As drugs flood market, users at risk: Ex-FDA head

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As drugs flood market, users at risk: Ex-FDA head

By Woodman

LONDON, Mar 18 (Reuters Health) - A former head of the US Food and Drug

Administration (FDA) said on Monday that rapid take-up of new drugs by

millions of patients soon after launch could prove disastrous unless

there was good post-marketing surveillance.

Kessler said in an interview in London that quick " ramp-up " of

medicines by companies was the issue that would cause him to " lose most

sleep " were he still in the FDA hot seat.

Clinical trials in a few thousand patients might not pick up rare,

life-threatening adverse drug reactions before the drugs were marketed

and " all of a sudden you could have a disaster, " Kessler said.

Although it was right to " fast-track " some products, he added, " If you

reduce the time that a drug is under review, you have an increased

responsibility to increase post-marketing surveillance. "

He said proper coordination of adverse reaction reports was also

important in the European Union. " The last thing you want--Baycol is the

best example--is that certain people know there are adverse events and

others did not know. "

Baycol, a cholesterol-lowering drug, was taken off the market in August

2001 after it was linked to more than 50 deaths.

Kessler, who left the FDA in 1997 to become dean at Yale School of

Medicine, was speaking to Reuters Health before giving a lecture about

his battle with the tobacco industry to have nicotine classified as a

drug.

He warned that efforts to combat bioterrorism could suffer because key

United States medical agencies such as the FDA remain leaderless due to

the stalemate between the Republican administration and the Democratic

majority in the Senate.

Tackling bioterrorism requires strong coordination between the heads of

the US Centers for Disease Control and Prevention, the National

Institutes of Health and the FDA, Kessler noted, yet these positions

have been vacant for months.

" With those positions unfilled you suffer, " he said. " It's not that I

think terrible things will happen but I don't think we are doing the

public any service by not placing a higher priority on filling those

positions. "

He said bioterrorism, food safety and ensuring important new drugs reach

people in a rapid and safe manner were the three big challenges facing

the FDA.

" The FDA has 10,000 individuals who work very hard and are very

dedicated but I don't think one should underestimate the effect that a

lack of leadership has, " he said. " First, tough decisions don't get

made. The agency has too many tasks and not enough funds. Setting

priorities is very important and only a commissioner can do that. "

The current lack of leadership has exposed the FDA to criticism, he

noted. " You have voices saying the agency is in pocket of the industry,

you have the industry saying that the agency is slowing down, you have

the agency saying there are no changes. "

Kessler also noted that the recent appointment of Les Crawford as deputy

commissioner as a strategy to bypass the need for Senate confirmation

was " unacceptable " and " not tenable. " He added, " If they thought he

should be chief, then they should have appointed him to be chief. "

Kessler said that the pharmaceutical industry gained from the pediatric

exclusivity program, but the benefits to children were far greater. The

1997 law, renewed late last year by the US House of Representatives,

gives 6 extra months of market exclusivity to drug companies that test

their products in children.

" What you are trading is getting more information about how to use drugs

in children but you are increasing the price of the drug which can have

an effect on the elderly and others who can't afford it.

" So you have to achieve a balance but I think it is a success story. The

time has passed when you can use a drug in a child and have to guess

what the dosage should be or whether the drug works. Children are not

just small adults where you can cut the dose based on their size. "