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Air-Moving Device

@airmovingdevice.bsky.social

1K followers 230 following 110 posts

China and the world in data and graphs 一点浩然气千里快哉风 [email protected]

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Air-Moving Device @airmovingdevice.bsky.social · Feb 16

一致性评价是确保仿制药有效、安全的关键监管措施。然而，若仿制药在通过一致性评价后，生产环节发生变化，是否依旧符合与参比试剂的一致性？

实际上，一款仿制药在通过一致性评价后，可对原材料供应商、生产工艺、生产厂址等多项生产环节进行变更，而无需重新进行一致性评价，多数情况只需在省级药监部门进行备案。

我分析了国家药监局公布的2019年至今的16万余条药物补充备案，发现通过一致性评价的仿制药、进入集采的药品中，广泛存在过评后生产环节的变更。

并且，进入集采的药品，相对于同成分但未进入集采的药品，进行了更多此类变更。

这些变更并非一定会影响药效、安全性，但仍需解决如何对此进行有效监管的问题。

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Air-Moving Device @airmovingdevice.bsky.social · 16d

Update: 在最近公布的《全国药品集中采购文件》中，增加了两项关于集采药品生产环节变更的规定：变更时需公开变更内容、未发生变更的企业在同等价位时优先入选。

这两项规定明显弱于之前征求意见稿中的硬性规定：首个中选周期内不得进行重要生产环节的变更，否则取消中选资格。

大概是多方博弈的结果，baby steps也好吧。

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Air-Moving Device @airmovingdevice.bsky.social · Mar 27

You have a great point! — re if most grants are to universities then that’s the hidden variable. The majority of grants/contracts are not to universities, and I see similar results when excluding universities from the analysis.

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Air-Moving Device @airmovingdevice.bsky.social · Mar 23

Relevant analysis: bsky.app/profile/airm...

Air-Moving Device @airmovingdevice.bsky.social · Mar 23

DOGE/Musk preferentially cancelled grants and contracts to recipients in counties that voted for Harris in 2024.

Among cancellations with election data available, 92.9% and 86.1% cancelled grants and contracts went to Harris counties, representing 96.6% and 92.4% of total dollar amounts.

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Air-Moving Device @airmovingdevice.bsky.social · Mar 23

It is therefore possible that they made cancellations unbiasedly across the Trump-Harris political spectrum but preferentially disclosed ones to Harris counties for publicity purposes.

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Air-Moving Device @airmovingdevice.bsky.social · Mar 23

Potential caveat: DOGE doesn't specify how it chose certain contract/grant cancellations to disclose. They claim the ones disclosed represent "~30% of total savings".

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Air-Moving Device @airmovingdevice.bsky.social · Mar 23

Clearly, the background/control sets are distributed across the Trump-Harris spectrum, but the cancellations are biased towards Harris counties.

Statistically significant differences shown with Mann-Whitney and Kolmogorov-Smirnov tests (p < 1e-100).

Large cluster on very left is DC.

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Air-Moving Device @airmovingdevice.bsky.social · Mar 23

To answer this, I need a good background/control set. I compiled all contracts/grants from FY2021-2025 on USAspending, totaling ~19M/24M. ~99% of all cancelled contracts/grants were from this period.

Similar results were seen with more restricted time periods, e.g. only FY2024.

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Air-Moving Device @airmovingdevice.bsky.social · Mar 23

I plotted every cancellation, with total dollar amount obligated on the y axis against Trump-over-Harris margin on x.

Clearly, there's a bias for more cancellations in Harris counties. But does this reflect true bias or simply more contracts/grants awarded to Harris counties?

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Air-Moving Device @airmovingdevice.bsky.social · Mar 23

I used election data scraped from Fox News (www.foxnews.com/elections/20...) by github.com/tonmcg/US_Co...

For each contract/grant, I found Trump's popular vote margin over Harris in the recipient county.

Similar results were seen with NYT's election data (github.com/nytimes/pres...).

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Air-Moving Device @airmovingdevice.bsky.social · Mar 23

These metadata include total dollar amounts obligated, dates, and information on contract/grant recipients (address, county, congressional district, etc).

I extracted county info (FIPS code) and cross-referenced them to county-level presidential election data from 2024.

