Gottlieb lays out FDA plans to speed generic reviews, spur label updates
- Commissioner Scott Gottlieb said Monday the FDA plans to use funding expected to be soon approved by Congress to modernize generic drug reviews and enable the agency to take a more active role in updating generic drug labels when a branded drug has been withdrawn.
- The agency is set to launch a new review tool — dubbed the "Knowledge-aided Assessment and Structured Application (KASA) platform" — aimed at reducing the number of cycles of application review, which Gottlieb says will help speed generic competition.
- FDA also plans to use some of the money to "assume more responsibility to help bring generic product labels" up to date, starting with certain cancer drugs.
The effort by FDA aligns with Gottlieb's efforts to promote generic competition with an aim at ultimately putting downward pressure on drug prices. The two planks outlined by Gottlieb were first included in President Donald Trump's fiscal year 2019 budget proposal, which asked for $37.6 million in funding for the measures.
In May, both the Senate Appropriations Committee and House Appropriations Committee advanced FDA funding bills. According to the Alliance for a Stronger FDA, the House bill would provide $27 million to speed generic drug reviews, while the Senate bill provides $37.6 million.
"We appreciate that the appropriations committees of both chambers of Congress supported this budget request in their appropriations bills," Gottlieb wrote. "Congress has long recognized the need for — and importance of – investments in our generic drug program and efforts to promote generic drug use."
Gottlieb noted that while branded drug companies generally update their drug labeling, there are instances where a brand drug manufacturer withdraws from the market and ceases to continue updating the product label.
"When this happens, the FDA loses a key mechanism that the agency relies on as a way to update generic labeling. This can stymie the ability to modernize generic labels. In turn, when labels become out-of-date, providers may not have complete information about the full range of benefits and risks of the product," Gottlieb said.
FDA already has the authority to step in to allow certain labeling changes for generic drugs when a branded drug is withdrawn, Gottlieb said. The new funding will allow the agency to process more generic drug label updates to "promote more widespread use of low-cost, generic alternatives."
The KASA platform will help FDA reviewers by changing generic drug review from a "text-based to a data-based assessment." The goal is to cut down on the number of review cycles to allow for more timely competition, according to Gottlieb.
"Having a structured template that completely replaces the current largely narrative-based review will allow for more consistent and predictable entry and analysis of data. Current assessments require manual review of the entire application. KASA will enable automated analysis of some portions of the application, which will save time, and ensure consistency," Gottlieb said.
The announcement comes a month after Trump laid out his blueprint to tackle high drug prices, which touted increasing competition in the market as a cornerstone.
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