The Food and Drug Administration is vowing to get tougher and act faster when it comes to protecting public health.
Over the past several years, the FDA's enforcement activities have declined significantly, and those enforcement actions taken have been hamstrung by delays, mostly due to internal red tape, said Dr. Margaret A. Hamburg, the agency's new commissioner.
“The pathways to enforcement action can be too long and arduous when the public's health is in jeopardy,” Dr. Hamburg said at a Food and Drug Law Institute conference in August. “We're fixing these pathways to improve the effectiveness of our enforcement system,” she said.
Dr. Hamburg outlined six steps to streamline the way the FDA handles enforcement across all regulated areas—drugs, devices, and food.
For example, in cases where agency officials deem that public health is at risk, the FDA is prepared to take enforcement action before issuing a formal warning letter. Agency officials will also work with other regulators—state, local, and international—to figure out who can act fastest in a public health emergency.
The FDA also plans to change some of its internal processes. The agency will establish a 15-day deadline for industry to respond once a significant problem is identified during an inspection. The agency will also aim to get warning letters out the door more quickly by limiting review to significant legal issues.
Prompt follow-up on warning letters and other enforcement actions is also part of Dr. Hamburg's plan.
The Food and Drug Administration will move more quickly in assessing corrective actions that are taken by industry after a warning letter is issued or a major product recall occurs. And in an effort to motivate industry to act quickly, the FDA is developing a formal warning letter “close-out” process.
Once the FDA has confirmed that a firm has fully corrected its violations, the agency will issue a “close-out” notice and post theinformation on the FDA Web site.
“What we want to create is really a standard of practice that is a little bit different than what's been happening in recent years, where we commit to being as transparent as possible about our expectations and industry commits to working in as responsive a way as possible to address our concerns,” Dr. Hamburg said.