Medliorate

Improving medical students

Brand Names Drugs vs Generics

Posted by medliorator on April 24, 2008

From Melinda Beck at the Wall Street Journal …

Some 65% of all prescriptions dispensed in the U.S. are for generics, though they account for only 20% of the dollars spent

While there is no hard evidence of growing problems from generics, consumers and physicians are increasingly concerned as cost pressures push more patients away from brand-name drugs. At the same time, the globalization of pharmaceutical manufacturing has revealed regulatory lapses.

By law, generics must have the same active ingredient …as the brand-name [allowing] them to piggyback on the original safety and efficacy trials. But generics do have different inactive ingredients, which can affect how they are absorbed into the body. Generics can produce blood levels as much as 20% below or 25% above that of the original drug and still be considered “bioequivalent,” according to Food and Drug Administration guidelines.

Some patients are more sensitive to those differences than others, and people who experience problems with medications are advised to contact their doctors, the drug manufacturer and the FDA’s MedWatch.

HOW TO REPORT DRUG PROBLEMS
• You can also submit a consumer report to the FDA’s MedWatch program at http://www.fda.gov/MedWatch. You will be asked to describe the medication, the adverse event and some brief medical history. Your identity isn’t requested. If you supply an email address, you will receive confirmation that your report was received. You can also speak to an FDA representative at 1-888-INFO-FDA .
http://www.PeoplesPharmacy.com also logs complaints about generic drugs, but these aren’t counted as official FDA adverse-event reports.

Inexact Copies: How Generics Differ From Brand Names [WSJ Health Journal]

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