Tell the FDA to Follow the Same Standards for Supplements as for Alzheimer's Drugs

FDA is planning to loosen guidelines in approving new treatments for Alzheimer’s drugs. Companies would no longer have to show that the drugs improved daily, real-world functioning (such as dressing, feeding, etc.). Under the new proposal, drugs in controlled clinical trials can qualify for approval if people at very early stages of disease subtly improve performance on memory or reasoning tests, before they develop any obvious impairments. FDA would then require companies to study the drugs after they are placed on the market, but these post-marketing studies might not require RCTs. 

If the FDA is going to lift the proof-of-effectiveness requirement for drugs, they need to do the same for supplements and food! If the proposal for Alzheimer’s drugs were applied to natural foods and supplements, supplement manufacturers would be able to prove effectiveness without RCTs, while also having the opportunity to prove long-term effectiveness in post-marketing (i.e., observational) studies.

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  • Stephen Ostroff

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