The most beautiful things in the world cannot be seen or even touched, they must be felt with the heart
~ Helen Keller (June 27, 1880 - June 01, 1968)
The underlying problem is that the FDA has little ability to enforce these commitments, short of withdrawing approval for the drug — an outcome that may not serve the public health well. The great majority of post-marketing studies address safety issues, at least in part, so patients and physicians are denied critical safety information when these studies are not completed in a timely fashion.
~ Peter Lurie (January 16, 1962 - )