On April 23, FDA issued draft guidance entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” which aims to clarify how firms in a product distribution chain should prepare to facilitate timely initiation of a voluntary recall, respond to an indication of a problem with a distributed product, and initiate a voluntary
Category Archives: Communications
Subscribe to Communications RSS FeedCommerce Secretary Ross to FCC: Overbroad TCPA Rules Could Have a “Devastating” Impact on Federal Agencies and the 2020 Census
As we head towards 2020, it’s time once again for the decennial U.S. national Census – one of the broadest data collections that the United States federal government undertakes to learn more about its citizens, recalibrate Congressional districts, allocate public funding, and deliver critical public services. But the government’s ability to conduct the upcoming Census
FTC takes on deceptive stem cell therapy claims for blindness cure and autism treatment
On October 18, the Federal Trade Commission (FTC) announced it settled charges against California-based Regenerative Medical Group, Telehealth Medical Group, and the founder of both companies, Dr. Bryn Jarald Henderson, based on deceptive stem cell therapy claims. In its complaint, the FTC alleged Henderson and the companies made unsupported claims, including that “amniotic stem cell
12 Years Later: Court Prohibits Marketing of Prescription Versions of OTC Drug
In a big win for the Food and Drug Administration (FDA), the D.C. Circuit of the United States Court of Appeals reinforced FDA’s position on what constitutes a “meaningful difference” between prescription and over-the-counter (OTC) versions of a drug product. Under FDA’s longstanding interpretation, section 503(b) of the Food, Drug, and Cosmetic Act (FDCA) “does
CMS proposes requiring drug prices in TV ads
On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer (DTC) advertisements for prescription drugs covered by Medicare or Medicaid to include the Wholesale Acquisition Cost (WAC). This proposed rule resembles a rejected Senate amendment to the FY-2019 Labor-HHS-Education appropriations bill (analyzed here) that would
U.S. Senate passes bill requiring prescription drug ads to include prices (updated)
Update (9/18/2018): Last week, as the U.S. House of Representatives was reconciling its spending bill for the Health and Human Services Department (HHS) with the amendment package passed by the U.S. Senate that is discussed below, House Republicans declined to adopt S.Amdt. 3964, which would have provided HHS with $1 million to issue rules requiring pharmaceutical companies to list prices
FCC Seeks to Refresh the TCPA Record
Now that the dust has settled from the D.C. Circuit’s highly anticipated Telephone Consumer Protection Act decision in ACA International, et al, v. FCC, the Federal Communications Commission is going back to the drawing board in a new Public Notice that seeks comment on foundational TCPA issues. In March, the D.C. Circuit struck down the
OECD publishes issues paper on blockchain and competition law
Competition law questions are increasingly raised in the public debate about the blockchain technology. While there is yet to be any investigation in this field, the policy debate about applying competition law instruments to this disruptive, decentralised technology is heating up. The latest and probably most comprehensive approach to structuring the discussion comes from the
“New Deal for Consumers” – draft package adopted by the European Commission
The European Commission has adopted a “New Deal for Consumers” package which aims to empower consumers, promote fairness and build trust across the single market. The package was adopted by the Commission in response to an evaluation on EU consumer protection and marketing directives. The evaluation found such laws need to be better applied, enforced
D.C. Circuit Calls 2015 FCC TCPA Autodialer Decision “Utterly Unreasonable”; Strikes Down Reassigned Numbers Framework
The United States Court of Appeals for the District of Columbia Circuit issued its long-awaited decision in ACA International, et al, v. FCC, a case involving multiple petitions for review of the Federal Communications Commission’s (FCC’s) omnibus 2015 ruling interpreting provisions of the Telephone Consumer Protection Act (the TCPA or Act).
