Businesses engaged in human drug compounding, both traditional pharmacies and the more recently created outsourcing facilities, have been on quite a rollercoaster ride since congressional enactment of the Drug Quality and Security Act (DQSA) approximately four-and-a-half years ago. Federal and State inspectional mandates have changed, FDA guidance documents (and a few regulations) have been churned out, and some entities have been the target of aggressive enforcement actions and even criminal prosecutions by the FDA/Department of Justice. Suffice it to say, this blog post cannot capture everything that compounders have been grappling with or how their compliance policies have been evolving. So today, we are sharing one important and positive bit of news for health systems and other entities that may be considering whether and how to set up an outsourcing facility under Section 503B of the Food, Drug, and Cosmetic Act (as amended by the DQSA). Continue Reading FDA Alters Course on Definition of Compounding “Facility” in Final Guidance
Although the options for accelerated FDA pathways have recently expanded, the current political climate has increased scrutiny of expedited approvals. Next week, my colleague Bethany Hills will be moderating a panel discussion in our Boston office about the realities of pursuing an accelerated pathway. Panelists from J&J Innovation, Synlogic, and Analysis Group will focus on the risks and potential rewards of the shorter time to market.
Topics to be covered include:
- When to consider an alternative pathway to approval
- Risks – including the chance of FDA denial
- Market perceptions — increased value, rising stock prices
- Realities of the pathways
- Clinical and data risks
- Pairing exclusivity and accelerated pathways
- Finance theory on risk and stock pricing
The event will take place next Thursday, March 29th at 5:00 PM in our Boston office (registration starts at 4:30). For more information or to register or the event, please click here.
Last week, Mintz Levin released an Advisory reminding holders of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) of the February 14, 2018, deadline to submit data to the U.S. Food and Drug Administration (FDA). The Advisory summarizes the notification requirements as well as the risks associated with failing to provide the required information, including removal of a manufacturer’s drug products from the active section of FDA’s Orange Book. The data submission requirements are part of the FDA Reauthorization Act (FDARA), which aims to improve FDA’s ability to track drug products in the commercial marketplace and represents one of Congress’ attempts to control drug pricing and address patient access issues for prescription drugs.
It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation’s abbreviated marketing pathway for biosimilar products.
After the Supreme Court issued its first ruling on the BPCIA in June 2017 (see our prior post here), it sent the dispute between Amgen and Sandoz back to the Federal Circuit Court of Appeals to resolve the question of whether Amgen’s claims asserted under California law, including a claim of unfair competition, were preempted under the BPCIA. Continue Reading Biosimilar Market Developments Continue Apace in 2018
Yesterday we started off our year-end series of blog posts with the first part of a review of FDA’s actions for 2017 in the therapeutic products space. Part 1 recapped Commissioner Gottlieb’s initiative to tackle drug competition issues, with the end goal of affecting drug prices, as well as current figures related to this year’s new drug and biologic approvals. A large proportion of those new products took advantage of the Breakthrough Therapy program and other expedited development/review pathways. Today we’ll begin where we left off and consider how the newest expedited review pathway, the RMAT Designation program, is doing one year after its creation by Congress. Continue Reading FDA 2017 Year in Review: Therapeutic Products, Part 2
As is the tradition here at Health Law & Policy Matters, towards the end of the year we take stock of what transpired in our respective industries and highlight important legal, regulatory, and business developments. For those of us who monitor the Food and Drug Administration (FDA or the Agency) and counsel FDA-regulated entities, it has certainly been a whirlwind of a year.
2017 began with no clear picture of who would be assuming leadership of the Agency, but also with a brand-new piece of critically important (and bipartisan!) legislation – the 21st Century Cures Act (see our prior posts here) – which imposed new obligations and authorities on FDA that needed to be implemented, operationalized, and fully funded. In early May, Dr. Scott Gottlieb was sworn in as the 23rd Commissioner of FDA and he moved quickly to shift policy priorities in almost every area that the Agency regulates, a goal that in some ways was made more efficient due to the concurrent timing of modernization mandates imposed by the Cures Act. This year’s must-pass User Fee Act, the FDA Reauthorization Act or “FDARA” (see our prior posts here) engendered some hand-wringing and political drama over the summer, but was ultimately passed by Congress in August and signed into law. FDARA includes some important policy and programmatic changes for new prescription drugs/biologics, generic drugs, and biosimilars, but it did not contain major wholesale reforms to the Agency’s authorities due to the very recent passage of the Cures Act.
This is the first in a series of three installments that will review the actions FDA took in 2017, reflect on what they may mean for regulated industry, and provide a few predictions for 2018. This first installment, which will be broken up into two posts, focuses on therapeutic products; that is, drugs, biologics, human cells and tissue products, and gene therapies. Our subsequent posts will focus on medical devices and diagnostics, including whole-genome sequencing tests, and digital health and other software-related developments, respectively. Continue Reading FDA 2017 Year In Review: Therapeutic Products Energized by Cures Act, Bold Leadership
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