FDA Must Become An Information Provider As Well As A Regulator

By Daniel R. Matlis

“This is a Challenging time for the FDA and the Industry” said Janet Woodcock, MD, FDA’s Deputy Commissioner of Operations and Chief Operating Officer, at the Drug Information Association’s 42nd Annual Meeting.

She listed 6 key trends facing the industry:

1-Biomedical Science Investment by industry is beginning to pay off with new personalized medical treatments and combination therapies.

2-Healthcare is entering the Information Age in the US where patients are not waiting for Doctors to assess their condition. With access to information on the internet, patients are going to the doctor’s office armed with information on their condition and possible treatments options.

3-The shift in population trends and level of activities have caused obesity and nutritionally related illnesses to reach an alarming level.

4-The cost of healthcare has had a severe impact on industry competitiveness. Healthcare economics, not outcomes are directing patient care.

5-Globalization is requiring the FDA to look outside of its originally mandated domestic jurisdiction.

6-Constraints on FDA resources are challenging the agency in the face of higher expectations from Congress and the American public.

To respond to these realities, the FDA must undergo a transformation. The agency must become an “enterprise agency instead of separate centers” said Woodcock alluding to the silos within the agency.  “The public wants to interact with one FDA, not separate centers” she added. 

As we move away from therapeutic areas and into solutions based medicine, including pharmacogenomics, personalized medicine and combination products, “FDA must become an information provider as well as a regulator” said Woodcock. Her mandate is to re-assess the agency’s structure to leverage technology investment and human capital across the agency.

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