| Title |
Should benefit–risk assessment have its own drug “label”?
|
|---|---|
| Published in |
Drug, Healthcare and Patient Safety, August 2011
|
| DOI | 10.2147/dhps.s21927 |
| Pubmed ID | |
| Authors |
R Scott Braithwaite |
| Abstract |
Many consumers and clinicians incorrectly believe that the Food and Drug Administration (FDA) approval of a new therapeutic implies that its benefits have been proven to exceed its harms. While the FDA could require proof that benefits exceed harms prior to approval, it has been argued that this approach would be infeasible because of prohibitively large sample sizes. One possible alternative would be for the FDA to supplement its standard "label" denoting "safe and effective" with a secondary "label" denoting benefits have been demonstrated to exceed harms, which would be granted only after sufficient post-marketing data had accumulated to prove that its benefits exceeded its harms. This secondary label would not necessarily be linked to marketing restrictions or other commercial prohibitions but, rather, would be only information for consumers and clinicians. Strengths, weaknesses, and feasibility challenges of this approach are discussed. |
X Demographics
The data shown below were collected from the profiles of 3 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United States | 3 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 3 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 3 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 3 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Other | 1 | 33% |
| Unknown | 2 | 67% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 1 | 33% |
| Unknown | 2 | 67% |
Attention Score in Context
This research output has an Altmetric Attention Score of 2. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 12 October 2011.
All research outputs
#16,783,081
of 25,457,858 outputs
Outputs from Drug, Healthcare and Patient Safety
#111
of 160 outputs
Outputs of similar age
#91,746
of 130,520 outputs
Outputs of similar age from Drug, Healthcare and Patient Safety
#2
of 2 outputs
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