The market for apps designed to improve health and wellness or even to diagnose and treat medical conditions continues to grow.  Last week, the U.S. Food and Drug Administration (“FDA”)  approved a new smartphone-based “carbon monoxide breath sensor system” that measures carbon monoxide levels on a user’s breath. The sensor, which is intended to help users quit smoking, tracks the real time effects of a user’s smoking behavior.  And just a few weeks ago, the FDA gave its approval to a cognitive behavioral therapy app to be used in outpatient therapy for substance use disorders related to alcohol, cocaine, marijuana and stimulants.  Continue Reading Building a Health App? Part 4: Avoiding an FTC Enforcement Action

This is our third installment in our series about the legal issues involved in launching a health app, which the U.S. Food and Drug Administration (“FDA”) refers to as “mobile apps.” The goal of this post is to provide you with a basic understanding of FDA’s evolving approach to mobile apps so that you can make informed decisions about the legal consequences of your app’s functionality. Continue Reading Building a Health App? Part 3: What You Need to Know About FDA’s Regulation of Mobile Apps

Last week, Apple announced the new Apple Watch Series 3 which will feature an enhanced heart rate app.  The app will notify you when it detects an elevated heart rate even when you are not working out.  The sensor will also be able to analyze cardiac arrhythmia. According to one estimate, 165,000 health-related apps were available for Apple or Android smartphones last year. Forecasts predict that such apps will be downloaded 1.7 billion times by 2017.  Without a doubt, health apps are turning into a big business presenting not only an opportunity for financial success but the potential to impact the health and wellness of millions of consumers.  The success of a health app will depend on careful consideration of some key legal issues during the early stages of development.  In a series of weekly blog posts, we will cover these issues and provide best practices to help guide you through the successful launch of your health app.  Below is a preview of what this series will cover.    Continue Reading Building a Health App? What You Need to Know

In a major public move that has been long-awaited by proponents of evidence-based stem cell science, FDA Commissioner Scott Gottlieb issued a lengthy statement on August 28, 2017 “on the FDA’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine.” Continue Reading FDA Commissioner Announces Stem Cell Enforcement Shift, Plans to Develop Comprehensive Regenerative Medicine Policies

Facing pressure from stakeholders and technological realities, the U.S. Food and Drug Administration has again delayed its enforcement of parts of the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post, the DSCSA requires enhanced security and accountability for prescription drugs throughout the U.S. pharmaceutical supply chain, with phased-in obligations for the various trading partners over 10 years, beginning with the law’s passage in November 2013. Covered trading partners include manufacturers, repackagers, wholesale distributors, and dispensers, whose upcoming compliance obligations under the DSCSA are all addressed by FDA in the recently issued Compliance Policy guidance documentContinue Reading FDA Delays Enforcement of Prescription Drug Product Identifier and Related Requirements

It appears that – at least for now – the U.S. Food and Drug Administration (FDA) is serving as the public face of the executive branch’s efforts to tackle the increasingly contentious debate about prescription drug prices. As we previously reported, following a May 25, 2017 budget hearing, FDA Commissioner Scott Gottlieb has made increased competition in the drug marketplace a high policy priority for the Agency. To that end, we have recently seen concrete steps being taken to advance Dr. Gottlieb’s multi-pronged “Drug Competition Action Plan.” Continue Reading FDA Stays in the Spotlight with Drug Pricing Moves, but Could Be Facing Risk as UFA Bill Loses Attention

On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological products finally exhaled. The June 12, 2017 opinion followed the parties’ oral arguments on the last day of the Court’s October 2016 Term, as we previously reported. With respect to both of the significant issues presented, the Justices unanimously reversed the Federal Circuit Court of Appeals split opinion and remanded for further consideration of questions related to State law.

Although our intellectual property colleagues have separately analyzed the “Patent Dance” implications of the Court’s decision in Amgen v. Sandoz (see here), the second issue presented in the case related to the proper interpretation of the 180-day notice provision of the Biologics Price Competition and Innovation Act (“BPCIA”). The Federal Circuit had held that such notice by the biosimilar applicant can only be provided to the reference product sponsor after FDA licenses (i.e., approves) the biosimilar application.  Continue Reading SCOTUS Ruling Gives a Boost to Biosimilars; FDA Continues to Advance Products Through AdComs

During his first appearance before Congress as FDA Commissioner on May 25, 2017, Scott Gottlieb reported that the Agency is preparing a “Drug Competition Action Plan” that it will unveil in upcoming weeks and months. This was likely welcome news to many politicians from both parties, as well as to President Trump, who has publicly shamed pharmaceutical companies for the high prices of their products but has done little to advance concrete policies in this area.

Dr. Gottlieb has been consistent over the years, including during his recent confirmation process, in his view that FDA should take a more active role in fostering competition and reducing unnecessary regulatory barriers. So it was not surprising when he was selected by Trump to lead the Agency, nor when he received a relatively warm welcome from Senators concerned about the direction prices have been going in recent years. Continue Reading FDA Commissioner Hints at Drug Pricing-Related Initiatives

In my last post, I introduced a series of posts that will explore FDA’s historical approach to off-label drug and device communications, how that position has evolved (or not) to the modern day, and predict where that policy might end up a few years from now. This post focuses on the history of FDA’s off-label communication and promotion policy, and while it is by no means a comprehensive history, I attempt to reveal some of the origins and early development of the Agency’s approach to off-label uses and promotion.  In fact, FDA’s early position on off-label communications closely resembles the Agency’s stance on the subject today. Continue Reading The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 2

Just as the public comment period for the bicameral, bipartisan discussion draft of the “FDA Reauthorization Act of 2017” ended on Friday, what we have been calling the User Fee Games got even more interesting and engaging.  As we previously reported, a discussion draft of the FDA Reauthorization Act was released jointly by leaders of the Senate HELP Committee and the House Energy & Commerce Committee two weeks prior to that comment deadline.  It now seems that the late start to the 2017 user fee legislative process – along with the rapid approach of summer and the risk of Agency layoffs if this five-year reauthorization cycle is not completed before August – has gotten everyone pushing on the accelerator a bit. Continue Reading More Bipartisan Bills Hope to Catch a Ride on the UFA Reauthorization Legislation