It’s not all bad news at the Federal level. The FDA is changing certain approval and screening policies to allow for more widespread use of basket studies. This means that more patients will have access to drugs that haven’t gone through the traditional – arduous – FDA approval process. This means that more people will have access to potentially life saving drugs.

This is fantastic news.

Always remember that when you think about regulatory agencies like the FDA taking steps to “protect” people, you never hear about the people who die because drugs aren’t approved. You only ever hear about people who die because something went wrong with drugs that are approved. While it’s impossible to say with any certainty, it is likely that in many cases, the number of people who die because drugs aren’t approved outnumber those who die because of mishaps with approved drugs*. Relaxing approval processes will surely help prevent some of these “silent” deaths.

-JD Cross

* – This is the distinction between type 1 and type 2 errors. Type 1 errors (approved drug kills somebody) are self-correcting; the victims’ families go on Oprah and the drug company is destroyed and/or the FDA pulls approval for the drug (never mind that the drug still may be useful for millions of other people). Type 2 errors are not self-correcting; people die and nobody can definitively point at the lack of available drugs as the culprit. Type 2 errors being non-self-correcting, and the result solely of regulation, are much more insidious and dangerous.

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