Rachel Sachs
@rachelsachs.bsky.social
Law professor. Researching and writing about innovation and access to new healthcare technologies, mostly in health law, FDA law, and patent law.
Manufacturers agree to provide supplemental rebates, but states must adopt coverage/UM criteria proposed by the manufacturer (see p. 8) and negotiated between CMS and the manufacturer. 4/4
November 6, 2025 at 10:34 PM
Manufacturers agree to provide supplemental rebates, but states must adopt coverage/UM criteria proposed by the manufacturer (see p. 8) and negotiated between CMS and the manufacturer. 4/4
The model envisions that manufacturers will report to CMS international net prices (of a specific set of countries, see p. 7). It's not clear that other countries are thrilled with that. 3/4
November 6, 2025 at 10:34 PM
The model envisions that manufacturers will report to CMS international net prices (of a specific set of countries, see p. 7). It's not clear that other countries are thrilled with that. 3/4
This is a voluntary model, so it's not clear that a legal challenge is likely, but it's also not clear what this model is really "testing." As the model goes on to note, CMS is not waiving any legal authority to test the model. 2/4
November 6, 2025 at 10:34 PM
This is a voluntary model, so it's not clear that a legal challenge is likely, but it's also not clear what this model is really "testing." As the model goes on to note, CMS is not waiving any legal authority to test the model. 2/4
Important new analysis from @matthewherper.bsky.social and @lizzylawrence.bsky.social about the ongoing situation at FDA. This quote from an agency staffer sums up the potential concerns. www.statnews.com/2025/11/04/f...
November 4, 2025 at 2:41 PM
Important new analysis from @matthewherper.bsky.social and @lizzylawrence.bsky.social about the ongoing situation at FDA. This quote from an agency staffer sums up the potential concerns. www.statnews.com/2025/11/04/f...
Interestingly, the NYT piece adds support for something Commissioner Makary said in an interview a few days ago - that a voucher meeting had already occurred/begun. Maybe I missed it, but I haven't seen an approval announced as a result of such a meeting or other reporting on this topic. 3/3
November 2, 2025 at 10:12 PM
Interestingly, the NYT piece adds support for something Commissioner Makary said in an interview a few days ago - that a voucher meeting had already occurred/begun. Maybe I missed it, but I haven't seen an approval announced as a result of such a meeting or other reporting on this topic. 3/3
In September, the website was updated to reflect the ability of drug review divisions to nominate products for the program. web.archive.org/web/20251009... 3/4
October 24, 2025 at 7:32 PM
In September, the website was updated to reflect the ability of drug review divisions to nominate products for the program. web.archive.org/web/20251009... 3/4
As initially developed and publicly presented, FDA invited companies to apply to participate in the program. Those applications opened in July. At the time, the website said nothing about FDA nominating companies/products for vouchers. web.archive.org/web/20250908... 2/4
October 24, 2025 at 7:32 PM
As initially developed and publicly presented, FDA invited companies to apply to participate in the program. Those applications opened in July. At the time, the website said nothing about FDA nominating companies/products for vouchers. web.archive.org/web/20250908... 2/4
Importantly, CBO's analysis depends on CMS policy going forward. A decision to aggregate across formulations of these drugs for negotiation would increase the cost further, to $10.9 billion. 3/4
October 20, 2025 at 3:40 PM
Importantly, CBO's analysis depends on CMS policy going forward. A decision to aggregate across formulations of these drugs for negotiation would increase the cost further, to $10.9 billion. 3/4
This increased cost comes from CBO's incorporation of just three drugs (Darzalex, Keytruda, and Opdivo) into its analysis, where CBO had not accounted for them in its initial estimate. 2/4
October 20, 2025 at 3:40 PM
This increased cost comes from CBO's incorporation of just three drugs (Darzalex, Keytruda, and Opdivo) into its analysis, where CBO had not accounted for them in its initial estimate. 2/4
FDA has updated their CBER/CDER net hiring data for FY 2025. Although both Centers grew in FY2023 and FY2024, in FY2025 they've lost ~16-18% (respectively) of staff, over a thousand people at CDER alone. www.fda.gov/industry/fda...
