The US Food and Drug Administration (FDA) has issued a letter, dated July 23, over the issue of drugs shortages and refutes any implication that the FDA is responsible for the delay. The letter is written by Jeanne Ireland (Assistant Commissioner for Legislation).
The letter was issued in the wake of the US House Committee on Oversight and Government Reform recently criticizing the FDA for contributing –towards the shortage of prescription drugs.
In its response, the FDA suggests the committee is misguided for blaming oversight upon the Agency and indicates that its role is, foremost, to protect patient safety. In the letter, the FDA states:
"In recent years, more than half of shortages were related to manufacturing production problems, including quality-control related issues and delays. The remainder of the shortages was caused by business decisions to discontinue certain products, difficulty obtaining raw materials, loss of manufacturing sites, increased demand and component problems.”
To read the letter, visit: FDA letter