The US boasted faster review times for drug applications over the past decade compared to those in the EU and Switzerland, according to a new paper published Monday in the Annals of Internal Medicine.

The researchers assessed the length of regulatory review times for both primary and supplemental indications in the US and Europe between 2011 and 2020 as well as differences in submission times during that period. The researchers found that overall, the median review time, from submission to approval, was 39 weeks (about nine months) in the US compared with 44 weeks (about 10 months) in the EU and Switzerland.

The FDA’s PDUFA VII deal established that FDA must review and and act on 90% of standard applications within 10 months of the 60-day filing date, whereas for expedited submissions, FDA is tasked with completing 90% within six months. The EMA says its reviews typically take about one year, with the review clock stopped at various points in the process.

The Annals researchers accounted for “clock stop” periods in application reviews, during which the respective agency is not actively reviewing the application while it awaits responses to questions from the applicant. Overall, the EMA was 29% slower, and Swissmedic was 39% slower than the FDA, but excluding the clock stop period, the agencies were 6% slower and 7% slower than the FDA, respectively.

The paper underscores that minimizing the differences in review times between the US and Europe will help increase patient access to needed drugs.

Kerstin Vokinger, a professor of law and medicine at the University of Zurich and the lead author of the paper, told Endpoints News that manufacturers should try and submit their applications to different agencies at the same time or as close as possible to each other. She said this will help patients receive equal and quick access to new drugs.

Regulators have also begun further collaborations to review cancer drug applications in parallel, including via FDA’s Project Orbis, with Swissmedic, Health Canada, Australia’s TGA and others.

Vokinger said these agencies should work more on parallel review of drug applications.

The paper emphasizes that in the 1980s, the US focused on speeding up review times in response to concerns that it was lagging behind the EU. Since then, the FDA made strides in establishing expedited review programs, like the accelerated approval pathway and priority review, to speed up review times.

“Faster is not always better — drugs with high therapeutic value should be prioritized in the review process,” she said. “But accelerated approval should be applied cautiously.”

For review times within each drug, the EMA took a median of 3.9 weeks longer to review applications than the FDA, while Swissmedic took a median of 0.3 weeks longer.

Review times for secondary indications were faster across the board, but the US was still faster than the EU in that area.

Further, the paper reveals that applications in the EU were submitted about 1.3 weeks later than than they were in the US, and in Switzerland, they were submitted about 17.9 weeks later than in the US.

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It is 2023, eight years after 2015, the year of flying cars and climate-controlled clothing that Marty McFly traveled to in a time machine. In our own world, the ruling elite wants to ban cars to control the climate. How did we get here? What caused the discrepancy between our vision of a more advanced future and the reality we face now?

We had reason to expect it. From 1860–1970, the United States grew at an average of over 5 percent per year. But starting in the 1970s, and for the last five decades since then, America has experienced an average GDP growth rate of 2.7 percent. Had the previous growth rate continued, the economy would be at least 65 percent larger than it is today. The current GDP would be an additional $15 trillion, or $45,000 per capita.

The gap in unrealized potential is massive and accounts for the discrepancy between our past visions of the future and our current reality. If people knew about the future that was stolen from them, they would be outraged. The loss of a potential that was never known usually cannot affect people, but there is a growing sense that something doesn’t add up.

In the new reality of anemic growth, a strange mix of cutting-edge technology and crumbling infrastructure is emerging. This is mirrored in contemporary science fiction, which is more likely to depict a dystopian future than one like that envisioned by The Jetsons or a Jules Verne novel. How did this happen? What sent us so wildly off the path set by previous achievements?

There is a common political narrative that the “laissez-faire” push to deregulate and cut taxes under Reagan in the 1980s resulted in a consolidation of wealth and corporate power that led to our current malaise. The main problem with this narrative is that there was no recent laissez-faire moment. Regulation and public spending continued to increase through the 1980s. When the government couldn’t raise taxes high enough to keep up with spending, it just inflated the money supply, a strategy that became easier when the gold standard was fully abandoned in 1971.

Starting in the late 1960s, the number of pages published in the Federal Register exploded (figure 1). The number of pages of the Code of Federal Regulations, which is thought to reflect the overall regulatory burden, has increased by a factor of 10, from twenty thousand to over two hundred thousand pages (figure 2).

Figure 1: Total pages published in the Federal Register (1936–2022)

Source: Regulatory Studies Center.

Figure 2: Total pages published in the Code of Federal Regulations (1950–2021)

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Source: Regulatory Studies Center.

The longest period of low growth in our history is also characterized by the expansion of the regulatory state. Corporate consolidation skyrocketed in the same period. In 1970, the top four companies in any given industry made up on average 20 percent of the market share. Today, the top four companies in any given industry control roughly 80 percent. Regulatory monopolies create single points from which special interests can control whole markets and enrich the wealthiest people. They are fully endorsed by the elite institutions yet sold through the pretense of keeping vulnerable consumers safe from asymmetries of power.

People who legitimately care about the poor or the environment should not support these federal agencies. The viewpoint that regulations lead to improved standards puts the cart before the horse. If the US regulation of the maximum amount of pesticide residue allowed on produce were imposed on a developing country, that country’s agricultural production would be wiped out overnight.

Reducing the use of chemicals, when done correctly, saves resources and improves soil quality and yield, but it also requires a great deal of knowledge and technology. Without being able to know exactly when insects will arrive, it may be necessary to spray every day for weeks to minimize the chance of catastrophic failure. Without knowing how to implement a system of crop rotation correctly, the soil will likely degrade over time. Without testing, mapping out, and integrating the soil into the tractor’s spray system, it won’t be possible to limit fertilizer use to the areas that need it.

The regulatory strictness of a country tends to vary directly with its level of economic development because mandates require infrastructure. Eventually, tractor components that can identify and kill weeds with an electric current will largely eliminate the demand for herbicides. A law will then be passed, with much self-congratulation, that bans herbicides, reinforcing the advantages of the bigger players and creating new barriers for the smaller.

Mining deaths dropped dramatically with the advent of electrical lighting and ventilation technology. The decline was not affected in any observable way after the creation of the Occupational Safety and Health Administration (OSHA) because the government only legally codifies standards after the relevant technology and knowledge has entered the market. They do, however, take credit for the improvement and write the standards in a way that favors the specific practice of a particular industry association or corporate cartel.

This preference often takes the form of regulations that favor scale, which is why local food supplies have shrunk while centralized supply chains run by a few companies have come to dominate the market. It is ironic that regulators claim to be protecting consumers: surveys show that 96 percent of consumers think locally produced food is “the freshest, healthiest and most nutritious food.”

Regulatory restrictions slow the rate of innovation by creating barriers to market entry but also by protecting corporations that operate within the confines of the regulatory standards from legal liability for harming consumers or the environment.

Regulatory capture was described by Lao Tzu 2,500 years ago in China. “In the kingdom the multiplication of prohibitive enactments increases the poverty of the people” and “the more display there is of legislation, the more thieves and robbers there are.” Such policies drastically increase income inequality, not to keep you safe but so that special interests can bring back mercantilism by controlling markets as guilds once did. The resulting lack of options facilitates technocratic control of society. Nothing would hurt the average billionaire more than to see the average American stop falling for this ruse.

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