News Archive
Cell & Gene Therapy is making swift progress, and Catalyst is keeping pace.
Scientific innovation in Cell & Gene Therapy (C>) is advancing rapidly, sparking hope for patients with rare diseases, cancer, and other debilitating conditions. The key is knowing where the advances may come [...]
Califf: FDA will be a ‘more activist’ agency
Regulatory Focus - Aug. 24, 2023 Note: This article describes an interview co-moderated by Catalyst CEO Nancy Myers, along with Tom Kraus, VP- Government Relations, American Society for Health-System Pharmacists. The webinar interview [...]
Telework helps FDA compete for scientists. What if it’s no longer an option?
STAT+ May 11, 2023 Catalyst CEO and Founder Nancy Bradish Myers provided her perspective on FDA hybrid/telework policies and the impact of any potential changes in the future. With over 2,000 vacancies [...]
HHS Floats Trio of Drug Pricing Models, Some More Ambitious Than Others
AISHealth.com - February 23, 2023 Jeff Myers, Catalyst’s Senior Vice President, Market Access & Reimbursement Strategies, comments on the pricing models recently announced by CMS. Mr. Myers "says cell and gene therapy manufacturers [...]
Former FDA Chief Counsel Elizabeth Dickinson Hailed For Her Expertise, Warmth and Mentorship
The Pink Sheet - September 27, 2022 In an article on the legacy of retiring FDA Chief Counsel/Deputy Chief Counsel Elizabeth Dickinson, Catalyst’s Nancy Bradish Myers comments that Dickinson’s management style won [...]
FDAnews Webinar: On Challenges Facing the New FDA Commissioner
During her panel for FDAnews, Nancy Myers highlighted impending challenges looming over FDA’s commissioner hopeful, Robert Califf. If confirmed, Califf would enter the FDA at a time crucial to rebuilding public trust [...]
Accelerated Approval Standards: Application to Gene Therapy
At the ASGCT Policy Summit 2021, Nancy Bradish Myers shared these slides to help participants understand FDA’s accelerated approval standards and how they specifically apply to gene therapies. In addition, she highlighted [...]
Ruling Blocks Okla. MCO Program, But Fight May Not Be Over
AISHealth.com — June 25, 2021 Jeff Myers, Catalyst’s Senior Vice President, Market Access & Reimbursement Strategies, discusses the legal technicalities which tripped up Oklahoma as the health providers win their lawsuit against [...]
Not A Time For Novices: FDA Needs A Leader With Deep Agency Roots And Expertise
Clinical Leader Online – May 5, 2021 Nancy Bradish Myers encourages the Administration Senate to move quickly to choose an FDA Commissioner and highlights the challenges the next FDA leader will face. [...]
Wall Street Sees Woodcock Commissionership As Positive for Aducanumab, But Eyes Should Be On Cavazzoni
Pink Sheet: Informa Pharma Intelligence – January 29, 2021 Nancy Bradish Myers shares views with Sarah Karlin-Smith that approval watchers’ eyes should more appropriately be on what CDER’s Cavazzoni is thinking around [...]
Woodcock Faces Maze Of Rules To Become Commissioner Nominee
Pink Sheet: Informa Pharma Intelligence – January 21, 2021 Nancy Bradish Myers is quoted by the Pink Sheet explaining the potential value of nominating a former Center Director to be a Commissioner. [...]
Biden’s FDA Commissioner Playbook: Build On COVID Innovations To Modernize Agency
Pink Sheet: Informa Pharma Intelligence – January 6, 2021 Nancy Bradish Myers, President & CEO at Catalyst Healthcare Consulting, explores how the Biden Administration FDA Commissioner pick will determine how significant agency [...]
Recently Approved Evrysdi May Have Big Impact on SMA Class
AIS Health Daily- September 1, 2020 Jeff Myers, Senior VP of Market Access and Reimbursement Strategies at Catalyst Healthcare Consulting Inc., examines potential prior authorization requirements and payor thinking around the recent [...]
States May Tighten Medicaid Rates Amid Pandemic
AIS Health Daily – August 3, 2020 Catalyst’s Jeff Myers discusses how states are cutting Medicaid rates during the COVID-19 pandemic, how this will affect MCOs, and whether the federal government will [...]
