FDA Commissioner Notes System Shortcomings
In an unusual move of speaking out against the President, FDA Commissioner Andrew von Eschenbach noted the limitations that will be placed on his already strained agency with the proposed funding for the agency for FY 2009. An article published in the Wall Street Journal includes excerpts from an interview with the Agency head.
Dr. von Eschenbach noted concerns about the ability of the FDA to fulfill its responsibilities in light of the funding proposed by President Bush for the coming year. Funds will be even further strained as increasing oversight responsibilities are placed on the strapped agency. Along with financial concerns, he suggested that the agency requires a fundamental overhaul over the next few years to the entire organizational structure in order to successfully complete its mission.
An outside advisory panel suggested that the FDA actually requires at least twice the budget amount proposed by President Bush, which was $2.4 billion, described on HospitalBuyer. The FDA, however, is unlikely to receive the funding required as partisan politics may not be willing to grapple with this issue during an election year. Some Congresspeople have suggested that pouring money into an agency that is not effective or unwilling to change is a waste.
The FDA has come under increasing fire in light of drugs pulled off the market after approval secondary to concerns about side effects, lack of adequate means to conduct inspections, issues with bias among product reviewers, and a slew of problems among products imported from overseas, particularly from the Far East. The GAO issued a report in early February, posted on HospitalBuyer, noting some of the problems with inspections, which also relates to imports from overseas.
In light of some of these concerns, the FDA recently unveiled new plans for post-marketing surveillance. These efforts will improve the assessment and, perhaps more importantly, detection of drug safety considerations following product approval. The Office of Surveillance and Epidemiology at the FDA will be given additional responsibilities to further these efforts. Dr. von Eschenbach has also detailed plans to update the entire organization’s antiquated computer systems and improve the food safety process.
Nevertheless, the Agency has come under significant and accelerating fire. A report from an outside panel, completed at the behest of Dr. von Eschenbach, noted that the agency is not able to keep pace with scientific advancements. The FDA has also been criticied for its fundamental culture and habits. The ability make significant changes with strained resources is unlikely, at best, and impossible, at worst.
March 17, 2008 Related topics: Legal & legislative, Finance, People, Quality, Safety, Errors, Industry & Market