In the late 1990’s a generic version of diclofenac eye drops caused corneal melts in some patients causing permanent damage to their eyes. Economic forces for the government, insurance companies, and patients will certainly draw patients over to less expensive generic formulations. Occasionally the pharmacy or the insurance company may dictate the use of generics without the patient being aware of this. Dr. Ashraf advises patients to keep their doctors informed of all their medications that they receive from the pharmacy. He states, “It may be a good idea to bring all of your medications with you and show your doctor each medicine.” Dr. Ashraf points out that there may be a few medications that may not be as efficacious as the branded version for certain patients. Any new drug approved by the FDA enjoys patent protection for a number of years before competitive generic versions are allowed to enter the market. During the FDA testing period, the companies spend extraordinary amounts of money on the formulation of both the active and inactive ingredients, packaging, and delivery mechanisms of the drugs to ensure safety and efficacy. Generic drug manufacturers are generally required by the FDA to demonstrate equivalence, which means their products must contain the same concentration of active ingredient as the formulation that earned FDA approval. They are not, however, required to prove therapeutic equivalence.
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