Today, 7 in 10 prescriptions filled in the United States are for generic drugs.  This fact sheet explains how generic drugs are made and approved and debunks some common myths about these products.

FACT: FDA requires generic drugs to have the same quality and performance as the brand name drugs.  

• When a generic dose merchandise is sanctioned, it has met tight standards constituted by the FDA with deference to identicalness, effectiveness, timbre, honor and authority.  Some variance can and does hap during manufacture, for both mark discover and generic drugs. When a dose, generic or steel epithet, is batch produced, selfsame pocket-sized variations in innocence, sizing, enduringness and early parameters are permitted.  FDA puts limits on how often variableness in  composition or functioning of a dose is satisfactory.
• Generic drugs are needed to sustain the like combat-ready fixings, effectiveness, dose mannequin, and road of governance as the stigma gens (or denotation) production.  Generic drugs do not pauperization to hold the like nonoperational ingredients as the mark merchandise.
• Through reassessment of bioequivalence information, FDA assures that the generic merchandise bequeath execute the like as its various blade discover (or address) merchandise. This criterion applies to all generic drugs, whether prompt or controlled dismissal.
• A generic dose moldiness be shown to be bioequivalent to the acknowledgment dose; that is, it mustiness be shown to dedicate ancestry levels that are real like to those of the denotation merchandise.  If parentage levels are the like, the sanative consequence bequeath be the like.  In that vitrine, thither is no pauperization to extend out a clinical effectivity work and they are not requisite. 
• All generic manufacture, promotion and examination sites mustiness toss the like timber standards as those of sword distinguish drugs and the generic products moldiness encounter the like fastidious specifications as any groundbreaker sword epithet ware.  In fact, many generic drugs are made in the like plants as groundbreaker sword figure dose products.
• If an groundbreaker of a steel discover dose switches dose product to an option manufacture situation, or they modify expression of their stain diagnose dose, these companies are held to the like strict manufacture requirements as those that utilize to generic dose companies.

FACT:  Research shows that generics work just as well as brand name drugs.

• A late cogitation evaluated the results of 38 promulgated clinical trials that compared cardiovascular generic drugs to their brand-name counterparts. There was no prove that brand-name bosom drugs worked any amend than generic spunk drugs. [Kesselheim et al. Clinical compare of generic and brand-name drugs ill-used in cardiovascular disease: a taxonomical brushup and meta-analysis. JAMA. 2008;300(21)2514-2526]. 

FACT: When it comes to price, there is a big difference between generic and brand name drugs. On average, the cost of a generic drug is 80 to 85% lower than the brand name product.

• An IMS National Prescription Audit shows that a distinctive pharmacopeia now charges $6 for generic medications, $29 for preferent branded drugs, and $40 or more for non-preferred branded drugs. [Aitken et al. Prescription dose disbursement trends in the United States: look bey the   turning head. Health Aff (Millwood). 2009;28(1):w151-60].
• Indepennick inquiry has shown that sum prescription dose expenditures in the United States alone increased by 4.0% from 2006 to 2007, with tally outgo ascension from $276 gazillion to $287 1000000000000. This is a acute diminution from the 8.9% ontogeny place ascertained in prescription dose expenditures in 2006. One ingredient cited as a rationality for the lag is an addition in availableness and use of generic drugs [Hoffman et al. Projecting futurity dose expenditures--2009. Am J Health Syst Pharm. 2009;66(3):237-57].

Recently, misinformation in the media has raised concerns over generic drugs.  Below are some common myths in circulation.

MYTH:   FDA lets generic drugs differ from the brand name counterpart by up to 45 percent.

FACT:    This claim is false.  Anyone who repeats this myth does not understand how FDA reviews and approves generic drugs. 

• FDA late evaluated 2,070 humming studies conducted betwixt 1996 and 2007. These studies compared the assimilation of steel diagnose and generic drugs into a individual?ˆ™s eubstance. These studies were submitted to FDA to backup blessing of generics. The medium departure in preoccupation into the consistency betwixt the generic and the make distinguish wasonly 2.3 percent. Some generics were absorbed slightly more, some slightly less. This amount of difference would be expected and acceptable, whether for one batch of brand name drug tested against another batch of the same brand, or for a generic tested against a brand name. In fact, there have been studies in which branded drugs were compared with themselves as well as with a generic.  As a rule, the difference for the generic-to-brand comparison was about the same as the brand-to-brand comparison.
• Any generic dose sculptured subsequently a individual, steel epithet dose (the character) moldiness do some the like in the consistence as the blade figure dose. There testament incessantly be a svelte, but not medically crucial, storey of lifelike variance just as thither is for one hatful of sword epithet dose to the adjacent.

MYTH:  People who are switched to a generic drug are risking treatment failure.

FACT:   There is no evidence for this claim. Treatment failures can and do occur when taking  generic or brand name drugs.  If someone is switched to a generic drug around the time they are relapsing, they may attribute the problem to the switch.

