WASHINGTON — President Trump on Tuesday called on the Food and Drug Administration to speed the approval of drugs to treat life-threatening diseases, deriding the agency’s current process as “slow and burdensome.”
In an address to a joint session of Congress, Trump said that the FDA approval process “keeps too many advances … from reaching those in need.”
Do not relieve drug makers of the burden of proving their products are efffective and safe. Yes, thalidomide, also Framingham compounding lab. I do not want to be a test animal!
One word: Thalidomide
How much is safety and effectiveness worth ?
Approving Cempra’s solithromycin (an antibiotic) without requiring the extra financially burdensome safety studies the FDA asked for in December (the company just laid off about 67% of their personnel due to this unexpected demand) could be one of the very first “quick wins” that the Trump administration can rapidly accomplish.
For more info, see: “Cempra’s Solithromycin And The Great FDA Echo Chamber”, on Seeking Alpha. (An account is needed past the first page.)
So, you would rather the public complete the safety studies for Cempra by consuming an inadequately characterised drug? I would add that potential hepatotoxicity is not a trifling thing.