FDA questions 'innovative industry' tag
and Drug Administration is becoming such a serious issue that the
pharmaceutical market's tag as the 'innovator industry' is being
called into question, reports Wai Lang Chu.
That was the opinion of Murray Lumpkin, acting deputy commissioner, international and special programs, US Food and Drug Administration, who was speaking at the Drug Discovery Technology conference in Europe this week.
Lumpkin argued that the task of innovation was made harder by the increasingly lengthy and costly business of investment, not helped by the great deal of risk involved. Lumpkin placed a figure of $800 million (€617 million) to bring a successful novel drug to the market including the amortised costs of all the product failures.
The sheer unpredictability involved in drug research is a long and uncertain development process, hindered by the often-fickle capital market and regulatory processes, which can prove to be impenetrable and unresponsive.
Lumpkin continued: "In a marketplace such as this, payment is hard to predict. As a result 'low hanging' fruit has been picked."
"The impact a drug makes in the marketplace is a marked decrease in innovation," he added.
To demonstrate the risk involved Lumpkin pointed to the fact that 4 out of 5 potential products (80 per cent) that start clinical development fail to make it to the market. In addition, 50 per cent of drugs that undergo phase III trials turn out to be unsafe or not effective enough for marketing. This means that the benefit/risk calculus can fail.
Lumkin said: "Although the rate of discovery is rising, fuelled by investment in biomedical science, there is a serious bottleneck between the laboratory and the bedside in bottle development."
It is a risk that some pharmaceutical companies refuse to take. In 'playing safe' with established compounds and 'marketable' diseases, the industry is currently shifting its emphasis away from curative and preventative interventions along with rare and less common diseases.
Even more worryingly, there could be a decreased emphasis on individualisation of therapy, so often being talked about as the future of medicine, which threatens to further challenge the industry.
Lumpkin said in his speech that the prospect of more effective, more targeted, individualised targeted therapy was an advancement we could all look forward to. He said a time would come where doctors would be able to treat disease at a genetic level and at an individual level, to a degree that products would be given to patients who have the highest probability to benefit and who will have the least probability of an adverse reaction.
He also stressed the seriousness of the current situation, stressing that diseases that afflict populations, are in dire need of quicker, more accurate diagnoses and better treatments. He specifically highlighted Alzheimer's, HIV/AIDS, cystic fibrosis and rheumatoid arthritis as diseases in need of a breakthrough.
