Orthopaedic Surgery and Food and Drug Administration Off-Label Uses

2000 ◽  
Vol 378 ◽  
pp. 31-38 ◽  
Author(s):  
Michael R. Zindrick
Keyword(s):  
Drug Administration ◽  
Orthopaedic Surgery ◽  
Food And Drug Administration ◽  
Off Label

scholarly journals Tale of Two Erythropoiesis-Stimulating Agents: Utilization, Dosing, Litigation, and Costs of Darbepoetin and Epoetin Among South Carolina Medicaid-Covered Patients With Cancer and Chemotherapy-Induced Anemia

2017 ◽  
Vol 13 (6) ◽  
pp. e562-e573 ◽  
Author(s):  
Virginia Noxon ◽  
Kevin B. Knopf ◽  
LeAnn B. Norris ◽  
Brian Chen ◽  
Y. Tony Yang ◽  
...  
Keyword(s):  
South Carolina ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Advisory Committees ◽  
Criminal Conviction ◽  
Erythropoiesis Stimulating Agents ◽  
Off Label ◽  
Patient Costs ◽  
Patients With Cancer ◽  
The Us

Purpose: The US Food and Drug Administration (FDA) has approved epoetin and darbepoetin for chemotherapy-induced anemia (CIA). Approved epoetin and darbepoetin dosing schedules were three times per week and weekly, respectively, although off-label, less frequent scheduling was common. In 2004, 2007, and 2008, a US Food and Drug Administration Advisory Committees warned of risks associated with erythropoiesis-stimulating agents. During this period, lawsuits alleging illegal darbepoetin marketing practices have concluded, resulting in $1.1 billion in fines and settlements and one criminal conviction. No prior study, to our knowledge, has reported on the use of darbepoetin versus epoetin for CIA. Methods: We evaluated the dosing, utilization, and costs of erythropoiesis-stimulating agents among 3,761 South Carolina Medicaid patients with CIA. Results: Epoetin and darbepoetin utilization rates were 22% and 28% in 2003, 10% and 33% in 2007, and 3% and 7% in 2010, respectively. Mean per-patient per-administration epoetin and darbepoetin doses were 40,983 IU and 191 µg, respectively, in 2003 and 47,753 IU and 369 µg, respectively, in 2010. Mean monthly patient costs for epoetin and darbepoetin were $1,030 and $981, respectively, in 2003 and $932 and $1,352, respectively, in 2010. Epoetin use decreased steadily between 2002 and 2010; darbepoetin use increased steadily between 2003 and 2007 and then decreased steadily thereafter. Per-patient dosing of darbepoetin, but not epoetin, increased steadily between 2003 and 2010, and monthly per-patient epoetin costs decreased 3% while the per-patients costs of darbepoetin increased 30% between 2003 and 2010. Conclusion: To our knowledge, our findings are the first data reporting on epoetin versus darbepoetin use for CIA and support recently concluded lawsuits involving allegations of illegal marketing practices of the manufacturer of darbepoetin.

Off-Label Use and Prescribing What Does It Mean for the Foot and Ankle Surgeon?

2010 ◽  
Vol 3 (5) ◽  
pp. 303-306
Author(s):  
Christopher F. Hyer
Keyword(s):  
Drug Administration ◽  
Medical Devices ◽  
Clinical Studies ◽  
Food And Drug Administration ◽  
Good Thing ◽  
Foot And Ankle ◽  
Off Label Use ◽  
Off Label ◽  
Practice Of Medicine ◽  
Indications For Use

Drugs and medical devices obtain specific on-label indications for use by the Food and Drug Administration. Physicians are able to use such devices and drugs off label as part of the practice of medicine, but is this is good thing? This edition of In the Profession examines what it means to be off label in terms of regulations, clinical studies, industry marketing, and common areas of use.

scholarly journals Collection of the BD SurePath Pap Test with a broom device plus endocervical brush improves disease detection when compared to the broom device alone or the spatula plus endocervical brush combination

CytoJournal ◽  
2008 ◽  
Vol 6 ◽  
pp. 4 ◽  
Author(s):  
Sharon Davis-Devine ◽  
Sarah J. Day ◽  
Amy Anderson ◽  
Ashley French ◽  
Darcy Madison-Henness ◽  
...  
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Pap Test ◽  
Disease Detection ◽  
Diagnostic Utility ◽  
Transformation Zone ◽  
Off Label ◽  
Collection Device ◽  
The Us

Objective: Here we examine the diagnostic utility of the US Food And Drug Administration (FDA) approved Spatula + endocervical brush combination for the BD SurePath Pap Test (SPPT) and compare it to SPPT collection with the broom alone or to an off-label combination of broom + EC brush. This question is important due to lingering concerns over the value of EC detection to a satisfactory Pap test. Methods: 20,125 SPPT vials were examined for the collection devices contained. The SPPT collection device combinations allowed were: Rovers Cervex-Brush (broom, FDA approved), Medscand Pap Perfect Spatula + Medscand CytoBrush Plus GT (spatula + GT brush, FDA approved) or Rovers Cervex-Brush + Surgipath C-E Brush (broom + CE brush, off label). Results: Examination of SPPT vials revealed 11,130 collected with the broom, 4,687 collected with the spatula + GT brush and 2,921 collected with the broom + CE brush. Absence of an endocervical/transformation zone was seen in 22.86% of broom cases, 13.10% of spatula + GT brush cases (p= 0.00005 vs broom) and 10.17% of broom + CE brush cases (p= 0.00005 vs broom, p= 0.00005 vs spatula + GT brush). Importantly, LSIL detection was: broom 2.99%; spatula + GT brush 2.45% (p= 0.053 vs broom); broom + CE brush 4.18% (p= 0.034 vs broom, p= 0.0001 vs spatula + GT brush). Conclusion: When broom + brush combination is compared to broom alone or to spatula + GT brush, the broom + CE brush combination better sampled the endocervical/transformation zone and increased LSIL detection.

