Accurate Race and Ethnic Representation in Pivotal Clinical Drug Trials: Why...
Pivotal clinical trials for new drugs have historically lacked racial and ethnic diversity. Over the past decade, the National Institutes of Health, the Food and Drug Administration, and private...
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In Defense of “Cornucopianism” and a More Populous Planet
“On what principle is it that, when we see nothing but improvement behind us, we are to expect nothing but deterioration before us?” —Thomas Babington Macaulay The Essay In defense of ‘cornucopianism’...
View ArticleAppropriate for the Protection of the Public Health: Why We Need Electronic...
Since the landmark Surgeon General’s report on smoking in 1964, public health officials have worked to reduce combustible cigarette use, with longstanding efforts having saved an estimated 8 million...
View ArticleThe 510(K) Third Party Review Program: Promise and Potential
Since the passage of the Medical Device Amendments of 1976, the FDA’s the Center for Devices and Radiologic Health (CDRH) has been responsible for regulating medical devices. These devices have a...
View ArticlePreparing for the Federal Legalization of Cannabis
Over the past decade, a wave of state legalization of cannabis has spread across the US. Currently, 37 states permit adult medical use, while 22 states and Washington, DC, permit recreational use. Yet,...
View ArticleStatus of Plans to Import Prescription Drugs Purchased at Canadian Prices
In the 2003 Medicare drug coverage law, Congress authorized the importation of prescription medications sold originally in Canada—but only if the Food and Drug Administration (FDA) certified that the...
View ArticleRegulators Face Novel Challenges as Artificial Intelligence Tools Enter...
The emergence of artificial intelligence (AI) tools ushers in a groundbreaking opportunity in medicine. They have the potential to dramatically streamline drug development, broaden the spectrum of...
View ArticleA Priority Review Voucher Program to Fuel Generic Drug Development
Attempts to curtail the cost of pharmaceuticals by both political parties have drastically increased as millions of Americans are unable to fill their prescriptions due to cost, leading to lapses in...
View ArticleDiscussing the FDA’s new Alzheimer’s drug approval: Gottlieb on CNBC’s...
Senior Fellow Scott Gottlieb discusses the FDA’s new Alzheimer’s drug approval on CNBC’s ‘Squawk Box’ The post Discussing the FDA’s new Alzheimer’s drug approval: Gottlieb on CNBC’s ‘Squawk Box’...
View ArticleDiscussing Supreme Court decision on access to Mifepristone: Yoo on Fox...
Senior Fellow John Yoo discusses the Supreme Court ruling regarding the abortion pill Mifepristone on Fox News’ ‘Fox News @ Night’ Watch the latest video at foxnews.com The post Discussing Supreme...
View ArticleHow AI Could Save Healthcare
Dr. Brian Miller joined Rep. Crenshaw to talk about the coming Artificial Intelligence (AI) revolution in healthcare. They cover the prospects for everything from automating mundane tasks to easing...
View ArticleThe 510(k) Third Party Review Program: Promise and Potential
In a follow-up to their prior working paper, Brian Miller, William Blanks, and Brian Yagi published a review of 510(k) Third Party Review Program in the Journal of Medical Systems. In their article,...
View ArticleAppropriate for the Protection of the Public Health: Why We Need Electronic...
ABSTRACT Combustible tobacco products (e.g., cigarettes and cigars) continue to be one of the leading causes of preventable disease, disability, and death in the United States. Despite over a century...
View ArticleHow to Safely Integrate Large Language Models into Health Care
Long before ChatGPT popularized the use of artificial intelligence (AI) for everyday interactions, AI devices were being used to enhance medical care. The primary applications in health care have been...
View ArticleRethinking Tobacco Control: Electronic Nicotine Delivery Systems and FDA...
Over 30 million Americans use combustible tobacco, with resulting annual downstream mortality exceeding 480,000. In the face of this long-standing public health challenge, electronic nicotine delivery...
View ArticleThink Clinical Trials Are Working OK? Ask a Cancer Patient
I can’t stop thinking about a recent series of poignant blog posts, written by an emergency room physician affiliated with the Mayo Clinic. Her husband has been battling a terrible cancer –...
View ArticleThe House-Passed Health Care Bill: Price Transparency Requirements, PBM...
Last week, the House passed a medium-sized health care bill, the Lower Cost, More Transparency Act (H.R. 5378), with substantial bipartisan support (the vote was 320 to 71). The measure is a grab bag...
View ArticleNavigating Emerging Technologies in Cell and Gene Therapy
In 2023, the Food and Drug Administration (FDA) approved the first gene therapy for sickle cell disease, a frequently debilitating condition resulting in chronic pain, repeated hospitalizations, and a...
View ArticleAn Innovation-Driven Future For The Food And Drug Administration
With a variety of candidates vying for the Republican presidential nomination and President Joe Biden seeking re-election in the wake of the COVID-19 pandemic, health policy will remain a central...
View ArticleIntegrated Devices: A New Regulatory Pathway to Promote Revolutionary Innovation
As Medical Devices have continued to innovate, embedded software has grown. Software, artificial intelligence (AI), and machine learning (ML) are now a part of nearly every medical device. These...
View ArticleAutomation and Artificial Intelligence in Medicine
Event Summary On April 10, AEI’s Brian J. Miller moderated a panel with the University of Florida’s Jane Baumbauer, the Medical Device Manufacturers Association’s Mark Leahey, and a16z Bio + Health’s...
View ArticleThe Product of Regulatory Sloth
With over 30 million Americans still using combustible tobacco, millions of Americans remain in harm’s way. That’s because millions of illegal Chinese e-cigarette imports are flooding the U.S., often...
View ArticleDiscussing cancer drugs with accelerated approval: Gottlieb on CNBC’s ‘Squawk...
Senior Fellow Scott Gottlieb, MD, discusses cancer drugs with accelerated approval on CNBC’s ‘Squawk Box.’ The post Discussing cancer drugs with accelerated approval: Gottlieb on CNBC’s ‘Squawk Box’...
View ArticleBolstering FDA Pathways for Reducing Death and Disease from Tobacco
In the decade since passage of the Family Smoking Prevention and Tobacco Control Act (TCA) in 2009, overall cigarette use has declined by 26%. There is little doubt that the Food and Drug...
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