Frank Torti has been appointed to the newly created post of chief scientist at the FDA, with a brief to "oversee, coordinate, and ensure quality and regulatory focus of the intramural research programs".
The post was created in the FDA Amendments Act 2007 seemingly with the intention of providing a focus for the disparate branches of the FDA. Of particular interest is the section of the act detailing the chief scientist's role in developing post-market safety protocols that have the same rigour as their pre-market counterparts.
Following the Vioxx (rofecoxib) debacle, where the FDA is alleged to have attempted to cover up a post-market publication linking Vioxx with increased risk of heart attacks, the industry's post-market regulation has come under increasing scrutiny. PricewaterhouseCoopers published a report in January 2007 stating that pharmaceutical companies were independently increasing their "pharmacovigilance" but urged them to go further.
Michael Mentesana, PricewaterhouseCoopers' US pharmaceutical and life sciences R&D advisory services leader, said: "The time for companies to develop and implement effective, best-in-class pharmacovigilance solutions is now. "Neither the industry nor those who depend on its lifesaving possibilities can afford anything less than the fulfillment of its promise."
This was the industry seeking to protect itself amidst the belief that the FDA was ill-equipped to adequately handle post-market safety monitoring. Post-market drug safety in the FDA is monitored by two organizationally distinct bodies, the Office of New Drugs (OND) and the Office of Drug Safety (ODS).
The US Government Accountability Office has previously probed the interaction between the OND and ODS and stated the "postmarket safety decision-making process was complex and iterative". It added: "FDA lacks clear and effective processes for making decisions about, and providing management oversight of, post-market safety issues. The process has been limited by a lack of clarity about how decisions are made and about organizational roles, insufficient oversight by management, and data constraints."
Internal reviews have been attempted, such as 2005's "Risk Management Plan Activities in OND and ODS" and the Drug Safety Oversight Board has been established but the chief scientist appointment suggests that there is still work to be done. Torti's appointment coincides with the "Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan," under which staff levels of medication error experts, post-market safety evaluators, risk management experts, regulatory project managers and epidemiologists are all set to rise at the agency.
However, where this funding will come from is a source of some consternation on Capitol Hill. President Bush's 3 per cent increase in the FDA budget has been met by dismay from people on both sides of the political divide, with the Senate having previously sought a 20 per cent increase.
Considering the lack of funding and the challenges faced by the FDA in protecting US citizens in an increasingly complex global market it seems inevitable that some departments will face budget restrictions.
How this will affect Mr Torti as he attempts to fulfill his brief remains to be seen.