FDA guilty of impeding antibiotic research

By ACSH Staff — Dec 20, 2010

Thanks in large part to FDA over-regulation, there is a paucity of new antibiotics. Yet antibiotic-resistant bacteria run rampant worldwide, ACSH’s Drs. Josh Bloom and Gilbert Ross write in an op-ed published in National Review Online. The number of new antibiotics being approved is negligible, and currently only four companies manufacture 80 percent of the world’s vaccines. Dr. Bloom and Dr. Ross point out that the FDA is mostly to blame for this predicament:

In the mid-1990s, the FDA tightened up rules for approval of new antibiotics, requiring companies to provide evidence that not only was a new drug candidate effective and safe, but it was also more effective than existing antibiotics. Bad move.

The drug regulators also began requiring that more patients be enrolled in clinical trials, increasing the cost of drug development. The results were predictable — drug companies dropped out of antibiotic research en masse.

Meanwhile, the bugs keep growing and mutating. If the resistance problem jumps ahead of the discovery process, we may again find ourselves with no reliable weapon against infection.