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Reasons of drugs in shortages in 2020 reported by University of Utah Drug Information Services (UUDIS)

A human right is realized when all persons have secure access to its object, to what this right is a right to.

States and particularly governments have a responsibility to make this happen principally by not taking measures that prevent such secure access. Governments currently award and enforce 20-year product patents on pharmaceuticals in accordance with the TRIPS Agreement they included in the 1995 founding treaty of the World Trade Organization. Patent enforcement involves preventing generic manufacturers from offering patented medicines at competitive prices. So protected from competition, patented medicines are often sold with exorbitant monopoly markups that effectively deprive many poor patients of access to them.

This is a critical time for pharmaceutical reform in the United States. The Biden administration introduced the Build Back Better Bill, which included several provisions to reduce prescription drug costs. But the fate of the bill is uncertain. Although these reforms have direct implications for the US healthcare system, their international impact is seldom appreciated. Given the global influence of the US drug market and increasing unaffordability of medicines worldwide, the stakes of pricing reform are high.

The US has the largest drug market in the world, estimated at over $48bn, over four times larger than the next country (China $88.3bn), and accounts for an estimated 46% of global pharmaceutical sales. The US is also the world's largest funder of biomedical research, so it is responsible for funding a substantial proportion of global medicine development. For this reason, many drug and biotechnology companies have a large presence in the country. But drug prices are so high in the US that companies typically earn enough to cover all global research and development costs associated with a new molecule. 3 These features combined-research and development and potential revenues-are a powerful incentive for manufacturers to prioritise admission into the US market.

PHILADELPHIA – Increasing patients’ out of pocket costs for HIV pre-exposure prophylaxis (PrEP), medications, which have been shown to dramatically reduce the risk of HIV infection, could lead to a significant reduction in PrEP use and a rise in HIV infection rates, according to a new study co-led by researchers at the Perelman School of Medicine at the University of Pennsylvania and Johns Hopkins Bloomberg School of Public Health.

The study, published today in the January issue of Health Affairs, was designed, in part, to explore the impact that out-of-pocket cost increases could have, depending on the outcome of an ongoing court case challenging certain provisions of the 2010 Affordable Care Act (ACA).

HIV is a threat to U.S. military interests for two principal reasons: the direct biomedical threat of, and the costs and consequences incurred by, infection to warfighters and the destabilizing effects that HIV may have on the sociopolitical systems of our strategic allies. MHRP has a multipronged strategy to counter these biomedical and sociopolitical threats posed by HIV.

Effective prevention of HIV infection is the cornerstone of the strategy, and MHRP has emerged as a leader in HIV vaccine research. Areas of research include both the development of effective vaccines and “passive vaccination” approaches with monoclonal antibodies to directly neutralize HIV before infection is established. MHRP also conducts research in acute HIV infection to deepen understanding of the early events of infection. Intervening in acute infection allows for the evaluation of strategies to vastly simplify treatment or even present the possibility of a functional cure, or treatment that effectively suppresses viral replication and blocks immune decline and forward transmission without the requirement for ongoing therapy. In addition to these product development initiatives, MHRP collects and analyzes data on HIV epidemiology and threat patterns, using domestic and international observational studies of both military and civilian populations to identify opportunities to mitigate the risk of HIV and other sexually transmitted infections.

Today, the world faces a fundamental dilemma in balancing the interests of patent owners, the public's right to health, and the beneficaries in the most need-the poor. Scientific and technological changes have accelerated and changed the way society approaches public health. Society cites the millennial idea that rapid changes are self-healing and assumes that such advancements immediately provide an "enhanced ability to overcome problems related to poverty and poor health."Is The globe has expanded its technological and economic potential, hoping to strike a balance between the rise of technology and finding a solution to the current health issues. The apparent upside of recent innovations are the associated new medicines and treatments that bear life-saving potential. The down-side, of course, is the high price tag of such innovations.

