Legal Definitions - Approved Drug Products with Therapeutic Equivalence Evaluations

The term Approved Drug Products with Therapeutic Equivalence Evaluations refers to the official publication by the U.S. Food and Drug Administration (FDA) that lists all drug products approved for safety and effectiveness. More commonly known as the "Orange Book," this resource also provides the FDA's evaluations of whether generic versions of these drugs are considered therapeutically equivalent to their brand-name counterparts. This means the generic drug is expected to have the same clinical effect and safety profile as the original brand-name drug when used under the same conditions.

Here are some examples illustrating this term:

• Pharmacist Drug Substitution: A patient receives a prescription for a brand-name medication to treat high blood pressure. When the patient goes to the pharmacy, the pharmacist consults the Approved Drug Products with Therapeutic Equivalence Evaluations. If the publication indicates that a specific generic version of the blood pressure medication is therapeutically equivalent to the prescribed brand-name drug, the pharmacist can confidently offer the patient the generic alternative, knowing it will provide the same therapeutic benefit and safety profile at a lower cost.

  This example demonstrates the term because the pharmacist relies on the FDA's evaluations within this publication to determine if a generic drug can be safely and effectively substituted for a brand-name drug, ensuring therapeutic equivalence.

• Insurance Company Formulary Decisions: An insurance company is developing its list of covered medications (formulary) for the upcoming year. To manage healthcare costs while ensuring patients have access to effective treatments, the company's pharmacy and therapeutics committee reviews the Approved Drug Products with Therapeutic Equivalence Evaluations. They use this resource to identify all FDA-approved generic drugs that are therapeutically equivalent to more expensive brand-name options, allowing them to prioritize coverage for the generics and encourage their use among policyholders.

  This example illustrates the term by showing how an insurance company uses the FDA's therapeutic equivalence evaluations to make informed decisions about which drugs to cover, balancing cost-effectiveness with patient outcomes.

• Physician and Patient Medication Choices: A physician is discussing treatment options for a chronic condition with a patient who is concerned about the high cost of prescription medications. The physician explains that while a particular brand-name drug is highly effective, there are also generic versions listed in the Approved Drug Products with Therapeutic Equivalence Evaluations that the FDA has determined to be therapeutically equivalent. This information allows the patient to choose a more affordable generic option with the assurance that its effectiveness and safety are comparable to the brand-name drug, based on rigorous FDA assessment.

  This example highlights how the information within this publication empowers both healthcare providers and patients to make informed decisions about medication choices, ensuring that cost-saving generic options meet the same standards of efficacy and safety as their brand-name counterparts.