Over the years, generic medicines have benefited millions of Americans and saved trillions of dollars. Accounting for approximately 90% of prescriptions in the US, generic medicines are essential to increasing patient access to important drug therapies.
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Milestones of Generics: 55 Years of Advancement
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1962 - New FDA authority: safety and effectiveness
Manufacturers required to prove safety and effectiveness prior to FDA approval; the FDA now controls the marketing of generic drugs; and the Agency is also mandated to retrospectively evaluate the safety and effectiveness of drugs approved between 1938-1962, under the Kefauver-Harris Amendments
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1966 - Effective or ineffective?
By request of the FDA, the National Academy of Science (NAS) begins the process of classifying all drugs approved from 1938–1962 as effective, ineffective, or needing further study
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1968 - Evaluating generics
The FDA announced it would apply the NAS findings, above, to generic versions of drugs
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1970 - Abbreviated approvals
The FDA creates a pathway for abbreviated new drug applications (ANDAs), allowing approvals based on proof a drug has the same active pharmaceutical ingredient; is identical in strength, dose, and route of administration; and is bioequivalent to an already approved drug
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1974-1980 - Substitutions allowed
45 states permit drug product substitutions or selections by pharmacists when filling prescriptions, unless the prescriber designates "dispence as written," repealing their drug antisubstitution laws
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1979-1983 - Slow and steady progress
Only 19 generics are approved under a rule that, for generic versions of most brand-name drugs approved after 1962, requires just the filing of a “paper new drug application,” in which safety and efficacy could be established based, in part, on citations to published reports
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1984 - Simplifying generics applications
The The Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) is signed into law, allowing the FDA to approve applications for generic versions of brand-name drugs released after 1962 through an ANDA without repeating efficacy and safety research
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1985 - Generics growth phase
FDA receives approximately 1,050 applications for new generics, with a projected annual savings of $1 billion, in the first year following enactment of the Hatch-Waxman ANDA approval pathway
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1986 - Increasing generic substitutions
The substitution rate at pharmacies for FDA-approved generic drugs jumps from 12% to 22% by the second year after the Hatch-Waxman Act
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1992 - Requiring more quality data
Generic Drug Enforcement Act requires generic drug manufacturers to include more scientific data about quality and bioequivalence and establishes penalties for including false information in ANDAs
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2003 - Improving access by limiting "stays"
The Medicare Modernization Act improves access to generic drugs by limiting brand name drug companies to a single 30-month stay of an ANDA approval, eliminating multiple 30-month stays
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2007 - Tripling generics
The proportion of prescriptions filled with generics grew to 63% from 18.6% in 1984
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2014 - Savings surge
The generic substitution rate at pharmacies reaches 86%, with an estimated savings of more than $230 billion
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2017 - Savings continue to build
Generics save US consumers more than $265 billion for the year
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2017 - FDA's focus on competition
FDA announces its Drug Competition Action Plan to encourage generic drug development
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2018 - New pathways for approvals
FDA approves first generic drug under new “Competitive Generic Therapy” (CGT) pathway aimed at enhancing market competition for sole-source drugs.
About USP and the Generics Access Plan
USP standards provide generics manufacturers with publicly available requirements and testing methods, as well as expectations for quality. Those quality standards can help manufacturers develop generic versions of off-patent drugs. With our Generics Access Plan, we are committed to helping increase patient access to medicines by facilitating competition through developing and updating quality standards, offering training and education, and convening FDA and others to identify additional ways to support generics development.