FDA Works On New Drug-Approval Rules
The Food and Drug Administration is urged to work up policies for drugs withdrawn after being deemed unsafe or ineffective. It also is working on new rules for approving old drugs in order to replace the unsuccessful Unapproved Drug Initiative.
Stat:
FDA Urged To Move Faster To List Medicines Withdrawn Over Safety Concerns
Arguing patient safety is at risk, an advocacy group is urging the Food and Drug Administration to create a new policy for updating an official list of medicines that are withdrawn after being deemed unsafe or ineffective. In a petition filed with the agency, Public Citizen noted that the FDA has, in most cases over the past two decades, taken “at least several years” to update this list. Meanwhile, patients could be potentially harmed by compounded formulations that physicians and pharmacists are legally permitted to make in the interim. (Silverman, 4/14)
KHN:
The FDA Seeks A New Way To Review Old Drugs Without Causing Prices To Soar
Chuck Peterson of Omaha, Nebraska, recently experienced a swollen, painful knuckle caused by arthritis. He got a prescription for colchicine. Doctors have used the drug for treating gout and other rheumatic conditions for well over two centuries. When Peterson went to the pharmacy, he was shocked to discover that a two-month supply of 120 pills, distributed by Par Pharmaceutical, would cost him $225 out-of-pocket on his Medicare Part D drug plan. Taking it for an additional three months, as his rheumatologist wanted him to do, would cost him nearly $600 under his drug plan. (Meyer, 4/15)
Health News Florida:
Federal Officials Design New Mask Guidelines To Better Protect More Workers
Federal officials announced new measures to help get fresh, new N95 masks to health care workers and expand their use in other industries after scientists argued that the highly protective masks are essential to keep workers safe from COVID-19. The changes come as U.S. mask-makers say the demand from hospitals is so sluggish that they’ve laid off 2,000 workers and fear some new protective gear companies could collapse. Yet in a letter to lawmakers, hospitals cite ongoing concerns about scarce supplies, saying limits on which workers should get N95s must stay in place. (Jewett, 4/14)
Al Jazeera:
Former World Leaders Urge Biden To Waive COVID Vaccine Patents
A group of more than 170 former world leaders and Nobel laureates is calling on United States President Joe Biden to make COVID-19 vaccines more readily available by waiving US intellectual property rules. In an open letter shared by Oxfam on Wednesday, the signatories also urged Biden to support a proposal spearheaded by South Africa and India demanding the World Trade Organization (WTO) temporarily waive COVID-19 vaccine patents. (4/14)
Yahoo News:
Biden's Top Intelligence Officials Won't Rule Out Lab Accident Theory For COVID-19 Origins
President Biden’s top intelligence chiefs have yet to determine how people first became infected with COVID-19, but they say they haven’t ruled out the possibility that it escaped from a lab in Wuhan, China. “It is absolutely accurate that the intelligence community does not know exactly where, when or how the COVID-19 virus was transmitted initially,” Director of National Intelligence Avril Haines told lawmakers Wednesday during a Senate Intelligence Committee hearing. (McLaughlin, 4/14)
