@yalecrrit
The Collaboration for Regulatory Rigor, Integrity, & Transparency (CRRIT), based out of Yale Medical, Public Health, & Law schools, researches the regulation, approval, & coverage of medical drugs & devices to advance policies that improve patient health.
This team was comprised of @pennmehp.bsky.social @hollylynchez.bsky.social, CRRIT Co-Director @reshmagar.bsky.social , Washington University @rachelsachs.bsky.social, @pennmehp.bsky.social Steven Joffe, & @ohiostatelaw.bsky.social Patricia Zettler (5/5)
www.healthaffairs.org/content/fore...
While this new pathway is suited to individualizing treatments for rare diseases, there are still concerns regarding transparency, scope of the program, and coverage, which will be discussed in Part 2 (4/5)
If FDA believes the plausible mechanism approach is appropriate, they will “move toward granting marketing authorization for the product” once a sponsor “has demonstrated success with several consecutive patients with different bespoke therapies” (3/5)
www.nejm.org/doi/full/10....
The pathway was announced in @nejm.org without a policy process open to public comment. Approval based on plausible mechanism can be a path to market entry when a RCT is not feasible if a sponsor “has [had] success with several consecutive patients with different bespoke therapies” (2/5)
We are excited to share Part 1 of our Health Affairs article on the promises & concerns of @fda.gov’s new ‘Plausible Mechanism’ pathway, announced in Nov 2025 in a manner that deviated from the proper, transparent legal process FDA is required to follow (1/5)
CRRIT Co-Director @reshmagar.bsky.social & NYU Law @cmorten.bsky.social discuss how decisions at FDA are reliant on staff and experts driven by science rather than political interference & how increased political interference may have a larger role in regulatory decision-making (6/7)
There were 2 decision points where political appointees overrode staff scientists to veto changes that would have increased access to mifepristone (5/7)
FDA staff consistently took a cautious approach and used both sponsor data as well as meta-analyses of independent studies investigating the drug’s safety (4/7)
A recent article by Dilek and colleagues reviewed over 5000 documents obtained via the Freedom of Information Act (FOIA) on how the FDA carefully made changes to the REMS for Mifepristone. (3/7)
In September 2025, @fda.gov and @hhsofficial.bsky.social announced that HHS would be conducting a study on mifepristone REMS to “determine whether modifications are necessary” (2/7)
We are excited to share a recently published editorial in @jama.com that discusses the FDA’s review of REMS requirements for mifepristone. (1/7)
This team was comprised of @yaleschoolofmed.bsky.social student Omar Qureshi, CRRIT Co-Directors @jsross119.bsky.social and @reshmagar.bsky.social, and @ucsanfrancisco.bsky.social Anand Habib (5/5)
Read the full article: link.springer.com/article/10.1...
For LOE ratings: 768 (10%) had strong evidence, 1676 (22%) had moderate evidence, 2421 (32%) had weak or very weak evidence, and 2717 (36%) had evidence lacking a rating. 5088 (67.1%) recommendations had SOR-LOE rating concordance. Overall SOR-LOE rating concordance was moderate (4/5)
Key points: Of the 7582 recommendations, society guideline writing committees rated SOR as strong for 2303 (30%), moderate for 1351 (18%), weak for 2028 (27%), and 1900 (25%) had no strength assigned (3/5)
Medical societies’ clinical practice guidelines are used to inform evidence-based patient care. However, the concordance between strength of recommendation (SOR) ratings and corresponding level of evidence (LOE) rating is unclear (2/5)
We are excited to share a recently published article in @journalgim.bsky.social which investigates the level of evidence and strength recommendations of US Medical Society clinical practice guidelines (1/5)
Full story: (3/3)
wpintelligence.washingtonpost.com/topics/2026/...
CRRIT Co-Director @reshmagar.bsky.social told @washingtonpost.com how reviewers are “being forced to move as quickly as possible” & how companies would rather use the 6-month pathway authorized by Congress instead of pathways of “dubious legality” (2/3)
There have been significant changes at @fda.gov including “ultra-accelerated” reviews. (1/3)
Read our full comment written by CRRIT Postdoctoral Associate Erfan Taherifard, CRRIT Core Faculty Joshua Wallach, and CRRIT Co-Directors @jsross119.bsky.social & @reshmagar.bsky.social: (3/3)
www.regulations.gov/comment/FDA-...
Our public comment applauds the FDA’s efforts to modernize and clarify the procedures governing SLCs and discusses opportunities to further strengthen transparency and public accessibility of safety information (2/3)
In September, the @fda.gov announced draft guidance on safety labeling changes (SLCs) under section 505(o)(4) of the FD&C Act. (1/3)
CRRIT Co-Director @reshmagar.bsky.social recently told @rollcall.com how this may be “setting [a] precedent that the agency cannot rely on scientific integrity in making decisions and, instead, can go forth and do whatever it wants”
🔗: rollcall.com/2026/01/08/t...
While @fda.gov typically engages with the public & convenes advisory committees for expert advice, this has happened less in the past year. (1/2)
First announced in June, these vouchers are meant to shorten drug review to 2 mos or less. Despite current FDA leadership claiming prior inappropriate industry influence, CRRIT Co-Director @reshmagar.bsky.social noted “cut to now, and it seems like the hen has let the fox into the henhouse.”
On Friday, @fda.gov announced 2 more drugs awarded Commissioner National Priority Vouchers. But as @lizzylawrence.bsky.social @statnews.com laid out, political interference has clouded this program, raising questions on the scientific integrity & rigor of FDA's drug review:
But that among those for which confirmatory evidence was expected to support the approval, 80% had none, creating uncertainty as to how the approval was made (journals.sagepub.com/doi/10.1177/...) (4/5)
