Michael S. Sinha | Lightnews

Michael Sinha

@drsinhaesq.bsky.social

3.2K followers 6.1K following 2.3K posts

MD JD MPH FCLM FAMWA • Associate Prof @SLUHealthLaw.bsky.social @SLULAW.bsky.social • Former #NUSLHealth @PORTALResearch.org #HarvardMIT_CRS #HeForShe • 🇮🇸 🇮🇳 🇺🇸

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Michael Sinha @drsinhaesq.bsky.social · 29d

Thrilled to share that I was selected to be a Fellow of @amwadoctors.bsky.social, a program that "serves to recognize and honor distinguished members of #AMWA who have accomplished outstanding achievements in science, medicine, or academia." amwa-doc.org/members/phys... cc: @sluhealthlaw.bsky.social

Fellowship Program - American Medical Women's Association

Become a Fellow of the American Medical Women’s Association Honoring Excellence in Medicine and Science The American Medical Women’s Association Fellowship Program serves to recognize and honor distin...

amwa-doc.org

Michael Sinha @drsinhaesq.bsky.social · 2d

Terrific guest lecture by @ghorvath.bsky.social @uclawsf.bsky.social to my Drug and Device Regulation and Innovation seminar at @slulaw.bsky.social @sluhealthlaw.bsky.social on Tuesday, focused on Incremental Innovation in medical devices.

Article here: scholar.smu.edu/scitech/vol2...

Incremental Innovation

Transformative innovations—the ones that use new technologies to disrupt the world—command our attention. But most new products are the result of a more mundane process of incremental iterative innova...

scholar.smu.edu

Michael Sinha @drsinhaesq.bsky.social · 5d

Patients viewing unbranded ads “may not be able to attribute that this information is coming from a company with a clear profit motive,” my former colleague @asarpatwari.bsky.social said at the time. Certainly true of this ad, starring tight ends but making no mention of Novartis until the very end.

Michael Sinha @drsinhaesq.bsky.social · 5d

A 2016 @statnews.com piece from @rebeccarobbins.bsky.social sheds light on the issue of unbranded advertising www.statnews.com/2016/08/29/e...

Behind the stealth ad campaigns for the EpiPen and other drugs

The drug industry is widely distrusted, so companies are relying on stealth ad campaigns, which don't even mention their products by name, to drive sales.

www.statnews.com

Michael Sinha @drsinhaesq.bsky.social · 5d

The PSA test has come under scrutiny in recent years because of its unreliability in detecting prostate cancer. False positive rates of 50-75%. PSA can also be high for other reasons. Some medications (like finasteride) can dramatically lower PSA. Simply put, it is not reliable as a diagnostic tool.

Reposted by Ameet Sarpatwari

Michael Sinha @drsinhaesq.bsky.social · 5d

Catch that #$NVS ad last night? It is a form of unbranded advertising. Novartis wants men to have their PSA levels checked because the company is heavily invested in prostate cancer therapies.

Michael Sinha @drsinhaesq.bsky.social · 5d

I am far less confident than Novo's chief counsel that their patent will not be invalidated. Recent actions by FDA/HHS/DOJ are much more likely to protect the company's prized asset #Wegovy.

pharmalot.bsky.social @pharmalot.bsky.social · 6d

Lawsuit against Hims & Hers should be ‘wake-up call’ for compounders, Novo chief counsel says.. statnews.com/pharmalot/20... #pharma #patents #compounding #Wegovy #weight #obesity #Novonordisk #HIMS #infringement #FDA

Lawsuit against Hims & Hers should be ‘wake-up call’ for compounders, Novo chief counsel says

Novo's chief counsel says telehealth companies and compounding pharmacies that are continuing to make copycat versions of Wegovy “should be very, very much on notice.”

statnews.com

Reposted by Michael S. Sinha

pharmalot.bsky.social @pharmalot.bsky.social · 6d

Lawsuit against Hims & Hers should be ‘wake-up call’ for compounders, Novo chief counsel says

