When Medicine Makes People Sicker
Written by Editor   
Tuesday, January 15, 2019 05:42 PM

Since the start of 2013, pharmaceutical companies based in the U.S. or abroad have recalled about 8,000 medicines, comprising billions of tablets, bottles, and vials that have entered the U.S. drug supply and made their way to patients' medicine cabinets, hospital supply closets, and IV drips. The recalls represent a fraction of the medicines shipped each year. But the flawed products contained everything from dangerous bacteria or tiny glass particles to mold -- or too much or too little of the drug's active ingredient.

Over the same period, 65 drug-making facilities recalled nearly 300 products within 12 months of passing a Food and Drug Administration inspection.  Those recalls included nearly 37,000 generic Abilify tablets that were "superpotent," and nearly 12,000 boxes of generic Aleve (naproxen) that were actually ibuprofen, according to the recall data.

Just how often people are sickened or die from tainted drugs is next to impossible to determine. No government agency tracks cases unless they're linked to a major outbreak among hospital patients. And sudden, seemingly random illnesses in disparate places are notoriously hard to link to a tainted drug. That’s in part because drugmakers don't have to divulge which products are made in which manufacturing plants, since that is regarded as proprietary information.  The result: Even someone who buys drugs for a major hospital can’t track down where a potentially dangerous product came from.

The FDA is supposed to inspect all factories, foreign and domestic, that produce drugs for the U.S. market. But inspectors miss serious hazards. Drugmakers fail to meet standards even after the FDA has taken enforcement action. Hundreds of plants haven't been inspected for years, if ever.

Plants making drugs for U.S. consumers are supposed to be inspected every few years, according to a risk-based system. However, in the past decade more than 2,500 facilities, both foreign and domestic, have gone more than five years without an FDA drug-quality inspection. The FDA has no drug-quality inspection records over the past decade for more than 1,200 domestic plants and nearly 400 foreign plants.

The FDA has issued thousands of enforcement actions against drug plants over the years, citing safety violations, issuing warning letters, and blocking imports from certain foreign plants. In rare cases, the FDA can also seize drug products and has done so 23 times in the past decade. The last drug seizure was more than two years ago, according to FDA records.

In an emailed statement, FDA chief Gottlieb said the FDA is "taking new steps" to identify problems before they occur and is "not shy" to use its powers to mitigate risks.

But the system can be stymied or gamed and the FDA's enforcement abilities are limited. For instance, it doesn't have the power to issue a mandatory recall, and manufacturing citations don't come with fines.

Many cases come to light only when a whistleblower sounds an alarm.  Since the FDA has little power to force a drugmaker to fix problems or issue recalls, FDA inspectors often flag the same violations again and again. Over the past decade 70 drug plants -- most of them domestic -- were penalized for the same violation at least four times. And more than a third of those plants has issued a recall at some point.

Because of lax labeling laws drug labels need to includeonly the manufacturer, the packer, or the distributor — not all three.  Often, drug manufacturers wouldn’t identify which drugs are made in which plant, or where they were packaged, making identifying sources of contamination difficult.


Source:  https://www.medpagetoday.com/publichealthpolicy/fdageneral/77311