FDA Running At Reduced Capacity - Government Shutdown

Government Shutdown Leaves FDA Operating at Reduced Capacity, But User Fees Act as Agency Savior:

" . . . Steven Immergut, another FDA spokesman, who elaborated on the practical effects of the shutdown.

The facts and figures are stark: 45% of the agency's staff is not permitted to work until funding is provided. Nearly 75% of FDA staff remaining on the job are funded through industry-paid user fees, otherwise they would likely be furloughed as well. It was not immediately clear if they would receive pay at the usual intervals."

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FDA Website Redesigned

The FDA reports that "Through collaboration with users in testing site-wide designs, we made improvements to make FDA.gov easier and more satisfying to use." That may well be true as they describe their thinking on the redesign, About the FDA.gov Redesign - Why did FDA change its Website? Unfortunately, one unintended adverse effect impacts this blog. So, my apologies to folks who use and follow this blog . . . The FDA redesign has broken many links to FDA images, documents, and webpages. Here's to hoping they won't be redesigning the site again, any time soon. Peace.

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Testing Approved Drugs In The Real World With Real People

Updated November 25, 2022

The original link broke.

You can still read about the same topic here:

New Arena for Testing of Drugs: Real World - TuscaloosaNews.com

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In the drug development process, drugs are clinically tested in very select patient populations. This means that once a drug gets approved, the drug is often given to quite a different kind of patient population, and the results of drug treatment could be different. For the big picture, read this compelling Star News Online article, "New Arena for Testing of Drugs: Real World." I find the story so compelling for the following reasons . . .

1. Patients, health care professionals, and the pharmaceutical industry bring their own unique health and business issues or needs to the table
2. It's ultimately about the patient, and there's a need to know whether approved drugs help or harm in the real world

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Ouch! Black Box, Black Eye. Watch Out For These Antibotics.

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Updated March 19, 2022

The original link broke.

You can still read about the same topic here:

FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects - FDA.gov

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Increased risk of tendinitis and tendon rupture - It's tough to be a drug company, and it's tough to be a patient taking medications. The FDA just released this alert, Information for Health Professionals - Fluoroquinolone Antimicrobial Drugs. So, if you're taking any of the following: Cipro, Proquin, Factive, Levaquin, Avelox, Noroxin, Floxin, or their myriad generically named brethren, then you should read the FDA release. This class of drugs just earned a black box warning, which means patients and prescribers should pay more attention to this unwanted effect. It's worth repeating the main thrust of the alert, "Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture. This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy. Physicians should advise patients, at the first sign of tendon pain, swelling, or inflammation, to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug." 

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