Washington Post Article on Future of FDA
The Washington Times carries an article on the future of the US FDA (Food and Drug Administration), written by Robert Goldberg and Peter Pitts.
The article focuses on the need for the regulatory process to evolve so as to more effectively deal with developments like personalized medicine. The authors are heavily in favour of a bill promoted by Senators Mike Enzi and Ted Kennedy, which they say would encourage “the evolution toward targeted, predictive and preventive approaches to drug development with the creation of Reagan-Udall Applied Biomedical Research Institute”.
The article’s authors, who are vice president and president of the Centre For Medicine in the Public Interest, say that the Enzi-Kennedy bill reduces risk by encouraging personalized medicine, and also that:
“The legislation recognizes that the current patchwork of after-the-fact paper submissions of adverse events just won’t cut it for next-generation medicines. It strongly encourages investment in electronic data capture services to promote collection of real-world data from registries and also promotes observational studies looking at a medicine’s uses to other ongoing safety studies.”
They go on to heavily criticize a competing bill, which they say will create extra bureaucracy and damage the FDA. Despite searching on the sites of the U.S. Senate, and those of Senators Enzi and Kennedy, I could not find the actual Enzi-Kennedy legislation, so I am not able to provide a link where readers could go and form their own views by reading the text of the bill. If anyone knows where it can be found, please post a comment.
