Document Detail

No longer "if," but "when": the coming abbreviated approval pathway for follow-on biologics.
MedLine Citation:
PMID:  19998743     Owner:  HSR     Status:  MEDLINE    
Abbreviated approval of follow-on biologics involves answering complex scientific, legal, and policy questions. The Food and Drug Administration (FDA or the Agency) asserts that it lacks the statutory authority to approve follow-on versions of biologics licensed under Section 351 of the Public Health Service Act (PHSA). Despite persuasive arguments to the contrary the one hundred and tenth Congress entertained four legislative proposals to give FDA this authority, each markedly different. It is no longer a question of "if," but "when" FDA will receive authority to review and license abbreviated applications for follow-on biologics. Any legislation in the one hundred and eleventh Congress must determine: (1) if FDA should be granted authority to develop an abbreviated pathway through rulemaking or guidance; (2) if human clinical trials should be mandatory or discretionary; (3) the feasibility of interchangeability determinations in light of patient safety concerns; (4) the duration of marketing exclusivity for associated products; (5) which products are eligible for follow-on approval; and (6) the degree to which uniformity is achievable between the FD&C Act and the PHSA. This paper recommends the one hundred and eleventh Congress strike a balance between patient safety, incentives for product innovation, price competition, and the need for a flexible, transparent process that capitalizes on FDA's growing expertise with follow-on biologics approvals under Section 505(b)(2) of the FD&C Act.
Jeremiah J Kelly; Michael David
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Food and drug law journal     Volume:  64     ISSN:  1064-590X     ISO Abbreviation:  Food Drug Law J     Publication Date:  2009  
Date Detail:
Created Date:  2009-12-10     Completed Date:  2009-12-22     Revised Date:  2010-01-13    
Medline Journal Info:
Nlm Unique ID:  9215384     Medline TA:  Food Drug Law J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  115-48     Citation Subset:  T    
Whiteford, Taylor & Preston, LLP, Baltimore, MD, USA.
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MeSH Terms
Biological Products*
Clinical Trials as Topic
Drug Approval / organization & administration*
Drugs, Investigational
Economic Competition
Government Regulation
Guidelines as Topic
Investigational New Drug Application / organization & administration*
Legislation, Drug
United States
United States Food and Drug Administration
Reg. No./Substance:
0/Biological Products; 0/Drugs, Investigational

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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