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FDA Drug Approval: Too Fast, Too Slow Or Just About Right?

In the realm of federal oversight over marketplace drug approval, do officials from the U.S. Food and Drug Administration act so cautiously that they dangerously slow up the process and materially delay the marketplace entrance of new drugs and medications that many consumers badly need?

Or, conversely, do they signal approval in precipitous fashion, so quickly and without due regard for the facts that they imperil the public’s health?

Or might it just be the case that the FDA acts in a close-to-optimal manner most of the time, duly vetting new drug offerings and getting them in the hands of consumers in an efficient and timely manner that is unparalleled by regulatory authorities elsewhere across the world?

Seemingly, there is no correct answer to those posed queries, with viewpoints ranging widely and being wholly dependent upon the individual or organization entertaining the question.

A recent NBC News article chronicles views that both endorse the current presidential administration’s stated inclination to expedite FDA drug approvals and countering arguments that excoriate it, respectively.

On the one hand, President Trump notes his objective “to streamline the FDA” and — as he recently told pharmaceutical company executives — to make regulatory approval “a quick process.” His administration says that drug makers are too often straitjacketed in their efforts to get products to market.

On the other, though, critics — and there are many — contend that the process is already hurtling along at excessive speed, which undermines public safety.

Agency regulators themselves unsurprisingly state their view that the FDA is doing things in a nearly perfect manner. One ex-agency principal calls the perceived need for greater speed “bogus.” And a former head of the agency says that the American drug regulatory process is already “the fastest in the world” and does not require any adjustments.

Given the materially disparate viewpoints, a future clash regarding the FDA approval process relevant to new drugs would reasonably seem to be on the horizon.


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