FDA’s Dr. Hamburg Speaks to RAPS in Philadelphia

Dr. Margaret Hamburg, the new FDA Commissioner spoke to about 1,000 people attending the annual

FDA Dr. Hamburg RAPS

Dr. Margaret Hamburg

meeting of the Regulatory Affairs Professional Society (RAPS) in Philadelphia. Her prepared remarks noted that when she took the job four months ago FDA was an organization in crisis. She noted that in a recently published poll FDA received the second worst approval ratings of any federal agency, worse than the IRS. She also congratulated RAPS for its continued excellence and the importance of industry professionals in maintaining public health through “Quality by Design.” She used the Orphan Drug Act as an example of how FDA could adapt to public health needs in the drug approval process. She repeatedly praised FDA staff as committed public health professionals.

Dr. Hamburg continued to discuss her theme of “effective enforcement” that she outlined in a previous speech to the Food and Drug Law Institute. She repeated themes including clear enforcement standards, publicizing enforcement actions, and explaining the reasons for those actions. She also took questions in a lively Q & A session that lasted nearly a half an hour.

Responding to one question she stressed the importance of food safety and addressed legislation moving forward in Congress that would give FDA new powers including mandatory recalls and tracebacks during a food safety crisis. FDA currently cannot require a company to recall an adulterated product. She also said that there would be a Deputy Commissioner for Food that would be part of the Office of the Commissioner in addition to the Director of the Center for Food Safety and Applied Nutrition noting that food crossed multiple jurisdictions in FDA (veterinary food) as well as government agencies (15-16).

She was asked about the foreign inspection program which the questioner said had “less rigor” than domestic inspections. Hamburg candidly replied that “we have a system that is inadequate,” and that FDA doesn’t have the strategic framework for their international program. Hamburg stated that there was an ongoing “intensive internal discussion” on international issues. She spoke of the need to collaborate with other regulatory agencies around the world, to “share on the ground information,” and work with other developed countries to develop the regulatory capacity of developing nations. “We cannot and should not go it alone,” Hamburg emphasized.

She also said that FDA had a “very large agenda with respect to clinical trials.” Unfortunately she didn’t elaborate very much on this point as it was the last question she took before leaving the conference. She received very strong applause as she concluded, indicating that many in regulated industry think that she is a breath of fresh air, as well as very smart. I’m in agreement.

2 Responses to FDA’s Dr. Hamburg Speaks to RAPS in Philadelphia

  1. pharmareg says:

    Wow….”She also congratulated RAPS for its continued excellence and the importance of industry professionals in maintaining public health through “Quality by Design.”…

    This sentence amazes me..!!…I really dont understand how RAPS maintaining industry professionals…I am RAPs certified professional myself….spending $$ for exam and buying books from them attending training sessions alone wont

    I am not very happy with RAPS doing now…

  2. pharmareg says:


    alone wont make a regulatory affairs professional…

    I have Focus book infront of me…21 out of 64 are with advertisements from different Regulatory Consultancies…one thing I can say…its good at Marketing..

    Its just opinion..!!

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