Warning letters FDA sends to pharma companies: publicly available on its website

I didn't know that such letters were publicly available, but apparently they are.

Here's the page on the FDA website that describes such letters generally:

https://www.fda.gov/drugs/enforcement-activities-fda/warning-letters-and-notice-violation-letters-pharmaceutical-companies

To see the actual warning letters sent to various pharma companies, about such things as "poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use," according to the site, on above page click on "Search FDA Warning Letters."

This takes one to the "Warning Letters" page, which provides a search box for entering pharma company name, subject (such as "prostate" or "prostate cancer" for example), along with filtering options (such as FDA issuing office, letter issue date).

Entering terms and searching them produces a display of hits that includes company name, subject (violation), whether the FDA has received a response letter from the company, and if the FDA has answered that letter back.

Clicking on the "Company Name" tab calls up the FDA letter that was sent to the company.

Especially interesting was clicking on the filter "Letters with Response or Closeout" to see how the company answered back to the FDA, if it did.

(NOTE: apparently the way this FDA search tool works is that ANY occurrence of a company's name in the text of an FDA letter sent causes its name to appear in the "search results" listing, whether the letter was sent directly to the company or not. The company was just "involved" somehow).

(But for an example of the FDA addressing a major pharma company in a warning letter, search AstraZeneca in the screen search box, then click on the company's linked name in the hits list to see the letter).

And it was especially interesting to enter "prostate" and "prostate cancer" into the search box, which then resulted in 42 and 13 hits respectively, as of today's date (Dec. 18). That means the FDA letter to the company included those terms, as explained in the "Excerpt" column at right.

It's handy to know that such a tool exists on the FDA website, and is available for public use to find out the "warning status" of specific pharma companies, as well as what's going on with their involvement with certain subjects, such as "prostate."

The government obviously considers such letters as public documents, and as such they are available for public search and viewing.

So that if we are interested, we can find out in detail what the regulatory situation is for a particular pharma company and one of its products.