How to Work with the US FDA When You Can’t Meet with Them
On July 23rd, 2020 during the Informa Pharma Intelligence COVID-19 24-hour Webinar Series Event, Catalyst’s Nancy Myers was a panelist on the “How to Work with the US FDA When You Can’t [...]
What Does the Future Hold for Medicaid, and How Will COVID-19 Impact the Public Payor Space in the Near Term
On June 16th at the Mostly Medicaid 2020 Summer Virtual Conference, Catalyst’s Jeff Myers gave a keynote presentation on how the COVID-19 pandemic will likely change the public payor landscape. Jeff discusses [...]
Gene Therapy CMC Constriction Points and Ideas for Solutions – A Catalyst Moderated Panel at the DIA 2020 Annual Meeting
On June 15th at the DIA (Virtual) Annual Meeting, Catalyst’s Nancy Myers moderated a panel titled “Gene Therapy Manufacturing: How Can Innovation Help Overcome This Anticipated Hurdle?” The esteemed panelists were Peter [...]
Hahn Pledges FDA Independence While Maintaining Role On Warp Speed
In the Pink Sheet, Catalyst's Nancy Myers discusses the Administration's Operation Warp Speed and conflicts of interest. Though "the commissioner doesn't approve drugs or vaccines. That is really left up the center [...]
Woodcock, Marks Recusals From COVID-19 Product Reviews ‘Protect FDA’s Reputation’
In the Pink Sheet, Catalyst’s Nancy Myers commends how "Marks and Woodcock recognize they can't be both referee and player" as they recuse themselves from reviewing COVID-19 products while working on Operation [...]
Health Insurers Hail SCOTUS Ruling in Risk Corridors Case
AIS Health Catalyst’s Jeff Myers weighs in on the SCOTUS 8-1 ruling of CMS owing billions to health insurers in risk corridor funding, discussing while it’s mandated by law, the risk corridor [...]
Trump’s New Vaccine Timeline Met with Deep Skepticism
In The Hill, Catalyst’s Jeff Myers says the administration’s vaccine timeline is “a highly aggressive view of this place that we’re at today”, implying it would be challenging to compress the vaccine [...]
Race for Coronavirus Vaccine Faces Early Challenges
In The Hill, Catalyst’s Jeff Myers argues it’s unlikely early COVID-19 treatments will have remarkably high efficacy, but it’s still worth making and having them be available options to combat the deadly [...]
Medicaid MCOs Brace for COVID-Related Enrollment Surge
AIS Health – April 16, 2020 issue of RADAR on Medicare Advantage Catalyst’s Jeff Myers discusses how the COVID-19 outbreak is affecting Medicaid enrollment and how this can influence health insurers’ financial [...]
CMS Approves Scores of Emergency Medicaid Waivers
AIS Health – March 30, 2020 edition of Health Plan Weekly Jeff Myers, Senior Vice President of Reimbursement Strategy and Market Access at Catalyst Healthcare Consulting weighs in on the CMS Medicaid [...]
Gene Therapy opinion piece – The Pink Sheet: Scientific Wave Pushes CBER Into Brighter Light
The Pink Sheet Nancy Myers, Catalyst President and former FDAer, penned an op-ed in The Pink Sheet on the gene therapy wave and how US regulators can address it. Scientific leaps forward [...]
Original Medicaid Favors Brand Insulin; Managed Care Favors Generics
Inside Heath Policy highlights new study showing how states continue to use branded insulin despite cheaper and equally effective options. Jeff Myers, Catalyst Senior VP of Market Access and Reimbursement Strategies, explains [...]
Stephen Hahn for US FDA Commissioner: Will Academic Experience Suffice for Confirmation?
The Pink Sheet Commenting in an article on the recent nomination of MD Anderson Cancer Center’s Stephen Hahn as FDA Commissioner, Catalyst President Nancy Bradish Myers says that the wide depth and [...]
FDA After Gottlieb –Catalyst Presentation on the Future of FDA
Healio and MM&M May 22, 2019 What lies ahead for FDA under Acting Commissioner Ned Sharpless? This article in Healio covers a presentation by Catalyst President Nancy Bradish Myers at the May [...]
Raising the Bar: The Silver Lining of FDA Commissioner Gottlieb’s Exit
Pharmaceutical Online Scott Gottlieb was unusually effective as a commissioner, and future commissioners would do well to learn from his playbook, Catalyst President Nancy Bradish Myers writes in a guest column published [...]
