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Technically the US Food and Drug Administration goes out of business at the end of September, when legislation authorising it expires. The US Congress is working on a new law to address some of the controversies that have dogged the agency in recent years. FDA commissioner Andrew von Eschenbach talks to Bob Roehr
It's been a tough few years for the US Food and Drug Administration, as it grapples with the problem of partial funding from the drug industry, which may compromise its impartiality; potential conflicts of interest on advisory committees; and the increasing difficulties in assessing risks and benefits of drugs.
Congress is expected to pass a law to cover the FDA soon after it returns from its summer break. Meanwhile the FDA commissioner, Andrew von Eschenbach, a surgeon and friend of the Bush family, says he sees the controversies as part of a more fundamental shift. He thinks medicine is rapidly changing from the observation of symptoms of late stage disease to a molecular understanding of the mechanisms of earlier stages of disease, with interventions becoming increasingly early and pre-emptive.
“The challenge for us is to not be a barrier to that new future but to be a bridge to it,” the commissioner told a small group of reporters last month. He acknowledges that the changes the agency must make may not be easy.
The commissioner says that the FDA has to be engaged in the full lifecycle of the drugs, devices, diagnostics, and foods that it regulates: “It has to begin to work much more effectively at the front end of the process and engage more actively in the discovery and development end of the continuum if it is going to succeed in its mission to protect and promote the health of every single American.”
The ongoing modernisation effort is known as the critical path initiative (see www.fda.gov/oc/initiatives/criticalpath). “Many of the pieces are intended to help us be able to work before the application, before that product even comes to us, to help build quality in, to help reduce the risk of failure, to be able to change the way that we are discovering, developing, testing, and bringing these products forward.”
He uses the example of pandemic flu. Under the old model the agency would sit and wait for a vaccine application, which might come at about the time of a pandemic itself, and “then start figuring out what was wrong with the application and what they had to go back and redo.”
But to truly protect public health “the FDA has to get out in front and start working with vaccine manufacturers [to] facilitate success and not simply try to eliminate failure.”
A controversial aspect of this is the programme known as the Prescription Drug User Fee Act, which began in 1992. It allows industry to pay a fee for expedited review of a licensing application. Those fees are used to hire additional FDA staff for that process. The agency has about 10000 employees and had a $1.5bn (£800m; €1bn) budget in fiscal year 2007. The programme generates about 20% of the overall budget but about 40% of the budget for drug regulation.
Some critics say that the fee and accompanying “fast track” consideration of drug applications compromises the independence of the review—a charge that the agency denies. Congress has been unwilling to directly fund such expanded operations, however, because of financial constraints.
The FDA proposed increases in fees that would raise revenue to a projected $392.8m a year for the next five years. Congress does not want to find $400m a year through cuts to other budgets or raising taxes.
Von Eschenbach defends the programme: “It will allow us to be much more engaged in pre-application consultations with developers so that we are helping them get it right from the very beginning. That reduces risk; it makes the process much more effective and streamlined; it aligns things with us in the regulatory process.”
At the same time as this uncertainty, the FDA is grappling with scientific advances that affect its work. Tailoring drugs to personal genetic make-up is becoming important , for example, and is creating its own tensions.
“You can't personalise a therapy until you have a personalised diagnosis; genetics and genomics is becoming an important part of the equation,” Von Eschenbach says. Increasingly, the FDA does not view products as drugs, biological agents, devices, or diagnostics, “It is beginning to see things as solutions that will almost invariably draw on the integration of those parts and pieces.”
The public's perception of the agency is also a challenge. He says that for the FDA transparency means that the public must be able to understand the regulatory process: how the members of its advisory committees are selected and how the agency makes its conclusions. It does not necessarily mean that industry must make more proprietary information public. He argues that the FDA's decisions are being made by dedicated professionals, and he uses the analogy of the doctor-patient relationship, in which “there has got to be a level of trust at some point.”
Because the fast track programme and its revenue will expire at the end of September, the FDA must begin the 60 day notification process to terminate employees' positions that are funded through this mechanism. That should have begun on 1 August.
But the commissioner has resisted doing so because of possible effects on employee retention.
“There is nothing more important at the FDA than its people.” says von Eschenbach, calling the agency “an information management business that by its very nature is absolutely, critically dependent on intellectual capital.” That is reflected in the budget: 84% is spent on staff.
He describes his workforce demographic as like an inverted pyramid—the average age is over 48. Some 30% have qualified for retirement and could leave, and others are being courted by industry. Von Eschenbach has been criticised for offering a retention bonus programme for staff even though surveys have shown that most employees have a strong commitment to the mission of the FDA.
Later this year the FDA will announce a two year fellowship programme to recruit a thousand fellows a year at postdoctoral level “across the dimension of postgraduate degrees and experience.” The hope is to recruit and retain about 20% each year as permanent employees to rebuild the workforce base.
Andrew von Eschenbach, aged 66, trained as a surgeon and had a decades long research career at the M D Anderson Cancer Center, in Houston. He was president elect of the American Cancer Society when the president, George Bush, named him director of the National Cancer Institute, in December 2001. He became acting FDA commissioner in 2005 and took over in 2006.