Category: Generic Drugs

Hundred dollar bills rolled up in a pill bottle

Ketamine Is the New Viagra

Vincent Joralemon Leave a comment

By Vincent Joralemon

Spravato, the first FDA-approved psychedelic therapy, just outsold Viagra. Johnson & Johnson’s ketamine-based formulation generated $183 million in Q3, surpassing Pfizer’s erectile dysfunction (ED) drug, which earned $110 million over the same period. Remarkably, a therapeutic made from ketamine, once dismissed as a “club drug” or “horse tranquilizer,” now sells more than one of the most notable 21st-century pharmaceuticals. 

Yet, these two drugs have more in common than meets the eye, and the path Spravato has taken looks strangely similar to that of Viagra. By looking at the journey traversed by Viagra over the past twenty years, we can predict where Spravato (and other psychedelic therapies) are headed.

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Narcan Naloxone nasal spray opioid drug overdose prevention medication.

Public Health Product Hops

The Petrie-Flom Center Staff 1 Comment

By Michael S. Sinha, Edna Besic, and Melissa Mann

Members of Congress have been focused on drug pricing for the last several years, culminating recently in new drug pricing provisions within the Inflation Reduction Act of 2022. One reason for our drug pricing problem is that we allow manufacturers to charge whatever the market will bear for a new therapeutic. However, as we have also seen, manufacturers often engage in anticompetitive “games” aimed at extending market exclusivity and forestalling generic competition. One of these games is product hopping.

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Hundred dollar bills rolled up in a pill bottle

How Soon Could President Biden Enable Generic Competition to Xtandi? Very Quickly, If There Is the Will.

James Love Leave a comment

By James Love

On March 21, 2023, the NIH, acting on behalf of HHS Secretary Xavier Becerra, rejected a petition from four cancer patients asking HHS to use the government’s rights in the prostate cancer drug enzalutamide, in order to remedy pricing abuses by the patent holder. The abuse is charging U.S. cancer patients two to six times as much as other high income countries for Astellas’ and Pfizer’s Xtandi, a drug invented on federal grants.

The cancer patients could seek a remedy to the abusive and discriminatory pricing because the U.S. government had funded the R&D for each of the three patented inventions that are currently blocking generic competition.

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Interior of an Italian pharmacy. Pharmacist looks for medicines to sell to the customer. Puglia, Italia - 29/01/2009.

Falling Revenue Means Pharmacies in Italy Aren’t Keeping up with Other EU Countries

Sarah Gabriele Leave a comment

By Gianluca Ceci and Sarah Gabriele

In 2021, the total revenue of Italian pharmacies dropped by 4% compared to 2015, despite Italy being the fifth largest country in the EU for pharmaceutical expenditures. The main reasons: the reabsorption of demand and small pharmacy size, as well as the failure to innovate the current business model.

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Person in protective yellow hazmat suit and mask holds pills in hands.

Book Review: ‘The Truth Pill: The Myth of Drug Regulation in India’

Aparajita Lath Leave a comment

By Aparajita Lath

The Truth Pill, authored by Dinesh Thakur and Prashant Reddy, is a monumental work that convincingly shows that drug regulation is but a myth in India.

In their investigative style, the authors explain drug regulation in India through the lens of history, both Indian and global. The book’s combination of history and contemporary issues makes for an immersive and compelling read. It may, however, leave you feeling frightened, given the dysfunctional regulatory system in India and the impact this can have on patients around the world. However, the book not only highlights problems but also offers several well-thought-out and actionable paths to reform.

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Bill of Health - Globe and vaccine, covid vaccine

Reclaiming Global Public Health

The Petrie-Flom Center Staff Leave a comment

By Zain Rizvi

By December 2020, the world had astonishingly powerful tools against COVID-19. New mRNA vaccines, underpinned by decades of public investment, had been authorized by global regulators. Yet the promise of the vaccines was unevenly realized: deep fault lines emerged between those who were able to secure vaccines and those left behind, or what South Africa’s president Cyril Ramaphosa called “vaccine apartheid.”

Dose shortages elevated the role of pharmaceutical executives. Fielding calls from heads of state, they decided what vaccine deliveries to prioritize, shaping which countries could protect lives and livelihoods. The answer to one of the most important public health questions of our time — who gets access to vaccines? — was mostly determined neither by political representatives nor scientists, but by corporate executives.

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A male pharmacist is examining a drug from a pharmacy inventory.

Monthly Round-Up of What to Read on Pharma Law and Policy

Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari, Alexander Egilman, Aviva Wang, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of April. The selections feature topics ranging from a discussion of manufacturer’s restricted delivery of 340B drugs to contract pharmacies and ensuing litigation, to an analysis mapping the European patent landscape for medical uses of known products, to an evaluation of the clinical benefit of novel drugs approved in the U.S. from 2018-2019. A full posting of abstracts/summaries of these articles may be found on our website.

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Bill of Health - Globe and vaccine, covid vaccine

COVID ‘Compromise’ on International IP Underscores Need for New Approach

The Petrie-Flom Center Staff Leave a comment

By Cynthia M. Ho

The leaked compromise regarding a “waiver” of international intellectual property (IP) obligations under the TRIPS Agreement for World Trade Organization (WTO) members has met harsh criticism as a shadow of the original proposal to waive international obligations regarding patent, trade secret, and copyright obligations relating to any COVID vaccine, treatment, diagnostic, or personal protective equipment (PPE).

The compromise excludes diagnostics, treatments, and PPE. It only narrowly modifies compulsory licenses of patents covering COVID vaccines. Moreover, it imposes additional restrictions on use of compulsory licenses. But still, multinational pharmaceutical manufacturers have protested even these modest changes from the status quo, arguing that there is no IP problem that needs to be fixed.

Clearly there is a problem. It has taken 18 months since the original Indian and South African proposal to get to this limited compromise, while gross vaccine inequity between wealthy and poor countries continues. In addition, the leaked compromise between four WTO members is still being debated — and even if agreement can be reached, it needs agreement of over 100 other WTO members. We need a new approach.

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Large pile of amber prescription pill bottles

Monthly Round-Up of What to Read on Pharma Law and Policy

Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari, Alexander Egilman, Beatrice Brown, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of January. The selections feature topics ranging from a discussion of why state laws restricting mifepristone access may be subject to federal preemption, to an analysis of patents impacting the availability of biosimilars, to an evaluation of the hypothetical out-of-pocket costs of guideline-recommended medications for the treatment of older adults with multiple chronic diseases. A full posting of abstracts/summaries of these articles may be found on our website.

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