Novo's chief counsel says telehealth companies and compounding pharmacies that are continuing to make copycat versions of Wegovy “should be very, very much on notice.”

statnews.com

Michael Sinha @drsinhaesq.bsky.social · 11d

Really enjoyed having @davidasimon.bsky.social @nusl.bsky.social join my "Drug and Device Regulation and Innovation" seminar today at @slulaw.bsky.social @sluhealthlaw.bsky.social to discuss his ongoing work on medical device safety (www.safemedicaldevices.org) and Data Distortions with the class!

Michael Sinha @drsinhaesq.bsky.social · 18d

Pleased to be listed in @heinonline.bsky.social's Scholarly Impact Rankings for Food and Drug Law! heinonline.org/HOL/scholarl...

ABA-Approved Law Schools Most-Cited Authors by Subject - HeinOnline.org

heinonline.org

Michael Sinha @drsinhaesq.bsky.social · 22d

#FenwayPark in June

Reposted by Michael S. Sinha

SLU Law Center for Health Law Studies @sluhealthlaw.bsky.social · 23d

Submissions for the 2026 #HealthLaw Scholars Workshop are being accepted now through April 13. The strength of the workshop relies on a strong pool of submissions, so please share this call widely.

Excited to celebrate our 25th year with four excellent new scholars!

www.slu.edu/law/health/s...

Group photo of all 2025 Health Law Scholars Workshop participants on the rooftop patio of Scott Hall with the Gateway Arch behind.

Michael Sinha @drsinhaesq.bsky.social · 24d

Cites my piece from the Journal of Law and the Biosciences with Lisa Verity and Ana Santos Rutschman: The pressing need for FDA regulation of tattoo ink academic.oup.com/jlb/article/...

Glad to see that FDA now has guidance for industry on tattoo ink safety (Oct. 2024): www.fda.gov/regulatory-i...

Michael Sinha @drsinhaesq.bsky.social · 26d

Nice to see industry pushing back, akin to its response to right-to-try.

Essentially, "no thanks, we prefer the status quo."

Reposted by Ameet Sarpatwari, Michael S. Sinha

Lizzy Lawrence @lizzylawrence.bsky.social · Jan 13

Read @elaineywchen.bsky.social's write-up of former top FDA drug regulator Rick Pazdur's explosive panel at STAT's event at #JPM2026 last night, moderated by @matthewherper.bsky.social. Drug makers should be more concerned by what's happening at FDA, Pazdur said. www.statnews.com/2026/01/13/r...

Pazdur warns that politics, ‘chaos’ are damaging FDA

At a STAT event, veteran drug regulator Richard Pazdur, who left the FDA last month after 26 years, said that politics and 'chaos' were damaging the agency.

www.statnews.com

Michael Sinha @drsinhaesq.bsky.social · Jan 12

This semester at @slulaw.bsky.social @sluhealthlaw.bsky.social, I will be teaching Patent Law and a seminar on Drug and Device Innovation. Looking forward to it!

Michael Sinha @drsinhaesq.bsky.social · Jan 9

Now published in @uchilegalforum.bsky.social --

Vaccines for Pandemics: Lessons from COVID-19 for H5N1 and Beyond (with Alison McCarthy, SLU LAW '25)
legal-forum.uchicago.edu/sites/defaul...

cc: @slulaw.bsky.social @sluhealthlaw.bsky.social @ciclslulaw.bsky.social

Reposted by Michael S. Sinha

JAMA @jama.com · Jan 8

💬 Viewpoint: Combination-only approvals for new #HIV drugs limit generic substitution and sustain high antiretroviral prices, even after key patents expire.

ja.ma/4jw2Dqz

A JAMA article titled "Combination-Only Approvals as a Barrier to Affordable HIV Care" by S. Sean Tu, et al. Published online December 1, 2025. The article discusses prescription drug costs and HIV treatment access.