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Air-Moving Device @airmovingdevice.bsky.social · Mar 23

I retrieved all publicly available cancellations from DOGE on 3/22, which according to DOGE is a subset of all cancellations.

I then cross-referenced them to official spending data on USAspending using links provided by DOGE and ended up with 5,137 and 4,679 contracts and grants with rich metadata.

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Air-Moving Device @airmovingdevice.bsky.social · Mar 23

Data source:
doge.gov/savings — cancelled federal grants and contracts
USAspending.gov — contract/grant recipient info
github.com/tonmcg/US_Co... & github.com/nytimes/pres... — county-level election data

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Air-Moving Device @airmovingdevice.bsky.social · Mar 23

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Air-Moving Device @airmovingdevice.bsky.social · Feb 18

Again, I’m in no way against centralized volume-based procurement and generics. In fact, I think they’re fundamentally a great idea for patients, given that their safety and effectiveness are demonstrated with rigorous testing and proper regulatory oversight.

Air-Moving Device @airmovingdevice.bsky.social · Feb 18

While these production-related changes do not necessarily affect drug efficacy or safety, NMPA does not disclose the regulatory tests and inspections done (if any) that addresses whether new suppliers, processes, or sites materially impact drug composition or performance.

Air-Moving Device @airmovingdevice.bsky.social · Feb 18

Expanding this to the entire dataset, I found 121 drugs that had both jicai and non-jicai generics, n = 352 and 768 respectively.

While the number of total filings were similar between the two groups, production-related changes in jicai drugs were ~2-fold that of non-jicai.

Air-Moving Device @airmovingdevice.bsky.social · Feb 18

Here I am plotting the cumulative number of changes, averaged by the number of drugs.
Clearly, Telmisartan generics that entered jicai underwent more production-related changes than non-jicai generics.

Same trends were also seen for metformin hydrochloride generics.

Air-Moving Device @airmovingdevice.bsky.social · Feb 18

For example, there are a total of 28 Telmisartan generics that passed BE, and 7 of these entered jicai on 2021/2/8. I tabulated the number of production-related changes (supplier, process, or site) that happened for jicai vs non-jicai drugs starting on 2021/2/8.

Air-Moving Device @airmovingdevice.bsky.social · Feb 18

To test this more rigorously, I compared jicai drugs with drugs that (1) share the same active ingredient and (2) passed BE tests, but (3) did not enter jicai.

Air-Moving Device @airmovingdevice.bsky.social · Feb 18

An interesting finding here is that percentages of drugs that underwent postapproval changes are higher for jicai drugs than generics. A hypothesis is that jicai drugs undergo more postapproval changes due to cost pressures associated with low bids.

Air-Moving Device @airmovingdevice.bsky.social · Feb 18

Drugs that entered jicai:
Here I plotted for each drug the date it entered jicai and dates of all supplemental filings.

* 45.7% of jicai drugs changed suppliers post-approval
* 16.4% changed production processes
* 15.3% changed manufacturing sites

Air-Moving Device @airmovingdevice.bsky.social · Feb 18

Generics that passed BE:
Here I plotted for each drug the date it passed BE and dates of all supplemental filings.

* 28.2% of generics changed suppliers post-approval
* 9.6% changed production processes
* 14.1% changed manufacturing sites

Air-Moving Device @airmovingdevice.bsky.social · Feb 18

I focused on 3 types of changes: supplier, production process, and manufacturing site. These are more likely to impact drug efficacy than other changes.

Using permit no (国药准字), drug name and manufacturer name, I matched filings to approved generics and jicai drugs.

Air-Moving Device @airmovingdevice.bsky.social · Feb 18

Data source--

Supplemental filings:
www.nmpa.gov.cn/datasearch/s...

Generics that passed BE:
www.cde.org.cn

Jicai drugs: Shanghai division of NHSA
www.smpaa.cn

Air-Moving Device @airmovingdevice.bsky.social · Feb 18

I analyzed supplemental filings disclosed by NMPA during 2019/1/1-2025/2/5 and found a total of >160k filings.

I cross referenced these with generics that passed BE disclosed by NMPA (n = 1,988) and drugs that entered centralized procurement jicai disclosed by NHSA (n = 1,933).