In mid-September the U.S. Food and Drug Administration received a 19-page document with some startling claims about a popular medicine. The online pharmacy Valisure, which tests prescription drugs before dispensing them, said it had found extremely high levels of a probable human carcinogen in the antacid ranitidine, best known under the brand name Zantac.  As for the carcinogen, NDMA, the FDA knew it well: For more than a year the agency had been recalling batches of the blood pressure medication valsartan because they were contaminated with it.

The FDA issued an alert, one that seemed to downplay Valisure’s findings. The agency said it had learned that some ranitidine medicines contained low levels of NDMA, but it wasn’t advising people to stop taking the drug. In fact, Valisure had found high levels of NDMA in every version of ranitidine it tested and concluded the problem was inherent to the molecule itself. In other words, if Valisure is correct, there is no safe version of ranitidine.

The muted quality of the FDA’s statement didn’t stop concern from going global. By mid-October, a month after the FDA’s alert, at least two dozen countries had pulled ranitidine from stores or halted its distribution. Numerous companies had acted on their own to slow or stop the supply of the drug. The FDA continued to conduct tests.

Finally, on Nov. 1, the agency announced that it had found higher-than-acceptable levels of NDMA in some ranitidine- though not nearly as high as Valisure detected. The FDA then deployed the strongest weapon available to it: The agency asked manufacturers to voluntarily recall some of the Zantac on the market.

At a time when a poorly policed global supply chain and demand for ever-cheaper generics have exposed drugs to new safety risks, an effective recall system is crucial. Spotting problems earlier is getting harder: From 2016 to 2018 the number of FDA inspections of drug manufacturers declined 10% overseas and 13% for domestic facilities, according to a recent report from the Government Accountability Office.

But the agency’s authority over this system is limited. It can only request a pullback – manufacturers can and do say no. It can’t contact patients directly; it relies on pharmacies for that. It doesn’t control how the recall is conducted or how its effectiveness is assessed.

Rosa DeLauro, in her role on the House committee that oversees the agency, has tried to give it more authority over recalls. She sponsored a bill that gave the FDA the power to order food recalls; it was signed into law by President Barack Obama in 2011. The agency also has recall power over manufacturers of vaccines, medical devices, infant formula, and tobacco products. As of last year, it can order a recall of opioids deemed dangerous. It can do all of that, but it can’t order a recall of any other prescription drug.

DeLauro tried to push a bill two years ago to change that.  The bill went nowhere. At least one reason was opposition to it from the trade group representing drug manufacturers. Now, after two high-profile recalls of common drugs have exposed flaws in the system, DeLauro plans to try again to give the FDA more clout.

When the federal government couldn’t make progress, states tried. The first was California, which, because of its size, can establish de facto national standards for industries. In 2004, California passed a law requiring electronic tracking of drugs all the way to the patient by 2009. The drug industry pushed back, saying the changes were technologically impossible to make that quickly. The deadline was extended to 2014. Nothing happened.

Then, in 2013, the industry preempted the California statute and its deadline by winning passage of a federal drug tracking law. The law created a uniform national system for electronically tracing pharmaceuticals from the manufacturer to the pharmacy’s back door. The industry was given 10 years – until November 2023 – to fully comply. Other countries trying to create tracking systems aren’t moving any faster, says Eric Marshall, executive director of a new industry governance group for implementation of the law.

The legislation exempts pharmacies completely. Even after the law goes into full effect, pharmacies won’t have to track which lots they sell to which customers. Nor will they be required to put lot numbers on labels. Some pharmacies do that now, and others don’t. One concern is patient privacy. To further complicate matters, high-volume pharmacies, such as mail-­order companies, mix pills from different lots. Pharmacies can also subdivide packages.