Facts and Myths about Generic Drugs

The popularity of generic drugs has recently reached such an extent that more and more prescriptions filled are done for generic drugs and not for the brand ones. This article is designed to provide with some explanations about the nature of generic drugs and it is also presupposed to refute some widespread myths regarding these medications.
FACT: According to the standards of FDA generic drugs must be equivalent to the referential brand medications in quality and functioning.

• Both generic and brand name drugs are demanded to meet very strict standards stated by FDA. Regarding generic drugs they presuppose equivalency in the component composition, quality level, purity and the efficiency. Only very small variations are allowed during the process of manufacturing as inevitable for both generic and brand name medicines and even this very limited allowance is rigorously conditioned.
• The standards require generic drugs to resemble their brand name counterparts in the containing active compounding, dose, efficiency and the mode of administration though they do not necessarily have to be an exact analogues when it comes to inactive ingredients.
• Due to the numerous researches on the subject of bioequivalence FDA makes it clear that generic drugs work in exactly the same way as their counterparts regardless of their immediate or extended-release form.
• Any generic drug is required to show the same blood levels as its reference brand drug in order to be acknowledged. Therefore it turns out to be more proficient as only this test is necessary and excludes the necessity of other clinical trials.
• The sites where generic brand manufacturing takes place are also as rigorously checked for the requirements compliance as the brand drug plants.
• On the other hand provided that a brand drug manufacturing decided to relocate or to make any alternations in their formulations they will have to adhere to the same standard requirements that are in power when it concerns generic drugs.

FACT: It is proved by the investigation that generic drugs perform with the same efficiency as their references.
There have been made approximately 38 published clinical studies on the account of the efficiency of cardiovascular generic and brand-name drugs that showed no difference in their performance.

FACT: Generic medications appear to be less pricy in comparison with brand ones; they are approximately 80 to 85% cheaper.

• For instance the average price for a generic drug rates at $6, for a popular brand drug - $29 and around $40 for a less popular one according to the IMS National Prescription Audit.
• During the period of 2006-2007 the prescription drug expenditures showed only 4.0% rise while the spent sums rising from $276 billion to $287 billion. And this may be due to the increased availability of generic products of lately.

Here are some myths and explanations about generic products.

MYTH: The difference between generics and brand drugs amount to 45 percent.
FACT: The assertion does not correspond to reality. FDA considers the review and approval questions with all the seriousness of the subject.

• All the clinical trials and investigations carried out during the period of approximately the last ten years showed only 3.5 percent difference in the absorption of generics and brand drugs by the body. This gave FDA the reason for the approval of the former as the slight difference like this is supposed to be normal and expected and is not rare when even brands are compared among themselves.
• Every generic has its reference brand medication and is required to work with the same efficiency with a slight allowance for variability.

MYTH: Shifting to generics can evoke undesired consequences and impair the condition.
FACT: This assertion has no proofs as the treatment can go wrong both during the therapy with generics and brand name drugs.

• Relapses are not rare in depression treatment regardless of the type of the medication taken.
• Long-term treatment of seizures also does not guarantee that they will not repeat.
• People with a condition of gastric ulcers generally re-experience this condition despite of even the successful treatment with strength antacids; http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=8131#nlm34067-9).

MYTH: Low quality of generics explains their price.
FACT: Generics manufacturers do not have all those brand-name drug expenditures concerning development, approval, advertising and promotion. This allows to reduce prices and to make drugs more available.

MYTH: Generics do have problems with quality. A recent recall of generic digoxin (Digitek) proves this.
FACT: FDA lays down high demands to both generic and brand name drugs and this case illustrates the principle quite well.
In March 2008 during the scheduled inspection of the Actavis production facility FDA found the small amount of the products not corresponding the required specifications. The drug list included the above mentioned Digitek. FDA made sure that ALL of the Digitek pills were recalled. This very action shows that FDA adheres to the policy of current Good Manufacturing Practice (cGMP) regulations and will take all the necessary preventive measures even if none of the ill-effects or other problems were reported.

MYTH: Imported drugs have problems with quality and the case with Ranbaxy company proves this.
FACT: The case only proves that FDA is concerned about the safety of the products.
Dewas, Paonta Sahib and Batamandi Unit facilities of the Ranbaxy manufacturer violated the U.S. cGMP requirements and therefore FDA issued two warning letters and also established an Import Alert that forbade the entry of the Ranbaxy products. More than 30 different generic drugs are still not allowed into the U.S. (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149532.htm). FDA has also invoked its Application Integrity Policy (AIP) against the Paonta Sahib facility and does not review any new or pending drug approval applications concerning this very facility. FDA carried out 2,221 resembling drug-related inspections in the fiscal year 2008 and for more information on the subject follow http://www.fda.gov/downloads/ICECI/EnforcementActions/EnforcementStory/UCM129812.pdf

MYTH: Generics can not be considered as safe and reliable drugs.
FACT: FDA is responsible for the evaluation of the drugs after their approval. The reported adverse effects evoked by generic drugs are mostly the same as those that have already been known for brand-name medications.

MYTH: FDA is not concerned about generic drugs.
FACT: FDA is concerned about the safety of all the products be it generic or brand ones.
There is a chance that the drug interchangeability problem can happen but these cases and reports are quite rare. As soon as FDA has no options to carry out the researches and find out the reasons on their own accord it encourages the generic industry to do this. FDA does its best to investigate the already reported cases and takes the necessary measures if needed.

Source: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ucm167991.htm