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  • FDA Seeks to Determine how Consumers Find Health Information Online, Perceive Benefit-Risk

    Direct-to-consumer marketing is a topic of regular interest to regulators with the US Food and Drug Administration. At various times during the past several years, it has announced studies involving the use of composite scores in DTC advertising, the affect of DTC advertising on healthcare professionals , and corrective advertising resulting from improper DTC marketing. Now it's making some substantial changes to a DTC study first approved in 2011, according to docu...
  • Do They 'Like' Us? FDA Wants Tool to Better Assess its Impact on Social Media

    The US Food and Drug Administration (FDA) doesn't always seem like it's listening to its stakeholders. But if a recent sources-sought notice posted to the Federal Business Opportunities (FBO) website is any indication, it's listening a lot more closely than most people would realize. A hallmark of many businesses in the last few years has been the use of analytics tools to gauge the impact of various "campaigns," including on social media. For example, by using special p...
  • FDA Preparing to Devote more Resources to Social, Mobile Outreach

    The US Food and Drug Administration (FDA) is, first and foremost, a public health agency responsible for regulating the safety and efficacy of healthcare products. But central to that mission is how it communicates with the public about those products, something made even more complicated with the advent of new technologies. Background These difficulties are put on display in a new report just published by FDA, which notes that the last two decades have seen the develop...
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    RSS Comes to Regulatory Focus: One More Way You Can Follow Focus

    You spoke, and we listened. We're proud to unveil a brand new way to connect with Regulatory Focus : through RSS feeds. Regulatory Focus now has several RSS feeds you can subscribe to, depending on your needs: All Regulatory Focus Content Regulatory Focus News Latest News Regulatory Updates Regulatory Focus Features Regulatory Focus Departments It's the Law Perspective Quality and Compliance Science and Technology...
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    Legal Issues in Digital Pharmaceutical Communication in the EU--Part 3

    In March 2011, the European Commission launched a public consultation on an updated eHealth Action Plan for the period 2012-2020 1 , which had been called upon by the Council Conclusions on Safe and Efficient Healthcare through eHealth of December 2009 2 , and superseded the first plan adopted in 2004. Similarly, the US Food and Drug Administration (FDA) promotes the development of mobile medical apps that provide consumers and healthcare professionals with valuable he...
  • False Statements on Facebook Regarding FDA-Regulated Product Lead to Jail Time for Iowa Man

    Rarely does one person influence how the US Food and Drug Administration (FDA) looks at a company, but every so often one person comes along and-for better or worse-changes the agency's perspective. This article is about the latter of those two possibilities. Background An example of the former may well be Dinesh Thakur, who blew the whistle on deficient practices at Ranbaxy, practices for which the company has now paid hundreds of millions of dollars. But if that's ...
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    Regulatory Issues in Digital Pharmaceutical Communications in the EU--Part 1

    • 25 April 2013
    The use of eHealth systems and services-defined as healthcare practice using the Internet-offers great potential to enhance patient safety by avoiding medical errors and improving communications, while reducing costs and inefficiencies in areas such as record keeping. 1 Because of this potential to improve health systems, the use of eHealth technology to aid in medical diagnosis and treatment and support pharmaceutical communication will likely become increasingly commo...
  • FDA Gets Go-Ahead for Study of DTC Advertising and Social Media

    The US Food and Drug Administration (FDA) will move forward with a survey of healthcare professionals regarding their opinions and perceptions about prescription drug promotion after receiving approval from the Office of Management and Budget (OMB), the executive branch's regulatory clearing house. Background FDA's intent to conduct the survey was first announced in January 2012, when it said in a Federal Register posting that it was soliciting comments on a propo...
  • SEC Out with New Social Media Policy, But Parallels for FDA are Few

    For the second time in as many weeks, a major regulatory agency has announced the release of a new social media policy governing interactions between companies and the customers they serve, again permitting the practice within certain reasonable limits. The difference: This agency is the Securities and Exchange Commission, which, along with the US Food and Drug Administration (FDA), oversees one of the most stringent and complex regulatory areas in the entire US economy. ...
  • Could FTC's New Social Media Guidance be Similar to one Pending at FDA?

    If pharmaceutical and medical device companies are eagerly awaiting the US Food and Drug Administration's (FDA) social media guidance for promoting their products using social networks like Twitter and Facebook, a new guidance released by the US Federal Trade Commission (FTC) may provide some insight into how the agency will treat mobile and social advertising. Background: Authority FTC and FDA operate under a slightly unusual agreement in which FTC voluntarily cedes so...
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    Regulatory Experts Urge Caution With Communications Activities

    The Office of Prescription Drug Promotion (OPDP) and its Advertising and Promotional Labeling Branch (APLB) of the US Food and Drug Administration (FDA) have been busy. Over the past year, they have released multiple guidances, expanded the so-called "bad ad" program that asks healthcare professionals to police inappropriate promotional efforts, and issued a number of untitled and Warning Letters. During a panel discussion at 2012 RAPS: The Regulatory Convergence , regu...
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    Experts Examine Regulation of Health-Related Mobile Apps, Software and Social Media

    When it comes to the regulation of mobile apps, software and social media in the healthcare space, intent is key but absolute clarity is elusive, according to the expert presenters who spoke to attendees during a session at 2012 RAPS: The Regulatory Convergence in Seattle. The speakers, Center for Medicine in the Public Interest Founder Peter Pitts; Head of Emerging Technologies, Devices Division for the UK's Medicines and Healthcare products Regulatory Agency (MHRA) Ne...