The reasons for lack of access to essential medicines are numerous and diverse. Available literature suggests that this issue is largely due to inadequate public expenditures, insufficient health coverage, deficient supply of essential medicines, and inflated drug prices.19 Other reasons include storage problems, substandard drug quality, inappropriate selection of drugs, inefficient use of drugs, and inadequate protection of the public's health.? Though, one argument not often discussed is the effect international patent protection may have on access to affordable medicines.21

To our knowledge, this study was the first to quantitatively explore whether research and development investments were associated with drug prices in the US. Research and development investments for the 60 new drugs examined did not explain variation in list prices, providing little support for arguments by pharmaceutical manufacturers that high drug prices are justified by high research and development costs. Although this empirical evaluation was limited by the number of drugs with available data, the findings were robust to the choice of covariates and the years of the price data (launch vs 2021). A small inverse association between research and development investments and treatment costs from 2021 was observed when generalized linear models were fitted, but this association disappeared in the parsimonious model in which correlated covariates were excluded. No association was found between research and development investments and treatment costs that were estimated using net prices for the subset of products for which net pricing data were available.

The lack of association between research and development investments and list prices of drugs was not unexpected, given that pharmaceutical firms aim to maximize profits based on consumers' willingness to pay. This study offers empirical evidence that, in the US, drug companies charge what the market will bear. The lack of association between research and development investments and list prices of drugs is, however, of major policy relevance because drug companies and their trade associations often claim that high drug prices are needed to recover research and development investments. If research and development costs justified drug prices, an association between the 2 variables would be found.

These policy changes have resulted in many negative effects, starting with monopoly pricing. In the drug industry, as with any industry, consolidation facilitates collusion. When a few companies control a market, it becomes easier to maintain an effective cartel because no member can step out of the agreement without being quickly detected by the others. The market for insulin may be a case in point. Since 2010, the three American manufacturers of the drug have all raised their prices by 168 percent, 169 percent, and 325 percent, respectively.

Even without forming cartels, monopolistic companies have a greater ability to raise prices because they don’t face the full pressure of a competitive market. Mylan Pharmaceuticals could raise the price of its Epipen by 450 percent precisely because it held about 90 percent of the market. And this applies to all kinds of drugs, branded and generic alike. Between 2010 and 2015, for instance, nearly a quarter of all generic drugs saw at least one price increase of 100 percent or more, and some saw increases of 1,000 percent or more.

Racial inequity penetrates every corner of the American health care system, and high prescription drug prices are no exception. Nearly 30 percent of individuals taking prescription medications struggle to afford the cost, with the burden most severely impacting those who make less than  a year and have medication costs over $100. These factors disproportionately impact American Indians and Alaska Natives, who are more likely to require medications for chronic health conditions, while simultaneously earning household median incomes nearly  less than white counterparts, resulting in reduced ability to pay at the pharmacy counter. In addition, many American Indians and Alaska Natives live in one of the  yet to implement Medicaid expansion, with people of color comprising  of individuals living in the coverage gap. 

“Structural racism has led to American Indians and Alaska Natives being disproportionately burdened by both high drug prices and wealth inequality in the United States,” said Protect Our Care Chair Leslie Dach. “It is unacceptable that millions of people can’t afford the drugs they need to survive. Bringing down the cost of drugs is an essential step in addressing racial inequities in health care. It’s time to put an end to Big Pharma’s greed and give Medicare the power to negotiate for lower drug prices.”

Drug corporations tout so-called patient assistance programs as a solution for people who cannot afford their drugs. But 97 percent of these programs exclude people who don’t have insurance. Why? Because these programs are really about selling more drugs at high prices; drug companies want to spend patient assistance money to cover patient copayments in order to leverage the much higher total insurance payment for a drug. Since Black Americans are almost twice as likely to be uninsured, these programs are frequently of no help to them. Those without insurance are often condemned to pay the high list prices set by drug corporations — not the discounted prices that insurers negotiate for their customers.

Yet, there is a more insidious and far-reaching impact of our drug pricing system in perpetrating systemic racism: We permit drug corporations to dictate whatever price they choose, and as a result, they extract an unearned and disproportionate share of the nation’s resources. For every dollar of taxpayer money we send to drug corporations in unwarranted profits through Medicare and other public programs, that is a dollar we don’t have to provide insurance coverage, improve nutrition, clean up water, increase funding for education, and generally support the steps that can lead to a healthier and higher quality of life for communities of color.

