By now, designing a web site for a product should be second nature. The Internet is no longer so new, after all. And it should not be surprising that such an effort should include necessary risk info about a medication. But for AMAG Pharmaceuticals, this somehow proved more challenging than one might imagine otherwise.
The backdrop involves two AMAG drugs. One is GastroMark, which is indicated in adults for oral use with magnetic resonance imaging to make it easier to distinguish the bowel from other organs near the upper reaches of the gastrointestinal tract. The other is Feraheme, which is aproved for treating iron deficiency anemia in adults with chronic kidney disease.
The FDA, however, found problems with the web sites for each med. Both GastroMark and Feraheme sites omitted risks; the GastroMark page omitted important info about its approved indication and certain contraindication patient info; and both sites misleadingly suggested unapproved new uses, all of which amounts to misbranding, according to an FDA warning letter dated Oct. 18.
But here's the part that surprises. AMAG attempted, sort of, to include risk info. But the site design was done in such a way as to make it appear as if the drugmaker was almost hiding something. The FDA, for instance, points out that there was a link called “Download the GastroMark Package Insert” at the bottom of the GastroMark site and another link called “Download the Feraheme Package Insert” buried in the second sentence of the Feraheme page.
This could hardly be mistaken for an easy-to-find way to alert doctors and patients to risks. As the FDA noted, the links did not "mitigate the complete omission" of risk info. Perhaps none of this is surprising. After all, AMAG never submitted the web sites and the appropriate forms to the FDA for review in advance of launching its web sites, which are now down (take a look at the GastroMark page and the Feraheme page). When discussing side effects, every drugmaker is quick to say that every drug has risks. Why AMAG appeared reluctant to properly acknowledge as much on its web sites isn't clear.