> For the complete documentation index, see [llms.txt](https://why.dfda.earth/llms.txt). Markdown versions of documentation pages are available by appending `.md` to page URLs; this page is available as [Markdown](https://why.dfda.earth/1-introduction-and-challenges/deaths-due-to-us-regulatory-drug-lag.md).

# Deaths Due to US Regulatory "Drug Lag"

**Delayed Life-Saving Treatments**

One unanticipated consequence of the amendments was that the new burden of proof made the process of drug development both more expensive and much longer, leading to increasing drug prices and a “drug lag”. After that point, whenever they released some new cancer or heart medication that would save 50 thousand lives a year, it meant that over the previous ten years of trials, 500 people died because they didn't have access to the drug earlier.

**Deaths Due to US Regulatory "Drug Lag"**

A comparative analysis between countries suggests that delays in new interventions cost anywhere from [21,000 to 120, 000](https://www.fdareview.org/features/references/#gieringer85) US lives per decade.

Deaths owing to drug lag have been numbered in the [hundreds of thousands](https://www.fdareview.org/features/references/#wardell78a). It's estimated that practolol, a drug in the beta-blocking family, could save ten thousand lives a year, if allowed in the United States. Although the FDA allowed the first beta-blocker, propranolol, in 1968, three years after that drug had been available in Europe, it waited until 1978 to allow propranolol to treat hypertension and angina pectoris, its most essential indications. Despite clinical evidence as early as 1974, only in 1981 did the FDA allow a second beta-blocker, timolol, to prevent a second heart attack. The agency’s withholding of beta-blockers was alone responsible for probably [tens of thousands of deaths](https://www.fdareview.org/features/references/#gieringer85).

[Data](http://csdd.tufts.edu/databases) from the Tufts Center for the Study of Drug Development suggests that thousands of patients have died because of US regulatory delays relative to other countries, for new drugs and devices, including:

* interleukin-2
* Taxotere
* vasoseal
* ancrod
* Glucophage
* navelbine
* Lamictal
* ethyol
* photofrin
* rilutek
* citicoline
* panorex
* Femara
* ProStar
* omnicath

Before US FDA approval, most of these drugs and devices had already been available in other countries for a year or longer.

Following the 1962 increase in US regulations, one can see a divergence from Switzerland's growth in life expectancy, which did not introduce the same delays to availability.

![US vs Swiss Life Expectancy](/files/cTM8gWRVBQtnGJpFVU0N)

Perhaps it's a coincidence, but you can see an increase in drug approvals in the '80s. At the same time, the gap between Switzerland and the US gets smaller. Then US approvals go back down in the '90s, and the gap expands again.

![US vs Swiss Life Expectancy](/files/Ib7Cm7dimw1tORyFOn7B)

***


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