“The Food and Drug Administration announced on Wednesday that it would ease regulatory roadblocks for low-cost copycat versions of certain medicines,” reports The New York Times:
Biosimilars, as the copycats are called, are seen as a crucial way to drive down drug prices. They are akin to generics of biologic drugs that are made through complex biological processes. Some well-known blockbuster drugs are now available as biosimilar competitors, including Herceptin, for breast cancer; Lantus, a widely used insulin; and Humira, for autoimmune conditions like arthritis.
The F.D.A. said it would advise drug developers that they generally no longer need to conduct expensive and time-consuming clinical trials aimed at showing that the copycat is just as effective as the original brand-name product. The agency also said it would push to make it easier for pharmacists to swap in biosimilars when dispensing a prescription, as is standard with generics…
The makers of biosimilars often spend several years and tens of millions of dollars conducting a clinical trial to show that its version is as effective as the original brand-name version. Under the F.D.A.’s proposed changes, developers would still have to show that their molecule and manufacturing process are similar.
Dr. Marty Makary, the F.D.A. commissioner, said at the news conference that the move would halve the current five- to eight-year timeline to win approval for a biosimilar. He said the changes would save biosimilar manufacturers tens of millions of dollars in development costs, saying that could be passed down in the form of lower costs for payers and patients.
The FDA can take many years to approve medical devices and drugs. The FDA didn’t approve a home test for HIV until 24 years after it first received an application. According to an FDA advisory committee, the test held “the potential to prevent the transmission of more than 4,000 new HIV infections in its first year of use alone.” That means thousands of people likely got infected with AIDS as a result of the delay in approving it. At least a hundred thousand people died waiting years for the FDA to approve beta blockers.
As we noted back in 2024, “The FDA restricts the functions on the Apple Watch, even though it saves lives by helping people diagnose and manage ailments. For example, the FDA bans the Apple Watch from warning users that they are experiencing atrial fibrillation, if users admit they have a history of atrial fibrillation.”
The FDA can be very slow. At least a hundred thousand people died waiting for the FDA to approve beta blockers. One of the FDA officials involved in delaying their approval was John Nestor. Nestor was notorious for following rules in ways designed to frustrate and inconvenience other people. As the Journal of American Physicians and Surgeons notes:
Nestor had the unique habit of getting into the leftmost lane [on the highway] with his cruise control set at 55 mph, the posted speed limit. He would drive at this speed regardless of what came up behind him. Cars would zoom up close to his rear bumper; drivers would flash their lights and blast their horns,some swerving around him on the right while giving him the finger—none of this fazed Nestor in the least. As he explained it, 55 mph was the law, and he had a right to drive in whichever lane he chose: “Why should I inconvenience myself for someone who wants to speed?”
Nestor followed this rigid mindset in his work at the FDA. He was very good at using agency red tape, and minor risks or side effects of drugs, as an excuse to avoid approving life-saving drugs.
