PUBLIC INTEREST GROUPS WARY OF FDA'S RISK-BASED ASSESSMENT SYSTEM
Public interest groups are concerned that an FDA initiative to use risk-based reviews to speed drug approvals could cause more problems than it solves.
The agency recently announced the establishment of the Office of New Drug Quality Assessment (ONDQA) to facilitate the implementation of a modern, risk-based pharmaceutical quality assessment system (PQAS). ONDQA, which becomes effective Nov. 1 under the auspices of the Office of New Drug Chemistry, will be charged with several goals, the biggest of which is balancing the need for faster drug approvals with the rapid introduction of new technologies into pharmaceutical manufacturing.
The PQAS will replace the FDA's current chemistry, manufacturing and controls (CMC) review system, which the agency said may be slowing manufacturers' adoption of new technologies. Under the CMC review system, drugmakers must seek FDA approval through a supplement before implementing postmarketing manufacturing changes.
"ONDQA is a science-based organization designed to be more efficient, effective and flexible in managing CMC issues and workload. ... I believe that the establishment of ONDQA is an important step in the continuing improvement of FDA's CMC review practices for the 21st Century," Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said.
But activists say the move might not improve the drug-review process, and may potentially result in more harm to patients. "I am wary of any change that seems to make it easier for industry to avoid monitoring," said Celia Wexler, vice president for advocacy for consumer lobbying group Common Cause.
Making decisions based on prospective estimates of risk is problematic, Wexler added. Vioxx was not initially seen as being potentially dangerous for patients, but that notion turned out to be very wrong, Wexler said. "FDA does not have a very good track record" in making such decisions, Wexler added.
The ONDQA will include dedicated premarketing and postmarketing divisions, focused on investigating drugs. The office will also use Pharmaceutical Assessment Leads focusing on each drug application to determine how extensive of a review is necessary.