Gottlieb Spells out Vision for FDA Modernization Efforts to Create a new Data Enterprise
As the US Food and Drug Administration (FDA) continues to navigate a bumpy road toward modernization, a new data enterprise will aim to enhance regulatory decisions on products.The growing number of novel medical products in the US prompted FDA to “refashion” the approaches to drug and device regulations and “create more modern platforms that are better suited to the efficient evaluation of these advances,” said FDA Commissioner Scott Gottlieb.
The initiatives already underway that Gottlieb highlighted in a Wednesday FDA Voice blog post form part of FDA’s Medical Innovation Access plan.
Thanks to new FDA authorities and resources from recent legislative actions, these initiatives will help “fund the creation of a cross-cutting data enterprise for the generation of evidence, and a more modern and integrated approach to the evaluation of this information,”Gottlieb said.
Modernization is intended to make regulatory premarket reviews more consistent and predictable to ultimately increase competition among firms and allow for more timely patient access to a greater number of drugs and devices in the US market that are more affordable and of higher quality. This culture shift could also lead to reduced burden and potential cost savings.
A large number of FDA initiatives have been launched in recent years as part of the agency’s vision for regulatory modernization. From updated and newly drafted guidance documents to the launch of new voluntary pilot programs for industry, the revamp has been far-reaching.
This year “nearly 100 guidance documents” have already been issued, Gottlieb noted. FDA also plans to “issue many more product-specific guidance documents” and “develop hundreds of new clinical guidance documents and make sure they stay up-to-date to reflect the latest science.”
FDA’s efforts involve plans for reorganizing and restructuring internal operations in support of the total product lifecycle. These include a “super office” envisioned as part of the Center for Devices and Radiological Health’s (CDRH) reorganization plans and a proposed modernization of the Office of New Drugs within the Center for Drug Evaluation and Research (CDER).
The role of clinical trials is also being reimagined as part of the work around modernizing drug and device regulations. New steps to improve clinical development programs include breaking down barriers to device early feasibility studies and new policy initiatives for pharmaceuticals.
“Right now, when it comes to drugs targeted to unmet needs, we’re seeing a trend where second and third-to-market competition is taking longer to reach patients,” Gottlieb said. “There are complex reasons for this. But one is the difficulty of conducting traditional clinical trials in settings where there is an available therapy, but still significant unmet medical need.”
An FDA analysis to be published in the near future indicates new competition has been entering at an even slower pace for “novel sole source drug” after approval, according to Gottlieb. Similar trends have been observed with non-orphan drugs and certain first-in-class drugs and biologics.
Yet another area of focus involves FDA’s use of standards. To better support innovation in the medical technology space, the agency is exploring not just a new regulatory framework on digital health products, but also the use of artificial intelligence in the radiogenomics field and annotated imaging data sets for disease indications, Gottlieb noted.
The creation of “a new operating system for innovation,” including the previously proposed medical data enterprise for greater use of real-world evidence, will “help unlock the full public health potential of America’s public and private investments in medical research, Gottlieb added.