FDA test generic drug product when it comes to approval, it has to go through rigorous standards which are recognized by FDA with respect to strength, quality, identity and potency. Only minor variable is accepted that is also limited by FDA. It has to involve the same active ingredient, dosage and strength same as the brand name has. Generic drug will also have to prove that its drug is the same as the brand name drug has. FDA also ensures that the performance of generic drugs is same as the brand name. Generic drugs have to pass the test of FDA and have to be the same as the brand name in every aspect.
How generic drugs work?
One research which was evaluated from the result of 38 published medical trials was match by cardiovascular generic drugs with their brand name.
FDA does not even allow 45% of difference in both drugs
Lately FDA examined 2,070 human studies that were conducted from 1996 to 2007. These studies compare brand name and generic drugs into human’s body. These studies were handed to FDA; supporting approval of generics drugs. The average variation was 3.5 percent in incorporation into the body between brand name and generics drugs, some of them would absorb little more and some bit less. The research was also conducted with same brand to one person and also with brand name to generic drug, moreover the result were same on both this research. There will always be slight deference which is medically not important; and that is as same as one batch of brand is compared with another batch.
Why is price so high for brand name product compared to generic drugs?
On an average generic drug is lower than 80 to 85 percent than the brand name product. In 2010 itself FDA ‘approved generics drugs’ saved up to $158 billion, which is an average of $3 billion each week.
Cheaper is not lower here
Generic drugs are available on lower price, is just because they do not have to pay expense on experiment, costly marketing and advertising expense, and also in promoting its product. And in addition to that, there are many other companies approved to market a sole product, giving a cut-through competition resulting in a lower price.
FDA monitors generic drugs
FDA is always monitoring unfavorable effects for each drugs product, even including generic drugs. It is FDA’s attempt to assess the safety of drugs even after approval. Reports are been investigated and monitored by FDA to check the proper functioning.
FDA’s constant attempt to make products safer
FDA is awake about the reports that few people may experience an undesired effect while switching from brand name to generic formulation otherwise from one generic to another. FDA wants to know what possibly will be the cause problems with certain formulations, if they are associated to precise generic products. FDA is also cheering the generic industry to examine under what situation these problems take place. FDA continues to investigate this information to make sure that it will have all the details about these treatment failures and as such will recommend to healthcare professionals and even public if it requires.