It Used To Be Only Small Number Of Drugs Were Fast-Tracked For FDA Approval, But That’s Been Flipped On Its Head
The proportion of new drugs receiving expedited approvals has been at least 60% for each of the past five years. The result is a rising proportion of new drugs for fatal diseases that lack extensive evidence they can prolong lives. Many continue to lack that proof years after entering the market.
The Wall Street Journal:
Fast-Track Drug Approval, Designed For Emergencies, Is Now Routine
For decades, most drugs for critical illnesses passed through a standard battery of tests before regulators allowed them onto the market. A smaller portion were “fast tracked” to make them available to patients sooner. Now that dynamic has flipped. Most drugs are released faster than ever through federal programs expediting their approval. The new normal is transforming medical decision-making for the seriously ill, especially those who are out of other options. Families and doctors are thrust into a new world of trade-offs, raising complex questions about the medical and financial value of drugs with limited track records. (Loftus, 7/5)
In other news on FDA drug approvals —
Stat:
FDA Approves New Multiple Myeloma Drug Despite Toxicity Concerns
The Food and Drug Administration on Wednesday approved a new drug to treat patients with multiple myeloma, overruling a panel of outside cancer experts who expressed concerns about its toxicity. The new multiple myeloma drug, called selinexor, will be marketed by Karyopharm Therapeutics under the brand name Xpovio. The FDA cleared Xpovio under an accelerated, or conditional, approval based on a single-arm clinical trial showing a 25% tumor response rate. (Feuerstein, 7/3)
