Sep 13, 2019

Concerns rise about generic drugs from overseas

Illustration: Aïda Amer/Axios

The FDA is inspecting fewer overseas drugmakers as it simultaneously increases the number of generic drug approvals, contributing to concerns about the safety of our generic drug supply, Bloomberg Businessweek reports.

Why it matters: 90% of drugs sold in the U.S. are generics, and 80% of the active ingredients are produced abroad. The FDA inspects less than 1% of drugs before letting them come into the country.

  • This weak quality-control system led to last year's announcement that a carcinogen had been found in a popular blood-pressure medicine, prompting a massive FDA recall.

The big picture: "Where the FDA's drug approval process is founded on testing and more testing, the regulatory system for generics is built on trust, specifically trust in manufacturers," Bloomberg writes.

  • "[The global system is] designed to, above all, make and distribute drugs in a cost-efficient manner. It usually functions beyond view. Until there’s trouble."

Go deeper: Some seniors pay more for generic drugs than brands

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Generic prescription drugs are sometimes inaccessible to seniors

Illustration: Rebecca Zisser/Axios

Plans providing Medicare's prescription drug benefit are often slow to cover the first generic competition to a branded medication, according to a new white paper by the Association for Accessible Medicines, which represents generics.

Why it matters: Generics are our system's way of keeping drug prices in check. But this doesn't happen unless patients have access to them.

Go deeperArrowSep 24, 2019

Trump's smoke-and-mirrors 2020 health care strategy

Illustration: Sarah Grillo/Axios

President Trump may be telling voters everything that they want to hear when it comes to health care, but much of it isn't true.

Why it matters: Trump is claiming victories he hasn't achieved and making promises he's not prepared to live up to, all on an immensely personal subject that voters consistently rank as one of the most important issues of 2020.

The world's first drug made for only one patient

The first ultra-personalized drug — made for one patient, the only one who will ever take it — is raising all kinds of new questions about how to handle a scenario that's likely to only become more common, the New York Times reports.

Driving the news: The drug, described yesterday in the New England Journal of Medicine, treats the neurological disorder of an 8-year-old girl.

Go deeperArrowOct 10, 2019