Moonshot and independence… A week in the life of the US FDA
First up this week, the US Food and Drug Administration (FDA) has triggered its role in US Vice President Biden’s vision to eliminate cancer – the National Cancer Moonshot Initiative – by announcing it is creating the Oncology Center of Excellence (OCE).
The Center aims to speed-up the review of combination products in development, Commissioner Robert Califf said in a statement yesterday, but despite his perceived urgency to get it up-and-running as soon as possible, he called for “a thoughtful approach” to its establishment, without any disruption of the FDA’s ongoing work.
The FDA has appointed Dr. Richard Pazdur as “an internal leader in an acting capacity who can focus on bringing together oncologists across the FDA.”
Califf continued: “Dr. Pazdur is the person the FDA needs to get the OCE up and running, because of his in-depth understanding of the inner workings of the FDA, his deep expertise in treating this complex disease and his ability to move the agency forward in this complicated task.”
Guidance and more guidance
Also this week, the FDA has published several documents that are worth drugmakers having at least a quick glance over.
A new draft guidance looking at the conflict of interest between advisory committee members and the decisions made by the 50 or so such committees looks to update previous guidelines from 2008 by administering potential uncertainties around Government-wide standards of ethical conduct.
“To the extent that a member’s performance of official duties might appear to benefit her or certain other individuals close to her, she must take appropriate steps to avoid even an appearance of violating these ethical principles,” the Agency says.
Meanwhile, the Agency has also published a technical reference document on the back of last July’s draft guidance on quality metrics.
“This Guide provides technical recommendations for the submission of quality metric data. It is intended to ensure clear expectations for industry on the submission of quality metric data as described in the Request for Quality Metrics draft guidance,” the ten-page document says.
Independent FDA?
And finally this week, could the FDA become an independent body, untied from the Department of Health and Human Services?
Well at the Aspen Ideas Festival in Colorado, six former commissioners have called on Congress to do just this in order to help reduce bureaucracy and political interference within the Agency, according to Politico.
“The micromanagement from on top has probably gotten to the point where an independent agency is necessary,” said former Commissioner David Kessler, the US political-journalism organisation reported.
