On July 9, 2024, the Food and Drug Administrations (FDA) replaced a 10-year-old draft industry guidance on misinformation and social media information on prescription drugs and medical devices. The new guidance assists...more
We hosted an engaging discussion with Sarah-Lloyd Stevenson and Matt Rubin, two former Faegre Drinker colleagues who now serve on Amazon’s Public Policy team. With more than a decade of experience advocating for health care...more
The Drug Supply Chain Security Act (DSCSA) (Title 2 of the Drug Quality and Security Act, P.L. 113-54 (Nov 27, 2013)) amended Chapter V of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding subchapter H —...more
The American Telemedicine Association (ATA) brought together change-makers and front-line providers from across the telehealth industry for its annual conference, ATA Nexus 2024, on May 5-7, 2024, in Phoenix, Arizona. Below...more
On May 16, 2024, the U.S. Department of Justice (DOJ) published its proposed rule to move cannabis from the highly restrictive Schedule I tier under the federal Controlled Substances Act (CSA) to the more loosely regulated...more
Due to convenience and effectiveness, patients are increasingly seeking care via telehealth, including for conditions that require treatment with medication. During the pandemic, patients gained access to telehealth for...more
In late December, Congress passed and President Biden signed into law a $1.7 trillion year-end omnibus spending bill to fund the federal government through FY2023. This alert summarizes the notable health policies and...more
In one year (plus a few days, as of this writing), regulation of the U.S. drug supply chain will be historically changed. On November 27, 2023, the final phase of the Drug Supply Chain Security Act (DSCSA) goes into effect....more
Once an innovative outlier in the world of health and life sciences, telemedicine has exponentially gained ground in the current landscape shaped by COVID-19 restrictions. Ann Mond Johnson — CEO of the American Telemedicine...more
Throughout much of 2020, Members of Congress, the Trump Administration, and even Associate Justice Clarence Thomas have highlighted the reasonableness in reevaluating Section 230 of the Communications Decency Act (47 USC...more
Faegre Drinker professionals Megan Herber, Sarah-Lloyd Stevenson and Libby Baney provide ongoing support to the American Telemedicine Association’s (ATA) policy work.
This week, the comment period closed for the calendar...more
March 17, 2020, will be a day to remember in the history of telehealth in the U.S. Thanks to a slew of federal policy changes, it is now easier for providers to offer telehealth, more people can access telehealth services,...more
On Thursday, March 5, the Food and Drug Administration (FDA) submitted its long-awaited report on the agency’s activity related to regulation of cannabidiol (CBD) and CBD-containing products. The FDA was required to submit a...more
As many brand owners know, WHOIS data is the publicly available information on who has registered a particular internet domain name. In layman’s terms, WHOIS records are akin to land title or property tax records: a record of...more
Dr. Mark Fleckner, a board-certified New York ophthalmologist, will pay almost $7 million to settle civil fraud claims arising from giving patients imported macular degeneration drugs that had not been evaluated or approved...more
On January 11, 2018, the Food and Drug Administration (FDA) released its 2018 Strategic Policy Roadmap, which sheds light on the agency’s key focus areas for the year. This Roadmap builds on some of the FDA’s existing work,...more
On Friday, September 29, the Department of Veterans Affairs (VA) released its long-awaited proposed rule amending medical regulations to improve access to care for beneficiaries regardless of patient or provider locations....more
Even with the prospect of Obamacare repeal and replace on the backburner for now, the federal government continues to focus on health care. Following August recess, Congress will have less than four weeks to work through...more
On December 12, 2016, the Office of the U.S. Intellectual Property Enforcement Coordinator (IPEC) in the Executive Office of the President issued a much-awaited interagency plan on intellectual property (IP) enforcement. The...more
Even with the federal legislators poised to head home at the end of the week, two significant telehealth measures continue to work their way through the House and Senate, further evidence that telehealth services have become...more
Donald Trump’s election as president of the United States of America was as unexpected in the polls as the United Kingdom’s vote to embrace Brexit. Now Democrats and Republicans alike are trying to assess how Mr. Trump, a...more
The Food and Drug Administration (FDA) released a final guidance on July 29, 2016, saying that it does not plan to require pre-market review for low-risk "general wellness products," such as wearable fitness monitors,...more
Substantive changes to IP protection in the recently signed Trade Facilitation and Trade Enforcement Act of 2015 (the Act) may be advantageous to U.S. IP owners. However, many of the Act's enforcement tools still need to be...more
Telehealth services are in-demand and, quite literally, on-demand. Patients are increasingly seeking out health services via real-time synchronous audio-video encounters with health care providers (known as “telehealth” or...more