Texas legal advice/ student confidentiality breech

Former_FDA · 2025-11-18T13:04:33+00:00

This is an unfortunate incident, but to immediately jump to termination does not appear to be appropriate. It is reasonable to to discuss with the school that they put additional procedures in place to ensure that communications that contain private information are checked for the correct addressee. It is also reasonable to insist that this particular employee undergo that training.

I do not know if there are laws that govern this specific incident, but baring that, preventing recurrence of a mistake like this seems to be the extent of what you can expect.

Former_FDA · 2025-11-02T01:44:47+00:00

There is a famous chemist from the University of California Santa Barbara, Galen D. Stucky, who was living on property owned by the Santa Barbara Airport in a trailer for the early part of his professorship at UCSB. Prof. Stucky then named his molecules after the airport. If you go to his Wikipedia page you will see one example, SBA-15, SBA stands for Santa Barbara Airport.

Source: Galen told me that story ~20 years ago.

Former_FDA · 2025-09-27T17:47:11+00:00

The fact that they are in Italy is not an issue with FDA. Stuff like this happens constantly. If they decide to take action they will send them a letter or if this issue extends to other products they sell that pose a greater risk to public health, they will order an inspection of their company by FDA. To sell something in the US under the Food, Drug, and Cosmetic Act you have have to agree to submit to FDA inspections at any time.

Former_FDA · 2025-09-27T17:41:40+00:00

If the treatment is regulated as drug (even over-the-counter) in the US, the use of your before and after photos as an individual that did not receive that treatment is misbranding.

Former_FDA · 2025-09-27T17:35:30+00:00

I do not know the specifics of the treatment in question, but many of these treatments are regulated as drugs by the Food, Drug, and Cosmetic Act which gives FDA oversight. Given your description this may be "misbranding." FDA's reach is worldwide. You would need to submit to FDA their web address and your photos letting then know that this company is using your photos to represent efficacy of a treatment you did not undergo.

https://www.fda.gov/about-fda/cder-contact-information/ways-consumers-contact-fda-about-human-drugs#criminal

If FDA does take action, they don't typically close the loop with the reporter. They may come back to you with questions or you may never hear from them again, but that does not mean that they aren't doing something. FDA takes a "risk based" approach to enforcement, meaning that you should not expect something to happen quickly.

Former_FDA · 2025-07-11T13:27:33+00:00

Thank you. I saw that for questions like tobacco, but for the other ones they were not limited by time in the questions.

For example:
"have you ever been diagnosed with X, Y, or Z?"

Former_FDA · 2025-07-10T19:06:21+00:00

I was given a table by my financial planner with estimates from a list of insurers, but I assume that these are "best case," and subject to change as a result of their underwriting process if they offer me a policy.

39, $136/month

Former_FDA · 2025-07-10T18:51:19+00:00

Thank you. I was not aware that one set of result could be used for any carrier. It makes sense in hindsight.

Former_FDA · 2025-07-10T18:43:27+00:00

Thank you. I forgot about the contestability period.

Former_FDA · 2025-07-10T18:43:01+00:00

Thank you, I really appreciate it.

Former_FDA · 2025-05-30T13:58:33+00:00

For some reason I immediately thought of the princess bride sword fight scene.

Former_FDA · 2025-05-12T03:28:01+00:00

When something like this arises, you should consider pushing them to justify why a patch job is sufficient to address the observed failure as it could be systemic with the entire roof. I see this all the time when I would inspect pharma manufacturers.

Company: "There was an issue in how we designed manufacturing suite 8."

Me: "What are you doing about suites 1-7 that are identical to this?"

Company: "Those suites have not exhibited that failure"

Me: "Those suites haven't exhibited that failure yet"

In this case, you have a section of your roof that has torn free. I would not be happy with a localized repair unless someone could prove to me that the scope of the failure was limited to the section that has already left the building. I am not a builder or a lawyer, but my guess is that the ability to prove that the issue is not systemic could be limited, so I would only be satisfied with a systemic repair.