October 17, 2025 at 6:16 PM
FDA has updated their CBER/CDER net hiring data for FY 2025. Although both Centers grew in FY2023 and FY2024, in FY2025 they've lost ~16-18% (respectively) of staff, over a thousand people at CDER alone. www.fda.gov/industry/fda...
FYI to other FDA National Priority Voucher watchers: yes, the July version of the website did say that "no more than 5" vouchers would be given out "during the initial year." (Screenshot below.) That language is not present in the current version of the website. www.fda.gov/industry/com...
October 16, 2025 at 8:52 PM
FYI to other FDA National Priority Voucher watchers: yes, the July version of the website did say that "no more than 5" vouchers would be given out "during the initial year." (Screenshot below.) That language is not present in the current version of the website. www.fda.gov/industry/com...
However, if you examine the FDA's NDC Directory, there are already a number of oral leucovorin products on the market. Why approve this NDA? One inference based on the notice (but again, will wait to learn more) is that it's about the label. /4
September 22, 2025 at 5:51 PM
However, if you examine the FDA's NDC Directory, there are already a number of oral leucovorin products on the market. Why approve this NDA? One inference based on the notice (but again, will wait to learn more) is that it's about the label. /4
But the FDA notice appears related to the autism announcement, as there is language in the notice on the subject. /3
September 22, 2025 at 5:51 PM
But the FDA notice appears related to the autism announcement, as there is language in the notice on the subject. /3
Of note, if you click on the Federal Register notice, it states that this document has now been withdrawn. I'm not sure what plans are to re-issue it and will look forward to learning more. /2
September 22, 2025 at 5:51 PM
Of note, if you click on the Federal Register notice, it states that this document has now been withdrawn. I'm not sure what plans are to re-issue it and will look forward to learning more. /2
Those who don't subscribe to the Federal Register might be missing some very unusual developments today on the leucovorin front. There's a notice that FDA is approving a previously withdrawn NDA for leucovorin tablets. That in itself is unusual. /1
September 22, 2025 at 5:51 PM
Those who don't subscribe to the Federal Register might be missing some very unusual developments today on the leucovorin front. There's a notice that FDA is approving a previously withdrawn NDA for leucovorin tablets. That in itself is unusual. /1
This is a story about process as well as substance. CBO had scored this provision as costing $5B (a benefit for industry, even as the bill cut nearly a trillion dollars from Medicaid). But CBO somehow missed the best-selling drug in the world, among others. /2
August 4, 2025 at 2:53 PM
This is a story about process as well as substance. CBO had scored this provision as costing $5B (a benefit for industry, even as the bill cut nearly a trillion dollars from Medicaid). But CBO somehow missed the best-selling drug in the world, among others. /2
FDA's new website about the national priority review program asks for a brief 350-word description of how the company's work aligns with national priorities. In comparison, FDA envisions requests for fast-track and breakthrough designation to take 10-20 pages. www.fda.gov/industry/com... (1/2)
July 22, 2025 at 6:10 PM
FDA's new website about the national priority review program asks for a brief 350-word description of how the company's work aligns with national priorities. In comparison, FDA envisions requests for fast-track and breakthrough designation to take 10-20 pages. www.fda.gov/industry/com... (1/2)
As a reminder, Congress (with support from the administration) is simultaneously cutting federal support for food assistance by $300 billion in reconciliation, and also cutting Medicaid/ACA funding in a way projected to cause >10 million people to lose health insurance. www.cbpp.org/research/foo...
May 27, 2025 at 2:35 PM
As a reminder, Congress (with support from the administration) is simultaneously cutting federal support for food assistance by $300 billion in reconciliation, and also cutting Medicaid/ACA funding in a way projected to cause >10 million people to lose health insurance. www.cbpp.org/research/foo...
