US Pharmaceutical Research Articles

Why Does Price Control Policies Do Not Apply in the US Pharmaceutical Market, as Opposed to Many EU Markets?

The pharmaceutical market is always the most profitable industry in the US, and private companies dominate the healthcare market. The US ranks the highest globally on healthcare spending due to the high price of healthcare. As a result, American citizens face increased difficulties affording basic health insurance. The main reason behind this problem is that the US does not apply price control policies. Compared with the US, most EU countries’ pharmaceutical markets have government interventions, such as price control policies; hence EU countries have a much lower amount of healthcare spending. This article describes the history of pharmaceutical markets in the US and EU and analyzes why the US does not apply price control policies. This article also critically elaborates on the positive and negative implications of why the US does not apply price control policies. Although there are many benefits to the US does not apply price control policies in the pharmaceutical market, in this research, the disadvantages of applying price control policies outweigh the benefits. As the US does not apply price control policies, this would lead to a higher profit for pharmaceutical companies. In addition, this likely incentivizes pharmaceutical companies to dedicate more funds to research and development. In the long term, without price control policies in the US could increase human longevity.

Patent Laws in Light of New Realities in the US Pharmaceutical Industry

Patent Laws in Light of New Realities in the US Pharmaceutical Industry

Assessing US Pharmaceutical Policy and Pricing Reform Legislation in Light of European Price and Cost Control Strategies.

This article compares the pharmaceutical pricing policies employed by public and private insurers in the United States with seven price and spending control strategies employed in the United Kingdom, France, and Germany. Differences between American and European policies explain why American pharmaceutical prices and per capita spending are higher than in European nations. The article then analyzes two recent bills as examples of significant American reform ideas-H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act (introduced in 2019) and the Build Back Better Act (BBBA, introduced in 2021)-and compares them with European cost control strategies. Key drug price provisions of the BBBA were incorporated into the recently enacted Inflation Reduction Act (IRA). H.R. 3 would have used an international (mostly European) price index to cap U.S. prices; the BBBA would cap Medicare prices at a discount from average U.S. market prices. Neither bill would employ the key cost control strategies that European nations do. Both bills would have significantly less impact on prices than legislation that employs European-style cost controls. This article proposes steps that Congress could take in line with European strategies to lower purchase prices and costs for patients. These measures would have to overcome political obstacles that currently stymie reform.

Countries Manufacturing Pharmaceuticals for the US Market: A 10-Year Analysis of Public Data

Concerns about strategic supplies and quality have increased the scrutiny of the countries where US pharmaceuticals are made. To examine the locations of manufacturers of brand name, biological, and generic drugs over 10 years. This longitudinal descriptive study used publicly available data from US government Web sites, including the Food and Drug Administration (FDA) Drug Establishments list, FDA National Drug Code Directory, FDA Orange Book, FDA Purple Book, and the National Institutes of Health DailyMed Drug Labels. These data were collected from 2011 to 2020. Brand name drug manufacturing in the United States and Europe decreased from 89% in 2011 to 79% in 2020. Biological manufacturing in the United States decreased, while that in Western European countries increased; 100% of biological manufacturing was done in the United States or Europe in 2011 and decreased to 93% by 2020. Generic manufacturing in India increased from 21% to 51%, while US manufacturing decreased from 52% to 35% from 2011 to 2020. These analyses were limited to publicly available data, and the results could be affected by the accuracy and completeness of the data. Brand name drugs and biologicals are primarily made in the United States and Europe. Generic drugs are increasingly made in India, but the United States remains a major supplier. If the country of origin for pharmaceuticals is important, these findings support supply chain concerns for generic drugs. We recommend that product containers and official labeling prominently include the manufacturer and location for active pharmaceutical ingredients and finished dosage forms.

Risk of Venous and Arterial Thromboembolism in Patients With Giant Cell Arteritis and/or Polymyalgia Rheumatica: A Veterans Health Administration Population-Based Study in the United States