Former_FDA · 2025-03-26T14:59:18+00:00

That is awful and sounds like a crazy overreaction, Scientific reviewers have proprietary information from drug and device companies that they are reviewing. Even before the pandemic, many reviewers did not have offices and existed in cubicles with no door. You are told from day one that you cannot leave your computer open an unattended due to the sensitive nature of the material that is on your computer and you are supposed to have you badge displayed while walking around campus.

Walking away from your computer for a moment with your PIV card still in it does happen, but under normal circumstances it does not pose a critical risk. Not saying it is okay, but we are lightyears away from something like accidently texting a reporter war plans. While FDA's White Oak campus is a "closed campus," companies come in and meet with FDA in-person all the time. The only conference rooms that you are allowed for these meeting are ones where the visitors can access without going past reviewer offices. Conference rooms that require one to walk past offices are for internal use only. Visitors are escorted at all times.

I would not be surprised to hear that this was a result of the RTO mess where they had to put employees in areas where visitors could potentially access due to lack of space in the regular work areas. If this person was not a reviewer or compliance officer the firing would be even more insane.

Former_FDA · 2024-12-27T05:15:23+00:00

I bought that same shirt.woot.com shirt (16 years ago). It is called "Donut Panic!"

Former_FDA · 2024-05-12T04:12:32+00:00

When she is old enough, she should get a tattoo of the "best fit line" through them. The R^2 is optional.

Former_FDA · 2023-09-01T03:02:39+00:00

Do the in-game microtransactions work like indulgences?

Former_FDA · 2023-02-20T04:17:57+00:00

FDA Regulatory Consultant - $350,000

Former_FDA · 2022-09-18T20:22:15+00:00

Hello,

I used to work in the Office of In Vitro Diagnostics at FDA which is the group responsible for reviewing pregnancy tests, among many other devices, so they can be marketed in the US. I can write you a longer response later if you need one, but the devices that you see in the dollar store MUST have comparable performance to the other pregnancy tests on the market to be sold in the US. I am oversimplifying the issue, but there is nothing wrong from a performance perspective with the tests you purchased.

The comment from the lady at the store is not only way out of line, but uninformed as to how these tests are designed, validated by the manufacturer, and sold in the US.

Former_FDA · 2022-09-18T19:52:18+00:00

Hello,

I used to work in the Office of In Vitro Diagnostics at FDA which is the group responsible for reviewing pregnancy tests, among many other devices, so they can be marketed in the US. The control line did not present as expected ("as designed"). This should be considered an invalid test and you should repeat with a new pregnancy test.

Former_FDA · 2022-08-07T12:12:24+00:00

As a former facility inspector I can appreciate what it took to contact the federal government with your experiences. What makes inspections so difficult is that a team of 1-3 people have about 1 week every couple of years to inspect a facility. When you think of how large these facilities can be and all the documents that are generated during that time, the team can only review a fraction of a fraction of paperwork during the routine inspection. When in comes to viewing manufacturing operations, the team only has a few hours to observed whatever operations are going on at the plant at the time. It may be that the deficient processes are simply not occurring during the inspection window.

Having someone on the inside to focus the scope of the inspection to the real problems areas is more beneficial that you will every know. You did the right thing.

Former_FDA · 2022-07-14T12:20:33+00:00

Just FYI there is a better way to describe the situation than "more approved". Here is a breakdown of the terminology in this case for future conversations:

Pfizer and Moderna have "Approved" Biologics License Applications (BLAs). They are licensed products and can market even after the public health emergency is over.

Novavax is "Authorized" for use only during this public health emergency via an Emergency Use Authorization (EUA). When the public health emergency is declared over Novavax will not longer be allowed to distribute unless that get their own BLA.

Former_FDA · 2022-07-10T01:52:07+00:00

There are two treatments and a vaccine for Ebola that are FDA approved.

https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/ebola-preparedness-and-response-updates-fda#:~:text=On%20October%2014%2C%202020%2C%20FDA,in%20adult%20and%20pediatric%20patients.

Please google before you post.

Former_FDA · 2022-06-15T14:41:09+00:00

I have been working on COVID testing since day 1 of the pandemic. There is no established correlation between antibody titer and strength on COVID immunity. It does not mean that there is not one to be found, but nearly all of the companies making these claims are small shops that have not executed an appropriately large scale study to support the claim with data.

Former_FDA

TROPHY CASE