Republican Senate Takeover’s Impact on FDA Remains Uncertain

The Republican landslide in last Tuesday’s midterm election will put GOP lawmakers in the driver’s seat on the generics labeling rule, user-fee negotiations and agency funding, but experts say the political shift’s impact remains uncertain.

The GOP takeover of the Senate will result in assignment of new committee chairs, and Sen. Lamar Alexander (R-Tenn.) — an outspoken critic of the FDA’s proposed generics labelling rule — could make the jump to chairman of the Health, Education, Labor & Pensions (HELP) Committee, where he is currently the senior Republican.

Alexander already is on record opposing the rule that would give generic drugmakers the ability to change labeling without agency approval, a power only brand drugmakers have now.

The senator, in a letter to the White House that challenged whether the FDA had the legal authority to make the rule change, argues that it will promote product liability lawsuits against generics makers.

Steven Grossman, deputy executive director of the advocacy group Alliance for a Stronger FDA, cautioned that just because Alexander is in line to get the chairmanship doesn’t mean it will happen. He expects the picture won’t be clear until the party caucuses to resolve chairmanships over the next two to three weeks.

Also uncertain is how the upcoming GOP-controlled congress might impact industry user fee negotiations. Starting next year, industry and the FDA will begin the process to reauthorize its various user fee programs that expire in 2017.

Craig Burton, a director with the research firm Avalere Health, says he expects both HELP and House Energy & Commerce Committee to be involved in early negotiations on what needs to be changed or adjusted to the user fee program. 

“What you have seen from [Capitol] Hill from both sides in recent years is the desire to be kept in the loop early in the process,” Burton said.

A GOP-controlled congress, however, is not expected to have a big impact on the appropriations process, Burton said. The FDA currently is being funded at fiscal 2014 levels under a continuing resolution that is set to expire Dec. 11.

The lame-duck Congress could pass a long-term continuing resolution or put together an omnibus appropriations bill for the rest of fiscal 2015, which ends Sept. 30, 2015. The Senate’s fiscal 2015 package, which hasn’t yet been approved, would give the agency $2.588 billion in discretionary funds, a $36 million boost over current levels and $13 million more than the House’s already-approved package.

Meanwhile, little is expected to change on the House side.

The House Energy & Commerce Committee will remain under Republican control, but will get a new Democratic ranking member as Rep. Henry Waxman (D-Calif.) is retiring. Chairman Fred Upton (R-Mich.) said Wednesday that the committee will continue its 21st Century Cures Initiative in the next Congress. — Robert King

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.