Recommendations for Clinical Trials of Off-Label Drugs Used to Treat Advanced-Stage Cancer

2012 ◽  
Vol 30 (6) ◽  
pp. 661-666 ◽  
Author(s):  
C. Daniel Mullins ◽  
Russ Montgomery ◽  
Amy P. Abernethy ◽  
Arif Hussain ◽  
Steven D. Pearson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Administration ◽  
Randomized Clinical Trials ◽  
Technology Policy ◽  
Food And Drug Administration ◽  
Decision Makers ◽  
Public And Private ◽  
Off Label ◽  
The Us ◽  
Before And After

Purpose To provide recommendations to trialists and sponsors that guide the design and implementation of prospective postapproval clinical trials for oncology drugs used outside US Food and Drug Administration–labeled indications for treatment of late-stage cancers. Methods A meeting was hosted by the Center for Medical Technology Policy in Baltimore, MD, on November 12, 2009. Discussions during the meeting and key informant interviews were conducted before and after this stakeholder meeting. Peer review by multidisciplinary stakeholders was followed by a public comment period. Input was received from patient advocacy groups, medical oncologists, pharmaceutical companies, the US Food and Drug Administration, Centers for Medicare and Medicaid Services, the National Cancer Institute, foreign government agencies involved in health technology assessment, public and private payers, drug compendia, clinical research entities, statisticians, academics, and the American Society of Clinical Oncology. Results To address the needs of patients and their clinical providers, compendia, payers, and policy makers, recommendations are proposed to guide the design of future prospective trials for off-label use of oncology drugs across four areas: trial design and data analysis, patient and site recruitment, comparators, and outcomes. Conclusion The US Food and Drug Administration provides guidance to the pharmaceutical industry and others designing randomized clinical trials for regulatory approval. However, a gap exists for postregulatory decision makers, including patients, prescribers, and payers, because regulatory trials do not answer the questions most relevant to them. Therefore, guidance is needed for trials performed in the postapproval environment for these postapproval decision makers.

Unapproved Uses of Approved Drugs: The Physician, the Package Insert, and the Food and Drug Administration: Subject Review

PEDIATRICS ◽  
1996 ◽  
Vol 98 (1) ◽  
pp. 143-145 ◽  
Author(s):  
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Age Groups ◽  
Package Insert ◽  
Age Group ◽  
Off Label Use ◽  
Off Label ◽  
Fda Approval ◽  
Approved Drugs

Physicians who prescribe a new drug that has not been approved for a specific indication or a specific age group frequently find themselves in a quandary. Physicians who prescribe "old," time-honored drugs usually do not consult the package insert or search for US Food and Drug Administration (FDA) approval. This statement was written to clarify the legal and informational status of the package insert and the role of the FDA in approving or not approving drugs for specific indications or specific age groups. The unapproved use of approved drugs, or so-called "off-label" use, is extremely prevalent among physicians who care for children. It is important that such use of compounds be brought up to date with current FDA policies and to emphasize the responsibility of the prescribing physician in the use of these compounds.

Bias at the Gate?: The Pharmaceutical Industry's Influence on the Federally Approved Drug Compendia

2014 ◽  
Vol 40 (1) ◽  
pp. 141-163
Author(s):  
Lindsey Gabrielsen
Keyword(s):  
Bipolar Disorder ◽  
Pharmaceutical Company ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
The Other ◽  
Insurance Companies ◽  
Off Label ◽  
Treatment Of Epilepsy ◽  
Clinical Indications ◽  
Federal Food

As of 2002, the Federal Food and Drug Administration (FDA) had approved Neurontin, a drug developed by the pharmaceutical company Pfizer, for two uses, the treatment of epilepsy and pain related to shingles. A staggering ninety-four percent of Neurontin prescriptions in the prior five years, however, were for other (non-FDA) approved uses. These other uses effectively tripled Medicaid’s costs for the drug between 1998 and 2003. Insurance companies covered the off-label uses because they appeared in the Drugdex compendium, a federally authorized listing of drugs that includes evidence regarding the drug’s effectiveness, clinical indications, and proper dosing. Drugdex included an additional forty-eight uses for Neurontin, ranging from bipolar disorder to the hiccups. Two other federally approved compendia existed at that time; one listed seven uses for Neurontin while the other listed only one.

scholarly journals A Tale of Two Citizens: A State Attorney General and a Hematologist Facilitate Translation of Research Into US Food and Drug Administration Actions—A SONAR Report

2012 ◽  
Vol 8 (6) ◽  
pp. e158-e167 ◽  
Author(s):  
Brian Chen ◽  
John Restaino ◽  
LeAnn Norris ◽  
Sudha Xirasagar ◽  
Zaina P. Qureshi ◽  
...  
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Attorney General ◽  
Safety Issues ◽  
Off Label ◽  
New Approaches

The authors reviewed FDA and manufacturer responses to a citizen petition filed to address thalidomide safety issues and concluded that new approaches addressing off-label safety are needed.

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