Do You Trust FDA to Assure Safety Of Approved Products?
[Thursday, March 21, 2019] A recent study by researchers from MIT and Harvard University raise concerns about the risks of adverse reactions due to excipients in drugs, reporting that more than 93% of drugs containing inactive ingredients that could cause allergic reactions. The study, though well-intentioned, could create unreasonable anxiety and fear in patients taking the same drugs. All drugs require approval by FDA before they can be sold to patients. All products approved by FDA withstand a robust review by full time reviewers at FDA who are perhaps one of the strongest subject matter experts in the contents of the market approval application. By the time a given drug is approved, these FDA reviewers have been involved in the product since the very beginning of its development, have read numerous documents submitted over years of development, have interacted with the sponsors several times, and are privy to all aspects of the product, public and confidential. After the drug is approved, FDA collects ongoing safety related information for as long as the product is in the market. All approved product labels and marketing material clearly identifies potential allergens to warn patients. The report fails to acknowledge any of the above. It further failed to emphasize that its findings of safety concerns are not as robust as that conducted by FDA. The authors of the report suggest that manufacturers list the amount of all excipients, basically disclose the proprietary formulation, or develop alternate formulations not containing the excipients objected to. Both suggestions are unreasonable. The very fact that 93% of medications contain these ingredients suggest that whatever negative effects they may exert, have been addressed in clinical trials or after approval and they do not pose risk to patients in the opinion of FDA. Any patient-specific adverse effects should be addressed by their physicians. Reports like these could be misinterpreted by the patients for their perceived risk, particularly because they get much publicized by the media while the FDA processes are poorly understood by general public. This kind of research is needed to understand the complexity of medications, but they should carry clear disclaimers regarding the limitations of such research. This is not the first time groups have tried to second-guess the FDA review process. Earlier this year, FDA had to come to the defense of drug manufacturers in India and China due to media reports indicating sub-standard drugs coming from those countries. All reports of such kind must carry disclaimers that any analysis done by non-FDA parties based on publicly available information or independent studies cannot even come close to review conducted by FDA. For patients and physicians, the stamp of FDA approval should be enough to use drugs without fear.
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