FDA

Donald Trump Announces Approval for Convalescent Plasma to Treat Coronavirus

President Donald Trump on Sunday announced that the Federal Food and Drug Administration (FDA) had approved the use of convalescent plasma to treat coronavirus for emergency use. The president spoke about the approved treatment during a White House press conference on Sunday evening. “This is a powerful therapy that transfuses very, very strong antibodies from the blood of recovered patients to help treat patients battling a current infection,” Trump wrote. “It’s had an incredible rate of success.” The treatment takes convalescent plasma from blood donated from patients that have recovered from coronavirus. Under current FDA guidelines, convalescent plasma is regulated as an “investigative product.” “We broke the logjam over the last week,” Trump said when asked about the difficulty getting the treatment approved for emergency use by the FDA. The president thanked FDA administrator, Dr. Steven Hahn, for helping lead the project. “It is only made possible because of Operation Warp Speed. That is, everybody working together,” Trump said referring to his administration’s effort to speed treatments and vaccines for coronavirus. Trump said that approvals were years ahead of schedule and previewed exciting news about vaccines in the upcoming days. “We are removing unnecessary barriers and delays, not by cutting corners, but by marshaling the full power of the federal government,” he said. Hahn said that the expanded access program for convalescent plasma was started at the Mayo Clinic in April and over 70,000 people had received treatment. “This is one of the largest expanded access programs in the history of FDA, so a very successful approach to evaluating how convalescent plasma would work,” he said. Hahn said that the scientists at the FDA evaluated both the data from the program and over a dozen published studies before approving the treatment. In a June 3 article, the JAMA network outlined the history of the use of convalescent plasma dating as far back as the Spanish Flu epidemic and identified the treatment as a potential route to coronavirus containment. A later study published by the JAMA Network, however, concluded that the use of convalescent plasma as a treatment is less effective in severe coronavirus cases. “In the optimal patients, as described by Secretary Azar, treated with convalescent plasma at the highest tiers there was a 35 percent improvement in survival,” Hahn said. Hahn said that the FDA would continue evaluating the data and study the emergency use of the treatment. “We’re waiting for more data, and we’re going to continue gathering more data, but this clearly meets the criteria we’ve established for the emergency use authorization and we’re very pleased with these results,” he said. Hahn said that everyone recovering from the Covid-19 should act to donate their blood. “If you’ve recovered from Covid-19, please donate, you could save a life,” he said.

For more from the FDA, click on the text above.

FDA to ban all e-cig flavors except menthol and tobacco, report says

The Food and Drug Administration plans to ban the sale of fruity flavors in cartridge-based e-cigarettes, but the restriction won’t apply to tank vaping systems commonly found at vape shops, according to people familiar with the matter. The action is seen as a compromise between Trump administration officials who want to address a rise in teen vaping and those concerned about the impact on small businesses and the possible political fallout for President Trump, these people said. Polls commissioned by the vaping industry have shown an outright ban would be unpopular in key states for the 2020 election. Federal officials are expected to announce the new plan as soon as Friday. Open-tank vaping devices, which allow users to mix their own nicotine liquids, aren’t popular among children or teenagers, who tend to use vaporizers with prefilled cartridges such as those made by Juul Labs Inc. Open tanks are typically found in vape shops and allow consumers to custom-mix flavors. The new policy, intended to curb a surge in underage vaping, would apply only to pod-based vaporizers such as those made by Juul, NJOY Holdings Inc. and Reynolds American Inc. It would pull from the market all e-cigarette refill pods except those formulated to taste like tobacco or menthol, the people said, dealing a blow to an industry estimated to have $9 billion in annual revenue. The sweet and fruity flavors that would be banned under the new policy represented about 80 percent of retail-store e-cigarette sales in 2019, according to analyst estimates.

We all saw this coming for months.  To be clear, the new regulations were put in the 2020 budget by the Dem-controlled House as part of a compromise with the Administration.  For that, they agreed to fund Trump’s border wall, increase the DoD budget, create Trumps “Space Force,” and a host of other priorities for the Administration.  And, in election year, those are priorities which Trump can claim as promises kept.  For more, click on the text above..

Beer brewers push back against proposed FDA rule restricting use of old grains

Beer brewers push back against proposed FDA rule restricting use of old grains

The FDA has become much like the EPA and ATF; a bunch of thugs out to make life more difficult and costly for everyone.  This proposed rule by the FDA just shows how clueless that large, bureaucratic federal agency is.  If this gets implemented, the cost of beer will skyrocket.  Again, we-the-taxpayers are left holding the bag imposed on us by big government.