Another round of drug price increases, averaging more than 10 percent, made the news early this month.
So far in 2019, more than 3,400 drugs have boosted their prices, a 17 percent increase compared with the roughly 2,900 drug price hikes at the same time in 2018, reported Rx Savings Solutions, a consultant to health plans and employers.
Ah, but we tend to take solace in the increasing availability of lower-cost generics.
Our confidence is called into question by Katherine Eban’s “Bottle of Lies”, a 500-page book published in May that sent me checking the manufacturing source of my once-a-month prescription for osteoporosis.
The federal Food and Drug Administration earlier this year in a press release responding to reports of problems stated, “Generic drugs are just as safe and effective as their brand drug counterparts.”
The generics represented 90 percent of U.S. prescriptions dispensed in 2017, and the FDA approved or tentatively approved more than 2,000 generic drug applications in 2017 and 2018 alone, the agency reported in June.
Eban, a longtime investigative journalist and lecturer on pharmaceutical industry, raises questions about the oversight.
About 40 percent of generics are manufactured in India, while 80 percent of active ingredients of brand and generic drugs are produced in India and China, she wrote.
The problem: The push to cut costs is leading to shortcuts.
Congress, seeking less expensive drugs for Medicaid, Medicare part D, and federal employee/retiree insurance benefits, pressures the FDA to approve new drugs, generics and manufacturers more rapidly.
The FDA, for its part, tasked with assuring safe manufacturing, faces a challenge of finding qualified plant inspectors who understand the languages and can manage travel in difficult regions.
In her decadelong, four-continent research, Eban did find some willing and competent investigators who revealed fraudulent and manipulated data, circumvention of regulations, poor or non-existent controls, unsanitary conditions, destroyed records, improper formulas and inadequate dosages.
Qualified inspectors who reported serious deficiencies at plants, more than once saw the agency override or soften their recommendations, in part due to that pressure from Congress and even from non-profits. The latter, providing medications for AIDS, malaria control or other diseases in poor counties can make their money stretch further with less expensive generics.
Additionally, inadequate dosages, often sent to poor nations as in Africa, may be linked to worldwide antibiotic resistance. The less effective dose may kill off the weakest microbes but leave the strongest to reproduce and create a new generation capable of resisting even properly made medicine.
Eban writes that the FDA often announces its overseas inspections weeks in advance.
“These plants know that [the FDA inspectors are] coming,” Eban told NPR in a May interview. She discovered that some overseas drug companies would “... alter documents, shred them, invent them, in some cases even steaming them overnight to make them look old.”
The NPR interview included a statement from the FDA that it has “conducted a number of unannounced inspections” at foreign plants over the past several years.”
For consumers concerned about their generics, particularly those on long-term maintenance drugs, Eban suggested “Go into Google, put in the name of that company and check for a FDA ‘warning letter.’ What has the FDA found out about this company? Has this company had drug recalls? It is a bit of sleuthing, but if you’re taking this medication day in and day out, it’s worth it.”
By law, the active ingredient must be the same as the original drug, but generics may include different inactive ingredients such as preservatives or fillers. Trademark laws prevent generic drugs from looking just like the brand name drug, so the color and size may be different.
Of special interest to West Virginians are Eban’s references to Mylan NV in Morgantown and CEO Heather Bresch, “the glamorous, stiletto-heel wearing daughter of U.S. senator Joe Manchin.”
The author credits Bresch with a campaign to convince her colleagues and competitors to pay fees to the FDA for increased inspections to more effectively regulate the global industry.
But Mylan, too, later faced challenges. In March 2018, eight investigators scrutinized the plant after whistleblower allegations. Concerns of product contamination and possible cross-contamination between drugs led to a warning letter to the one-time industry model for generics.
Mylan has expanded worldwide, listing 36 countries in addition to the U.S. on its website. They range from Australia and Denmark, to India and Thailand.
Pharmaceutical-technology.com reported in April that Mylan was the world’s biggest generic pharmaceutical company in 2018 based on January to December revenues.
Both the Kanawha and Putnam libraries have copies of “Bottle of Lies.”