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Author: Admin | 2025-04-28
After all, the shelves of any local pharmacy are filled with medications (e.g., pain relievers, ulcer drugs, antiallergy agents) that were once prescription-only that are now available OTC. Interestingly, Pfizer tried to go down the OTC road a few years ago seeking FDA approval for another well-established drug, cholesterol-lowering Lipitor. In that case, the FDA had Pfizer conduct a phase 3 “actual use” trial. The FDA’s concern was patients would either misdiagnose themselves or not be motivated to get their blood tested for high cholesterol.In fact, the FDA worries were valid. The study that Pfizer conducted did not meet its primary objective of demonstrating patient compliance with the direction to check their LDL-C level and, after getting the results of this blood test, take appropriate action. Given the asymptomatic nature of high LDL-C, patients were simply not motivated enough to go through this process. Based on dialogue with the FDA about these phase 3 results, the program was terminated.However, the FDA might not have the same type of issues for OTC Viagra in the U.S. First, this is a highly motivated patient population. Second, this is a drug used as needed and not a chronic-use drug like drugs to treat blood pressure or LDL-C. Third, the drug has been in use for decades and its safety profile is well known. Finally, the FDA already has an “OTC experiment” now underway in the U.K. and will likely watch the progress of that closely. If the U.K. experience is successful, it would enhance confidence that OTC Viagra could be viable in the U.S.Also, the role of payers and insurers shouldn’t be overlooked. Even with the prospect of generic sildenafil being available, giving patients access to OTC Viagra would eliminate this cost from their budgets and put these costs back to the pockets of consumers.Given these factors, it wouldn’t be a surprise to see FDA head, Dr. Scott Gottlieb, move the agency toward making OTC Viagra available in the U.S.(The author is the former head of Pfizer R&D.)
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