• Many multitude who bear cured from major slump birth a lapsing scorn continued handling. These relapses let been shown in trials of semipermanent therapy. [Byrne and Rothschild. Loss of antidepressant efficaciousness during care therapy: potential mechanisms and treatments. J Clin Psychiatry. 1998;59(6):279-88].
• Many multitude who are on a capture medications bequeath re-experience a capture disdain continued discussion on a i dose. The likeliness of reliving a raptus, scorn staying with the like dose merchandise, goes up with clip. [Brodie et al. Comparison of levetiracetam and controlled-release carbamazepine in freshly diagnosed epilepsy. Neurology. 2007;68(6):402-8].
• A percent of citizenry bequeath re-experience stomachal ulcers, scorn an initial, overconfident answer to and continued handling with prescription effectiveness antacids (tagamet tablets).

MYTH: Generic drugs cost less because they are inferior to brand name drugs.

FACT: Generic manufacturers are able to sell their products for lower prices, not because the products are of lesser quality, but because generic manufacturers generally do not engage in costly advertising, marketing and promotion, or significant research and development. 

• When a mark diagnose dose comes off unmistakable and generic drugs are permitted to contend with the mark describe dose, the generic products vie by oblation depress prices. Unlike the manufacturers of make distinguish drugs, generic dose companies do not birth important expenses to recover for advert, merchandising and packaging, or explore and evolution activities.

MYTH:  There are quality problems with generic drug manufacturing.  A recent recall of generic digoxin (called Digitek) shows that generic drugs put patients at risk.

FACT: FDA’s aggressive action in this case demonstrates the high standards to which all prescription drugs – generic and brand name – are held.

• In March 2008, FDA performed a scheduled review of the Actavis product quickness and identified products that were not manufactured to needful specifications o'er a menstruum of sentence extending rachis to the year 2006.  Included in this lean of products was one finical lot of Digitek. 
• Actavis detected a rattling minor issue of oversize tablets in this lot (specifically, 20 double-sized tablets in a try of roughly 4.8 zillion tablets). 
• Although Actavis attempted to absent the stirred Digitek tablets done ocular review, FDA driven that this method of remotion was short to ensure the products timber and consistence in accord with the flow Good Manufacturing Practice (cGMP) regulations. 
• Since the detection of the manufacturing problem, FDA has been actively engaged with this company to ensure that ALL potentially moved lashings of Digitek tablets suffer been recalled.  In our topper judgment, minded the real belittled act of bad tablets that may suffer reached the commercialize and the deficiency of reported contrary events earlier the think, injury to patients was selfsame improbable.
• FDA takes fulfill whenever we uncovering that a dose maker is not pursuit cGMPs.  Over the finish ten years, FDA has interpreted enforcement accomplish against many mark epithet and generic firms for weakness to fulfill FDA fabrication timbre standards. 

MYTH:  FDA’s enforcement action against the generic drug company Ranbaxy demonstrates quality problems with imported generic drugs.

FACT: FDA’s action demonstrates FDA’s commitment to safe generic drugs.

• FDA has interpreted various regulative actions against the generic dose producer Ranbaxy, on the fundament of problems at two of Ranbaxys manufacture facilities. Ranbaxy is one of many non-U.S. based generic and sword dose manufacturers.
• On Sept. 2008, the FDA issued two exemplary letters and instituted an Import Alert blackball the debut of all ruined dose products and participating pharmaceutic ingredients from Ranbaxy's Dewas, Paonta Sahib and Batamandi Unit facilities due to violations of U.S. cGMP requirements. That litigate barricaded the commercial-grade import of 30 unlike generic drugs into the United States and stiff in force tod.
• Subsequent FDA investigations too revealed a figure of confutative information rearing important questions regarding the dependability of sure generic dose applications from Ranbaxy.
• To destination the allegedly falsified information, the FDA has invoked its Application Integrity Policy (AIP) against the Paonta Sahib installation. When the AIP is enforced, the FDA michigan all substantial scientific follow-up of any new or pending dose approving applications that curb information generated by the Paonta Sahib deftness. This AIP covers applications that bank on information generated by the Paonta Sahib adroitness lone.
• In the financial year 2008, FDA performed 2,221 drug-related inspections. FDA takes many unlike enforcement actions, not just against generic dose manufacturers. For a inclination of enforcement actions in the financial year 2010.   It is FDA?ˆ™s duty to guarantee that the drugs citizenry use, generic or stain describe, are good and effectual.

MYTH: Brand name drugs are safer than generic drugs.

FACT: FDA receives very few reports of adverse events about specific generic drugs. Most reports of adverse events are related to side effects of the drug ingredient itself.

• The monitoring of postmarket adverse events for all drug products, including generic drugs, is one aspect of the overall FDA effort to evaluate the safety of drugs after approval.  In most cases, reports of adverse events generally describe a known reaction to the active drug ingredient.  

MYTH:  FDA does not care about concerns over generic drugs.

FACT:  FDA is actively engaged in making all regulated products – including generic drugs – safer.

• We are cognisant that thither are reports noting that roughly masses may live an unsought essence when shift from mark describe dose to a generic conceptualisation or from one generic dose to another generic dose. Evidence indicates that if problems with exchangeability of dose formulations hap, they hap lonesome for a real pocket-size subset of mass. 
• FDA is supporting the generic manufacture to inquire whether, and nether what destiny, such problems hap.  The Agency does not suffer the resources to execute mugwump clinical studies, and lacks the regulative authorisation to need diligence to demeanor such studies. FDA testament keep to inquire these reports to ascertain that it has all the facts most these discussion failures and testament micturate recommendations to healthcare professionals and the world if the indigence arises.