The US Food and Drug Administration (FDA) issued new rules which will make it easier for seriously ill patients to receive unapproved investigational drugs, in August 2009.
The new rules apply to those patients who have no other treatment options available to them and are not eligible to participate in a clinical trial. There will also be a new website created for patients to find out more about access to investigational medicines.
Manufacturers will be able to charge for expanded access to such drugs, and the FDA hopes the move will encourage more pharmaceutical companies to develop investigational medicines.
The changes will not result in changes to the FDA’s drug approval processes, but are expected to increase applications for investigational drugs by up to 50%.
Further reading - A detailed analysis of the US pharmaceutical market, including some background information on the FDA, is available from Espicom: The Pharmaceutical Market: USA (published June 2009)