RAPS ANNUAL CONFERENCE - The NEW FDA COMMISSIONER'S SPEECH

mdi attended the recent annual Regulatory Affairs Professional Society (RAPS) conference, where the new FDA commissioner Dr. Hamburg addressed the conference attendees. The following is some of the topics discussed by Dr. Hamburg.

Dr. Hamburg remarked that when she took the job just four months ago, the FDA was an organization in crisis. According to a recent poll data, FDA received second worst approval rating of any federal agency, even worse than the Internal Revenue Service.

Dr. Hamburg’s agenda is to restore public confidence in FDA and she has specific ideas on how to accomplish this. The new Commissioner spoke about the need to strengthen the discipline of regulatory science in both the government and regulated industry so that breakthrough discoveries in biomedical research can result in efficient product approval for the benefit of public. 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 also spoke on the subject of food safety and addressed legislation moving forward in Congress that would give FDA new powers. These will include mandatory recalls and tracebacks during a food safety crisis because under present regulations, FDA cannot require a company to recall an adulterated product. She also said that there would be a new position of the Deputy Commissioner for Food as part of the Office of the Commissioner besides the current Director of the Center for Food Safety and Applied Nutrition.

When asked about her viewpoint on the biosimilar biologics, Dr. Hamburg provided a very positive feedback and stated that preparations are underway at the FDA to address the scientific issues related to biosimilars. She believes that legislation on biosimilar products is approved by Congress.

Dr. Hamburg reiterated her agenda with regards to increased enforcement of GMP noncompliance. She repeated previously discussed topics on clear enforcement standards, publicizing enforcement actions, and explaining the reasons for those actions.

She was also asked about the foreign inspection program and why foreign FDA inspections appear to be conducted with less rigor than domestic inspections. Dr. Hamburg agreed that an FDA system may be 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.

If you need assistance with your Annual FDA Registration and Listing requirements you can contact mdi Consultants at info@mdiconsultants.com and reference Reg/List for 2010.