Sharpless calls for nimble FDA; Gottlieb had sought changing FDA rules due to new technologies

By PharmaCompass

2019-05-09

Impressions: 141 Article

In his first speech to an outside group since taking charge as the acting commissioner of the US Food and Drug Administration (FDA), Ned Sharpless has revealed that he will keep the agency headed in the same direction as his predecessor Scott Gottlieb. Last month, Sharpless took over the reins of the FDA from Gottlieb, who resigned from the post after two years on the job in order to spend more time with family.

“If we want to harness the full potential of therapies to transform care, we need to become more efficient, more collaborative, and more data-driven so that we can learn from every patient’s journey,” Sharpless said.

“It is crucial that FDA be nimble, flexible, and adaptable as we continue to advance regulatory frameworks, products, and interventions,” he added.

Known for his deep understanding of oncology and big data, Sharpless, said he has a commitment to science-based decision-making and will prioritize the FDA’s efforts to benefit public health. Sharpless spoke at the Food and Drug Law Institute’s (FDLI) annual conference in Washington, DC, and at the Reagan Udall Foundation’s annual public meeting at Pew Charitable Trusts.

Meanwhile, the US Congress passed a new law that gave the FDA the authority to impose Risk Evaluation and Mitigation Strategies (REMS) and Elements to Assure Safe Use (ETASU). These measures were meant for certain drugs that had serious safety concerns associated with their use. The agency’s aim was to help ensure that the benefits of drugs with known safety issues would outweigh their risks.

The agency also pursued, and acquired, the authority to require drugmakers to conduct post-market studies to minutely evaluate emerging safety concerns.

These new capabilities represent a fundamental modernization in the FDA’s review process.

Former FDA commissioner Gottlieb had talked about changes the agency maybe undertaking due to the new therapies and technologies that have come in the market. According to industry sources, old rules of the FDA do not apply to new technologies such as artificial intelligence and gene therapy. Moreover, safety issues will be more challenging to identify in clinical trial settings due to these new technologies.

According to sources, FDA may issue new guidelines for cell therapy in a year’s time. Moreover, as phenotype, genotype and other targeted and innovative medicines emerge, pre-market testing will become more challenging.

The agency is adopting a standard dynamic template for submissions. It will eliminate paper from the submission process. Moreover, the agency is also working on Medicare Part B reimbursements since Medicare has a difficult time adjusting payments for new medicines such as CAR-T or chimeric antigen receptor T-cell therapy, a relatively new immunotherapy for cancer.

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