By Maria Kempshall, Life Science Leader magazine
Greater transparency of drug development pipelines, increased media coverage of healthcare issues, and fingertip access to information about investigational drugs via websites and blogs have created a more educated and empowered population of patients.
The heightened awareness of drugs in development brings with it an increase in demand from patients, their physicians, and advocacy groups worldwide for access to these potentially promising medications despite their preapproval status.
Governments worldwide have created provisions for granting access to investigational drugs for patients who have exhausted all alternative treatment options and do not match clinical trial entry criteria. Often grouped under the labels of compassionate use, expanded access, or named patient supply, these processes allow companies to provide patients with access to their drugs while the drugs are still in the preapproval or pre-launch phase. Regulations governing such access define access criteria, data collection, promotion, and control of drug distribution.