Background: Giant cell arteritis (GCA) and polymyalgia rheumatica (PMR) are two chronic systemic inflammatory diseases that primarily affect elderly women. Both GCA and PMR can be complicated by thromboinflammation. We evaluated the risk of thromboembolic events as well as retinal vascular occlusive events in patients with giant cell arteritis (GCA), polymyalgia rheumatica (PMR), and overlap of GCA with PMR compared to patients with a non-inflammatory condition such as osteoarthritis (OA) in a Veteran based population. Methods: 1,535 patients with GCA, 10, 265 with PMR, and 1,203 with overlap of GCA with PMR as well as 39,009 age- and sex-matched patients with OA were identified in this retrospective study. Incidence rate ratios (IRR) of pulmonary embolism (PE), deep venous thrombosis (DVT), arterial thromboembolism (ATE), central retinal artery occlusion (CRAO) and central retinal vein occlusion (CRVO) were calculated among all three-study groups and trended over time after diagnosis. We also plotted cumulative incidence and calculated hazard ratios (HRs) of thromboembolic events in the study groups, adjusting for independent risk factors of thromboembolism. Findings: Patients with GCA, PMR and overlap of GCA with PMR had higher IRR of all thromboembolic events compared to patients with OA. IRRs of all thromboembolic events were highest within the first year of diagnosis for GCA and gradually decreased over time, whereas for the overlap and PMR groups the time trend of IRRs varied for each of the thromboembolic events. Patients with GCA had a higher risk of developing DVT and retinal vascular occlusive events compared to patients with overlap disease (2.01, 95%CI: 1.35-2.99, p<0.001, and 2.37, 95%CI: 1.23-4.53, p=0.009 respectively) and PMR (1.89, 95%CI: 1.50-2.41, p<0.001, and 95%CI: 4.68, 95%CI: 3.10-7.07, p<0.001 respectively). Patients with GCA had a higher risk of developing PE compared to patients with PMR (1.55, 95%CI: 1.1-2.18, p=0.01). Patients with overlap disease were at higher risk of developing retinal vascular occlusions compared to patients with PMR (1.97, 95%CI: 1.05-3.69, p=0.03). Interpretation: The risk of thromboembolic events differs in patients with GCA, PMR and overlap disease. Our findings may help physicians predict risk of thromboembolic events determined by disease phenotype and duration, and assist with the development of venous thromboembolism risk stratification tools in patients with GCA and/or PMR that would allow identification of high risk patients. Funding Information: D.M. is supported by the T32 NIH grant from Nutrition, Obesity and Atherosclerosis (#5T32HL007028-44) and Pfizer US Pharmaceuticals Group grant, award number 53857367 Declaration of Interests: DM received Advisory Board fee from Chemocentryx. All other authors report no competing interests. Ethics Approval Statement: MIRB#01854.

A regional analysis of payer and provider views on cholesterol management: PCSK9 inhibitors as an illustrative alignment model.

A regional analysis of payer and provider views on cholesterol management: PCSK9 inhibitors as an illustrative alignment model.

Strategic Alliances and Inventor Mobility - Evidence from US Pharmaceutical Industry

Attention on the same domain (e.g. industry, technology) often leads intensive competition between the firms; and such an attention also increases the likelihood of alliance formation, too. Particularly, in learning alliances, those ‘competitors turned collaborators’ often have a tension between to collaborate more to create new knowledge and compete within the alliance to misappropriate each other’s knowledge. While sustaining collaboration with good faith and trust would help to generate more technological innovation, poaching of the partner’s corporate scientists is often a result of such an effort of knowledge misappropriation. While the non-poaching mobiltiy is held stable, within-alliance compeittion increases poaching as the returns from learning-by-hiring exceeds those from the learning allaince. Integrating datasets of R&D alliances, corporate scientist mobility, and product market competition in the U.S. pharmaceutical industry from 1985 to 2008, we found that a firm’s competitive aggressiveness toward its alliance partner in the pre-alliance period positively affected the number of corporate scientists it poaches from its partner during the post-alliance period. This main effect is negatively moderated by the geographical and technological proximities between the paired partner firms and positively moderated by the firm specificity of the partner’s knowledge base.

Shortcomings in the US Pharmaceutical Supply Chain

Shortcomings in the US Pharmaceutical Supply Chain

More Resilient Supply Chains Needed to Aid Recovery From Hurricanes and Other Disasters.

Shortcomings in the US Pharmaceutical Supply Chain: Potential Risks Associated With International Manufacturing and Trade-Related Tariffs

Common Ownership in the US Pharmaceutical Industry: A Network Analysis

We investigate patterns in common ownership networks between firms that are active in the US pharmaceutical industry for the period 2004-2014. Our main findings are that “brand firms” — i.e. firms that have R&D capabilities and launch new drugs — exhibit relatively dense common ownership networks with each other that further increase significantly in density over time, whereas the network of “generic firms” — i.e. firms that primarily specialize in developing and launching generic drugs — is much sparser and stays that way over the span of our sample. Finally, when considering the common ownership links between brands firms, on the one hand, and generic firms, on the other, we find that brand firms have become more connected to generic firms over time. We discuss the potential antitrust implications of these findings.

