Law under the Microscope

Will Tysabri Withdrawal Revive Call for Stronger Drug Safety?

Yesterday, I noted that Biogen and Elan had taken their joint blockbuster drug, Tysabri, which treats MS, off the market temporarily because 2 patients had developed progressive multifocal leukoencephalophathy (PML). Each of these patients were taking another drug, and one of them has died from the condition.

Tysabri had been approved under the FDA's "fast-track" approval system, and some articles are now saying that this recent series of events may bring about another bout of hysteria about drug safety and call the FDA's fast-track system into question (this last link is to a WSJ article and requires a subscription). I say "poppycock" to that.

Viagra Ads too "Wild"

With all the murky, muddy news that seems to be filling the media these days about the biotech/pharma industry, there are a couple bright points that have made me smile.

The first bright point (at least for us television viewers - Pfizer might not be as amused) is the FDA demanding that Pfizer pull its Viagra ads featuring the song "Wild Thing."  It doesn't seem that the FDA is taking a page from Michael Powell's book at the FCC and is calling the ads racy; rather, Pfizer fails to clearly state that the drug is for erectile dysfunction and to list all of the drug's side effects in the ad.