Facts About Generics
Q. Can generics affect patient adherence?
A. Yes! Overall, patients taking generic drugs are 62 percent more likely to adhere to their therapy compared to patients taking nonpreferred formulary brand-name drugs, and they fill their maintenance medications more frequently when a generic is available.6 Why? Cost issues may lead patients to take prescribed medication inappropriately to make it last longer. Generic drugs are safe and effective and help patients save an average of $50 on each prescription filled.2
Q. What is the financial savings from generics?
A. Generic drugs represent 69 percent of the total prescriptions dispensed in the United States but only 16 percent of all dollars spent on prescription medications.7 To the consumer, this represents approximately $50 saved on each prescription filled with a generic drug.2
To the industry overall, the use of FDA-approved generic prescription drugs in place of brand-name counterparts saved the U.S. healthcare system more than $931 billion over the past decade (2001 through 2010). In 2010 alone, generic use generated more than $157 billion in savings. In addition, savings from generic medicines that entered the market since 2001 continue to increase dramatically and account for more than one-third of the total savings.3
Q. Are all generic drug manufacturers the same?
A. No two companies are exactly the same. While all pharmaceutical companies - including generic drug manufacturers - must follow the same FDA regulations and undergo regular FDA inspections, differences between companies can be seen in their efficiencies and in their investment in quality, manufacturing, and R&D processes. Companies can be large or small in size, have many or very few years of experience, and offer a wide variety or only a small line of medications.
Teva is the largest manufacturer of generic drugs in the world and supplies one out of every six generic prescriptions filled in the United States.11 With more than 100 years of experience, Teva is committed not only to meeting FDA standards, but to exceeding them, and providing affordable and quality medications.
Q. Do patients think I'm giving them a lower-quality medication when I prescribe them a generic medication?
A. Each year, more than 2.6 billion prescriptions in the United States are filled with generic versions of brand pharmaceuticals.8 This compares to approximately 1.2 billion brand-name prescriptions dispensed annually in the United States. With close to 70 percent of all prescriptions being filled with generics, patients, pharmacists, and physicians clearly recognize the tremendous value of generics.7 Plus, a recent Harris Poll shows that today's consumer has confidence in the safety, effectiveness, and sameness of generics, as well as an understanding of the savings generics provide. In fact, 81 percent of Americans state that they would choose a generic over a brand-name drug.9
Q. What is the generic approval process?
A. Generic drugs undergo a rigorous review process by the FDA to ensure their quality prior to becoming available to patients. Multiple facets of generic drug chemistry and production are evaluated by the FDA prior to approval including 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 the drug excipient and supply sections.2
Q. What is bioequivalence?
A. In order to meet FDA approval, a generic drug must contain the same active ingredient as its brand-name counterpart, be the same strength and dosage, and have the same route of administration. Bioequivalence means that the active ingredient in a generic medicine is absorbed into the body at the same rate and amount as the brand-name product and, therefore, will provide the same clinical results and safety profile.
The FDA has analyzed hundreds of bioequivalence studies and determined that small differences in blood levels - less than 4 percent - may exist in some cases between a brand and its generic equivalent. However, the FDA has repeatedly stated that this minor difference is no greater than the difference that may exist between two different manufactured batches of the brand drug.10
Q. Where are generics manufactured?
A. Generic manufacturing facilities are required to meet the same FDA standards of good manufacturing practices as brand-name medications. All manufacturing facilities, both inside and outside the United States, are inspected by the FDA to ensure these practices are followed for any prescription drug sold in the United States.
Q. Why don't generics always look like the brand equivalents?
A. The looks of brand-name drugs are trademarked. As a result, the generic equivalent will often differ in shape, color, flavor, or some inactive ingredients. However, the generic always contains the same active ingredient, so patients can be sure that it will work the same in their bodies.
Q. Why do generics cost less than brand-name products?
A. Generic medicines benefit from the scientific research and clinical trials that have already been done by their branded counterparts. Since the FDA has already determined that the medicine is safe and effective, generic manufacturers need only demonstrate that the generic medication has the exact chemical equivalent as the brand and that it will work the same way in the body - which is a great deal less expensive to do. Plus, generic manufacturers do not need to roll expensive advertising costs into the price of the medicine.
Q. Where can I find more information on generic drugs?
A. Concise Consult provides detailed information on the drug approval process, the impact of generics, and information specific to the healthcare provider.
- www.Smart-Health.com - a helpful resource to answer your patients' questions about generics.
- U.S. Food and Drug Administration, U.S. Department of Health & Human Services
- Generic Pharmaceutical Association
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.
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)
6 Shrank WH, Liberman JN, Fischer MA, et al. The consequences of requesting "Dispense as Written". Am J Med 2011;124(4):309-317.
7 GPhA, "Facts at a Glance." http://www.gphaonline.org/about-gpha/about-generics/facts
8 US Food and Drug Administration. Generic Drugs. [Presentation: Robert L. West, Deputy Director, Office of Generic Drugs. Side 4]. http://www.fda.gov/downloads/AboutFDA/Transparency/Basics/UCM226568.pdf
9 [Press Release] Arlington, VA, January 26, 2009. http://www.gphaonline.org/media/press-release/2009/02/12/gpha-says-new-harris-poll-confirms-consumer-believe-generic-medicin.
11 IMS Health NPA Data, MAT December 2011, Teva Data on File