FROM OUR EXPERTS
It's finally here! Merck's patent on the popular osteoporosis drug Fosamax has run out, and now other companies are offering generic alendronate at lower prices. For those whose doctors have recommended the medication but have been put off by the price, now you have one less excuse to disregard your bone health. There are at least three versions available, and it may be time to talk with your doctor to see if a cheaper alternative is right for you. But beware -- just because the drug is more affordable doesn't necessarily mean it's the best choice for everybody, so make sure you discuss this issue with your physician before starting or stopping any medication.
I had always been told that the active ingredients in generic medications had to be exactly the same as their brand name counterparts; that the only differences allowed were in the inactive ingredients, such as binders. But as I began to hear from more and more people who insisted that the generic of a particular medication was not as effective for them as the brand name, I decided it was time to dig deeper. As it turns out, brand name and generic medications aren't necessarily exactly the same. The differences and the reason we're often told they are equilivant are tied up in the definitions of three terms – bioequivalence, therapeutic equivalence and bioavailability. Bioequivalence means that two drugs given to the same patient in the same dosage regimen will result in equivalent concentrations of the drug in plasma and tissues. Generic drugs are required to be bioequivalent to the original brand name drug. Therapeutic equivalence means that...
A five-member majority of the U. S. Supreme Court concluded in late June that "it makes little sense" to bar suits against generic drug-makers while allowing them against brand-name manufacturers1.
The majority, however, sided with the supremacy of federal law in its potential conflict with state law, in that federal law bars manufacturers from labeling that varies from the FDA-approved labeling of the branded drugs they imitate. Thomas reasoned in writing the majority opinion that it would be "rare" that harmful side effects could become known by the time generic drugs come on the market.
Such thinking flies in the face of the importance of post-market surveillance and the continued collection and analysis of data upon a drug's usage - even after it is manufactured in generic camps. This is because the initial approvals and labeling for branded drugs are largely based on clinical trials in which research participants are highly screened. The results are recognized not to be wi...
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