Getting back to this thread on pharma and its production overseas where environmental standards are laxer than here in the States, WaPo has a report on the valiant efforts of a tiny pharmacy named Valisure to ensure the drugs it dispenses to customers are actually what they’re ordering.
The pharmacy, Valisure, is a start-up with only 14 full-time employees. But since its scientists alerted American regulators that Zantac and its generic form, ranitidine, contained a chemical thought to cause cancer, more than 40 countries from Australia to Vietnam have either stopped sales, launched investigations or otherwise stepped in to protect consumers from possible health risks.
In the United States, the Food and Drug Administration this month confirmed unacceptable levels of the chemical, N-nitrosodimethylamine (NDMA), in some ranitidine products — including in some syrups taken by babies. FDA officials have urged people not to panic, because the levels of NDMA are similar to the amount found in grilled and smoked meats. The agency is still investigating and asking companies to recall ranitidine and a similar drug, nizatidine, if they discover unacceptable amounts of NDMA. The agency’s testing suggests Pepcid, Tagamet, Nexium, Prevacid and Prilosec do not contain the chemical.
The item catching my eye was this:
For Valisure’s scientists, finding NDMA in ranitidine was a particularly dramatic example of the kind of discovery they make routinely. Valisure checks the chemical makeup of drugs before it ships them to consumers, and rejects more than 10 percent of the batches because their tests detect contaminants, medicine that didn’t dissolve properly or pills that contain the wrong dose, among other issues. Since late 2018, Valisure has reported more than 50 problems directly to drug companies. Occasionally — as in the case of Zantac — their scientists find a problem so urgent they play the role of watchdog.
Yeow! 10% is way more than I want to hear, now that I’ve become old, decrepit, and dependent on the health system to stay upright and pretend to be vital. But connecting to this thread is this:
Much of the concern over the quality and safety of the drug supply has been propelled by a massive movement of drug production to foreign factories in recent years, “driven by the pharmaceutical industry’s desire for cost savings and less stringent environmental regulations,” Woodcock said in testimony submitted to Congress in October.
The FDA rigorously evaluates drugs for effectiveness and safety before approval, including visits by inspectors, who review records to ensure compliance with requirements — including that companies test batches of medicine before distributing them, Kahn said.
A 2016 Government Accountability Office report found that almost a third of 3,000 foreign drug establishments licensed by the FDA may never have been inspected, although the FDA said it has now caught up on the backlog.
Sen. Charles E. Grassley (R-Iowa), has sent letters to the FDA questioning the adequacy of its foreign drug inspection program.
It sounds like neglect of product safety in favor of profits to me. So how to punish companies who are single source suppliers of drugs that many consider critical to their life styles, and sometimes even lives?
I suppose you could hang Forfeit of patent over the heads of the pharma company, although it’s a bit of a buzzkill for those who develop drugs for profit. Would it work? I’m not sure.