Michael Sinha @drsinhaesq.bsky.social · Jan 7

Check out our article, "Combination-Only Approvals as a Barrier to Affordable HIV Care," in this week's issue of @jama.com: jamanetwork.com/journals/jam...

cc: @sluhealthlaw.bsky.social @slulaw.bsky.social @portalresearch.org @dartmouthchem.bsky.social

Michael Sinha @drsinhaesq.bsky.social · Jan 6

Now in print in this week's issue of @jama.com!

JAMA @jama.com · Dec 1

💬 Viewpoint: Combination-only approvals for new #HIV drugs limit generic substitution and sustain high antiretroviral prices, even after key patents expire.

#WorldAIDSDay2025

ja.ma/4pwRTKi

A page from JAMA (Journal of the American Medical Association) titled "Combination-Only Approvals as a Barrier to Affordable HIV Care" by S. Sean Tu et al. It discusses prescription drug costs and HIV treatment access.

Reposted by Michael S. Sinha

Petrie-Flom Center @petrieflomcenter.bsky.social · Jan 6

New @jama.com article written by @medlawdan.bsky.social, @drsinhaesq.bsky.social, and I. Glenn Cohen examines the FDA’s plan to approve leucovorin for some patients with autism using evidence that departs from traditional regulatory standards jamanetwork.com/journals/jam...

Michael Sinha @drsinhaesq.bsky.social · Dec 28

A lot has happened at FDA since we wrote this piece in @jama.com, but leucovorin was a harbinger of things to come.

Daniel G. Aaron, MD, JD @medlawdan.bsky.social · Dec 22

NEW: Paper in @jama.com (me, Glenn Cohen, & @drsinhaesq.bsky.social) discusses FDA plan to approve leucovorin for new indication based on "case reports" and "mechanistic data"

1. Departure from FDA's evidentiary standards

2. May harm patients and set bad precedent

jamanetwork.com/journals/jam...

Michael Sinha @drsinhaesq.bsky.social · Dec 23

Also my life right now. #Torts

Michael Sinha @drsinhaesq.bsky.social · Dec 23

cc: @petrieflomcenter.bsky.social @slulaw.bsky.social @sluhealthlaw.bsky.social @sjquinney.bsky.social

Reposted by Daniel S. Goldberg, Michael S. Sinha

Daniel G. Aaron, MD, JD @medlawdan.bsky.social · Dec 22

Reposted by Raffaella Ravinetto, Michael S. Sinha

JAMA @jama.com · Dec 22

💬 Viewpoint: Approval of leucovorin for cerebral folate deficiency based on limited evidence raises concerns about weakening FDA drug approval standards and public trust.

ja.ma/4asLxYh

A JAMA viewpoint article titled "The FDA's Leucovorin Approval—A Departure From Evidentiary Standards" by Daniel G. Aaron et al. It discusses the FDA's intent to approve Wellcovorin for autism based on limited evidence.

Michael Sinha @drsinhaesq.bsky.social · Dec 17

Nice review of my AJLM article with Joseph DaVault (@slulaw.bsky.social '24) on lab grown meat www.theregreview.org/2025/12/17/a... via @theregreview.bsky.social

cc: @sluhealthlaw.bsky.social

Regulating Cultivated Meat | The Regulatory Review

Scholars discuss challenges and opportunities in lab-grown meat regulation.

www.theregreview.org

Reposted by Graham Dutfield, Ann Bartow

Michael Sinha @drsinhaesq.bsky.social · Dec 9

Officially out in UC Irvine Law Review: Unpatenting Product Hops! escholarship.org/uc/item/0kg3...

Bittersweet, as it shares an issue with the legendary @ucirvinelaw.bsky.social Prof. Dan Burk's final article (published posthumously).

cc: @sluhealthlaw.bsky.social @slulaw.bsky.social