WASHINGTON — It’s been five years since Congress gave the Food and Drug Administration sweeping authority to regulate compounding, but lawmakers — many of whom wrote that law — still don’t think the FDA is properly regulating the growing industry. The problem is, lawmakers can’t seem to agree on the tack the agency should take.
And they’re not the only ones pulling the FDA in different directions.
Since late August, the FDA has received multiple letters from Congress, pushing the FDA to apply the law more forcefully or to back off. More letters are coming, sources say. Lawmakers even included clear directions meant to shape the agency’s implementation in a recent bipartisan spending bill. Their heightened scrutiny comes as consumer groups and industry pile on in their own letters and listening sessions. One drug maker has even sued, forcing the FDA into a lawsuit that could upend the progress it has made to date.
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