It's election time in the US, when legislative activity moves “from theatre to circus with not much substance in between”. That’s the view of former US Food and Drug Administration commissioner Dr Lester Crawford, and he should know, having worked in this most powerful health agency on and off for 30 years.

In that time, he has first-hand knowledge of - to Australian eyes - the remarkable levels of scrutiny and criticism it comes under.

Crawford served under five different presidents – he managed to avoid the Nixon administration, and he’s pleased he did, he says - observing in that time the Democrat majority in the 1980s fall to the Republican revolution in the 1990s, and back to a Democrat majority in 2006 and how these political changes affected the functioning of the FDA.

He also observed the position of the commissioner of the FDA, the most powerful role in global healthcare outside the head of the World Health Organisation, become politicised, candidates for the job being nominated by the president and confirmed by the Senate.

In the past, confirmation was a painful enough process of up to four months. Now, it is up to two years.

“That happened in the Clinton administration and in the Bush administration,” he says. “That is also a period were it is very hard to get things moving and done.

“This will be the worst year for FDA in four years – actually in eight. We’ll just have to tough it out.”

Crawford, who was in Australia recently as a guest of Pricewaterhouse Coopers and QRxPharma, warns that approvals by the FDA will slow dramatically this year and into the next. The current leadership will bow out with President Bush, and the new president will probably not be in a great hurry to appoint a new one.

He doesn’t know Barack Obama well but has been on the receiving end of John McCain’s famous temper. Either way, things will not be the same, he says.

“I believe if the Democrats return to the White House, which people are predicting, you can pick out what FDA’s trend would be based on what’s happened since the Democrats took over Congress (in 2006),” he says. “That would be more regulation, in a nutshell.”

He is a little less sure of the alternative’s direction, but says McCain has never been impressed with the FDA.

“He has always, essentially since day one, thought that we did our job in not as efficient a way as he would like us to do it. He has sponsored some very constructive legislation and also fathered some resolutions in the Congress, which have tended to strengthen the FDA, but he would be a very strong critic of the FDA.

“I think there would be a period of time when there would be major changes and shifts in personnel. That may or may not be the case with Obama.”

Crawford himself was Bush’s nomination for the post of commissioner and had to undergo the griller that is a Senate confirmation hearing. He was deputy commissioner from 2002 and was nominated for the top role in February 2005.

He was confirmed in July 2005, despite some senators threatening to withhold confirmation following questions as to why the FDA delayed allowing Plan B, an emergency contraceptive, to be sold over the counter despite the agency’s own advisory panel recommending it do so.

In September of that year, just two months after his confirmation, Crawford abruptly resigned, saying he was tiring of the job and denying the decision had anything to do with financial irregularities.

He was later charged with conflict of interest and falsely reporting that he had disposed of or did not own stocks in companies the FDA regulates. He pleaded guilty to the charge, was put on probation and fined $90,000.

While his conviction has tarnished his record, and his small but regular donations to the Republican party put his comments about Obama and other Democrat senators, including Hilary Clinton and Ted Kennedy (see page 3 and 4), into perspective, he is quite certain about how the election will affect the functioning of the FDA in the short term.

According to Crawford, in an election year FDA activity essentially shuts down from July 1. The election is held on the first Tuesday in November and the new president is inaugurated on January 20.

In the transition time, a caretaker cabinet takes care of organisations like the FDA. “It’s a quiet time, or a dead time,” he says.

“After the inauguration, there is still a period of malaise because it is a long period of trying to find new leadership of the FDA. It is not remotely possible that the present leadership would continue, with either president.”