FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W1549079007> ?p ?o ?g. }

• W1549079007 startingPage "309" @default.
• W1549079007 abstract "I. INTRODUCTION II. FDA DRUG APPROVAL PROCESS A. History B. The Clinical Trial System C. Expanded Access Programs 1. Treatment IND 2. Group C Treatment IND 3. Emergency Use IND 4. Parallel Track III. BALANCING INDIVIDUAL RIGHTS WITH STATE PROMOTION OF PUBLIC HEALTH A. The Limits of Paternalistic Regulation B. Safeguarding the Clinical Trial System 1. Scope of the Constitutional Right of Access 2. Research Subject Motivation 3. Will a Market Exist? IV. CONCLUSION I. INTRODUCTION The prospective review and approval of drugs is central the public health mission of the United States Food and Drug Administration (FDA). Requiring pharmaceutical manufacturers generate information about their products' safety and efficacy enables the agency evaluate the risks and benefits associated with their use, thereby preventing overly harmful products from reaching the market. The majority of consumers benefit from this intervention by gaining access an array of drugs that are proven be safe and effective. Thus, governmental regulation in this area is arguably justified because the aggregate social welfare is substantially improved. However, this majoritarian view overlooks the concentrated costs that the drug approval process imposes upon minority groups within society. Drug testing is both resource intensive and time consuming, with an average of eight years required for human clinical testing alone. (1) For individuals suffering from terminal illness who have exhausted conventional therapies, this delay in access can be fatal. Many terminally ill patients are therefore willing tolerate vastly greater therapeutic risks in an effort find a cure. Under the current regulatory structure, however, willingness tolerate, risk does not necessarily translate into access unapproved drugs. The tension between drug safety and access developing experimental drugs most recently came the forefront in 2003, when the Abigail Alliance for Better Access Developmental Drugs [hereinafter Abigail Alliance] (2) brought suit enjoin the FDA from enforcing its current policy banning the use of post-Phase I investigational drugs by terminally ill patients excluded from Phase II clinical trials. (3) The Court of Appeals for the D.C. Circuit recognized a constitutional substantive due process right to access potentially life-sustaining medication where there are no alternative government-approved treatment options. (4) After concluding that the right asserted by Abigail Alliance merits due process protection, the court remanded the case the district court determine whether the FDA's current policy withstands the application of the rigorous strict scrutiny review, essentially, determine whether the policy is narrowly tailored serve a compelling governmental interest. (5) This article analyzes whether the government has a compelling interest in preventing mentally competent, terminally ill patients from accessing post-Phase I drugs. Part II reviews the history of FDA drug regulation and summarizes current law pertaining the drug approval process. Part III considers whether, in light of the constitutional right recognized by the D.C. Circuit, the government's interest in public health can validate restrictions on drug access for terminally ill patients. More specifically, Part III examines whether such restrictions can be justified either by the benefits they confer upon terminally ill patients themselves, or by the benefits they confer upon society at large. Finally, Part IV concludes by finding that both of these justifications fail, thereby undermining the government's claim a compelling interest in restricted drug access for this population. II. FDA DRUG APPROVAL PROCESS A. History Federal regulation of drugs began with the Pure Food and Drug Act [hereinafter PFDA]. …" @default.
• W1549079007 created "2016-06-24" @default.
• W1549079007 creator A5046162692 @default.
• W1549079007 date "2007-01-01" @default.
• W1549079007 modified "2023-09-22" @default.
• W1549079007 title "Restricting Access to Unapproved Drugs: A Compelling Government Interest" @default.
• W1549079007 hasPublicationYear "2007" @default.
• W1549079007 type Work @default.
• W1549079007 sameAs 1549079007 @default.
• W1549079007 citedByCount "1" @default.
• W1549079007 countsByYear W15490790072013 @default.
• W1549079007 crossrefType "journal-article" @default.
• W1549079007 hasAuthorship W1549079007A5046162692 @default.
• W1549079007 hasConcept C100001284 @default.
• W1549079007 hasConcept C118552586 @default.
• W1549079007 hasConcept C138885662 @default.
• W1549079007 hasConcept C142724271 @default.
• W1549079007 hasConcept C143998085 @default.
• W1549079007 hasConcept C144133560 @default.
• W1549079007 hasConcept C159110408 @default.
• W1549079007 hasConcept C162324750 @default.
• W1549079007 hasConcept C2775832928 @default.
• W1549079007 hasConcept C2776743756 @default.
• W1549079007 hasConcept C2778137410 @default.
• W1549079007 hasConcept C2780665704 @default.
• W1549079007 hasConcept C41895202 @default.
• W1549079007 hasConcept C535046627 @default.
• W1549079007 hasConcept C71924100 @default.
• W1549079007 hasConceptScore W1549079007C100001284 @default.
• W1549079007 hasConceptScore W1549079007C118552586 @default.
• W1549079007 hasConceptScore W1549079007C138885662 @default.
• W1549079007 hasConceptScore W1549079007C142724271 @default.
• W1549079007 hasConceptScore W1549079007C143998085 @default.
• W1549079007 hasConceptScore W1549079007C144133560 @default.
• W1549079007 hasConceptScore W1549079007C159110408 @default.
• W1549079007 hasConceptScore W1549079007C162324750 @default.
• W1549079007 hasConceptScore W1549079007C2775832928 @default.
• W1549079007 hasConceptScore W1549079007C2776743756 @default.
• W1549079007 hasConceptScore W1549079007C2778137410 @default.
• W1549079007 hasConceptScore W1549079007C2780665704 @default.
• W1549079007 hasConceptScore W1549079007C41895202 @default.
• W1549079007 hasConceptScore W1549079007C535046627 @default.
• W1549079007 hasConceptScore W1549079007C71924100 @default.
• W1549079007 hasIssue "2" @default.
• W1549079007 hasLocation W15490790071 @default.
• W1549079007 hasOpenAccess W1549079007 @default.
• W1549079007 hasPrimaryLocation W15490790071 @default.
• W1549079007 hasRelatedWork W1526352503 @default.
• W1549079007 hasRelatedWork W1844802243 @default.
• W1549079007 hasRelatedWork W1971259066 @default.
• W1549079007 hasRelatedWork W1988964755 @default.
• W1549079007 hasRelatedWork W1994689960 @default.
• W1549079007 hasRelatedWork W201254052 @default.
• W1549079007 hasRelatedWork W2033418665 @default.
• W1549079007 hasRelatedWork W2125976724 @default.
• W1549079007 hasRelatedWork W2150794482 @default.
• W1549079007 hasRelatedWork W2158818165 @default.
• W1549079007 hasRelatedWork W2202917426 @default.
• W1549079007 hasRelatedWork W2316822274 @default.
• W1549079007 hasRelatedWork W2366194671 @default.
• W1549079007 hasRelatedWork W2603538776 @default.
• W1549079007 hasRelatedWork W271851143 @default.
• W1549079007 hasRelatedWork W2897285983 @default.
• W1549079007 hasRelatedWork W2935742803 @default.
• W1549079007 hasRelatedWork W3158347179 @default.
• W1549079007 hasRelatedWork W43506985 @default.
• W1549079007 hasRelatedWork W2161178654 @default.
• W1549079007 hasVolume "20" @default.
• W1549079007 isParatext "false" @default.
• W1549079007 isRetracted "false" @default.
• W1549079007 magId "1549079007" @default.
• W1549079007 workType "article" @default.