Lawmakers Seek Drug Safety Reform at FDA

It's coming closer to the day when the practices of the pharma industry on postmarketing surveillance and advertising are going to be more tightly regulated:

Lawmakers Seek Drug Safety Reform at FDA

Reacting to wide concerns over prescription drug safety, lawmakers Wednesday proposed a bill to reform the FDA by forming a new independent safety office inside the agency. The bill would give the office new powers to police the safety of drugs already on the U.S. market, including authority to recommend banning further sales of drugs carrying unreasonable health risks.

The plan also gives the office's director the ability to order drug companies to perform safety studies of marketed drugs and to order changes in direct-to-consumer drug advertisements.

The industry earned this oversight the really old-fashioned way: through muddled thinking and neglect (at best).

From a medical informatics perspective, I believe rigid adherence to what I call the "assembly line data management" approach of the data-processing deparment of yesteryear - lacking any real creativity and utilization of healthcare informatics research and insights - has contributed to industry harm. Such "1970's thinking" has helped cause the need for a government-mandated oversight committee. The effects of "business driving the science" only compounded this problem.

As I have written before, healthcare informatics specialists are rare as hen's teeth in pharma despite NIH-funded training programs at major universities and many other internally-funded programs funded at universities in the U.S. and abroad. (As a personal observation, it was literally stunning that the pharma industry found my background wanting in terms of doing anything involved in drug safety data management - and, in fact, in doing anything at all other than overseeing research libraries under control of Management Information Systems personnel who themselves lacked substantive scientific credentials. )

-- SS