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Building a Culture of Transparency Is Key to FDA in 2018, Experts Say

Evidence-Based OncologyPatient Centered Oncology Care 2017
Volume 24
Issue 3

Coverage of regulatory changes from Patient-Centered Oncology Care, November 16-17, 2017.

The FDA's role in establishing the standards and regulations for public health would benefit from increased transparency, according to stakeholders who included a representative from the agency. The group was part of a panel that appeared on the first day of Patient-Centered Oncology Care®, presented November 16 and 17, 2017, in Philadelphia, Pennsylvania, by The American Journal of Managed Care®.

Panelists included Roger Brito, DO, senior medical director of Oncology Solutions at Aetna; Mark Fleury, PhD, principal of policy development at the American Cancer Society Cancer Action Network; and Frank F. Weichold, MD, PhD, director for Critical Path and Regulatory Science, Office of Regulatory Science and Innovation, Office of Chief Scientist, in the Office of Commissioner of FDA.

Brito discussed expanding the oncology footprint at Aetna through potentially collaborating with the FDA to increase data-sharing transparency; this would benefit clinical trials and pilot studies. Brito explained that such transparency could be achieved through top-down engagement not only with providers but also with Aetna members. “I think it’s an exciting time to be in healthcare. I think we need to collaborate, include the patients, include pharmaceutical industries, [the] FDA, [the] healthcare company,” he said.

Referring to the cost of care, Brito emphasized that transparency will allow all stakeholders to know about different therapies and treatments earlier in the pipeline, which will improve the cost-containing measures among therapeutics.

Weichold also explained that transparency is necessary to identify areas of improvement between the drug regulators and the patients. He expressed the need for building a new culture in which all stakeholders are contributing resources. “We need to be able to engage the stakeholders and include experts, not just opinion leaders but actual experts that can, through scientific means, define opportunities for solutions,” he said.

Weichold noted that increased transparency could be achieved through embracing the opportunities that technology provides. For example, he mentioned the app HUGO, which gives physicians easy access to patient records. Weichold also noted the signifi- cance for high-quality data and access to such data—a component that the United States could adopt from European models.

Fleury discussed the role of advocacy organizations in working to bring people together and sparking policy conversations among groups of stakeholders. He offered a recent example of a pediatric cancer drug that had biological, regulatory, and financial factors that were different from those of a drug developed for adults; stakeholders came together to reach a common understanding of the problem.

The FDA faces an ongoing challenge of deciding whether the benefits outweigh the risks for the average patient for a condition—although all patients are different, Fleury said. Therefore, he explained, the system is moving toward gathering the patient’s experience and perspective so the FDA does not have to make decisions based on the “average” patient.

Additionally, Fleury noted the importance of providing education to individual patients while ensuring that they trust their physician, as part of building the new culture. “I do think there’s an important role to make sure that we inform the system and create a system that makes sure that they are getting the best possible care and not rely on that patient on day 1 knowing everything that they should ask and everything that they could do,” Fleury said.

Although many changes to the care system are needed, the experts all agreed on the progress that has been made, and they believe progress will continue to be made by the FDA in 2018.

“The agency, I can tell you, from its leadership but also in particular from its staff, [is] very much interested and feels a high level of responsibility and also a sense of public service to make significant contributions to that,” Weichold said.

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