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Step 1
Begin by understanding how a drug gets approved. The responsibility for insuring a drug’s safety rests with the manufacturer that brings a drug to market. The entire process is tightly regulated by the Federal Food and Drug Administration (FDA). The major costs in drug development are research and testing, beginning with laboratory studies then on to animal testing. Once these investigational new drugs (INDs) reach clinical trials they have to demonstrate safety and effectiveness before the FDA allows marketing. In some cases, patients with no options left may be allowed access to unapproved products despite the potential risks. Drug manufacturers are then given a window in which they hold an exclusive patent on the medicine. This is when the pharmaceutical companies make their money, because the expensive part, the testing, is largely over.
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Step 2
Know that when a pharmaceutical finally reaches market, far more people will typically take the drug the first year than through the entire approval process so the FDA still keeps watch, because across a wider population segment, over time, side effects are more likely to show. The classic example of unanticipated side effects on an approved drug was with thalidomide in the 1950’s. It was marketed as a sedative and sleep aid. Although women soon started turning to it, thalidomide had never been tested on pregnant animals. By 1956 women who had used the drug started giving birth to babies with severe birth defects like flippers instead of limbs. Whatever the side effects are from a drug they are likely to be learned during the time that an exclusive patent is held.
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Step 3
Be aware that as the patent lapses, the FDA looks at applications for generic drugs which have to meet the same standards for brand name versions in strength and use. All generic drug applications must be reviewed and approved by the FDA. The process does not duplicate the initial approval steps but builds on them. Furthermore, the FDA inspects the drug’s manufacturing plant and monitors the drug’s quality. Generic drugs are bio equivalent. They may look different because inert ingredients and filler may vary from the brand name version, but they are just as safe and work the same.
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Step 4
Be aware that the big advantage of turning to a generic version of your drug is that it usually costs substantially less. Sometimes, these differences can be masked by your insurance company’s drug co pay. Do this simple comparison. Pick up two boxes for a medication like loratadine formerly available only by prescription as Claritin. By choosing the generic version, you can cut your costs in half. You’ll save big by choosing Minoxidil over Rogaine, and on down the line. Many hesitate for one reason only, direct to consumer adverting, which has become a huge business in just the last twenty years.
