There has been a steady drip, drip, drip of reports and regulatory actions for generic drug quality in recent years, with much of the focus on the dramatic growth of the Indian pharmaceutical industry since the turn of the century. Now, a new book from investigative journalist Katherine Eban, Bottle of Lies, combines these reports with on-the-ground reporting of the FDA investigators, the whistleblowers in India and elsewhere, and the worried US physicians and pharmacists over generic drug quality. The result is a damning indictment of the generics industry. While India bears the brunt of the concern, there are enough indications that generic drug quality is under duress regardless of its place of origin.
Now-retired FDA Commissioner Scott Gottlieb was proud of his agency’s ability to approve 1,021 Abbreviated New Drug Applications (ANDAs) in FY 2018, and if you read the agency’s Office of Generic Drugs summary of that year, you will see next to nothing about how well the agency combined the ANDA applications with on-the-ground inspections of the facilities for which the ANDAs were approved. One example: “The agency is committed to doing all we can, within our jurisdiction, to advance the critically important public health mission of providing the American public with more affordable medicines.” (To be fair, FDA increased its inspections in India by 18% in that year; but that was preceded by years of declining activity so that the increase only roughly matches the mid-2010s, while ANDA approvals have skyrocketed.)
Press reports from earlier this year, such as a Bloomberg report, “Culture of ‘Bending Rules’ in India Challenges U.S. Drug Agency,” note that FDA currently has all of eight inspectors for the country, trying to keep track of over 700 plants approved for exporting products to the US. In her book, Eban documents two troubling aspects of the Indian pharma industry that seem to be embedded in its very fiber: the philosophy of “jugaad,” a Hindi word loosely translated as “creative improvisation,” by which goals are achieved by any means necessary, including bending rules where possible; and so-called “multi-tier” manufacturing quality, where drugs are produced only to the quality levels necessary to pass inspection in the countries for which the drugs are exported. In other words, drug quality varies to the extent regulators pay attention to them.
Eban’s book appears at probably the worst possible time for a meaningful response to the picture it paints. The entire US pharma industry is under attack for its pricing policies, so who wants to question the quality of generics (now representing nearly 90% of all prescriptions) that keep drug costs down? And the White House’s casual approach to raising import tariffs, and canceling or contravening trade agreements, undercuts the efforts of an agency like FDA to properly police import quality.
Eban—remembered at Pharmaceutical Commerce and elsewhere as the writer who put a spotlight on drug counterfeiting in her 2005 work, Dangerous Doses—has written another compelling investigation of the pharma industry; the book is worth a read just to get a detailed picture of how the regulatory infrastructure is supposed to work. Perhaps its one oversight is to explore options or alternatives to the current situation, where readers could reasonably conclude to avoid using any drug imported from India (a next-to-impossible goal). There would seem to be few options, other than to hope that FDA can step up its inspections, and its reviews of adverse-event complaints—and good luck with that.
BOTTLE OF LIES: The Inside Story of the Generic Drug Boom by Katherine Eban (Ecco Hardcover; May 14, 2019; Price: $28.99; 512 pages; ISBN: 978-0062338785)