Gottlieb’s Short Tenure Will Be Felt Long After He Leaves US FDA
The Pink Sheet- Commenting on FDA Commissioner Gottlieb’s resignation, Catalyst President Nancy Bradish Myers says that “Gottlieb was pro-patient, pro-industry and pro-safety at the same time, which is difficult. He also used [...]
FDA Shutdown: Assessing the Potential Impact on Innovation and Public Health
In an opinion piece published in Pharmaceutical Online, Catalyst offers insights into the government shutdown and its effect on FDA, innovation and public health. While FDA has weathered past shutdowns, we are [...]
Catalyst Offers Insights on FDA and the Political Landscape During FDA/CMS Summit Panel Discussion
On Dec. 11, Catalyst President Nancy Bradish Myers spoke as part of a panel on changes in the political landscape impacting the biopharma industry at the FDA/CMS Summit in Washington, DC. Following [...]
How a Rapid and Well Messaged FDA Offense Is Driving Spectators to Their Feet and Twitter Accounts
The Pink Sheet- “How is FDA doing under Commissioner Scott Gottlieb?” is a question that, as a regulatory policy and strategy consultant, I am asked regularly. With amazing frequency, the questioner follows [...]
The Digital Health Tsunami Is Here. How Is FDA Gearing Up?
Med Device Online – In this “Insider’s View” column, Catalyst President Nancy Bradish Myers examines the coming wave of digital health, what FDA is signaling through its recent moves in the digital [...]
Shutdown Winds Down: Short ‘Lapse Period’ Likely Means Few Disruptions At US FDA
The Pink Sheet- This article looks at the impact of the recent government shutdown on FDA and includes Catalyst’s perspectives the challenges involved; Catalyst President Nancy Myers notes that timelines for a [...]
How a government shutdown could affect drug safety, flu response, and more
In this article, Catalyst’s Jill Hartzler Warner provides context for a potential future government shutdown, based on her experience at FDA. The article explores the potential impact of a federal government shutdown [...]
New FDA Leadership Changes Priorities But Doesn’t Change Administration Regulations, Panel Discussion Says
Biotech Investing News— Biotech Investing News reporters this week covered a panel featuring Catalyst’s President, Nancy Bradish Myers. In the panel, which took place on the first day of the JP Morgan Healthcare [...]
J.P. Morgan Notebook Day 1: Tax Reform At Last, Allergan’s Job Cuts, Teva Turnaround, Biogen’s Cash, And Getting FDA-Friendly
The Pink Sheet - In this article, The Pink Sheet covers the opening day of the JP Morgan Healthcare conference and notes comments by Catalyst’s President on the impact of new leadership under Commissioner Scott Gottlieb [...]
Pharmaceutical Online: Catalyst Earns a Spot on List of Top 10 Articles of 2017
A Catalyst-penned article on Trump’s deregulatory agenda has earned a spot on the list of top 10 most popular articles for Pharmaceutical Online in 2017, as well as its sister publication Bioprocess [...]
Commissioner Gottlieb, CAR T-Cells, & The Future Of Rare Disease Therapies
Pharmaceutical Online- What do Commissioner Gottlieb’s recent statements on orphan drug innovation—coupled with the FDA’s first gene therapy approval this summer (for the CAR T-Cell therapy, Kymriah)—mean for the industry? In her [...]
Innovation and FDA’s Regulatory Frameworks: Catalyst Co-Authors Explore How the Coming Data Shift Will Impact Medical Product Regulation in Therapeutic Innovation & Regulatory Science Article
Given rapid advances in technology and our understanding of disease, the future will bring a shift in how the health care system thinks about and uses data, Michael Doherty, Foundation Medicine/former Roche [...]
Former FDA Associate Commissioner Jill Hartzler Warner Joins Catalyst Team, Expanding the Firm’s Expertise in Regenerative Medicine, Rare Disease Drug Development and Combination Product Regulation
Press release Washington, DC – Catalyst Healthcare Consulting is pleased to announce that Jill Hartzler Warner, JD, has joined the firm as Vice President, Regulatory Policy. She will advise clients in strategic [...]
