Healthcare Professionals

About Generics

Generic pharmaceuticals are the safe, affordable alternative to brand-name drugs for your patients. Over the last 10 years (2001-10), the Generic Pharmaceutical Association (GPhA) reports that the use of generic prescriptions in the United States saved consumers approximately $931 billion.3 The GPhA also contends that without the availability of these lower-cost generics, millions of Americans would not be able to afford the medicines they need.3 The FDA reports that, on average, patients save $50 for every prescription filled with a generic.2

Talk to your patients! Studies show that patients who talk with their healthcare provider about generics are more likely to fill their prescriptions with a generic drug, and 62 percent are more likely to adhere to their treatment regimen when prescribed a generic medication.6 

Safety & Effectiveness
Generics undergo a rigorous review process by the U.S. Food and Drug Administration to ensure their quality prior to becoming available to patients. Manufacturers must submit an Abbreviated New Drug Application (ANDA) for review and approval, and each product is evaluated for drug components, drug stability, packaging, manufacturing processes, and facility descriptions. Generic labeling, such as prescribing information, must be the same as the brand-name labeling but may include differences in drug excipients and how the product is supplied.

Bioequivalence
All generic drugs must show bioequivalence to ensure that they have the same qualities and therapeutic equivalence to the FDA-approved brand-name drugs and will perform in the same manner. Bioequivalence replaces the need to complete animal studies, clinical studies, and bioavailability evaluations.

MPR Concise Consult To learn more about generic medications, bioequivalence, and the FDA's approval process, download or request a copy of the Concise Consult: The Role of Generic Drugs in Patient Care and the Healthcare System.

 


3 Savings: An Economic Analysis of Generic Drug Usage in the U.S. http://www.gphaonline.org/sites/default/files/GPhA%20IMS%20Study%20WEB%20Sep20%2011.pdf, Generic Pharmaceutical Association (GphA)
2 Buehler GJ, Conner D. The Food and Drug Administration process for approving generic drugs [Online training seminar]. Office of Generic Drugs. U.S. Food and Drug Administration Published June 2007. Updated June 18, 2009. http://www.fda.gov/downloads/Training/ForHealthProfessionals/ucm090413.ppt. Accessed December 3, 2010.
6 Shrank WH, Liberman JN, Fischer MA, et al. The consequences of requesting "Dispense as Written". Am J Med 2011;124(4):309-317.