the Senate in the elections.”

On October 3, Kennan was quoted in the FDAnews article “MDUFA Reauthorized as Part of Continuing Resolution Hours Ahead of Deadline,” on Congress reauthorization of the Federal Drug Administration’s (FDA) user fee program as part of a continuing resolution to fund the government.

The reauthorization, which includes the Medical Device User Fee Amendment V, the Prescription Drug User Fee Act VII, the Biosimilar User Fee Amendments III and the Generic Drug User Fee Act III, will be used to fund approximately half of the budget of the FDA over the next five years.

However, Kennan noted that the method of passing the law provides its own complications. The use of continuing resolution only funds the agency at the levels approved in the last fiscal year, which means that there will not be a budget increase or new programs until there is a passage of a law for fiscal year 2023.

“FDA didn’t want a short-term extension, but that’s what they’ve gotten,” Kennan told FDAnews. She also noted that additional riders may be discussed when Congress comes back for its lame duck session on November 14