FDA Promoting Generic Drugs

Food and Drug Administration (FDA) in the United States, after understanding the need for the generic drugs and because of the pressure from the government has now started promoting the generic drugs. According to the FDA, Generic drugs are same as their respective brand-name drugs in safety, dosage, strength, quality, the way they work, the way they are taken and the way they should be used. In simple words, generic drugs are the bioequivalent of the branded drugs.

FDA approves the generic drugs after checking the following points:

1. Generic drug contains the same ingredient as the original drug or not.
2. Generic drug is identical or bioequivalent to the original drug.
3. Whether the pharmacokinetic and pharmacodynamic properties of the generic drugs are similar to the original drugs.
4. Generic drugs are similar in strength in comparison with the original brand name drug.
5. Whether the side-effects of the generic drug are less or more than the original brand name drug.

Once, the generic drug undergoes all the above mentioned tests and gives the positive results then it has to undergo the clinical trials. If the drug clears the clinical trials then it is allowed to be sold in the market.

FDA is sending pamphlets to the big pharmacy chain in US to promote the generic drugs. FDA is even asking these pharmacies to promote the sale of generic drugs. FDA says that all drugs must work well and be safe. Generic drugs use the same active ingredients as brand-name drugs and work the same way. So they have the same risks and benefits as the brand-name drugs. They also made it specifically clear that the officials from the FDA visit the manufacturing unit of the generic drug manufacturer to check the quality standards. If the standards of the generic drug manufacturer meets the quality standards given by the FDA then only the generic drug gets approved.

FDA makes sure that generic drugs are of high quality, strong, pure and stable as their respective brand-name drugs. All factories must meet the same high standards. If the factories do not meet certain standards, FDA won’t allow them to make drugs. In the United States, trademark laws do not allow generic drugs to look exactly like the brand-name drug. However, the generic drug must have the same active ingredients. Colors, flavors, and certain other parts may be different. But these things do not affect the way the drug works and they are looked at by FDA.

When new drugs are first made, they have drug patents. Most drug patents are protected for 17 years. The patent protects the company that made the drug first. The patent doesn’t allow anyone else to make and sell the drug. When the patent expires, other drug companies can start selling the generic version of the drug. But, first, they must test the drug and FDA must approve it. FDA makes it clear that your doctor, pharmacist or other healthcare workers are the right sources of information on your generic drugs. FDA has also requested to all the customers to buy the generic drugs only when your doctor has asked you to do so.

FDA, an agency of the United States Department of Health and Human Services also says, “Generic drugs work in the same way and in the same amount of time as brand-name drugs. Creating a drug costs lots of money. Since generic drug makers do not develop a drug from scratch, the costs to bring the drug to market are less. But they must show that their product performs in the same way as the brand-name drug. All generic drugs are approved by FDA. Your medication guide should be kept with you and up to date. List your prescription and over-the-counter medicines as well as your dietary supplements.” FDA has also introduced the special department to promote the generic drugs. FDA is also arranging the special seminars for the doctors to know about the generic brands. Thus, FDA is doing it all to promote the sell of generic drugs and to make the best available drugs to customer at the lowest price.