We submitted comments to the FDA on its draft guidance for demonstrating drug effectiveness with just one pivotal trial. Expanding on our @nejm.org letter, we asked FDA to justify this shift with data, clarify vague terms, & account for risks when extrapolating trial data across diseases & products.

RE: FDA draft guidance on Substantial Evidence of Effectiveness for Human Drug and Biological Products

The Center for Science in the Public Interest respectfully submits these comments regarding the Food and Drug Administration’s draft guidance titled “Demonstrating Substantial Evidence of Effectivenes...

cspi.org

A vote to confirm Dr. Heidi Overton as FDA commissioner is a vote for more measles, more outbreaks, and, administration assertions aside, less medical freedom for Americans. Read my full statement below 👇

CSPI urges Senate not to confirm Overton as FDA Commissioner

CSPI urges the Senate to block Heidi Overton’s FDA nomination amid concerns about vaccine misinformation and anti-reproductive health stances.

cspi.org

Donald Trump’s Surgeon General nominee, Dr. Nicole Saphier, is unfit to serve as Surgeon General. We urge the Senate to vote ‘no’ on her nomination, and we urge the administration to pick a candidate who has not looked to profit at the expense of America’s health. www.cspi.org/statement/ni...

Nicole Saphier unfit to serve as Surgeon General

CSPI President Peter Lurie argues Nicole Saphier is unfit to serve as Surgeon General, citing investments in Philip Morris and other health-damaging industries.

cspi.org

Check it out 👇 We argue that recent SCOTUS rulings are dismantling independent public health regulation. By preempting state protections and expanding executive control over agencies, political preference is replacing science.

@gostin.bsky.social · 3w ago

In @jama.com, Peter Lurie @cspinet.org and I show how the Roberts Court has reduced the independence of federal health agencies, expanded executive political control over science, and curtailed parallel state-level public health protections. jamanetwork.com/journals/jam...

In @jama.com, Peter Lurie @cspinet.org and I show how the Roberts Court has reduced the independence of federal health agencies, expanded executive political control over science, and curtailed parallel state-level public health protections. jamanetwork.com/journals/jam...

The Supreme Court and Public Health Regulation

This Viewpoint summarizes the ways in which federal health agencies and state-level safeguards work in parallel to ensure public health and highlights how 3 recent Supreme Court rulings have reduced t...

jamanetwork.com

Happy to have spoken with @pbsnews.org about FDA's push to fix the GRAS loophole and how it unfortunately leaves much to be desired. Not requiring companies to wait for FDA review before marketing a substance will leave this loophole wide open.

What additives are in your food? The FDA doesn't always know, but seeks to change that

For nearly 70 years, food and beverage companies have been able to decide on their own that a new ingredient is safe and put it on the market without informing the Food and Drug Administration. But a ...

pbs.org

In @jama.com we show how the Trump administration, abetted by SCOTUS, is dismantling independent science and public health Trump's EO signed today altering child vaccine schedules turns science upside down. jamanetwork.com/journals/jam...

The Supreme Court and Public Health Regulation

This Viewpoint summarizes the ways in which federal health agencies and state-level safeguards work in parallel to ensure public health and highlights how 3 recent Supreme Court rulings have reduced t...

jamanetwork.com

Today, HHS Sec. RFK Jr. proposed defining "ultraprocessed foods" & fixing the GRAS food additive loophole. My view: the GRAS proposal leaves key gaps. FDA must fully close the loophole with mandatory premarket safety reviews.

RFK Jr. leaves GRAS loophole ajar

cspi.org

In my latest @jama.com piece with @georgetownlaw.bsky.social's @gostin.bsky.social, we argue that recent SCOTUS rulings are dismantling independent public health regulation. By preempting state protections and expanding executive control over agencies, political preference is replacing science.

The Supreme Court and Public Health Regulation

This Viewpoint summarizes the ways in which federal health agencies and state-level safeguards work in parallel to ensure public health and highlights how 3 recent Supreme Court rulings have reduced t...

jamanetwork.com

I just testified at an FDA meeting on whether seven popular peptides should be allowed in compounding. Here's what we said 🧵👇

“It’s a toxic mix of limited federal resources, limited federal authority, and ... similar limitations at the state level...." said @drpeterlurie.bsky.social “But the end result of it is that the products are sold in an almost unregulated fashion.”

I just testified at an FDA meeting on whether seven popular peptides should be allowed in compounding. Here's what we said 🧵👇

FDA staff have historically chosen their advisors on panels. I told @rachelroubein.bsky.social of @washingtonpost.com that HHS selecting members of the upcoming peptides panel implies a degree of political involvement - a classic case of the Trump admin breaking a norm without breaking regulation.

FDA raised conflict of interest concerns ahead of new peptide panel

That panel will meet to weigh whether the agency should allow Americans to have broader access to seven injectable peptides previously restricted over potential safety concerns.

washingtonpost.com

My colleagues Isabella Xu, MPH, Dr. Irene Ulrich, and I wrote a letter to the editor at @nejm.org in response to the announcement that FDA would shift its default clinical trial requirement for drug approval from two pivotal trials to one. 🔗 www.nejm.org/doi/full/10....

RFK, Jr. added several new members to a panel that will soon review peptides, and I can't help but think that a reputable panel would find it difficult to reverse the recent FDA's recommendation that peptides not be allowed to be produced by compounding pharmacies. We'll see how this panel reacts.

