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Scrutiny on FDA following new study on drug warnings

As we have duly noted in prior select posts, many individuals and enterprises operating within the health care realm in New York and nationally are routinely under intense public and regulatory scrutiny.

And among all those industry participants, there is perhaps no other entity so closely perused as the U.S. Food and Drug Administration, especially in its capacity as the nation's chief regulator of pharmaceuticals made available for public use.

The FDA approves such drug offerings, of course, and pursuant to doing so frequently endures a storm of criticism from widely varied critics.

Some agency naysayers say that the FDA does not adequately vet new offerings through the requisite amount of testing needed to ensure their safety. Conversely, criticism also comes in routinely from individuals and groups countering that the agency actually drags its proverbial feet, acting too slowly in getting badly needed products to the marketplace.

That constantly ongoing debate regarding agency performance was once again underscored most recently by a study now appearing in a prominent medical journal.

The bottom line concerning the research findings of that effort is this: many of the pharmaceuticals approved for public use by the FDA subsequently need to have additional safety- and/or use-related warnings affixed as product labeling.

One prominent industry voice has quickly spoken up to criticize the agency. Drug safety expert Thomas Moore says that the post-approval label modifications strongly point to derelict regulatory performance at the important pre-approval testing stage.

Conversely, Dr. Joseph Ross, a Yale University professor and researcher who led the study effort, says that the findings actually signify a positive message, namely, that the agency -- notwithstanding the severe workload and formidable pressures its employees encounter - continues to do a commendable job monitoring drugs following their market entry.

"[T]he FDA is working hard to evaluate drugs," he says, "and once concerns are identified, they're communicating them."

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