FDA Commissioner Details FY19 Budget Request to Support Generic-Drug Competition

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb issued a statement to highlight President Donald Trump’s fiscal year 2019 budget request for the FDA that includes funding of $37.6 million to fund two initiatives to modernize aspects of the generic-drug review process.

“The first initiative will create a new review platform—the Knowledge-aided Assessment & Structured Application (KASA) platform— to modernize generic drug review from a text-based to a data-based assessment,” Gottlieb said in a June 18, 2018 post on FDA Voice, the agency’s blog. “The KASA will enable a structured review that will make the application review process more efficient and allow deficiencies to be spotted earlier.” Gottlieb said that process is expected to help the FDA provide earlier feedback to generic-drug makers that will, in turn, help to reduce multiple cycles of application review and enable sponsors to submit high-quality and more complete applications on first submission.

“The new platform will also enable more efficient and robust knowledge management across different aspects of the FDA’s review process, helping reviewers capture and manage all of the information about products allowing for more seamless and effective product surveillance based upon quality and risk,” Gottlieb said in the June 18 post. Current assessments require manual review of the entire application, whereas KASA will enable automated analysis of some portions of the application, according to information from the FDA.

The second initiative is aimed at promoting the widespread use of existing generic drugs by looking for ways to keep generic-drug labeling up to date with the latest information about each medicine’s risks and benefits. Generic drugs are generally required to have the same labeling as the brand drug they reference. “However, when brand reference drug companies voluntarily withdraw their marketing applications, they also stop updating their labeling,” Gottlieb said in his post. “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 In turn, when labels become out of date, providers may not have complete information about the full range of benefits and risks of the product. This can serve to diminish the use of these lower cost alternatives.”

While certain types of labeling changes are allowed to continue to be made for generic drugs after the brand drug is withdrawn, Gottlieb says the budget request will provide the funding to allow the FDA to assume more responsibility to help bring drug labels up to date. The FDA plans to launch this initiative initially for oncology products, according to information from the FDA.

“We appreciate that the appropriations committees of both chambers of Congress supported this budget request in their appropriations bills,” Gottlieb said in the post. “Congress has long recognized the need for—and importance of—investments in our generic drug program and efforts to promote generic drug use.”

Source: FDA Voice

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