Issues

Bioequivalence means that the active ingredient in a generic medicine is absorbed into the body at the same rate and amount as in the brand-name product. This ensures that the generic delivers the same therapeutic effect as the brand counterpart and can be safely substituted with the brand product. Bioequivalence gives consumers, patients, physician and pharmacist the assurance that FDA-approved generic medicines provide the same medicine and the same clinical results, with the same safety profile, as their brand counterparts.

Federal law requires that, in order to receive FDA approval, generic drugs contain the same active ingredient as the brand-name counterpart, be the same strength and dosage form (tablet, capsule, etc.), and have the same route of administration (oral, topical, injectable, etc.). It is important to know that bioequivalent drugs, whether brand-to-brand or generic-to-brand, work in the body in the same way and provide the same safety and efficacy profile. In short, generics provide the same medicines, but at a more affordable cost.

Carve-out laws limit the consumer's right to choose affordable generics, which threatens patient access to these vital medicines. FDA and the American Medical Association (AMA) as well as many other medical and scientific groups have stated that generic substitution is clinically appropriate, effective and, above all, safe.

GPhA has long supported measures to strengthen the foreign drug inspection system to assure safety across the board for all pharmaceutical products and to ensure substantial compliance with Good Manufacturing Practices (GMPs) by: increasing FDA funding, setting up a uniform inspection system for foreign and domestic manufacturers, and creating a "risk-based" foreign inspection process.

Approximately 60% of all drugs dispensed through the Medicaid program are generic, costing on average 63% less per prescription than the corresponding brand and saving the Medicaid program tens of billions of dollars each year. GPhA works with federal and state governments to implement policies that promote increased generic use, thereby achieving greater savings.

GPhA supports providing the Office of Generic Drugs (OGD) an additional $14 million for the specific purpose of reviewing and approving generic drug applications which would ultimately result in greater cost savings for consumers and state and federal governments.

As policymakers look at the issue of patent settlements, they must avoid taking action that sweeps the bad settlements in with the good settlements that ultimately help consumers.

One of the main goals of the generic pharmaceutial industry is ensuring the quality of its products. The generic industry follows the same concepts and principles set by the FDA, incorporating the concept of "Quality of Design" or QbD as a core tenet in production and manufacturing. QbD is an important reason why generic manufacturers continue to produce high-quality medicines for all consumers.

The more consumers and health care providers know about the safety, quality and value of generic medicines, the more they will enjoy the tremendous benefits and savings offered by these important medicines. GPhA has long been committed to educating consumers and health professionals about the safety and effectiveness of generic medicines, and the leading role they play in keeping the American health care system among the world’s best.