In this "Refill" episode, Joe Grogan sits down with Dr. Brian Miller to discuss the "Valley of Death" - the gap between FDA approval and CMS coverage - and how regulatory reform can accelerate medical innovation. Miller explains how FDA product review can be made more efficient through automation and algorithmic analysis of routine tasks, allowing highly trained reviewers to focus on clinical interpretation rather than data processing. The conversation covers clinical trial reform, device review modernization, third-party review programs, and CMS coverage decision processes. Miller argues that these are operational challenges that can be fixed with executive leadership, and that transforming FDA and CMS procedures is critical to bringing new medicines and devices to patients faster.

Key Timestamps

1:23 Brian Miller background and AEI role

2:47 The Valley of Death - gap between FDA approval and CMS coverage

5:06 Making FDA and CMS review processes more synergistic

7:43 Example of hypertension drug review and routine tasks

8:26 Data overload in FDA review process

10:40 Supplemental applications and unnecessary information

12:01 FDA reviewer burnout and middle management proliferation

15:30 Automating routine tasks at FDA

17:33 Clinical trial reform discussion and regulatory risk

20:03 Practical approach for new FDA commissioner and DOGE

21:22 Operational changes needed at FDA

22:48 Tobacco regulation at FDA and resource allocation

25:10 Device world getting short shrift in FDA priorities

27:33 Third-party 510k review program and third-party organizations

29:09 COVID diagnostic tests and pandemic review process

30:51 Reforming CDRH through third-party reviews

31:36 70-year comparison of heart attack treatment advances

32:46 CMS coverage decisions and Coverage with Evidence Development

36:02 Medicare Administrative Contractors (MACs) and local coverage decisions

38:12 Practical market-based approach to MAC appeals

39:54 National vs local coverage decisions and reasonable and necessary standard

42:28 Defining reasonable and necessary through algorithms and guidance

Key Topics

FDA regulatory reform, Valley of Death, clinical trial reform, FDA product review automation, CMS coverage decisions, Medicare Administrative Contractors, third-party device review, drug development costs, medical innovation, device regulation, regulatory science, operational efficiency

About the Guest (at time of recording, March 2025)

Dr. Brian Miller is a physician and non-resident fellow at the American Enterprise Institute (AEI) focusing on FDA regulatory policy and Medicare payment policy. He practices medicine at Johns Hopkins Hospital and serves as an associate professor of medicine and business at Johns Hopkins University. His research and policy work emphasize making regulatory systems more efficient to accelerate the development and approval of innovative medicines and medical devices.

Podcast: DC EKG with Joe Grogan

Host: Joe Grogan

Guest: Dr. Brian Miller

Sponsor: Survivors for Solutions

Executive Producer: John CZ Czwartacki, DC EKG Podcast

Joe Grogan sits down with Peter Pitt, FDA veteran and expert on healthcare regulation, to discuss FDA advisory committees, the Make America Healthy Again initiative, and critical gaps in pharmaceutical labeling. Pitt addresses why obesity-related drug dosing information is missing from labels, the importance of vaccine safety, food regulation reform, and strategies for lowering drug prices through generic drug reviews and supply chain diversification. He also discusses the need for FDA and CMS to work together and warns against mission creep at CMS.

Key Timestamps

0:44 Background: East Coast native, McGill University, from New York City

1:07 How he got a professorship at University of Paris School of Medicine

2:35 Mark McClellan connection and FDA career start

5:19 Conflicts of interest versus interests in FDA advisory committees

7:07 Why people need to be dismissed from advisory committees

9:13 Three basic reasons FDA holds advisory committee meetings

11:08 Why Canada keeps advisory committees secret versus FDA transparency

14:08 Advisory committees for CYA, new science, and lack of consensus

19:44 Op-ed on vaccines and nutrition under Make America Healthy Again

22:44 Cancer drug dosing for obese patients and missing label information

27:15 Learning about drug dosing outside of clinical trials

30:42 Food regulation and FDA's second-class treatment of food safety

32:02 MAHA moment and removing red food dyes from food supply

34:00 Dietary supplements regulation under DSHEA

35:21 Nutrition labeling updates and soda bottle serving sizes

38:21 PDUFA reauthorization and user fees

40:32 User fees about predictability not speed

42:54 CMS mission creep and encroaching on FDA authority

Key Topics

FDA advisory committees, transparency, vaccine safety, Make America Healthy Again, pharmaceutical labeling, obesity and drug dosing, food regulation, dietary supplements, generic drug review, PDUFA reauthorization, user fees, CMS mission creep, drug pricing

About the Guest (at time of recording, May 2025)

Peter Pitt is President and Co-Founder of the Center for Medicine in the Public Interest and a visiting professor at the University of Paris School of Medicine. He is a former associate commissioner at the FDA where he oversaw advisory committees and served as a senior policy and communications advisor. Pitt is a native of New York City, a McGill University graduate, and speaks fluent French.

Podcast: DC EKG with Joe Grogan

Host: Joe Grogan

Guest: Peter Pitt

Sponsor: Survivors for Solutions

Executive Producer: John CZ Czwartacki, DC EKG Podcast

Podcast TitleDC EKG with Joe Grogan: A Healthcare Policy Podcast

This is a REFILL of Episode124 - (Original air date: January 27, 2026)

Episode Title - Ryan Long on the ACA Subsidy Fight, Phantom Enrollees, and Reforming 340B

Episode Description - Joe Grogan is joined by Ryan Long of Paragon Health Institute and the University of Southern California to break down two fights shaping health policy right now: a California wealth tax pitch framed as a health care fix, and the battle over extending enhanced Affordable Care Act subsidies.

They unpack how enhanced subsidies changed who qualifies, why zero-premium plans opened the door to broker-driven enrollment and fraud, and why the medical loss ratio creates perverse incentives that can push premiums higher. They also explain how silver loading and cost-sharing reduction policy distort the exchange market, and what reforms could lower costs without writing a blank check.

The episode closes with Ryan's latest work on the 340B program, including why drug arbitrage rewards hospitals with a stronger commercial mix and can fuel consolidation, and why direct, targeted assistance could better support hospitals that truly serve low-income and rural patients.

Chapters and Timestamps

00:01 Intro

00:23 Welcome, and what is on the agenda

01:25 California wealth tax and structural deficits

11:20 Enhanced ACA subsidies and the shutdown fight

16:54 Income caps, zero premium plans, and phantom enrollees

21:50 Fraud, Medicaid exposure, and public trust

30:39 Medical loss ratio incentives and ACA market fixes

38:41 340B: how arbitrage works and why it drives consolidation

44:51 What reform could look like

47:20 Closing

SEO Keywords | Affordable Care Act, ACA subsidies, enhanced subsidies, premium tax credits, exchange plans, zero premium plans, phantom enrollees, medical loss ratio, cost sharing reduction, silver loading, Medicaid fraud, Minnesota fraud, California wealth tax, 340B program, drug arbitrage, hospital consolidation, site neutral payments, commercial mix, Medicare Trust Fund

About Our Guest | Ryan Long is a health policy expert with experience on Capitol Hill, including years in the Speaker's office and on the House Energy and Commerce Committee. He is affiliated with Paragon Health Institute and the University of Southern California.

CreditsSponsor: Survivors for SolutionsExecutive Producer: John “CZ” Czwartacki, DC EKG PodcastProducer: Julie Riga, Stay on Course Studios, https://www.stayoncourse.studio