The US Food and Drug Administration has taken a lot of heat in recent years. Events such as the heparin scandal and the recall of Actavis’s (Morristown, NJ) Digitek product have led critics to call the agency a lax and ineffectual protector of the public health. These comments, which I think are partly justified, finally seem to have spurred FDA into action. Several initiatives seem to show an agency that wants to regain its credibility and shield us from dangerous medications.
Earlier this month, Commissioner Margaret Hamburg announced six steps to improve the timeliness of FDA’s enforcement actions. These steps (e.g., setting postinspection deadlines, prioritizing follow-up on Warning Letters, and taking action in response to public-health risks) seem so commonsensical that I wonder why they had not been taken before.
Evidently recognizing the importance of international facilities, FDA plans to double its foreign inspections for good manufacturing practice this year. The agency has established many offices around the world and plans to establish a Middle East location this fall. It also intends to staff its office in Mexico City by Nov. 1, 2009.
Sometimes the agency inspects the wrong facility because it has faulty information, but FDA is now drafting a direct final rule that would require more manufacturing-site information on drug-product applications, according to Drug Industry Daily. The rule could reduce the number of unnecessary inspections and prevent inspectors from barking up the wrong tree.
I’m heartened by these measures. This flurry of activity tells me that FDA is trying to identify the flaws in its procedures and come up with appropriate solutions. Reinforcing its international offices, requiring accurate information, and moving quickly are critical to reducing our exposure to potentially hazardous products. I’ll give Commissioner Hamburg credit for these efforts and hope that they meet with success.