There's relatively little substantive content in the text of the MFN EO, but this section is emblematic of the many, many questions people should have about its scope. Where will the Secretary get this pricing information? How will they decide "price targets"? For which drugs? Which countries? Etc.
May 12, 2025 at 3:40 PM
There's relatively little substantive content in the text of the MFN EO, but this section is emblematic of the many, many questions people should have about its scope. Where will the Secretary get this pricing information? How will they decide "price targets"? For which drugs? Which countries? Etc.
Reportedly, the Trump admin tried to engage in some type of drug pricing action legislatively. But as @sangerkatz.bsky.social notes, there is nothing in the draft text from the relevant committees. So it's not clear that anything the admin might do on its own will count as savings in reconciliation.
May 12, 2025 at 3:16 PM
Reportedly, the Trump admin tried to engage in some type of drug pricing action legislatively. But as @sangerkatz.bsky.social notes, there is nothing in the draft text from the relevant committees. So it's not clear that anything the admin might do on its own will count as savings in reconciliation.
On the MFN drug pricing EO, waiting to see both actual EO text and the content of any subsequent regulatory actions will be particularly important in light of the inconsistent statements from the admin on the substance of the policy:
May 12, 2025 at 1:49 PM
On the MFN drug pricing EO, waiting to see both actual EO text and the content of any subsequent regulatory actions will be particularly important in light of the inconsistent statements from the admin on the substance of the policy:
April 30, 2025 at 2:31 AM
In declining to finalize this formulary review provision (p. 11-12 of final rule), CMS doesn't grapple with the very detailed concerns CMS itself raised in the proposed rule (p. 403-08) as to why this proposal was needed in the first place. public-inspection.federalregister.gov/2024-27939.pdf /2
April 4, 2025 at 8:29 PM
In declining to finalize this formulary review provision (p. 11-12 of final rule), CMS doesn't grapple with the very detailed concerns CMS itself raised in the proposed rule (p. 403-08) as to why this proposal was needed in the first place. public-inspection.federalregister.gov/2024-27939.pdf /2
This is to say nothing of the legal reasoning in the opinion, which (to give just one example) opens the door much farther than do the plaintiffs' briefs to challenging FDA's regulation of software. /4
![In the final rule’s preamble, FDA asserts that the term “article” cannot be limited
to tangible goods because, in FDA’s view, computer software can qualify as a medical device
despite being “an intangible thing.” 89 Fed. Reg. at 37,331–32. Even assuming FDA is correct
that software may sometimes qualify as a device, that does not support FDA’s assertion that
the “device” definition can be stretched to cover the intangible professional services provided
by laboratory medical professionals, which are different from manufactured medical devices.
As the Supreme Court has explained, while it is possible to conceive of “software in the
abstract: the instructions themselves detached from any medium,” “[w]hat retailers sell, and
consumers buy,” are “tangible,” “physical cop[ies] of the software” that, whether “delivered
by CD-ROM” or “downloaded from the Internet,” are ultimately “contained in and
continuously performed by” a piece of physical hardware such as a computer. Microsoft Corp.
v. AT&T Corp., 550 U.S. 437, 446–48, 449–51, 127 S.Ct. 1746, 167 L.Ed.2d 737 (2007).](https://cdn.bsky.app/img/feed_thumbnail/plain/did:plc:qmrsn572b6lzkwlcy4kk3w4f/bafkreibo5vl2sv7xhf7bjq6sfgtgiho7wkd7rlms5jfqivefdcpuutsrsu@jpeg)
March 31, 2025 at 10:01 PM
This is to say nothing of the legal reasoning in the opinion, which (to give just one example) opens the door much farther than do the plaintiffs' briefs to challenging FDA's regulation of software. /4
But we know that these issues were specifically before the court, as they were raised in at least one amicus brief. /3
March 31, 2025 at 10:00 PM
But we know that these issues were specifically before the court, as they were raised in at least one amicus brief. /3