Inspections fail to halt flow of billions of doses of tainted and flawed drugs

dirtydrugs-300x143Even as Big Pharma launched the new year with yet another round of profiteering price hikes for prescription medications, a new investigation has uncovered how drug makers get away with nasty manufacturing practices, which, combined with lax oversight, send billions of doses of tainted products to market each year,  imperiling patients’ health.

Sydney Lupkin, writing for the independent, nonpartisan Kaiser Health News Service (KHN), has done the public a service in exposing the weak, irregular, and risky oversight of drug making by the federal Food and Drug Administration. This is a significant problem, Lupkin reported:

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, a Kaiser Health News investigation shows. 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…

The story explains that it is “impossible to determine,” the extent of harms, including deaths, that may be attributable to manufacturing problems with prescription medications. That’s because, unless multiple cases occur and affect, say, a big hospital or several of them, no official source even tries to track what can seem like small random occurrences in scattered area.

Oversight of drug making also is hampered by complex factors, including dense and confusing regulations, as well as Big Pharma claims that its processes, practices, and ingredients require proprietary protection.

Still, federal regulators, simply put, are falling down on their job, KHN found:

The FDA is supposed to inspect all factories, foreign and domestic, that produce drugs for the U.S. market. But a KHN review of thousands of FDA documents — inspection records, recalls, warning letters and lawsuits — offers insight into the ways poorly manufactured or contaminated drugs reach consumers: Inspectors miss serious hazards. Drug makers fail to meet standards even after the FDA has taken enforcement action. Hundreds of plants haven’t been inspected for years, if ever.

FDA inspectors lack the tools and the time to do little more too often than perfunctory checks at drug making plants, basically eyeballing some required paperwork provided by the manufacturers they are supposed to regulate. Inspectors too frequently announce their visits ahead of time, and they get shut out of facilities or parts of them when they arrive.

KHN found:

[I]n 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, excluding those that make animal drug products …

In my practice, I see not only the harms that patients suffer while seeking medical services, but also their struggles to afford and access safe, efficient, and excellent medical care. This is truer than ever as medical costs skyrocket and patients are staggered by ever-rising costs for what too often turn out to be harmful and dangerous drugs. It’s plenty bad to hear the Trump Administration bluster about how drug costs will be contained or lowered, but it’s worse to see that Big Pharma just waits a bit until inattentive officials look away — and, bam, here come yet more hard to explain and justify price increases on hundreds of medicines.

It’s not only galling but dangerous, then, to know that drug makers are pushing shoddy medications on the public, pushing as so many other manufacturers do dangerous and defective products. Lupkin’s story, by the way, details well the human toll that badly made drugs inflict on real people, for example, infecting babies and children with bacteria and wreaking havoc on their care.

FDA Commissioner Scott Gottlieb has pledged, at minimum, that his agency will catch up later this year on inspections of drug making plants. That isn’t good enough. As the KHN investigation found, the agency also lacks enforcement clout, so that, even if inspectors do their job right, scofflaws get warnings or other legal slaps on the wrist — and not much more.

The new Congress, which now includes a House full of Democrats who have vowed to look more after the interests of the public and less so of big business, including Big Pharma, has its work cut out for it, including ending a government shutdown that hits the FDA. As the new year advances, however, there’s some big and serious business for lawmakers to tackle in improving the oversight of the FDA, notably its inspection of drug making and efforts to figure how to slash outrageous Big Pharma prescription drug prices.

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