cannabis regulation
Closing hemp loophole opens can of worms
Congress recently passed a law to crack down on cannabis, specifically products that rely on certain kinds of THC derived from hemp. That worries patients who rely on them for a host of conditions like chemotherapy-induced nausea, chronic pain, anxiety, insomnia, colitis, fibromyalgia, PTSD, and multiple sclerosis, Lev Facher writes.
Public health experts are increasingly worried about the widespread recreational use of cannabis products in an unregulated market, but those products also have come to play an important role in many health and wellness regimens. The ban includes many non-intoxicating CBD products.
Read more about how Congress created the difficult situation.
drug regulation
Letting politicos do career scientists' job
Decisions on whether to approve drugs typically are supposed to come from career FDA scientists who helped review the products.
But Lizzy Lawrence has learned that the process looked different for the first drug from a firm that received a Commissioner's National Priority Voucher. The voting members for that product did not include the review team. Instead, they were leaders from the top of the FDA, according to three agency sources.
The FDA has not announced the approval decisions for any of the voucher recipients, so it's not clear what the outcome was. But it opens the agency to accusations of allowing politics to enter into scientific decisions. Two top Democratic lawmakers raised such worries in a letter to FDA Commissioner Marty Makary on Monday, launching a probe into the program.
Read more about the unusual vote.
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