FDA MUST BALANCE FUNDING FOR ENFORCEMENT, SURVEILLANCE

The FDA is balancing a number of factors in trying to assure that public health is protected and sufficient federal oversight is taking place, while addressing a funding situation that is unlikely to improve, current and former high-ranking agency officials say.

In developing its enforcement strategy, the agency needs to balance known versus unknown risks to public health. It must also walk a fine line between prosecuting the cases where the greatest threats exist and those that have the broadest impact in changing the behaviors of the industry they regulate, David Horowitz, the agency's deputy associate commissioner for compliance policy, said. This comes as the FDA continues to try to prove its worth to the American public and lawmakers in an effort to secure more funding, he told attendees of the FDA Regulatory and Compliance Symposium, co-sponsored by FDAnews. The agency needs to decide how to "leverage our resources," he said.

In doing so, the agency considers which cases will have the greatest effect on industry behavior. Given limited funds, regulators "need to maximize impact." This is why the number of enforcement actions are not necessarily accurate indicators of FDA oversight, he added. However, the agency has no methodology for deciding which enforcement action provides the greatest impact, he said.

The agency also must balance funding to address known threats through enforcement versus funding for surveillance in order to spot previously unknown problems. Furthermore, the FDA must "balance our health and safety focus with preserving the integrity of our regulatory system," by enforcing against lower-risk operations that are violating the law.