FDA staff recommendation undercuts RFK Jr.’s push to expand peptides

The chains of amino acids are increasingly marketed for antiaging and health benefits. However, medical experts say many of those claims have not yet been fully tested.

washingtonpost.com

For the past year or so, public health observers have been scratching their heads trying to figure out the actions taken by HHS. But the explanation was hidden in plain sight. RFK Jr. has been shouting “America, you’re not enough like me. Live your life the way I do." We are all RFK, Jr. now.

We are all RFK Jr. now: Personal beliefs trump public health

Unlikely lifestyle paragon RFK Jr.’s leadership at HHS drives national policy not by science, but by the Secretary’s personal beliefs.

cspi.org

ICYMI: CSPI prez. @drpeterlurie.bsky.social spoke with @cbsnews.com for an investigative report on the unapproved peptide retatrutide. 👇

I spoke with Adam Yamaguchi of @cbsnews.com for an investigative report on the unapproved peptide retatrutide. These products should not be sold consumers with the health claims they're making. Watch the full report (I appear at minute 2:30) www.cbsnews.com/video/doctor...

Doctors prescribing weight loss drug not yet approved by FDA, CBS News investigation finds

The weight loss drug retatrutide has been touted as "Ozempic on steroids." It's still in clinical trials and not approved by the FDA, but a CBS News investigation found that hasn't stopped doctors fro...

cbsnews.com

I testified at FDA yesterday to voice CSPI's opposition to the CNPV pilot program, particularly to the politicization of voucher selection, an expedited review timeline that poses dangers to consumers, and the lack of transparency in the implementation of the pilot.

Chaos reigns at HHS with the resignation (or firing) of FDA Commissioner Marty Makary. HHS is rotting from the head.

Chaos reigns at HHS as FDA gets an acting commissioner

cspi.org

RFK Jr. has said there's a "war on peptides," and in just a couple months an FDA committee will consider whether seven peptides should be added to a list of products that can be compounded. But the dangers to the American public cannot be understated.

Peptide compounding empowers ‘charlatans,’ undermines safety

cspi.org

CSPI has joined with 67 other organizations to write a letter to EPA Administrator Zeldin demanding that he rescind his recent firings of 19 agency employees. At a time when the EPA is already lacking sufficient staff, firing these civil servants without replacement is a mistake.

Transparency in the premarket review of drugs and devices is critical, but there are persistent gaps in the FDA's practices. I joined with CSPI senior policy scientist Dr. Irene Ulrich in @jama.com to outline 32 specific recommendations to improve FDA transparency, and to urge the FDA to act.

Greater Transparency at the FDA

This Viewpoint considers the US Food and Drug Administration’s track record for transparency and urges the agency to fortify transparency efforts.

jamanetwork.com

I was glad to speak at @standupforscience.bsky.social in Washington D.C. this past Saturday to remind us all of the many fireable offenses RFK, Jr. has committed while in office, and to encourage the science community to not lose hope. #StandUpForScience

Center for Science in the Public Interest@cspinet.org · 7mo ago

"When RFK, Jr. said 'I don't think people should be taking medical advice from me,' that's the one time he got it right!" On Saturday, CSPI's @drpeterlurie.bsky.social spoke at Stand Up For Science in D.C., reiterating the call to fire RFK, Jr. and to restore trust in science! . Photo: Brita Enflo

"When RFK, Jr. said 'I don't think people should be taking medical advice from me,' that's the one time he got it right!" On Saturday, CSPI's @drpeterlurie.bsky.social spoke at Stand Up For Science in D.C., reiterating the call to fire RFK, Jr. and to restore trust in science! . Photo: Brita Enflo

“The DGA report starts w/ a lot of talk about the importance of evidence. One part I don’t like, they didn’t follow any of that.” @drpeterlurie.bsky.social #CFAFPC #FoodPolicy

My colleagues Dr. Margaret Hamburg, Dr. Stephen Ostroff, and I have filed an amicus brief with the U.S. Court of Appeals for the Third Circuit in Philadelphia arguing that the Trump admin. manufactured “uncertainty” about the effectiveness and impact on women’s health of FDA-approved contraceptives.

Trump administration distorting science on safety of FDA-approved contraception, former FDA officials tell Appeals Court

cspi.org

Americans need and deserve reliable health advice from the Surgeon General. Casey Means, however, can be expected to act as a virtual PEZ dispenser for RFK, Jr.’s misinformation. Read my full statement 👇

Casey Means: Still unqualified to be Surgeon General

cspi.org

On March 3rd, I will be moderating a panel discussion on "The MAHA Mid-Terms" and will be participating as a panelist discussing "Unpacking the Dietary Guidelines for Americans" at the National Food Policy Conference. I'm looking forward to it, and we hope to see you there.

Center for Science in the Public Interest@cspinet.org · 7mo ago

Interested in #FoodPolicy? CSPI President @drpeterlurie.bsky.social and Directory of Regulatory Affairs Sarah Sorscher will be appearing at the National Food Policy Conference on March 3rd, speaking on topics like MAHA and the Dietary Guidelines. Register below! 🔗 consumerfed.org/events/natio...

The new Dietary Guidelines are confusing, contradictory, and leave much to be desired when it comes to clear, evidence-based science. Read my latest in @thelancet.com with @gostin.bsky.social 👇

@gostin.bsky.social · 8mo ago

In @thelancet.com, Peter Lurie & Alla Hill @cspinet.org and I examine the evidence for a nutritious diet. Sadly, the new Dietary Guidelines for America fail both on process (no transparency + COIs) and on substance (little science & evidence). www.thelancet.com/journals/lan...