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FDA Could Kill Millions of Us

February 8, 2011

Forbes magazine Editor in Chief Steve Forbes warns that the Food and Drug Administration’s foot-dragging on approving new antibiotics is leading to the “potential catastrophe” of a “bacterial apocalypse.”

The FDA has been making the approval of new drugs increasingly burdensome in recent years, Forbes — who was a Republican candidate for president in 1996 and 2000 — writes in a Forbes magazine editorial.

“The FDA’s behavior is no surprise to the organization’s watchers,” he says. “Approve a medication that has an unintended side effect and congressional headline-seekers will be giving officials the third degree. Better to let people die by depriving them of new medicines.”

As a result of the FDA’s foot-dragging, the pipeline for new antibiotics is drying up, according to Forbes.

Antibiotics have saved tens of millions of lives since the 1940s, but bacteria can become drug-resistant and new drugs are constantly needed to keep pace with new killer germs. But the flow of new antibiotics “has slowed to a trickle,” Forbes observes in the editorial headlined “How the FDA May Kill Millions of Us.”

One reason is that research is becoming more expensive, discouraging pharmaceutical companies from risking money on developing new medications that may not ultimately gain FDA approval.

“But the chief villain is the FDA,” Forbes declares.

He quotes David Shlaes, author of the book “Antibiotics: The Perfect Storm.” Shlaes writes: “Regulatory agencies like the FDA are contributing to the problem with a constant barrage of clinical trial requirements that make it harder, slower and more costly to develop antibiotics.”

Forbes also might have pointed to a new study by oncologist David Stewart and his colleagues at the M.D. Anderson Cancer Center in Houston, Texas. The study notes that the time from drug discovery to marketing increased from eight years in 1960 to 12 to 15 years now, Reason magazine reported.

The researchers calculate that five years of this increase is the result of ever tighter regulations boosting the costs and lengths of clinical trials.

Forbes declares: “Thus today we are faced with potential catastrophe. Lethal bacteria now threaten to colonize U.S. hospitals. If nothing is done, we will be facing a bacterial apocalypse. The horrors that we thought were banished 70 years ago are coming back.”

The FDA should be overhauled to remove its capricious hurdles, Forbes says, calling on the new Congress to “hold hearings on the FDA’s increasingly deadly and bizarre behavior.”

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