Generics
| Generic Drug Products Policy 9911 11/01/1999 Introduced 02/01/2005 Revised 11/01/2009 Revised 02/01/2014 Revised | AMCP encourages pharmacists and managed health care systems to promote the use and benefits of FDA-approved and therapeutically equivalent generic drug products as safe, effective, and cost-effective alternatives to brand-name equivalents. AMCP supports legislative and regulatory changes that would promote the development and use of safe, efficacious and equivalent generic drugs and eliminate barriers that can unnecessarily delay the entry of the generic drugs into the marketplace. AMCP believes that Congress must ensure that the FDA has access to adequate resources in order to review and process applications for generic drugs and eliminate unnecessary delays of their approval. AMCP opposes state and federal legislative and regulatory provisions that would restrict the right of pharmacists, in collaboration with prescribers and patients, to exercise their professional judgment in choosing the most appropriate generic or brand-name equivalent products for patients.
(See AMCP Managed Care Pharmacy Practice Positions - Generic Drugs) (See AMCP Managed Care Pharmacy Practice Positions - Biosimilar Drug Therapies)
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Interchange of Narrow Therapeutic Index (NTI) Drugs 11/01/1999 Introduced | AMCP supports the Food and Drug Administration's (FDA) position that when an FDA-approved and therapeutically equivalent generic drug is selected, patients, physicians, and pharmacists can be assured that they will see the same clinical results and safety profile as with the equivalent brand name product. Therefore, NTI drugs should not be considered as a separate category for purposes of generic substitution. AMCP believes that pharmacists, in consultation with prescribers, should have the right to use their professional judgment and knowledge of the available scientific information in determining when to substitute a generic product. (See AMCP Managed Care Pharmacy Practice Positions - Interchange of Narrow Therapeutic Index (NTI) Drugs). |
| Generic Drug User Fee Program Policy 1101 02/01/2011 Introduced | AMCP supports an effective generic drug user fee program to provide more resources that will reduce delays in the generic drug review process due to lack of appropriate Food and Drug Administration funding. AMCP believes that a generic drug user fee program must ensure that the resources invested produce a meaningful program with measurable results. Generic drug user fees should be adequate to generate resources assigned to the Office of Generic Drugs, but such fees should not hinder the benefit to society provided by cost-effective medications. |
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