PCP33 - COULD THE US ADMINISTRATION IMPOSE DRUG PRICE RAISES IN THE EUROPEAN UNION (EU)?

The United States pays the highest drug bill per capita despite unequal global distribution of drug prices and payment. President Trump has said that this “[is] ridiculous, and it’s not going to happen any longer.” His proposed solution is to fix trade through bilateral negotiation to raise US drug prices abroad. Opportunities for US drug price increase in the European Union (EU) were reviewed at the WTO level and among other international organizations. Currently, US drug prices in the EU are not subjected to value-added tax (VAT) or to a very low VAT rate. The customs drug tariffs are usually nonexistent or if applied, are low. Trump’s argument of American discrimination may not be legally valid. If pricing is well structured, transparent, and based on scientific grounds (ex. HTA processes) complemented by established economics rules (ex. funding processes) applicable to all products, regardless of origin, it is unlikely for opportunities through legal routes to impact prices. An alternative is through bilateral trade negotiations, where the US may have an advantage in negotiating. However, in response to Trump’s proposal to raise US drug prices abroad, the UK’s NHS has emphasized their commitment to provide affordable drugs to UK citizen. In Japan, the first US export market for pharmaceuticals, some experts have questioned the relationship between Trump’s visit and the 2-year delay for HTA implementation. Following timid AMNOG reform in Germany, which was expected to yield more, some questioned the potential influence of Trump’s administration. Despite no potential legal route for price raising of US pharmaceuticals in EU, it is likely that price of pharmaceuticals will be a focus of bilateral trade negotiations between individual EU countries and the US. However, increasing prices outside the US may not directly translate to lower prices within the US nor lead to benefiting US patients.

Physician Leaders in the US and Canada Launch Sweeping Pharmaceutical Reform Proposal

Physician Leaders in the US and Canada Launch Sweeping Pharmaceutical Reform Proposal

OR011 Safety of multi-dose immunotherapy vials after routine use

Recent proposed changes to US Pharmaceutical General Chapter <797> (USP <797>) have prompted discussion regarding the safety of multi-dose immunotherapy extract vials after routine use. We present evidence to support the argument that currently accepted aseptic protocols for handling and administration of multi-dose immunotherapy extract maintenance vials during routine patient care does not result in risk of microbial growth and that changes as suggested by the proposed USP <797> guidelines are not needed.

Innovation, Technological Position, and Lobbying: Evidence from US Pharmaceutical Industry

In this paper, applying institutional perspective, I suggest firm innovation is positively related to the firm's involvement in CPA. Institutions are not only the system to prevent uncertainty, but...

The Distribution of Surplus in the US Pharmaceutical Industry: Evidence from Paragraph (iv) Patent Litigation Decisions

Using an event study approach, and unique data on Paragraph (iv) pharmaceutical patent litigation decisions, we estimate that brand rms value deterrence at $4.6 billion on average while generic entrants value the right to enter, on average, at $236.8 million. These estimates account for probabilistic district court decisions and an appellate process. In 2002, the Schering-Plough vs. FTC decision led to a surge in pay-for-delay settlements. We estimate that surpluses at stake in decided cases are 73% lower after this decision, reducing the direct (per-case) consumer surplus gains anticipated by the 1984 Hatch-Waxman Act's procedures for early generic entry.

Patent Duration, Breadth and Costly Imitation: Evidence from the US Pharmaceutical Market

We investigate how changes in patent breadth and duration affect the imitation of new, patented drugs, and what those effects imply for the optimal patent policy design. We first formalize predictions of the basic theory of patent breadth and length, and derive a simple, testable rule for the optimal policy design that only requires data on generic firms' investments prior to patent expiration. We then test this theory in the US pharmaceutical industry where the Drug Price Competition and Patent Term Restoration Act of 1984 increased patent duration - by introducing term extensions that compensate for delays in regulatory approval process - while simultaneously narrowed breadth. Using two quasi-experimental approaches, we find evidence that suggests the probability of imitation increases with patent length and decreases with patent breadth. Our findings are consistent with the idea that society would benefit more from broader rather than longer patent protection.

