As I see it

Share this article:
Is drug advertising responsible for the FDA's loss of public confidence? Four ex-commissioners of the agency seemed to think so when they met in a public panel discussion in February. Most forthright in pushing this view was David Kessler, who's now dean and vice chancellor of medical affairs at the University of California San Francisco Medical School.

“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)


Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in As I See It

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in As I See It

As I See It: Patient Centricity

As I See It: Patient Centricity

A patient who is diagnosed earlier and receives the most efficacious treatment is the least expensive

As I See It: FDA's social-media moves

As I See It: FDA's social-media moves

FDA has insisted that its antique regulations can address every new promotional challenge

As I See It: FDA and marketing materials

As I See It: FDA and marketing materials

The more clarity that FDA provides, the more confident companies can be in their medical communications