Radio broadcast ads for Gaucher's disease therapy Cerezyme (imiglucerase) do not fulfill "adequate provision" requirement by directing consumers to a print ad, the Internet or their physician for additional information, FDA tells Genzyme in July 13 letter. The ad also "misleadingly minimizes the material fact that this drug is injected into the bloodstream over the course of one to two hours, and does not adequately explain that the patient may experience a variety of local reactions at the site of the injection (e.g., discomfort, itching, burning, swelling, or sterile abscesses)," FDA said. Cerezyme is an unusual choice for a direct-to-consumer campaign, given the extremely small Gaucher's disease population
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.
