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Uh go up to bat with the FDA.... but good luck
You must be new here
—Taking this medicine could cause very serious side effects, [including death]. Ask your doctor to explain these risks to you, and make the decision to take this medication together. Call your doctor if you have a serious side effect.
The point of view has been published in industry publications like MM&M. No takers yet.
I’ve been at this since they made it legal. What you’ve described in your version of ISI is exactly what doctors DO say to patients. Regardless of whether the drug is advertised. And in most cases, they know the real risk levels and don’t bother saying anything because the risk is so low.
Plus, if they go into the remote possibilities, there every reason to believe the patient won’t even fill the script.
The FDA is well aware of this and therefore says you can’t rely on the doctor filling in the blanks.
And know this: any rewrites of ISI will only homogenize the side effects, making it unfair to meds that are actually safer than others, something the pharma industry spends craploads of money on - making effective drugs that have fewer side effects.
I could offer 10 more reasons. But I’ll stop and see what you think
I agree with the above, and hadn’t thought about the effect on “me too” drugs that have better safety profiles than their competitors. Still, the current SISI needs a major overhaul
Become a lobbyist
...And of course there will be someone who will defend the institution of ISI, and the good folks who spell check it, those who have relationships with the decent folks at MLR, etc, etc
Nah.
The FDA occasionally offers panels, open to the public, when updating or creating draft guidance (such as what is required in the patient PI and what needs to be in consumer ISI/how it needs to be formatted). They solicit opinions from attendees