Expedited FDA Approval Leads to Unsafe Drugs? No. 
​​[Posted on: Thursday, September 14, 2017]

It has been argued that because expedited approval pathways allow drugs to be approved with incomplete analysis of safety and efficacy, it potentially leads to new drugs with limited benefit and/or with potential safety concerns. But this is a simplistic one sided argument that does not address the context in which such drugs are approved. A recent review by Harvard researchers of the number of times the labels of approved drugs were changed to add new safety warnings shows that the drugs approved under the expedited approval pathways are about 40% more likely to have such changes and about 50% of these changes are due to major new safety information as it appears in the Black Box warning or contraindication sections of the label. New safety issues are identified during post-market phase of most drugs and it is expected more such issues would be found post-approval for drugs approved through expedited regulatory pathways as these did not go through the extended safety analysis required for drugs approved via conventional approval pathways. However, expedited approval pathways are reserved for products that cater to an unmet medical need and are intended to treat serious life-threatening diseases meaning that not approving or delaying approval of such drugs would cause much more hardship to patients than to approve them, monitor for safety issues, and update the safety information appropriately. Arguably once a drug is approved by FDA, patients and their physicians have an expectation of the drug being safe and effective so any new safety information may get ignored. It has been suggested that manufacturers should take additional responsibility to educate the patients about the potential unknown safety issues beyond using the approved label and marketing material; and that physicians should warn patients about the potential risks of the new drug. There is little scientific and practical utility about informing patients and prescribers about unknown safety issues. FDA and other regulators the World over have taken the calculated measure of allowing treatments for unmet medical needs and rely on post-market regulatory processes to avoid major accidents. And the data shows that the process works. Taking the results of this recent survey, it shows that FDA and manufacturers are able to find new safety issue and take appropriate measures. Drug labels are revised, safety notices such as Dear Doctor letters are on the rise, and patients still have access to drugs they need. And the trends are that these regulatory mechanisms will get used even more for more and more products. Expedited approval pathways work and they are here to stay along with better post-market monitoring for safety issues.