FDA’s bigger piggy bank

How FDA plans to spend a proposed $400 million budget boost

FDA plans to use a proposed record-setting funding boost to invest in projects it believes could lead to fundamental improvements in the way medical products are tested, reviewed and manufactured. The goal is to use regulatory innovation to help industry create better medicines, manufactured less expensively and more reliably, that reach patients more quickly.

The agency wants to kick-start the transition to advanced manufacturing technologies for drugs, vaccines and cell therapies, fund the creation of natural history databases to accelerate the development of medicines for rare diseases, and use technology to streamline reviews of generic drugs.

The agency also has dusted off its wish list of internal improvements, including a long-sought knowledge management system that could make new drug review decisions more consistent and evidence based.

Some of the proposed budget increase would be put toward establishing an industry for large-scale compounding.

FDA’s plans also could unleash digital health technologies by financing new regulatory approaches that would distinguish between low- and high-risk products as well as streamline product certification.

These and other plans are all based on the Trump administration’s request for Congress to increase FDA’s FY19 budget by about $400 million, which would be the largest increase the agency has ever received, according to the Alliance for a Stronger FDA.

New funding also would allow FDA to design processes for continuous manufacturing of recombinant, cell-based influenza vaccines.

To actually get the money, FDA will have to persuade Congress to appropriate it.

The first step is to lay out a compelling case for giving more taxpayer money to an agency

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