Regulatory Considerations for Regulatory Considerations for Abbreviated New Drug g
pp
Applications
Timothy W. Ames, R.Ph., M.P.H.
Chief, Review Support Branch
pp
Office of Generic Drugs
Peking University
ignore subsequent bad blocksPeking University
March 5-8, 2009
O i
Overview
FDA Legislative History
W H t h A d t
Waxman-Hatch Amendments
Patents and Exclusivities
Recent Legislative Considerations S it bilit P titi
Suitability Petitions
FDA Legislative History
FDA L i l ti Hi t
1906 Pure Food and Drug Act-establishes regulation of foods and drugs
regulation of foods and drugs
1938Food Drug and Cosmetic Act introduced
1938 Food, Drug and Cosmetic Act -introduced safety standards
1962 Kefauver-Harris Amendments-tightened safety standards and required drugs to be effective
1984 Waxman-Hatch Amendments
DRUG PRICE COMPETITION & PATENT TERM RESTORATION (DCP&PTR)ACT TERM RESTORATION (DCP&PTR) ACT OF 1984
Statutory authority for FDA approval of pre-and Statutory authority for FDA approval of pre and post-1962 generic drugs
Make available high-quality, low-cost generics-g q y,g reducing health care costs
Eliminates costly and unnecessary duplicative f ff
safety and efficacy studies  Assure continued development of new drugs th h t t t i d l i it t d through patent extension and exclusivity granted to certain NDAs
COMPROMISE
Title I
Title I
More Drug Products Eligible for ANDAs  Reduce Costs of Health Care
y y
180 Day Exclusivity and Patent Protection  NDA Exclusivity and Patent Protection “Old”Antibiotics Not Covered
Old Antibiotics Not Covered
Title 2
P t D l t f N D
Promote Development of New Drugs
Up to Five Years of Patent Extension

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