Tweet #Risks as Well as #Benefits, FDA Tells Drugmakers

“Don’t use Viagra if your heart isn’t healthy enough for sex.” After that warning, Pfizer Inc. will have just 81 letters left to tweet about the benefits of its erectile dysfunction drug, say U.S. regulators.

Drug and device makers who send social media messages on services like Twitter will be required to include the risks and benefits of their products when they do so, the Food and Drug Administration proposed today in two draft guidelines. That means packing that information inside the strict 140-character limit of the social media site from Twitter Inc.

Drugmakers have been awaiting the guidelines since the FDA held a public meeting in 2009 to gather input on social media promotion. Companies have avoided tweeting about products as they wait on the FDA, Lori Leskin, a partner at the law firm Kaye Scholer LLP in New York, said in an interview.

“I think this is clear enough guidance you’ll start seeing more tweets,” Leskin said. “It’s the more significant drugs that do have black box warnings, that do have more significant risk, that are used in limited populations that this won’t be appropriate for.”

The guidelines also propose how drug and device makers can correct information about their products others post online.

Single tweets that tout a drug’s benefit must include the most pressing risks associated with the therapy and a link to a full description of potential harm. A tweet must also include the brand and generic name of a medicine.

One of FDA’s examples is: “NoFocus (rememberine HCl) for mild to moderate memory loss-May cause seizures in patients with a seizure disorder”

The example of the fictitious drug uses 134 characters of Twitter’s 140-character limit.

Correcting Misinformation

The second guideline allows drug and medical device companies to correct information posted about products on social media without adhering to the FDA’s labeling or advertising standards as long as the information is relevant to the misinformation, accurate and nonpromotional.

Companies until now haven’t mentioned products on social media site Facebook Inc. and take down comments that do, Leskin said. Pfizer Inc.’s Facebook page, for example, says the New York-based maker of Viagra and Lipitor removes product comments because there’s not a guarantee they represent a “fair balance” of risk and benefit information.

The FDA has released other draft guidances on social media, including one in 2011 on companies’ responses to unsolicited requests online about off-label use of drugs and devices, and another in January on how companies can submit online promotional material for the FDA to review.

“These guidance documents that came out today were the biggest pieces people were waiting for,” Leskin said.

Consumers, health-care professionals and companies have 90 days to comment on the proposals.

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