WIKIMEDIA COMMONS, TIBOR KADEK
The Faster Access to Specialized Treatments (FAST) Act made its debut on the floor of the US House of Representatives earlier this month. The bill is seeking to extend fast-tracked drug approvals beyond HIV/AIDS and cancer drugs, which already benefit from legislation that have increased investment, shortened timeframes, and decreased burdens of proof for garnering US Food and Drug Administration approval.
The FDA is cautioning patience because in order to accelerate the approval of drugs that treat Parkinson's, Alzheimer's, diabetes, and other diseases, scientifically meaningful clinical endpoints must first be established to ensure that the right safety and efficacy data is be submitted and evaluated. "We agree with the sentiment behind [the FAST Act] but have to avoid inadvertently lowering the efficacy standard," said director ...
