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It looks like the FDA is finally moving toward clarifying what’s long been a gray area for drug and device makers: How to deal with the Internet.

At a public hearing in November, the agency will try to hash out tricky subjects like what companies should do about reports of drug side effects appearing online, and how/whether companies should deal with wrong or misleading information that shows up on the Internet. Some companies try to correct information on sites like Wikipedia; others stay out of the fray, for fear of being on the hook for correcting everything once they start wading in.

The hearing will also look at how rules for presenting balanced information apply to online ads and social networking sites. An overview of the hearing was published yesterday in the Federal Register, and it was picked up by the FDA Law Blog and NPR’s Health Blog.

It’s been clear for a while now that the Obama-era FDA isn’t copascetic with the online business as usual. In April, the agency sent warning letters to 14 drug companies over text ads that came up on Google searches and, the agency said, failed to include information about drug risks. Recipients of the letters included big names like Pfizer, Merck and Johnson & Johnson.

And in May, the FDA warned J&J that a video ad for its pain drug Ultram ER didn’t pay enough attention to the risks of the drug. The company told the WSJ it had removed the ad and would respond to the FDA.

Photo: iStockphoto

See the rest here:
What Google and Facebook Have to Do With the FDA