• Regulatory NewsRegulatory News

    China FDA Seeks Input on Draft Regulation Tightening Control of Online Drug Sales

    The China Food and Drug Administration (CFDA) has released for public consultation a draft regulation that would tighten control of online sales of food and drugs. The rule will drug prohibit producers and wholesalers to sell products to online consumers, and will require sellers of food, health food, cosmetics, and medical apparatus and instruments to obtain permits. CFDA will crack down on false advertising, and information about certain drugs, including stu...
  • FDA Expresses Interest in Comparative Price of Drugs (But not in the way you Think)

    Watch a drug advertisement in the US-any one, really-and one thing you're unlikely to hear any mention of is the drug's cost. That's not always an accident, as the myriad of insurance companies, co-pays, state insurance programs, private assistance programs, coupons and other incentives mean that the true cost of a drug is rarely seen by consumers and is rarely the same for two people. But assume, for a moment, that such an instance existed-that a drug ("Drug A") cost ...
  • FDA Website Knockoff Markets Non-FDA-Approved Products

    In the mid-1990s, when "The Internet" was still in its infancy and government institutions were just beginning to develop an online presence, the world got perhaps its most notable look at how some purveyors will seek to profit off of website confusion. Twenty years later, though, it's still a problem, including for US healthcare product regulators. Background The problem then, as now, is that many people aren't always sure about which domain name suffix- .com, .org, .g...
  • When is a Live Case Presentation Promotional? FDA Draft Guidance Clarifies

    A new draft guidance document published by the US Food and Drug Administration (FDA) is aimed at clarifying which information should be included in an investigational device exemption (IDE) application if the sponsor intends or anticipates including a "live case presentation" during the course of the clinical trial. Background Many high-risk (Class III) "significant risk" medical devices are subject to the premarket application (PMA) process, which requires sponsors to ...
  • FDA Unveils New Changes to eCTD Submission Formats

    If you weren't paying attention closely late last week, you might easily have missed a small but important announcement made by the US Food and Drug Administration (FDA). By the end of 2014, it says, it expects to be able to receive submissions referencing version 3.1 of the electronic Common Technical Document ( eCTD )-a change that will primarily affect regulated pharmaceutical marketing. Pharmaceutical Marketing Changes The announcement, made on its eCTD Validation ...
  • FDA Releases (its Other) Social Media Guidance

    It may not be the social media guidance members of the pharmaceutical industry have be clamoring for, but the US Food and Drug Administration (FDA) today released a draft guidance document that offers some insight into how the agency thinks companies should use-and not use-social media channels. Background The pharmaceutical industry's advertising and promotional materials are tightly regulated by FDA and the Federal Trade Commission (FTC), the latter of which has veste...
  • 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...
  • FDA in Crackdown Against Diabetes Companies for Marketing Unapproved Drugs

    The US Food and Drug Administration (FDA) seems to be on a major kick against unapproved and misbranded diabetes drug products, according to the most recent batch of Warning Letters released on 23 July 2013. Start of a Crackdown FDA often uses batches of Warning Letters to make an enforcement point against practices it does not favor. Rather than releasing 10 Warning Letters over 10 weeks, it may concentrate them all into a single week in the hopes of making a statement...
  • Feature ArticlesFeature Articles

    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...
  • Cancer Drug Returns, and with it FDA's Willingness to Go After its Manufacturer

    Earlier this week, the US Food and Drug Administration (FDA) made a quiet but important announcement: Supplies of the drug Doxirubicin Liposomal Injection, a widely used cancer drug that has been experiencing massive shortages since 2011, have been resolved. But with the resolution of that shortage has come something else that has been in short supply in recent months as well: regulatory scrutiny for the drug. Background In late 2011, regulators became aware of mounting...
  • Changes Coming to Australian Advertising Rules

    Australia's Therapeutic Goods Administration (TGA) has opened a consultation on proposed changes to the current regulatory framework for the advertising of therapeutic goods to the general public. The TGA noted that it is not proposing any changes relating to the advertising of prescription and certain pharmacist-only medicines to the general public, which will remain prohibited in Australia. The objectives of the proposed reforms are to: Improve the timeliness and ...
  • Feature ArticlesFeature Articles

    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...