FDA Releases Social Media Marketing Guidance for Medical Industry

The FDA released draft guidance this week for pharmaceutical and medical device manufacturers, offering proposed regulations on how consumer information about their products can be provided through social media while still including important risk information.

The draft guidance document proposed by the FDA gives pharmaceutical companies and healthcare device manufacturers a framework on how to accurately and specifically communicate information about prescription drugs and devices on social media networks without running afoul of federal regulations.

Patients often turn to social media and the internet for information about FDA-regulated prescriptions and medical products, leading many manufacturers to use the mediums to promote benefits associated with their products. However, difficulties may be faced given the limited nature of some networks and the need to include information about potential risks, as well as benefits.

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The FDA believes that, if followed by industry, the new guidance document would provide consumers and providers more accurate information when making decision concerning products. 

If finalized, the guidance would not be an actual rule or regulation, but would lay out best practices and industry standards for how to avoid getting in hot water with the FDA over existing rules. Drug and medical device companies would not be required to adhere to the guidance, but would not be able to claim ignorance if they are cited for violating existing federal laws that predate social media technology.

“As a regulatory agency, we are committed to ensuring that the information about these products that their manufacturers and distributors direct at patients and health care providers is accurate and balanced,” said Thomas Abrams, director of the FDA’s Office of Prescription Drug Promotion, in an FDA blog announcing the guidance.

The proposed guidance would require drug and device companies to provide information to patients which will help them make well-informed decisions with the help of information from their healthcare providers.

According to the FDA, companies must to present both the risks and benefits of a particular drug or device in any statements on social media sources, including those with character limitations, such as Twitter and paid search results on Google, Facebook or other websites.

“But regardless of the Internet source used to communicate about medical products, the public health is best served by clear, accurate, truthful and non-misleading information about them,” Abrams said.

Companies must clearly offer the exact indication of the drug, but also potential side effects. In the case of an advertisement on Twitter, the benefits and risk must both be presented clearly within the 140 characters of the tweet.

The guidance suggests that advertisements on these sites could offer a hyperlink taking consumers to more complete information about the products.

Simple advertisements that provide only the name of the product, would also be allowed.

The guidelines also offered companies recommendations on how to correct misinformation posted about products by independent third parties. It calls on companies to recommend corrections to information, for both positive and negative criticism.

Corrections would offer clearly defined details on the products on a portion of a forum or social media site easily accessible to consumers, or the corrections could be sent directly to a blogger or author of a web page. However, the FDA said it would not hold a company accountable if a particular author or website failed to correct the information.

The agency would not require corrections to include both benefits and risks required of normal advertising posts, provided the corrections are clearly defined.

The FDA says the draft guidance comes in response to requests for best practices from companies and stakeholders alike.



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