Americans spend more on prescription drugs than anyone else in the world. It’s true that they take a lot of pills. But what really has set the US apart is how much drugs cost. Unlike in most other countries, their prices are set without direct government intervention. A new law aims to change that for certain drugs for elderly and disabled patients who rely on the government’s Medicare health program. The pharmaceutical industry opposes the change, and the law faces a raft of lawsuits seeking to stop it from taking effect.

How US Prices Compare Internationally

Concerns over the prices of new medicines have been growing over the past decade. In the US, estimated net prices of newly launched prescription drugs increased from a median of around $1400 a year (£1200; €1300) in 2008 to over $150 000 a year in 2021.1 Onasemnogene abeparvovec (Zolgensma), a gene therapy approved by the US Food and Drug Administration in 2019 for spinal muscular atrophy, was at the time of approval the most expensive drug ever, with a price of over $2m for a single dose treatment.2 Several more recent drugs for rare diseases are priced even higher,3 with a gene therapy for haemophilia B approved by the FDA in November 2022 costing $3.5m per dose.4 But even old and common drugs have seen inexplicable price increases: in the US, the list price of some insulin products increased more than twofold from 2007 to 2018,5 while a US government report identified 1216 products that had seen prices rise above inflation between July 2021 and July 2022, with an average increase of 31.6%.6

Prescription drug prices in the United States are significantly higher than in other nations, with prices in the United States averaging 2.78 times those seen in 33 other nations, according to a new RAND report.

The gap between prices in the United States and other countries is even larger for brand-named drugs, with U.S. prices averaging 4.22 times those in comparison nations.

Changing the metrics for diagnosing a disease is one reliable technique. Dr. Adriane Fugh-Berman, associate professor of pharmacology and director of the industry watchdog group PharmedOut.org at Georgetown University School of Medicine, pointed to how the numbers used to diagnose diabetes and high cholesterol have been lowered over time. "The very numbers we use have been reduced to the point of absurdity," she said. "120/80 was considered normal blood pressure; now it's considered 'pre-hypertension.'"

Entirely new diseases can be, and have been, invented to extend a manufacturer's patent on a highly profitable drug. Fugh-Berman said Eli Lilly stood to lose a lot of profits once the patent expired on its hugely popular antidepressant Prozac. "So they positioned this new condition, PMDD (Pre-Menstrual Dysphoric Disorder), and then went to physicians and the FDA with their highly paid experts who said PMDD is a tragic disease, and they got approved for Sarafem, the same drug. It's an on-label use for a repackaged drug; they created the disease and then got a drug re-approved that was going off patent."

A recent Pew Charitable Trusts study found that Americans spent $65.8 billion44 out of pocket in 2016 for retail prescription drugs, up from $59.5 billion in 2012. The high cost of prescription drugs is a significant driver of medical debt45 because Americans are increasingly reliant on medication to manage long-term chronic conditions.46 Additionally, the high cost of prescription drugs has forced many Americans to take drastic measures, including foregoing taking their medications as prescribed or traveling abroad in order to save on medications. A 2019 Centers for Disease Control and Prevention study found that 11.4 percent47 of adults aged 18 to 64 did not take their prescription drugs as prescribed in order to reduce how much they spent on their medications. And, as NPR recently reported, “The U.S government estimates that close to 1 million48 Americans in California alone go to Mexico annually for health care, including to buy prescription drugs.” In May 2019, a group of Americans49 living with Type 1 diabetes traveled to Canada to purchase insulin and call on the U.S. government to regulate the cost of lifesaving drugs. The costs associated with traveling abroad make it logistically and financially impractical for most Americans. Further, traveling abroad presents certain health risks given that some countries have lax drug certification standards compared with FDA standards.

The COVID-19 pandemic laid bare the longstanding vulnerabilities within the U.S. pharmaceutical supply chain. Just-in-time manufacturing practices, overreliance on both foreign and geographically concentrated sources for critical drug products, and insufficient supply chain visibility, among many other challenges, have resulted in widespread shortages of critical drug products over recent decades. Shortages of critical medical products, which are commonly used in hospital emergency rooms and outpatient settings, worsened throughout the COVID-19 pandemic as global demand increased and countries began initiating export bans to keep needed products.

