Last Wednesday I chaired the Fourth National FDA Regulatory Symposium. Being the chair gave me the privilege to introduce the event’s keynote speaker, FDA Commissioner Peggy Hamburg.
By way of introduction, I pointed out that everybody benefits from an FDA that leads. This means the agency has to be out in front of every issue for which it is responsible.
Every specific action the agency takes is an opportunity to speak to a larger public health issue. When the FDA confidently leads, other stakeholders follow with their expertise, resources and sense of duty. The FDA must be seen as leading rather than simply participating in the process.
As a former New York City Health Commissioner, Dr. Hamburg has the opportunity to bring to the FDA the ability to view regulatory issues from the viewpoint of the man on the street, the patient -- the consumer. And there are issues aplenty:
• There’s the question of REMS plans.
• And complete response letters.
• And the transparency of complete response letters.
• And biomarkers.
• And guidance on off-label promotion.
• And “net impressions” of DTC materials
• And oversight of social media.
• And of clinical trials.
• And of adaptive clinical trials.
• And follow-on biologics.
• And bioequivalence for generics.
• And GMPs
• And drug importation.
• And counterfeiting.
• And companion diagnostics.
• And the regulation of diagnostics.
• And 510(k) reform.
• And food safety and security.
• And dietary supplements.
• And nutritional health claims.
• And tobacco.
• And early safety signal communications.
• And pandemic preparedness.
• And greater international harmonization.
• And the balance of predictability vs. ambiguity.
• And food from the progeny of cloned animals.
• And the FDA’s working relationships with industry and academia.
• And the Reagan/Udall Foundation – wither the agency’s Critical Path program?
As Walter O’Malley – the man who moved the Brooklyn Dodgers to Los Angeles once commented, “The future is just one damn thing after another.”
The Commissioner began her remarks by commenting, “It’s a lot easier to ask the questions then to answer them.” Zing,
Some additional thoughts from Dr. Hamburg:
* Concerned that the agency “is under-appreciated by the public” (a recent poll shows that, among government agencies, the FDA ranks just one notch above the IRS) “and under-resourced.” In fact, she mentioned that she was going to OMB on Friday (October 2) to defend the FDA’s budget proposal for the coming fiscal year. I promised to pray for her.
* The FDA’s most valuable assets are the “extraordinary public servants” who work at the FDA. Can’t repeat that too many times.
* That to be FDA Commissioner requires “wisdom, common sense, and a sense of humor.” Well said.
* The urgency of the FDA’s Critical Path program and “the urgency to fund robust 21st century regulatory science. “ She aptly defined the agency’s role as “Reviewer, Approver – and Catalyst. And, “We must advocate for it.”
* “Success is not measured in warning letters.” Amen – and courageous of her to say so.
* Similarly, and relative to foreign drug manufacture, “The FDA will never be able to assure safety all on our own.” And that there must be “shared responsibility for global drug inspections.”
* During the Q&A she was asked whether or not the FDA would add comparative effectiveness as a third leg to the approvals process. Her smart response was that the FDA should find ways to share its data with researchers in order to “enrich understanding.” Short answer to direct question – no third leg.
* Per the FDA’s initiative on transparency (led by Deputy Commissioner Josh Sharfstein), Dr. Hamburg said she hoped to have some initial (“incremental”) recommendations by November. Stand by on that one.
Thank you Commissioner.
By way of introduction, I pointed out that everybody benefits from an FDA that leads. This means the agency has to be out in front of every issue for which it is responsible.
Every specific action the agency takes is an opportunity to speak to a larger public health issue. When the FDA confidently leads, other stakeholders follow with their expertise, resources and sense of duty. The FDA must be seen as leading rather than simply participating in the process.
As a former New York City Health Commissioner, Dr. Hamburg has the opportunity to bring to the FDA the ability to view regulatory issues from the viewpoint of the man on the street, the patient -- the consumer. And there are issues aplenty:
• There’s the question of REMS plans.
• And complete response letters.
• And the transparency of complete response letters.
• And biomarkers.
• And guidance on off-label promotion.
• And “net impressions” of DTC materials
• And oversight of social media.
• And of clinical trials.
• And of adaptive clinical trials.
• And follow-on biologics.
• And bioequivalence for generics.
• And GMPs
• And drug importation.
• And counterfeiting.
• And companion diagnostics.
• And the regulation of diagnostics.
• And 510(k) reform.
• And food safety and security.
• And dietary supplements.
• And nutritional health claims.
• And tobacco.
• And early safety signal communications.
• And pandemic preparedness.
• And greater international harmonization.
• And the balance of predictability vs. ambiguity.
• And food from the progeny of cloned animals.
• And the FDA’s working relationships with industry and academia.
• And the Reagan/Udall Foundation – wither the agency’s Critical Path program?
As Walter O’Malley – the man who moved the Brooklyn Dodgers to Los Angeles once commented, “The future is just one damn thing after another.”
The Commissioner began her remarks by commenting, “It’s a lot easier to ask the questions then to answer them.” Zing,
Some additional thoughts from Dr. Hamburg:
* Concerned that the agency “is under-appreciated by the public” (a recent poll shows that, among government agencies, the FDA ranks just one notch above the IRS) “and under-resourced.” In fact, she mentioned that she was going to OMB on Friday (October 2) to defend the FDA’s budget proposal for the coming fiscal year. I promised to pray for her.
* The FDA’s most valuable assets are the “extraordinary public servants” who work at the FDA. Can’t repeat that too many times.
* That to be FDA Commissioner requires “wisdom, common sense, and a sense of humor.” Well said.
* The urgency of the FDA’s Critical Path program and “the urgency to fund robust 21st century regulatory science. “ She aptly defined the agency’s role as “Reviewer, Approver – and Catalyst. And, “We must advocate for it.”
* “Success is not measured in warning letters.” Amen – and courageous of her to say so.
* Similarly, and relative to foreign drug manufacture, “The FDA will never be able to assure safety all on our own.” And that there must be “shared responsibility for global drug inspections.”
* During the Q&A she was asked whether or not the FDA would add comparative effectiveness as a third leg to the approvals process. Her smart response was that the FDA should find ways to share its data with researchers in order to “enrich understanding.” Short answer to direct question – no third leg.
* Per the FDA’s initiative on transparency (led by Deputy Commissioner Josh Sharfstein), Dr. Hamburg said she hoped to have some initial (“incremental”) recommendations by November. Stand by on that one.
Thank you Commissioner.
