FDA Focuses on Sex-Specific Data in Medical Device Clinical Trials The National Law Review The guidance outlines “FDA's expectations regarding sex-specific patient enrollment, data analysis, and reporting of study information.” According to the...
Over the last two years, two companies have found themselves in the sights of the US Food and Drug Administration (FDA) after the regulator warned them for violating federal advertising regulations by "liking" unapproved claims on the social networking website Facebook. But while FDA's warnings have yet to set off a wider crackdown on pharmaceutical companies, recent changes to the social media platform Twitter have raised the possibility that similar attention might soon be focused there.
Not only are today's healthcare consumers and patients relying more on the Internet to seek out information, locate needed medical experts and keep up on latest research and treatments, they're also sharing what they learn through an increasing number of social media outlets, including Facebook and Twitter.
Social media technologies provide users with quick and fast sharing capability and the potential to reach a huge swath of other users. The sites also afford the same capabilities to healthcare providers, vendors, pharmaceutical companies, payers and everyone else within the healthcare industry.
To that end, it's nice to see the U.S. Food and Drug Administration (FDA) finally catch up with how consumers and patients are sharing information online, especially since medical device manufacturers, pharma companies and other healthcare professionals are are doing the exact same thing.
In drafting a new federal guidance document on social media use, FDA offers medical device manufacturers and pharmaceutical companies insight on how to share benefit and risk information on 23 electronics digital platforms, ranging from Twitter and blogs to online paid search programs. Specifically, it calls for a balance between risk and benefit information posted to online platforms.
The guidance arrived several months after the FDA announced its intention to track social media talk about product risks. "The objective of this requirement is to provide FDA with the resources needed to use social media to inform and evaluate FDA risk communications," a solicitation notice published to the Federal Business Opportunities website in March said.
Doctors, nurses, pharmacists and healthcare consultants from the U.S. make up most of the healthcare professionals who use Twitter, according to research by Creation Healthcare, a London-based research and training consultancy. U.S. healthcare professionals make up 31 percent of the 75,000 worldwide total of healthcare professionals who turn to the social media site to "tweet" information about healthcare policy, research, individual medicines and treatments for the disease.
Still, social media, in general--for med device and pharma companies, as well as health payers and providers--is about actively influencing consumers, educating and empowering them to drive measurable results, according to a Deloitte University Press article published earlier this year.
The work of regulatory professionals working in the United States is notoriously tough. There are thousands of regulations to know, scientific knowledge to understand, colleagues to convince and regulators to placate. And now new data supports a commonly held belief: Your job really is getting more difficult every year.
A new early-stage pilot program quietly under development by the US Food and Drug Administration (FDA) hopes to make it easier for medical device companies to see how their device is progressing through the agency's regulatory processes, all at a glance.