Morning Briefing
Summaries of health policy coverage from major news organizations
FDA Clears Way For Sale Of Gene-Edited Beef
AP: Gene-Edited Beef Cattle Get Regulatory Clearance In US
U.S. regulators on Monday cleared the way for the sale of beef from gene-edited cattle in coming years after the Food and Drug Administration concluded the animals do not raise any safety concerns. The cattle by Recombinetics are the third genetically altered animals given the green light for human consumption in the U.S. after salmon and pigs. Many other foods already are made with genetically modified ingredients from crops like soybeans and corn. (Choi, 3/7)
In related news about genetically altered food —
New Food Magazine: New Gene Editing Techniques – Savior Or Nemesis?
There are few food-related areas of discussion more emotive than that of genetically modified organisms (GMOs). Public debate often takes place at the extremes of the argument, where combatants on both sides are accused of playing fast and loose with the future of the planet and strong opinions are held on the morality of use, the independence of any research and the exact nature of any benefits or potential risks .It is now 27 years since the US Food and Drug Administration (FDA) approved the first GMO food (the Flavr Savr tomato, modified to slow the ripening process and thus extend shelf life), but consumer surveys still suggest there is public unease with genetic modification globally, differentiated only by degrees of distrust. (McNamara, 3/3)
Genetic Literacy Project: Latin America’s Embrace Of Gene Editing Positions Americas To Become The Global Leader In Agricultural Innovation
Over the 25 years since the introduction of GM crops in Latin America, the continent has been a battleground between proponents of biotechnology versus groups, mostly agrarian activists funded by global environmental technology skeptics in North America and Europe. Faced with these competing lobbying forces, a sharp divide has evolved across the Americas. There are countries with restrictive regulatory frameworks regarding GMOs that even today make their adoption unlikely—such as in Peru, Ecuador, and Mexico. In contrast, Brazil and Argentina have taken a totally different approach allowing, deliberately, and fervently embracing biotech innovation, and transforming South America into a global leader in GM crop production. These same countries are now embracing advancing the latest cutting-edge genetic engineering tools, CRISPR, and other forms of gene editing. (Ventura, 3/8)
In other news about the FDA —
Stat: Key Democrat Moves To Crack Down On FDA Accelerated Approvals
A powerful Democratic lawmaker has introduced a bill that would dramatically rein in the Food and Drug Administration’s so-called accelerated approval program. Under accelerated approval, the FDA can approve drugs without clear evidence that they actually prolong patients’ lives, so long as drug companies complete follow-up studies and demonstrate that the therapies actually do have a “clinical benefit.” The bill, which was introduced Monday by the chairman of a key health panel, Rep. Frank Pallone (D-N.J.), would make it easier for the FDA to crack down on drug companies that do not complete those follow-up studies. (Florko, 3/7)
Stat: FDA Failed To Improve Clinical Trial Diversity For Black Patients
Six years ago, the U.S. Food and Drug Administration launched a five-year action plan to improve the diversity and transparency of pivotal clinical trials for newly approved medicines. But a new analysis finds the effort failed to make a difference for Black patients, whose participation in clinical trials remained inadequate. Specifically, Black people accounted for just one-third of the required enrollment for adequate representation, regardless of whether the trials started before, during, or after the FDA plan went into effect. Of 225 drug approvals for which mortality and morbidity information was listed on the FDA plan website, only 20% had data showing benefits and side effects for Black patients, according to the analysis, which was published in Health Affairs. (Silverman, 3/7)
