https://www.propublica.org/article/fda-generic-drug-equivalents-tacrolimus>The FDA approved the first generic version of tacrolimus that same year. In May 2010, one made by an Indian generics company called Dr. Reddy’s was approved. The next year, so was one made by another Indian company called Intas, whose U.S. brand is called Accord.>In all, six generics were greenlit before the FDA reversed course and decided in 2012 that tacrolimus should, after all, be made under tighter criteria. But the rule applied only to companies newly approved to sell a generic version of tacrolimus. The agency did not require Dr. Reddy’s, Accord and the others already on the market to meet the new standard. The agency stated later in a public filing that it doesn’t retroactively apply new standards to existing products.>Almost from the beginning, some transplant doctors had raised concerns that patients on Dr. Reddy’s tacrolimus were faring worse than those on other generics. The Cleveland Clinic was so alarmed that it banned Dr. Reddy’s generic for its transplant patients in 2013. Later, at the Tulane Transplant Institute, doctors found that patients taking generic tacrolimus by any drugmaker had a higher chance of organ rejection, and the hospital decided to use only the brand drug.>At Inova, Cochrane had noticed irregular fluctuations in patients taking Dr. Reddy’s as well as early signs of organ rejection. “Omg! … Another [patient], victim of Dr Reddy,” an Inova nurse wrote in a 2019 email obtained by ProPublica.>Holly knew none of this when she picked up her daughter’s tacrolimus at the local Kroger grocery store after Hannah’s discharge in the fall of 2019. (Kroger didn’t respond to requests for comment.) Unlike with Hannah’s medical care, where Holly could research and choose a doctor or hospital, the brand of generic tacrolimus Hannah received was out of her hands. She would get whichever one that pharmacy happened to have in stock.
