FDA-approved drugs - considerations

I'm posting this as a side topic so people can know more about the FDA approval process and what to ask their doctors about. And the big difference between known adverse effects (legally-required to be included in the "package insert" given to the customer along with the prescribed drug at the time of receipt) and the 'post-approval' adverse effects later reported. [When you read of a class action lawsuit against a drug manufacturer, the frequent focus is on adverse effects suffered by users that were not fully-identified or investigated before the drug was approved. ]

There are other factors to consider when taking a new drug. Including whether the prescribing physician is 'incentivized" by the maker or you might be an inadvertent participant in a drug study without being informed or allowed to demur.

The FAERS website is a public-access website where many post-approval adverse effects first show up. But they are thought to represent less than 20% of such incidents as doctors and patients have a low rate of reporting them.

Knowledge is power and the basis for confidence in the drugs prescribed. I hope people will be very proactive in understanding which drugs recommended. And especially diligent about any new drugs. This article explains where some doctors are also concerned that FDA is dropping the ball on protecting us when it rubber-stamps drugs that actually failed in the required follow-up testing.
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Raising the Bar: Rethinking the Accelerated Drug Approval Process

"More concerning was the fact that even when confirmatory trials FAILED to show a benefit, we have seen instances where the FDA convenes an advisory committee to decide whether to rescind the drug’s indication. In many cases we looked at, the committee has voted to continue the drug’s market approval, despite the drug having FAILED the confirmatory trial. And in recent years, we have seen an uptick of cases in which the FDA gives full approval based on surrogate endpoints without having to undergo further evaluation in confirmatory trials."

'By doing this, we inadvertently lower the bar for approval, which increases the number of drugs in our armamentarium, but it also allows too many drugs with uncertain benefit onto the market."

"This lowering of standards for new drug approvals is not a new issue. In fact, in 2014, the ASCO Cancer Research Committee challenged researchers and patients to raise the bar on expectations from novel therapies to significantly advance cancer care. So, we need to continue to press forward and make substantive changes to the system."

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