High Growth Firms, Innovation and Competition: The Case of the US Pharmaceutical Industry

Firms across sectors and regions are highly skewed in their ability to engage with innovation, and even more skewed in their ability to translate investments in innovation into higher growth. Recent attention has been placed on the importance of ‘high growth firms’ (HGF) for innovation policy. Our paper explores under what conditions HGF matter for translating R&D investments into economic growth and how this depends on firm-specific and industry-specific factors. We use quantile regression techniques to study the R&D-growth relationship in HGF compared to low growth firms. Unlike previous studies, we pay particular attention to whether this relationship depends on the particular period in the industry’s life-cycle. We focus on the US pharmaceutical (pharma) industry from 1963 to 2002 and find that the R&D-growth relationship is sensitive to the changing competitive environment over the industry’s history, which suggests that innovation policy must focus not only on firm attributes but also competitive structures.

Evaluation of Castor Oil Samples for Potential Toxin Contamination

AbstractCastor oil and its derivatives are widely used as a chemical feedstock for production of lubricants and greases, engineering plastics, plasticizers and surfactants. It also has wide application in consumer goods such as lipstick, deodorants and medicinal uses. Due to concerns about the possible presence of the ricin toxin in the oil, we have tested a collection of castor oils processed using different approaches, including cold‐pressed, US Pharmaceutical (USP) grade, and neutralized oils. Water soluble proteins were extracted from oil samples into phosphate‐buffered saline containing 0.05 % bovine serum albumin (PBSB) and analyzed for potential ricin contamination by ELISA. Our results indicate that only the cold‐pressed castor oil contained measurable levels of the toxin, estimated to be 35 ± 13 μg/l. A normal oral dose of castor oil for laxative use is 14 ml, so even cold‐pressed castor oil would be well below the toxic level of 1–5 μg/kg body weight. However, the presence of the toxin indicates that other soluble proteins, including allergens, may be present in cold‐pressed castor oil.

The Distribution of Surplus in the US Pharmaceutical Industry: Evidence from Paragraph iv Patent-Litigation Decisions

In paragraph iv pharmaceutical cases, a patent-litigation decision often determines whether a brand-firm monopoly continues or generic entry occurs. Using unique patent-litigation data and an event-study approach that accounts for probabilistic district court decisions and an appellate process, we estimate that brand-firm stakes in such cases average $4.3 billion while generic-firm stakes average $204.3 million. After the Schering-Plough v. FTC decision in 2002 that upheld a settlement in which the brand firm paid the generic firm in return for delayed entry, we find that settlement is more likely and stakes are significantly lower, despite greater average brand sales for the drugs in the cases. On the basis of this evidence, we conclude that pay-for-delay settlements led to less within-market competition after 2002.

In Whom We Trust: The Role of Certification Agencies in Online Drug Markets

Abstract This article uses an audit sample and a consumer survey to study the intriguing market of online prescription drugs facing US customers and assesses the role that certification agencies play in online drug markets. On the supply side, we acquire samples of five popular brand-name prescription drugs from three types of online pharmacies: tier 1 are US-based and certified by the National Association of Boards of Pharmacy (NABP) or LegitScript.com, tier 2 are certified by PharmacyChecker.com or the Canadian International Pharmacy Association but not by NABP or LegitScript, and tier 3 are not certified by any of the four agencies. Most tier-2 and tier-3 websites are foreign. We find that 37 of the 365 delivered samples are different from the products we ordered and, therefore, non-testable. Conditional on testable samples, Raman spectrometry test finds no failure of authenticity except for eight Viagra samples from tier-3 websites. After controlling for testability and authenticity, tier-2 websites are 49.2% cheaper (p&lt;0.01) and tier-3 websites are 54.8% cheaper (p &lt; 0.01) than tier-1 sites. These differences are driven by non-Viagra drugs. For Viagra, failing samples are cheaper, but there is no significant price difference across tiers once we condition on testability and authenticity. To study the demand side, we designed a survey that was distributed by RxRights. Among the 2,522 respondents who have purchased prescription medication and are concerned about the price of US pharmaceuticals, results show that 61.54% purchase drugs online and mostly from foreign websites, citing cost saving as the leading reason. Conditional on shopping online, 41.11% check with a credentialing agency. Both samples convey a consistent message that certification agencies deliver useful information for foreign websites and online consumers. Further, while these findings confirm the Food and Drug Administration warning against rogue websites, they do suggest that a blanket ban against all foreign websites may deny consumers substantial savings from certified tier-2 websites.