If the FDA lets a dangerous drug come to market, people are harmed and the damage is visible to all. But if the FDA blocks a promising drug from reaching market, the damage from that decision can be harder to document.
We believe that the FDA should err on the side of allowing patients and physicians to weigh a particular treatment’s costs and benefits and decide whether that treatment makes sense for that particular patient. But we also see the value of a government agency that can give the public confidence that the treatments they are using have received careful scrutiny from independent experts.
The debate about whether the FDA is being too ‘lax’ or too ‘restrictive’ is likely to continue as long as there is an FDA. Is it being too restrictive now? With so many people with psoriasis still in need of relief, let’s hope not.
Under growing scrutiny since the blockbuster painkiller Vioxx was pulled from the market, the Food and Drug Administration in recent months has rejected a slew of experimental drugs or delayed their approval and required more data.
Besides keeping drugs some patients might desperately need off the market, the rejections have battered drug company stock prices and are expected to increase the cost and time it takes to develop a new drug, not to mention the price of developing future ones.
… But Chris Milne, associate director of the Tufts Center for the Study of Drug Development, said Friday the FDA has systematically implemented more controls for scrutinizing drugs, particularly for heart and liver side effects. While he thinks the trend on approvals is not yet clear, he said the FDA now is requiring experimental drugs similar to ones already on sale to be more effective and safer than their predecessors.
Some experts say they already see a trend toward increased rejections, although drugs for life-threatening diseases or conditions with no good current treatment are generally being approved.
… James Kumpel at Friedman, Billings, Ramsey & Co. just published a report showing FDA approvals of “new molecular entities” – drugs made from new chemical compounds rather than just twists on existing drugs – so far this year are at their lowest level in at least a decade. Only seven were approved through the end of July, versus an average of 12 over the first seven months of each year since 1998.
“The FDA certainly has made it more difficult for pharmaceutical companies by pushing for more data and for more participants and for longer studies,” said Kumpel, barriers he said will start limiting the number of new blockbusters.
As we have written before, one of the dangers for the psoriasis community is that the FDA might place particularly restrictive demands on experimental psoriasis treatments, given that psoriasis is typically a non-life-threatening disease. We must make sure the good folks at the FDA understand that psoriasis is a serious disease for millions of Americans that is, for many, debilitating.
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