But is this decline really due to the FDA’s ability to demand earlier information about potential shortages from manufacturers?
“I am both amazed and delighted to see the progress that’s been made, said Hamburg. Key word: “Amazed.”
While the FDA’s new authorities are both timely and important, there are many pieces to the drug shortages problem – not the least of which is that (when it comes to hospital injectables) 30% of manufacturing capacity is off-line due to FDA inspection issues. That’s a lot of capacity. In fact, according to the agency, 43% of reported potential shortages were due to manufacturing issues.
Greater cooperation between agency and manufacturers is required so that this gap can be corrected before problems arise. A 30% hole in manufacturing is more than a hint that something’s amiss on both sides.
Is it a victory when you are solving the problems you create?