Trump’s Deregulatory Agenda: What It Could Mean For Biopharma & Medtech Companies
Pharmaceutical Online- What do President Trump’s deregulatory executive orders mean for the industry? In this article in Pharmaceutical Online, Catalyst’s Nancy Bradish Myers and Anne Petruska McNickle explore Trump’s “2-for-1” and Task [...]
A Burning FDA Hiring Freeze Question: What About User Fee-Supported Staff?
The Pink Sheet— In this analysis piece, The Pink Sheet looks at the potential impact of the Trump Administration’s federal hiring freeze on the FDA – specifically, FDA positions supported by industry [...]
21st Century Cures Becomes Law: What Must FDA Do Now to Implement Key Provisions? Catalyst Highlights 5 Takeaways for Biopharma Companies
Life Science Connect - Now that the 21st Century Cures bill has been signed into law, following a journey that included a fair number of detours and roadblocks, all eyes in the drug development [...]
Will US FDA Wind Up With More Political Positions Under Trump?
The Pink Sheet– This article looks at the approach that President-elect Trump and his HHS Secretary-nominee, Tom Price, may take in staffing FDA. Catalyst President Nancy Bradish Myers comments on the influence [...]
FDA Under Trump: What To Expect, and Why the Unique Nature of FDA Should be Considered by the Transition Team – Catalyst Guest Column
Life Science Leader – Trump’s advance team will soon be headed to FDA’s White Oak campus to observe and learn, as planning unfolds for the transition to the new Administration. In this [...]
Press release:
The Future of Big Data: Quality Standards, Importance of Collaboration Emerge as Themes in Catalyst-Moderated Panel at DIA
Philadelphia, PA, June 29, 2016 - The future of Big Data, while promising, will depend on the ability of stakeholders to come together and collaborate to develop quality standards for use of [...]
FDA Nominee Driven by “Data, Data, Data”
Genetic Engineering News – FDA Commissioner-nominee Califf brings “clinical trial experience, a deep understanding of the scientific standards industry is held to, and a healthy appreciation for innovation,” Catalyst President Nancy Bradish [...]
Califf Nomination Adds New Dynamic, Maybe New Provisions, To FDA Reform Bills
The Pink Sheet – This article on Dr. Califf’s nomination to be the next FDA Commissioner explores how his confirmation process could become entwined with the Senate HELP Committee’s drug development/FDA reform [...]
DIA 2015: Catalyst Again Chosen to Participate in Annual Meeting Planning Process
Catalyst President Nancy Bradish Myers is reprising her role in helping to plan the Drug Information Association’s annual meeting. As she did last year, Ms. Myers is serving both as a member [...]
Cures Bill Heads to Floor Vote with FDA Funding Worry
House Energy & Commerce Committee Chief Health Counsel Clay Alspach provided an update on timing for full House consideration of the 21st Century Cures bill, during a Catalyst-moderated panel June 17. This article [...]
FDA Deputy Califf’s New Role
In an article on the challenges and opportunities Robert Califf faces as the newly appointed FDA Deputy Commissioner for Medical Products and Tobacco, Catalyst President Nancy Bradish Myers provides perspective on the [...]
Letter to Congress: FDA Appropriations Catalyst Co-Signs Letter to Congress on FDA Appropriations From Alliance for a Stronger FDA
The Alliance for a Stronger FDA sent a letter to House and Senate appropriators on Dec. 20, 2013, urging that they prioritize funding for the FDA. While the agency’s responsibilities have grown [...]
Shutdown Week Two: Could Sponsors Find A More Focused FDA?
This piece describes the impact of the federal government shutdown on FDA activities, noting that user fee-supported staff are continuing to work on pending drug application reviews. While the agency is not [...]
Further FDA guidance unlikely to move the needle on collecting demographic subgroup data – experts
In this article, Catalyst comments on FDA’s developing plans related to collection and analysis of demographic subgroup data in clinical trials. Under FDASIA, the agency is required to develop an action plan [...]
Catalyst Presents FDA Alumni Association Award to FDA’s Bob Temple During FDLI Annual Conference
On April 23, Catalyst Healthcare Consulting President Nancy Bradish Myers presented the 2014 Wiley Award to CDER Deputy Director for Clinical Science Bob Temple, MD. Ms. Myers presented the award during the [...]
