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On a Fast Track to Nowhere?
Periodically when the FDA is criticized for slowing the approval of new drugs they announce a new policy like Fast Track. I'm skeptical of these announcements since they are inconsistent with the FDA's incentives. A recent investigative report in the Cleveland Plain Dealer seems to suggest that I am right to be skeptical but in the end makes me wonder whether Fast Track may be useful after all. Here's the part that supports my skepticism.
A decade ago, the Food and Drug Administration introduced a Fast Track designation for drugs in development that was intended to speed the availability of medical treatments for serious diseases.
However, a seven-month investigation by The Plain Dealer shows that this government blessing has not increased the number of drugs approved or moved them to market faster.
...Dr. John Jenkins, director of the FDA's Office of New Drugs, acknowledged that the Fast Track designation only gives companies the same access to FDA programs that was already in place when they lobbied Congress for the provision in 1997.
"There's really not much other, if any, benefit for Fast Track," he said.
The report, however, makes a big deal of the fact that stock prices do respond positively to Fast Track designation. The report spins this as pump and dump with the FDA in effect doing the pumping and insiders and hedge funds doing the dumping.
...frenzied trading occurs regularly when companies announce Fast Track status. The number of shares bought and sold more than doubled on 49 percent of days that companies announced Fast Track designations. Trading was 10 times higher than the day before in 22 percent of instances....hedge funds and others who [short the stock] bet that the price of a stock will fall - and it often does after the initial jump a company receives from Fast Track designation.
But I'm also skeptical of stories that suggest markets are systematically fooled by non-events and the numbers presented do not seem wildly inconsistent with a modest but real positive signal from being listed as Fast Track.
Stock prices of companies that trade on the New York Stock Exchange rose just 1 percent after Fast Track announcements... Excluding these companies, most of which are major pharmaceutical firms, Fast Track announcements boosted stock prices 11.5 percent.
I'll call this one a draw until further information arrives. What wisdom does the crowd offer?
Hat tip to Mike Giberson at Knowledge Problem.
Posted by Alex Tabarrok on December 12, 2007 at 07:25 AM in Economics, Medicine | Permalink
Comments
It looks like the Fast Track designation is the equivalent to being one of Jim Cramer's stock picks - good for a quick spike, particularly with a lower market cap company, but one that falls away, only staying positive if there is a compelling reason for it to do so (that "real positive signal.")
Or as the Freakonomics guys would put it: "How is the FDA like Mad Money's Jim Cramer?"
Posted by: Ironman at Dec 12, 2007 7:48:40 AM
I'd be willing to bet that the drugs that get Fast Track status have a higher chance of making it to the consumer than drugs that do not. Just because the mean time to market of all FDA drugs hasn't changed doesn't mean this is a worthless signal.
I'm skeptical of vague words like the "often" in the second quotation. Once adjusted for news, we expect stock prices to go down about 50% of the time anyways. Or, if what the writer means is that it goes down past its previous point.... well, that's what volatility is all about. These are large companies with many drugs; changing up or down 2% is unsurprising.
Posted by: at Dec 12, 2007 10:51:51 AM
In a classic article, MIT's Richard Wurtman described how a cure for AIDS (triple therapy) was found remarkably quickly - but only after the AIDS lobbyists had forced the FDA to drop their delaying and cost-inflating practices -
http://wurtmanlab.mit.edu/publications/pdf/937.pdf.
In another classic paper Wurtman described how reglators like the FDA have helped slowed-up medical discovery since the mid-nineteen-sixties -
http://wurtmanlab.mit.edu/publications/pdf/914.pdf
Posted by: Bruce G Charlton at Dec 12, 2007 11:38:18 AM
With regards to fast track drugs having a "higher chance of making it to consumer" I would say not necessarily. Fast-tracking is often the result of tremendous demand, i.e. and indication such as pancreatic cancer where patients are tearing through known therapies and doctors are throwing the kitchen sink out.
So while fast-tracking would suggest a higher likelihood of the drug becoming a first in class treatment and and quickly adopted it does necessarily suggest a much higher likelihood of efficacy or approval.
Posted by: Ex-Biotech Banker at Dec 12, 2007 11:48:54 AM
bruce,
i wouldn't trust someone who claims we've cured AIDS...because we haven't.
Posted by: BK at Dec 12, 2007 1:40:07 PM
Hard to believe there is not a positive effect on the stock price. It's reasonable that the impact would be greater, percentagewise, on a small company with many fewer products than the large pharmaceuticals.
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