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FDA requires 45 days to review ads

Where does protection end and smother begin?

By Anthony LaFauce | Posted: April 12, 2012

The FDA is an interesting agency when it comes to the American public and credibility. Think about it: whenever most government agencies release a report or statistic, the general public tends to question its validity. But when the FDA publishes a report, the public (with the exception of people who work in the food/drug industry) just assumes the agency is right.

The FDA has just submitted a document to the Federal Registry stating all television ads that are 'direct-to-consumer' have to be pre-submitted to the FDA for review and approval. The Federal Registry is the "official daily publication for rules, proposed rules, and notices of Federal agencies and organizations, as well as executive orders and other presidential documents." In layman's terms: if something is published here it is permanently "on the record" and part of American history.

I understand the argument for this approach: "The FDA just wants to make sure that my health interests are being protected." Ok, I get that. But what if the FDA fails to review an ad during that 45-day period? And then that ad doesn't run and the public doesn't know about a drug?

No big deal, right?

Wrong.

More and more people are finding out about medications that improve their quality of life and possibly save their lives from personal research. According to the Pew Research Center, about 93 million Americans research personal health matters online. Additionally, in a Porter Novelli HealthStyles survey, 26 percent of people polled reported that prime time shows were among their top three sources for health information, and 48 percent took some action after hearing about a health topic in a TV show.

If the FDA fails to review and grant approval for an ad, then people can't find out about a medication or procedure. That means the FDA could be hurting those people it is charged to protect.

Finally, there is a huge amount of money and research that goes into the development of a medication. As the FDA makes it harder for pharma companies to communicate about their products, the pharma companies will not be able to recoup the losses they incurred during the research and development phase. In the long run, that could mean spell bad news for both the pharma companies and the patients.

I understand the FDA is doing what it thinks is best. But if we think of the FDA as a parent trying to protect its children by locking them in their room so they never get hurt, in the end it's the child who will suffer.

Do you think the FDA is going too far?

Anthony LaFauce is director of digital strategy at Spectrum and a longtime member of the technology and social media community. A version of this article first appeared on Spectrum's Full Spectrum Blog.

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