Moving Too Fast? Expedited Drug Approvals Raise Questions

Over the past few years, the FDA has been hurtling toward increasingly speedier approvals for certain drugs as a growing cadre of patients, investors and politicians demand the agency move faster to satisfy unmet medical needs. As a result, the approach taken for approving drugs for AIDS, cancer and other life-threatening conditions is gradually being applied to treatments for a wider variety of illnesses. To some, this view is a welcome, if overdue, shift in thinking. In fiscal year 2012, the FDA reported that more than half of the drugs approved were done so through expedited reviews – fast track or priority reviews, or accelerated approval. And the agency noted that one drug was approved on the basis of a single clinical trial involving just 22 patients (see this). But while faster approvals for more drugs have gained accolades, the trend is also raising questions about the wisdom of changing standards - and applying different standards for different types of drugs and illnesses - and how this may adversely affect safety and efficacy. And a new study published this week in JAMA Internal Medicine draws attention to this concern. The study analyzed 20 new molecular entities – or new drugs – that were approved by the FDA in 2008 and found that efficacy testing among the medications granted some form of expedited review was performed on less than one-fifth of the median number of patients than drugs that underwent a standard review. This actual numbers were 104 compared ...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs