The landscape for experimental drugs continues to be dictated by the Food and Drug Administration with desperate patients clamoring for the one last medicine that might turn around the course of their disease. Ostensibly, these therapies are withheld from the general public because of safety reasons, but many contend that financial and legal concerns on the part of the private sector and government limits drug availability even when there is ability to pay.
Part of the problem is the bewilderingly complex drug approval process. By many estimates, it takes 10-20 years from molecule discovery to commercial availability. Furthermore, harsh copyright and trademark laws prevent small biotechnology companies from competing with existing but often poor efficacy drugs already on the market. Finally, current legislation limits making a profit on compassionate use, which completely erases any incentive to absorb the high fixed costs to produce these therapies. Streamlining the FDA's approval process, making the process more transparent, and allowing innovative knock-on therapies to enter the market will provide needed treatments to people who need it and may make it financially palatable for small companies to continue research and development.
Subscribe to:
Post Comments (Atom)
Posts
There is a nearly century-old ying and yang between the interests of getting potentially helpful drugs to market and preventing potentially unsafe ones from getting there. After AIDS, there was a push to get drugs to market faster. After Vioxx, the pendulum has swung in the opposite direction.
ReplyDeleteThe FDA needs more money to focus both on safety as well as speedy drug approval. When I last saw the numbers, the FDA regulated 20-25% of all U.S. consumer goods but had 1/50th the funding of the dept. of Agriculture. That needs to change.
I don't know what an "innovative knock-on therapy" is - sounds like an oxymoron to me. We don't need more knock-on therapies; we need better access to the therapies that work. And we need to know what therapies work - so more money to comparative effectiveness and research in general.
I agree with the need to break down whatever barriers exist to testing new drugs and bringing them to market. I am unsure of compassionate use; again, I would favor more research of potentially beneficial drugs. But compassionate use without the research will drive up costs and injure patients, with very uncertain benefits.