March 2, 2024

There are many vital drugs to do now. Here’s Why. : ScienceAlert

Public fear in the past exorbitant drug prices have recently given way to a more insidious problem – without drugs at any price.

Patients and their providers are facing more limited or non-existent drug suppliesmany of which treat essential conditions such as cancer, heart disease and bacterial infections.

Now the American Association of Health System Pharmacists over 300 active shortages are listedmainly twenty- or thirty-year-old generic drugs that are no longer protected by patents.

Although this is not a new problem, the number of drugs in short supply has increased in recent years, and the average shortage is lasting longer, with more than 15 critical drug products. shortage for over ten years.

Current shortage include widely known drugs such as the antibiotic amoxicillin; the heart medicine digoxin; the anesthetic lidocaine; and the medicine albuterol, which is essential for treating asthma and other diseases that affect the lungs and airways.

What to expect?

I am a health economist who has studied the pharmaceutical industry for the past 15 years. I believe the problem of drug shortages shows a major flaw in capitalism.

While expensive brand-name drugs often bring high profits to manufacturers, there is little money to be made in providing low-cost generics to the market, no matter how critical they are to patient health.

A generic problem

The problem has to do with the nature of the pharmaceutical industry and how differently the markets work for brand and generic drugs. Perhaps the clearest indication of this is the fact that the prices of brand name drugs in the United States are among the highest in the developed world, although generic drug prices are among the lowest.

When a druggist develops a new pill, cream or solution, the government grants the company an exclusive patent for up to 20 years, although most patents are filed before clinical testing, so the effective patent life is closer to eight to 12 years.

However, patents allow drug makers to cover the cost of research and development and earn a profit without the threat of competition from rivals making an identical product.

But when the patent expires, the drug becomes generic and any company is allowed to manufacture it. Since generic manufacturers are producing essentially the same product, profits are determined by their ability to manufacture the drug at the lowest marginal cost.

This often results in low profit margins and can lead to cost-cutting measures that can compromise quality and threaten supply.

Outsourced production creates more supply risks

One of the consequences of tight margins is that drug companies outsource production to lower-cost countries.

As of mid-2019, 72% of manufacturing facilities were making active ingredients for drugs sold in the US located abroadwith India and China alone making up almost half of that.

Although manufacturers are often abroad enjoy significant cost advantages beyond US facilities, such as easy access to raw materials and lower labor costs, outsourcing production on such a scale raises many issues that could harm supply.

Foreign factories are more difficult don Food and Drug Administration to inspectthey experience more production problems and are much more likely to shut down domestic factories when a problem is discovered.

In testimony to a House subcommitteeJanet Woodcock, the FDA’s chief deputy commissioner, acknowledged that the agency does not have much information about which Chinese facilities are producing raw materials, how much they are producing, or where the ingredients they are producing are being distributed around the world.

The COVID-19 pandemic has highlighted the country’s dependence on foreign suppliers—and the risks this poses to U.S. consumers.

India is the world’s largest producer of generic drugs but imports 70% of its raw materials from China. About one third of the factories in China closed down during the pandemic. To ensure domestic supplies, the Indian government restricted the export of medicines, disrupt the global supply chain.

This has led to a shortage of drugs to treat COVID-19, such as respiratory failure and sedation, and for a wide range of other conditions. like treating chemotherapy drugsheart disease and bacterial infections.

Low quality hurts profits

Manufacturing drugs to consistent quality standards requires continuous testing and evaluation.

A company selling a new, expensive branded drug has a strong profit motive to keep quality and production high. This is often not the case for generic drug manufacturers, and this could lead to shortages.

In 2008, a poor version of the blood thinning drug Heparin recalled worldwide has been linked to 350 adverse events and 150 deaths in the US alone.

In 2013, the Department of Justice the US subsidiary of Ranbaxy Laboratories was finedIndia’s largest generic drug manufacturer, US$500 million after pleading guilty to civil and criminal charges related to drug safety and falsifying safety data.

In response, the FDA banned products made at four of the company’s manufacturing facilities in India from entering the United States, including generic versions of gabapentinwhich treats epilepsy and nerve pain, and the antibiotic ciprofloxacin.

And while multiple companies may sell the same generic drug in the US, only one manufacturer may be supplying the basic ingredients. Therefore, any interruption in production or shutdown due to quality issues can affect the entire market.

A recent analysis found that about 40% of generic drugs were sold in the US only one manufacturerand the share of markets supplied by one or two manufacturers has increased over time.

Repatriate the drug supply

The impact of drug shortages on population health is difficult to quantify. However, a recent survey of US hospitals, pharmacists and other health care providers found that drug shortages medication errors increaseddelayed administration of rescue therapies, lower outcomes and patient deaths.

What can be done?

One option is to find ways to produce more generic drugs in the US

California passed a law in 2020 to do so by allowing the state to contract with domestic manufacturers to produce its own generic prescription drugs. In March 2023, California choose a Utah company begin producing low-cost insulin for California patients.

Not sure if this approach is feasible on a wider scale, but, in my opinion, it’s a good first attempt at repatriating America’s drug supply.

Geoffrey JoyceDirector of Health Policy, USC Schaeffer Center, and Associate Professor, University of Southern California

This article is republished from The conversation under a Creative Commons license. Read the original article.

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