The subsequent surge in respiratory viruses in the fall and winter of 2022, with a confluence of COVID-19, RSV, and influenza cases, resulted in increased demand for prescription and over-the- counter medications, further stressing the pharmaceutical supply chain. In addition, staffing shortages and transportation delays continue to present challenges. Since Senator Peters released his 2019 report on drug shortages, the number of active drug shortages has generally continued to rise. 1 As shown in Figure 1, injectable drug products, which can include supportive care medications (like IV saline), sedatives (such as propofol), and chemotherapy drugs, are more than twice as likely to experience shortages compared to other dosage forms, such as oral tablets or topical products. 2 However, recent shortages of basic over- the-counter medications, like pediatric Tylenol and Motrin used to treat children’s flu and fever, have also spiked due to increased demand, leaving many shelves bare and pharmacies limiting sales.

In our study of commonly used outpatient generic drugs available between 2008 and 2014, we found that the prevalence of shortages decreased from its peak in 2011-2012 to less than 4% of the overall sample by the end of 2014. We also found that market competition levels and market sizes were not associated with the likelihood of drug shortages. Rather, generic drug prices were strongly predictive of drug shortages; compared with their high-priced generic counterparts, low-priced generic drugs were more likely to experience shortages. Drug shortages were associated with a modest increase in prices.

Our finding that low-priced generic drugs were at an increased risk for drug shortages could be due to many different factors. First, because low-priced generic drugs are generally less profitable than high-priced ones, manufacturers may prioritize continued production of more profitable drugs within their portfolios. Other experts have attributed the higher incidence of drug shortages in the United States—compared with other developed regions such as Europe—to the higher reimbursement rates for generic drugs outside the United States

The second-quarter 2024 biopharma earnings season is upon us. Johnson & Johnson and Novartis kicked off the parade of Q2 financial results last week, and this week AbbVie, AstraZeneca, Roche and Sanofi joined the litany of announcements as well as Bristol Myers Squibb. So far, like most earnings seasons, it has been a ho-hum affair, with companies beating Wall Street expectations on strong drug sales and raising their outlooks for the rest of the year. Everything seems to be coming up roses for Big Pharma.

What’s more interesting than earnings is the fact that we are nearing a major deadline for drug price negotiations between the Biden administration and drugmakers under the Inflation Reduction Act (IRA). If you listen to companies’ Q2 calls, the IRA’s Medicare Drug Price Negotiation Program has been a topic of frequent discussion among executives—which is not surprising as the Centers for Medicare and Medicaid Services (CMS) has until the end of July to conclude negotiations on the maximum fair prices for the initial 10 drugs selected for the program, with those prices going into effect in 2026.

The Inflation Reduction Act of 2022 enabled Medicare to negotiate prices for prescription drugs for the first time in the program’s history. In August 2023, Medicare announced the first 10 Medicare Part D drugs selected for negotiation. The U.S. Centers for Medicare and Medicaid Services submitted its initial offer for negotiated prices in February 2024, and the negotiated prices will be finalized and published in September 2024. The negotiated prices will take effect in January 2026. These 10 drugs are among those with the highest annual Medicare Part D spending, indicating very high prices and/or very high utilization rates. Given limited transparency in drug pricing, it is often difficult to estimate drug costs, especially because net prices, which are often unknown, differ from list prices and vary among payers.

This new Center for American Progress analysis builds on net per-unit Medicare Part D drug price estimates from the Commonwealth Fund, inclusive of discounts, rebates, and price concessions, to estimate net Medicare prices for a typical 30-day supply of the first 10 drugs up for price negotiation. From there, the center calculated the likely monthly savings that will result from Medicare’s price negotiation.

The U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), today announced 41 drugs available through Medicare Part B will have a lowered Part B coinsurance rate from April 1 – June 30, 2024, if the drug company raises prices faster than the rate of inflation. An estimated 763,700 people with Medicare use one or more of these drugs annually.

Because of the President’s lower cost prescription drug law, the Inflation Reduction Act, which establishes the Medicare Prescription Drug Inflation Rebate Program, some people with Medicare who use these drugs during that time period may save between $1 and $3,575 per average dose depending on their individual coverage.