On drug safety, the public puts its trust in the F.D.A. which frequently drops the ball. The public would be better off adopting caveat emptor, and seeking private means of assurance of safety. These would include certification (stamps of approval) from private organizations like the United States Pharmacopeial Convention (USP).
They might also choose to buy well-known name brands, since a well-known brand has more reputation capital to lose if they produce a bad batch, and thus can be expected to invest more in quality control. (Lester Telser made this argument–I need to seek where.)
(p. A10) A highly drug-resistant bacteria that was linked to eyedrops imported from India and that spread from person to person in a Connecticut long-term care center has prompted concerns that the strain could gain a foothold in U.S. health care settings, according to the Centers for Disease Control and Prevention.
. . .
The outbreak has renewed longstanding concerns about the quality and frequency of the F.D.A.’s overseas inspections.
In June 2020, Senator Chuck Grassley, Republican of Iowa, held an oversight hearing on the F.D.A.’s foreign inspection process, noting that the plants were given 12 weeks’ advance notice, “plenty of time to doctor up a facility to make sure that it passes inspection.” The agency has since received budget authority to conduct unannounced overseas inspections.
. . .
The F.D.A. paused overseas inspections during the height of the coronavirus pandemic, and the number of foreign inspections remained low last year, at 684 compared with 3,272 in 2019, according to agency data.
The F.D.A. has 4,000 overseas facilities to inspect, with about 20 percent in India; one of its six inspector positions in that country was vacant in late 2021, according to a report issued last year by the Government Accountability Office.
For over-the-counter drugs, the F.D.A. uses a system that essentially lists a medication recipe. Companies can make the products without express agency approval but are expected to follow agency rules for manufacturing quality products, said John Serio, a lawyer with Withers who has pharmaceutical clients.
“If you’re not out there inspecting facilities,” Mr. Serio said, “these sorts of problems will crop up because there’s no threat that if you’re out of compliance that the inspector will come knocking at your door.”
For the full story see:
(Note: ellipses added.)
(Note: the online version of the story has the same date as the print version, and has the title “Drug-Resistant Bacteria Tied to Eyedrops Can Spread Person to Person.”)
The F.D.A.’s lax inspections of generic drugs made in India is documented in:
Eban, Katherine. Bottle of Lies: The Inside Story of the Generic Drug Boom. New York: Ecco, 2019.