On September 29, 2023, the FDA released a potent regulatory proposal to rapidly demand FDA clearance or approval for all lab-developed tests. My primary blog here.
In the initial blog, I noted that FDA had won the PR game that Friday.
- The rule was issued in the morning, so it would be part of the news day.
- However, the complicated rule had no "fact sheet" and was not explained in the FDA press release, which primarily touted the urgency of the FDA's action and the scale of benefits to public health.
- In addition to having no fact sheet and no explanation in the press release, the "executive summary" didn't really explain it well, either.
- At that point, few journalists would be equipped (certainly not rapidly) to digest the rule.
- Even experiened thought leaders would need hours to digest the FDA's proposal.
- Therefore, news on Friday and Saturday across the media was based largely on the FDA's very favorable press release about itself.
(FDA could have released the news after close of business on Friday (as CMS sometimes does), but didn't want to bury it that far, losing the Day One leverage of their press release.)
(FDA could have released a "Fact Sheet," as CMS often does, but didn't give the public that level of accessibility.)
Below, I provide a bullet-point outline which makes it easier to see the rhetorical structure of the FDA's press release. It's 13 paragraphs, and 1200 words. Here, trimmed down to 250 words.
- FDA releases rule
- LDT's play important role
- Concerns have been raised for many years
- Ensure their safety and effectiveness
- LDTs are tests used within a single laboratory
- Clinical tests measure substances and are used to diagnose, monitor, etc.
- Make explicit that LDTs are devices "when manufacturer is a laboratory"
- FDA is proposing "greater oversight" by "phase out" of discretion
- Risks of LDTs are "much greater" today
- Agency is concerned about inaccurate results and under perform relative to FDA tests
- Numerous sources of all types document these concerns
- Due to LDTs, patients are over-treated and under-treated, cancer patients get the wrong therapies, and disease from Alzheimer's to Autism are misdiagnosed
- These tests have lack assurance that they work. [Califf]. They significantly impact public health.
- LDTs used to be low risk and small volume.
- Changes in business practices magnify the risk.
- Specimens are shipped around the nation.
- With new FDA oversight, the public and professionals can have confidence [Shuren].
- Labs will have the flexibility to continue innovating and critically advancing public health, under the proposal.
- FDA would phase out enforcement discretion to better protect America's public health.
- Undue disruption will be avoided.
- The proposal will advance innovation, removing a discincentive to develop novel tests [by IVD mfgrs due to RUO copy cat or under cutting].
- Rectifying the current problems will incent innovation.
- FDA reviewed other enforcement approaches and seeks public comment.
- Topics include grandfathering and AMC's and role of NYS DOH and Third Party Review.
- Bottom line was clear: Economic analysis: BENEFITS FAR OUTWEIGH COSTS.
- [BQ: Benefits don't just balance or offset costs, they vastly are shown to outweight costs]
- The FDA knows that the patients deserve to have safe and effective tests.
- This is an important step for them,
I asked Chat GPT to offer four or five different, two-minute video scripts describing the FDA rule. These are in a variety of "voices," from neutral, to extremely antagonistic to the FDA.
"Benefits Outweight Costs"
FDA asserts in the press release the benefits greatly outweigh the costs. Digging into an obscure supplemental file, and then, slogging through to its tables 35 and 37, we learn the costs to industry are about $40 billion dollars in years 4-5. "Savings" or "benefits" are about $25 billion a year - $500B over 20 years - of quality-year intangible health benefits (at about $2M for every patient that is projected to live 3 years longer based on less LDT testing).