FDA Alumni Association: Catalyst President Begins Service as Chair of the Board
Catalyst Healthcare Consulting President Nancy Bradish Myers has been elected Chair of the Board of the FDA Alumni Association (FDAAA). Her two-year term began on April 22, 2014. She succeeds Joseph Levitt [...]
A “Breakthrough” Reality Check: Sponsors Seek FDA Flexibility On Manufacturing, Diagnostics
This article highlights a panel discussion on the state of FDA’s Breakthrough Therapy designation, moderated by Catalyst President Nancy Bradish Myers, during the DIA annual meeting. Panelists represented both industry (Pharmacyclics, Genentech) [...]
FDLI Update magazine
This issue of the FDLI Update highlights a panel discussion on FDA and "Interagency Dynamics" at FDLI's annual meeting. The article notes that the panel, moderated by Catalyst President Nancy Bradish Myers, [...]
Growing Pains for Generic Drugs: OGD Gains Respect, But Loses Geba
This article highlights the challenges that FDA’s Office of Generic Drugs now faces, following the abrupt departure of its director at a time of tremendous change under GDUFA. Catalyst's Nancy Bradish Myers [...]
FDA Generics Director’s Departure Shows Why Chemistry Matters
This article explores the implications of the recently announced departure of FDA’s Office of Generic Drugs Director Gregory Geba, MD. Catalyst's Nancy Bradish Myers offers insight on the future of the OGD, [...]
FDASIA Study Mandates Focus On Performance, But Could Slow Reviews
Under FDASIA, FDA will be required to complete many new performance studies and reports. This article quotes Catalyst's Nancy Bradish Myers on the potential effect of these new requirements on staff capacity [...]
Docs’ Push To Limit Painkiller Prescription Faces Long Odds
This article describes a citizen petition filed with the FDA by a physician group that is seeking to increase FDA's restrictions on prescribing of opioids. FDA recognizes the serious public health problems [...]
2012 FDA Distinguished Alumni Award: Catalyst Healthcare Consulting President Nancy Bradish Myers Receives 2012 FDA Distinguished Alumni Award
Ms. Myers has received FDA's 2012 Distinguished Alumni Award for "outstanding contributions advancing FDA's mission, creating a strong coalition to advocate for FDA resources, and establishing enduring connections between FDA alumni and [...]
Did PDUFA V Pass Too Quickly?
This article notes the swift completion of negotiations between House and Senate staff on PDUFA V (the FDA Safety & Innovation Act), and asks whether the bill could have been improved with [...]
FDA Reform Legislation Emerges as Exception to Washington Gridlock
This article highlights the bipartisan nature of the user fee reauthorization legislation and quotes Catalyst President Nancy Myers on the similarities between the House and Senate versions: "I would say it's pretty [...]
FDA’s $6.4 Billion Plan for Quick Reviews Moves to Senate
In this overview of the user fee legislation making its way through Congress, Catalyst's Ms. Myers comments on the new FDA review model for NMEs and novel biologics. "Drug developers feel there [...]
Catalyst Offers Strategic Regulatory Insights on Moving Innovations Forward at FDA During Biotech Showcase Conference
During an interactive workshop on the evolving FDA, Catalyst President Nancy Bradish Myers explored some of the challenges faced by drug and device companies in getting new, cutting edge technologies through the [...]
Alliance for a Stronger FDA Releases President Nancy Bradish Myers’ Annual Report for 2011
Catalyst President and Alliance for a Stronger FDA President Nancy Bradish Myers highlights the Alliance's successes over the past year and previews some of the likely future challenges for FDA funding in [...]
Video: CHI Discussion of Innovation and Access in Oncology Features Catalyst President
Catalyst's Nancy Bradish Myers is featured in this video, discussing the regulatory and reimbursement dynamics affecting the worlds of oncology and personalized medicine. She spoke as part of a panel during the [...]
Catalyst President Praises House-Senate Conferees For Increasing FDA’s FY 2012 Appropriations
As House and Senate conferees agreed to an increase of $50 million in FY 2012 funding for FDA, Catalyst President Nancy Bradish Myers commented on behalf of the Alliance for a Stronger [...]
FDA Aims to Bridge Communication Gap with Drug Industry During Reviews Through PDUFA V
In this overview of the impact of the PDUFA V FDA/industry agreement, Catalyst President Nancy Bradish Myers provides perspective on industry's position in seeking a new review model for new molecular entities [...]
