As I see it
“The notion that you can come up with a new drug and have millions and millions of people take it safely—the blockbuster—that is what got us into trouble,” he asserted. He said companies want to create “a mass market and sell as many drugs as they can,” and it was “inevitable” there would be more serious side effects from heavily promoted drugs because the question of whether it is the right drug, person, disease and dose often isn't asked.
Agreeing with him were his fellow panelists: Donald Kennedy (Carter era), Frank Young (Reagan) and Jane Henney (Clinton). They all expressed unhappiness over attacks on FDA's integrity and credibility and attributed problems to a lack of consistent and sustained leadership, insufficient resources and a lack of power to deal with safety issues.
Are drug safety issues exacerbated by increased exposure through marketing? Several public opinion polls have shown that respect for the FDA, and its independence from the drug industry, has fallen. But there have been no significant surveys associating that with drug marketing. To the contrary, some pollsters found that DTC ads have helped reduce respect for drugmakers.
It is likely the FDA's own behavior that influences the amount of confidence and respect the public has for it.
The four ex-commissioners hailed from a time when the FDA had a measure of isolation from politics. That measure needs to be restored.
Dickinson is editor of Dickinson's FDA Webview (fdaweb.com)