In today’s edition of The Wall Street Journal, Scott Hensley reports on the issue of post-market safety studies (and the supposed tardiness thereof) …
… Some in Congress and a recent report by the Government Accountability Office have faulted the FDA for not being demanding or vigilant enough on post-market studies. One solution proposed by some critics would be to give the FDA the authority to order companies to perform such studies, something the agency can’t do routinely under current law.
But even when the FDA does ask for more data or requires additional studies of drugs approved on an express path, companies often don’t follow through, FDA data show. The agency can yank a drug from the market if manufacturers don’t follow through, but that almost never happens.
FDA Deputy Commissioner Scott Gottlieb defended the current approach and reiterated his view that the agency doesn’t need or want unilateral authority to impose such studies on companies. “I think we have the tools we need, but we need to make sure we’re using them effectively,” he said.
Here’s a link to the full article …