Alliance for a Stronger FDA urges Congress to provide adequate funding for FDA to fulfill its mission
As the Senate Appropriations Agriculture Subcommittee begins its consideration of FY 2012 funding for FDA, the Alliance for a Stronger FDA is running an ad urging members of Congress to adequately fund [...]
Hamburg Creates New Positions to Oversee Medical Products, Global Regulation
In these two articles, Ms. Myers comments on FDA Commissioner Hamburg's appointment of Stephen Spielberg to fill the new role of Deputy Commissioner for Medical Products and Tobacco. "The reorganization is an [...]
Catalyst comments on FDA FY 2011 Funding Under Continuing Resolution
The Alliance for a Stronger FDA applauds Congressional action in proposing a $107 million increase over FY 2010 funding levels for the FDA. Catalyst President Nancy Bradish Myers, who also serves as [...]
FDA and User Fees: Time to Give 100%
The article highlights comments made by authors who contributed to the book recently co-edited by the Catalyst team and published by the Food and Drug Law Institute (see release, below, on PDUFA [...]
Catalyst Team Co-Edits Book on PDUFA and FDA User Fees
Press Release Washington, DC –Nancy Bradish Myers, Catalyst Healthcare Consulting President, and Anne Petruska McNickle, Director of Research and Communications at Catalyst, are the co-editors of a new book that provides a [...]
FDA Week
CDER Director Janet Woodcock comments on FDA experience with user fees during Food and Drug Law Institute panel moderated by Catalyst's Nancy Myers "Woodcock Expresses Concern With Too Much Reliance On User [...]
Hamburg Taps Advisor as Sharfstein Interim Replacement
Providing perspective on the departure of Principal Deputy Commissioner Joshua Sharfstein from FDA, Ms. Myers comments on the leadership and expertise that Sharfstein's interim replacement, John Taylor III, will bring to the [...]
Fall 2010 issue
Biotechnology Healthcare "Oncology Biomarker Diagnostics: Where We Are, Where We Need To Be" This wide-ranging article examines the reasons behind the relatively low number of commercialized diagnostic products in oncology. Catalyst President [...]
Biodel’s Linjeta likely to face delayed PDUFA in fallout from CMO manufacturing violations – industry sources
This article describes the implications of a recent FDA warning letter regarding serious manufacturing issues related to Linjeta, an injectable insulin product. Catalyst President Nancy Bradish Myers comments on the variables that [...]
FDA Aims For Flexibility In Upcoming Drug/Companion Diagnostic Guidance
Coverage of the breakout session, facilitated by Ms. Myers, on personalized medicine at the Food and Drug Law Institute’s 53rd annual conference. "FDA Aims For Flexibility In Upcoming Drug/Companion Diagnostic Guidance" The [...]
Catalyst President and Alliance for a Stronger FDA Vice President Nancy Bradish Myers comments on FDA’s new accountability initiative, “FDA TRACK.” Click below to view the Alliance for a Stronger FDA press release, issued April 7, 2010:
Alliance for a Stronger FDA Applauds FDA’s New Accountability Initiative “This is a bold but needed undertaking as FDA works to regain public confidence and respect,” Ms. Myers said. “Over the next [...]
FDA Budget Enhances Safety Programs, But Relies On Theoretical User Fees
Catalyst President and Alliance for a Stronger FDA Vice President Nancy Bradish Myers comments on FDA funding level in President Obama's FY 2011 budget proposal. "FDA Budget Enhances Safety Programs, But Relies [...]
Catalyst President and Alliance for a Stronger FDA Vice President Nancy Bradish Myers comments on FDA funding level in President Obama’s FY 2011 budget proposal. Click here to view the Alliance for a Stronger FDA press release, issued Feb. 2, 2010:
Alliance for a Stronger FDA "Disappointed" By President's FY 11 Budget Request for FDA
FDA Strengthens Capitol Hill Muscle With Legislative Office Appointment
“FDA Strengthens Capitol Hill Muscle With Legislative Office Appointment” Catalyst president Nancy Myers comments on the recent appointment of Capitol Hill veterans, including Jeanne Ireland, to key FDA leadership positions. The Pink [...]