12:00 AM
Mar 25, 2013
 |  BioCentury  |  Regulation

Commentary: Not so fast

Hype overstates risks, potential of FDA Alzheimer's guidance

FDA's new draft guidance on Alzheimer's disease is being alternately hailed as a breakthrough in FDA thinking about how to get new AD drugs to patients faster and attacked as a radical, risky step toward unleashing minimally tested new drugs on a desperate patient population.

Both the hype and the hope are misplaced, as the scientific and regulatory breakthroughs needed to make real progress don't yet exist.

The media and blogosphere feeding frenzy was provoked by a New England Journal of Medicine commentary, which followed FDA's publication of its draft guidance in early February.

The NEJM article was written by Russell Katz, the retiring director of the Division of Neurology Products at the Center for Drug Evaluation and Research (CDER), and Nicholas Kozauer, a medical officer in the division. The commentary describes a draft guidance on developing drugs to treat early stage AD.

If one were to believe The New York Times, FDA is opening the floodgates to allow drug makers to start pouring torrents of thinly tested putative Alzheimer's therapies onto the market. The Times claims FDA is "lowering the bar" by deciding to grant...

Read the full 910 word article

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury

Article Purchase

$150 USD
More Info >