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Antitrust activities in the pharmaceutical industry

High prices of prescription drugs have been highlighted as reducing access to essential drugs and have recently gained notoriety and political attention. Authors from Harvard Medical School and the law schools of the Northeastern and Rutgers Universities explain the role of antitrust law in restoring competition and restraining price increases [1].

Encouraging generics could cause high prices

A provision introduced in October 2017 awards eligible drugmakers 180 days of exclusivity to market a generic version of one of a list of 267 medicines for which no generic version currently exists. The provision was introduced to encourage generics of off-patent drugs without generics, however, some believe it could lead to high prices [1].

Trends in use of Lipitor after introduction of generic atorvastatin

Big savings can be made after the introduction of generics, especially when it comes to high volume categories, such as statins. Pfizer’s Lipitor (atorvastatin) was the best-selling drug of all time until it lost its patent protection at the end of June 2011 [1] and a generic version became available in the US in November 2011 [2]. However, the impact of the introduction of generics on use of Lipitor is not known. Therefore, researchers from Duke and Yale Universities analysed trends in use and expenditures associated with Lipitor after generic atorvastatin became available [3].

Switchback rates between generic and brand-name drugs

A study carried out by researchers from Harvard Medical School found a lower rate of switchback when patients were switched to an authorized generic from the brand-name product rather than when they were switched to another generic drug product [1].

Portugal increases use of generics for treatment of cardiovascular diseases

In Portugal, the use of medicines for cardiovascular system increased nearly two-fold between 2000 and 2010. As such, over a quarter of the overall expenditure on medicines during these years went towards the treatment of cardiovascular issues [1]. However, it is possible that there may be room for cost saving on these medicines through increased uptake of generic and essential medicines. A recent study by Gama et al. has outlined the trends in outpatient cardiovascular medicine use in Portugal between 2004 and 2012, with focus on the uptake of generic and essential medicines [2]. 

Pharmaceuticals and products liability litigation

In 2016, healthcare spending represented 17.9% of the economy of the US, a slight increase from 2015. By 2016, the average consumer in the US expended US$1,100 per capita on prescription drugs. Authors Katie McCarthy and Richard Hunter discuss the interconnections between the different types of product liability claims related to marketing and manufacturing of drugs in the pharmaceutical industry, rising drug costs, the increasing availability of generics in the marketplace. They also discuss several major cases and the outcomes of those cases as they relate to the social responsibility of drug manufacturers [1].

Portugal saves money with increased use of cardiovascular generics

Cardiovascular diseases are the primary cause of mortality worldwide [1-3], accounting for over 30% of all deaths. However, in the last few decades, the number of deaths attributed to cardiovascular diseases in higher-income countries has been on the decline. This is thought to be largely due to improved and increased healthcare interventions, according to Gama et al. [4].

Barriers to HIV generics in the US

Combination antiretroviral therapy (ART) has dramatically improved survival rates among people with HIV and is a mainstay of HIV prevention. Generic ART medications offer the potential for treating and preventing HIV at a lower cost [1].

Bioequivalence of brand-name and two generic tacrolimus in transplant patients

Although the US Food and Drug Administration’s (FDA) generic drug approval process has a long-term successful track record, concerns remain for approval of narrow therapeutic index generic immunosuppressants, such as tacrolimus, in transplant recipients. Several professional transplant societies and publications have generated scepticism of the generics approval process. Three areas of concern are that the pharmacokinetic properties of generic and brand-name products in healthy volunteers may not reflect those in transplant recipients, bioequivalence between generic and brand-name products may not ensure bioequivalence between generics and high-risk patients may have specific bioequivalence concerns. While this study tests tacrolimus, the novel trial design and results may globally impact regulatory considerations and strategies, not only for the approval of immunosuppressants but also for other narrow therapeutic index/ critical dose drugs.

Adverse outcomes for elderly using generic versus brand-name ARBs

Generics are commercialized once active ingredient’s patent of a brand-name drug expires. Brand-name to generics substitutions are encouraged and favoured due to the considerable savings for both patients and payers. Comparative bioavailability studies ensure pharmacokinetic equivalence between a given brand-name drug and corresponding generics, with similar requirements worldwide. However, no clinical equivalence studies are required before generics commercialization. After commercialization, few studies have assessed outcomes between brand-name and generic drug users in cardiology, especially at a population level.