The unanimous decision by an expert FDA committee to recommend the return of Tysabri is likely to usher the controversial MS drug back on the market in a relatively short period of time. Analysts, though, say that significant damage has been done to Tysabri's market prospects. Once seen as a $2 billion blockbuster, Tysabri now may have to settle for a market of a few hundred million dollars a year. Nevertheless, it's important to note that the FDA seems willing to let doctors and patients make informed choices about the benefits that they are likely to receive weighed against the clearly outlined risks of a drug linked to a rare brain disorder.
Virtually no drug is completely safe. If the FDA is more willing to allow drugs on the market that carry significant risks, drug developers overall may find it easier to be more fully forthcoming about the potential dangers that are inherent in these new therapies. It's not a perfect solution, but it's the best one at hand.
- here's the New York Times' Andrew Pollack's take on Tysabri