FDA Proposal Would Loosen Rules on Approving Alzheimer’s Treatments
Apr 18, 2013
Virginia Beach, VA (Law Firm Newswire) April 17, 2013 – The FDA plans to ease the rules governing approval of new Alzheimer’s treatments.
Under the proposal, drug companies would no longer be required to demonstrate in clinical trials that their products improved a patient’s life. Instead, approval could be granted based on test subjects in the early stages of Alzheimer’s showing small improvements in reasoning and memory in controlled tests.
The proposed change addresses a problem inherent in the agency’s existing policy. Medications are most likely to be useful to Alzheimer’s patients in the earliest stages of the disease. But those patients rarely show any obvious deterioration in their ability to reason or to perform daily functions. Therefore, the policy requiring drug makers to show improvement in these areas presents a high hurdle to clear.
The FDA would require drug makers to conduct studies after the drugs became publicly available in order to establish their benefits. However, those studies might not be as rigorous as the controlled clinical trials they replace. A number of studies currently in planning stages would enlist early-stage Alzheimer’s patients. The proposed rule changes are expected to increase incentives for such research.
Virginia elder law attorney Andrew Hook commented, “This proposal could very well bring beneficial drugs to market faster and increase research investment in the area, which is sorely needed. On the other hand, it’s easy to imagine patients and third parties paying a lot of money for drugs whose efficacy is in doubt.”
Researchers at the University of California-San Diego and Harvard are heading up a study of 70-year-olds who have no discernible impairment, but who show an accumulation in their brains of amyloid plaque, which is correlated with an increased risk of Alzheimer’s. Half of the 1,000 test subjects will receive an experimental drug created by drug maker Lilly, and the rest will receive a placebo.
Genentech is planning a study involving subjects who have no symptoms, but have a genetic mutation that is strongly correlated with the eventual onset of Alzheimer’s. They hope their drug will delay or prevent the disease. But, data accumulation in the study could take years, given the variability in age present in Alzheimer’s patients.
The FDA is soliciting comments on this proposal from the drug industry and the public.
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