Gender stereotyping in UK advertising – staying on the right side of the line
Unlike some other European countries, the UK does not currently have specific rules prohibiting or restricting gender stereotyping in advertising. To date, complaints about ads featuring stereotypical gender roles or characteristics have been brought based on the requirement in the UK non-broadcast and broadcast advertising codes (the CAP Code and BCAP Code) that advertising must
#Ad and the challenges of native advertising and social influencers
Westminster Media Forum recently hosted a seminar to discuss native advertising and social influencer marketing and their measurement, regulation and impact on brands. Industry insiders, advertising agencies, content producers, publishers, influencers and regulators joined forces to discuss the challenges faced by these new models of advertising. Central to these latest trends is the shift in
TCPA for the Boardroom – An Executive Focus
How do you protect your business from costly Telephone Consumer Protection Act (TCPA) lawsuits and regulatory enforcement actions? In this webinar, we will focus on the key decisions facing company executives as they navigate TCPA risks and assess compliance strategies. Businesses must stay in touch with their customers and their partners in order to succeed. But
The IoT in the Real World: An Armchair Discussion with Stacey Higginbotham
Connected devices are everywhere and create a wealth of data. How do we understand and use this data? And how do we protect it against disclosure and attack? With questions like these, Stacey Higginbotham, creator of the Internet of Things Podcast and the “Stacey Knows Things” newsletter, launched an “armchair discussion” about the Internet of
FCC Imposes $1.84 Million TCPA Penalty for Fax Advertisements
The Federal Communications Commission (“FCC”) recently imposed a $1.84 million penalty for sending unsolicited fax advertisements. According to the agency’s forfeiture order, Scott Malcolm, DSM Supply, LLC and Somaticare, LLC (the “DSM Parties”) sent 115 unsolicited fax advertisements to 26 consumers, primarily health care practitioners, in violation of the FCC’s Telephone Consumer Protection Act (“TCPA”)
FCC Workshop Reveals Secrets of 5G
The FCC held a Spectrum Frontiers and 5G Workshop last Thursday that Julius Knapp, Chief of the Office of Engineering & Technology, called a “landmark day” in wireless history. He likened the event to a similar conference thirty years ago when the industry was transitioning from analog to digital technologies, now referred to as the
FCC Circulates Privacy Rulemaking and Announces Commission Vote
On Thursday, Federal Communications Commission (“FCC”) Chairman Tom Wheeler circulated a highly anticipated broadband data privacy and security Notice of Proposed Rulemaking (“NPRM”) to the other Commissioners, slating the proposals for a full Commission vote at the agency’s March 31 Open Meeting. The rules would apply to internet service providers (“ISPs”), but organizations throughout the
The FCC Holds Company Owner Liable for $3.4 Million Forfeiture
The FCC recently adopted an order that fined two companies, Calling 10, and Telseven, as well as the owner of both companies, Patrick Hines, $3.4 million for cramming, deceptive marketing practices, and failing to pay required fees. The FCC concluded that Mr. Hines “personally participated” in the wrongdoing and formed “sham companies to facilitate the
FCC Harmonizes Pole Attachment Rates
The Federal Communications Commission’s (“FCC”) decision to further harmonize the rates that telecommunications and cable companies pay to attach to “utility” poles was recently published in the Federal Register. Federal law limits how much pole owners can charge attachers by tying monthly rents to the cost of constructing and maintaining the poles. These poles are
Sixth Circuit to Hear Oral Argument in Challenge to Municipal Broadband Rules
The Sixth Circuit Court of Appeals has scheduled oral argument for March 17, 2016, in an important case regarding the Federal Communications Commission’s (FCC’s) ability to preempt state laws that place restrictions on local municipalities’ ability to provide their own broadband networks. Today, 20 states limit the ability of local governmental agencies, such as utilities
Supreme Court Decision in Gomez Shifts Attention Back to FCC TCPA Petitions
In January, the United States Supreme Court issued a long-awaited ruling in Campbell-Ewald Co. v. Gomez, 577 U.S. __ (2016), a significant case for companies defending against consumer and other class actions, including those based on the Telephone Consumer Protection Act (TCPA) – as well as for contractors working on behalf of the federal government.
¡Bienvenidos a Cuba! FCC Removes Cuba from its Exclusion List for International Section 214 Authorizations
Last Friday, the Federal Communications Commission (the “FCC”) adopted an Order making it easier for telecommunications providers to provide facilities-based services such as undersea submarine cables and satellite services, between the United States and Cuba. As Focus on Regulation previously noted, in December 2014 the Obama Administration took executive action to ease trade sanctions and
FCC Launches Redesigned Website; Consumers and Practitioners Rejoice
On Thursday, December 9, the FCC launched its redesigned website, and it is a great improvement over the last incarnation. The FCC website serves two primary purposes. It is 1) a portal for consumers, companies, legal practitioners, and other stakeholders to interact with the FCC electronically; and 2) a phone book. The previous website frustrated
FCC Implements Additional Accessibility Requirements for Navigation Devices and Digital Apparatus
Last month, the Federal Communications Commission (“FCC”) released its second order (“Second CVAA Order”) further implementing the accessibility goals established in the Twenty-First Century Communications and Video Accessibility Act (“CVAA”) passed by Congress in 2010. The Second CVAA Order, which builds on the FCC’s 2013 order (“First CVAA Order”), imposes new requirements on multichannel video