[Ip-health] Public Citizen report on coronavirus R&D & congressional letter

Steve Knievel sknievel at citizen.org
Thu Feb 20 12:32:06 PST 2020


Hi all,

I'm writing to share with you Public Citizen's new report highlighting the public's role in coronavirus R&D, and how monopoly incentives fail to deliver treatments and vaccines that meet public health needs. 

The report calls for a greater public role in pharmaceutical R&D, and for coronavirus treatments and vaccines developed with public resources to be made available at an affordable price.

The report is available here: https://www.citizen.org/article/blind-spot/ 

Relatedly, today 46 members of Congress, led by Rep. Schakowsky, wrote the Trump Administration requesting that any publicly funded coronavirus treatment or vaccine is not exclusively licensed, and at the very least, that the government ensure that such medicines are reasonably priced.

Copied below you can find Public Citizen's press release, Rep. Schakowsky's press release, and finally the letter text.

FEBRUARY 20, 2020
Government Funds Coronavirus Research While Pharma Sits By
Vaccines and Treatments for Deadly Virus Not Lucrative Under Monopoly Model

WASHINGTON, D.C. - The federal government has played a vital role in researching and developing new treatments and vaccines for coronaviruses, with little support from the pharmaceutical industry, because of the model under which drugs are developed in the U.S., Public Citizen outlined today in a new report < https://www.citizen.org/article/blind-spot/>.

The pharmaceutical industry claims that the monopoly-based patent system "is the most effective tool to reward and incentivize innovation," but the industry has been on the sidelines in coronavirus efforts over the years. A Johnson & Johnson executive even admitted recently that "there is no real incentive to do this, no financial incentive."

The responsibility of developing new treatments and vaccines against the coronavirus disease (COVID-19) has fallen mostly to the National Institutes of Health, which has spent nearly $700 million on coronavirus research and development (R&D) since the 2002 SARS outbreak, the Public Citizen report found.

Nonprofit and public institutions have supported all six of the pharmaceutical industry's active coronavirus clinical trials prior to the outbreak and two-thirds of current vaccine and treatment efforts targeting COVID-19, the report found.

"Being truly public health-oriented is disruptive for Big Pharma's profit margins," said Zain Rizvi, law and policy researcher in Public Citizen's Access to Medicines program. "The coronavirus outbreak should be a wake-up call. We cannot depend on monopolies to deliver the medicines we need."

Public Citizen is calling for a new approach to vaccine and drug development that prioritizes public health. The government could increase its R&D work or reward innovation by using alternatives to monopolies. A minimum first step should be to safeguard affordable global access for all federally supported coronavirus treatments and vaccines.

Drawing on the report's findings, 46 members of Congress, led by U.S. Rep. Jan Schakowsky (D-Ill.)  sent a letter < https://www.citizen.org/wp-content/uploads/20200220-U.S.-House-Letter-to-the-President_Fair-Drug-Pricing-to-Fight-Coronavirus.pdf > today to President Donald Trump asking for government-supported coronavirus treatments and vaccines to be reasonably priced.

Read the full report here <https://www.citizen.org/article/blind-spot/>.





FOR IMMEDIATE RELEASE
February 20, 2020
CONTACT: mailto:miguel.ayala at mail.house.gov
(202) 374-1098


House Democrats Demand Fair Drug Pricing For Taxpayer-Funded Coronavirus Vaccine or Treatment

EVANSTON, IL -  Today, Congresswoman Jan Schakowsky, a Senior Chief Deputy Whip and Chair of the Energy and Commerce Consumer Protection and Commerce Subcommittee, led 45 of her colleagues in sending a letter to President Donald J. Trump to raise serious concerns about awarding exclusive licenses for the production of a potential coronavirus vaccine or treatment and allowing drug manufactures to monopolize drugs that have been funded by millions of taxpayer dollars.  

In the letter, Representatives Schakowsky, Lloyd Doggett, Ro Khanna, Max Rose, Mark Pocan, Peter A. DeFazio, André Carson, Ayanna Pressley, Andy Levin, Alan Lowenthal, Jerrold Nadler, Raúl M. Grijalva, Carolyn B. Maloney, Sheila Jackson Lee, Pramila Jayapal, Grace Meng, Susan Wild, Tim Ryan, Steve Cohen, James P. McGovern, Bennie G. Thompson, Peter Welch, Thomas R. Suozzi, Darren Soto, Nanette Diaz Barragán, Marcy Kaptur, Judy Chu, Barbara Lee, Raja Krishnamoorthi, Danny Davis, Lucille Roybal-Allard, Mark Takano, Mark DeSaulnier, Emanuel Cleaver II, John B. Larson, Rashida Tlaib, Gregory W. Meeks, Debbie Dingell, Rick Larsen, Henry Cuellar, Julia Brownley, Tulsi Gabbard, Brenda L. Lawrence, William R. Keating, Nydia Velázquez, and Charlie Crist implored that the price of a potential coronavirus vaccine or treatment must not threaten public health by deterring access to these vital therapies.

"We write to ask you to ensure that any vaccine or treatment developed with U.S. taxpayer dollars be accessible, available, and affordable. That goal cannot be met if pharmaceutical corporations are given authority to set prices and determine distribution, putting profit-making interests ahead of public health priorities. Americans deserve to know that they will benefit from the fruits of their public investments. Specifically, we urge the Department of Health and Human Services (HHS) not to provide an exclusive license to any private manufacturer for a coronavirus vaccine or treatment in any government grants, contracts, or licensing arrangements," the Members of Congress wrote.

The letter goes on to outline concerns with issuing an exclusive license using taxpayer dollars: "Providing exclusive monopoly rights could result in an expensive medicine that is inaccessible, wasting public resources and putting public health at risk in the United States and around the globe. If HHS or any other federal agency moves forward with such a proposal, we urge you to instead issue a limited license and implement requirements that a vaccine or treatment be made available at an affordable price. You should also allow HHS to intervene if a manufacturer prices a COVID-19 vaccine or treatment at an excessive level. Such action is particularly critical for vaccines, which are most effective when the vast majority of the public is immunized; you must use every tool of the federal government to ensure a coronavirus vaccine is affordable and accessible."

This is the third time in the last 20 years that a coronavirus has made the leap from animals to humans-severe acute respiratory syndrome (SARS) coronavirus in 2002, Middle East respiratory syndrome (MERS) coronavirus in 2012, and now the 2019 novel coronavirus. Though Big Pharma hasn't invested in coronavirus vaccines or treatments, the American taxpayer has. A Public Citizen report < https://www.citizen.org/article/blind-spot/> released today reveals that the National Institutes of Health has already spent nearly $700 million dollars on coronavirus research and development. 

The letter continues: "We are concerned that your Administration has already indicated its willingness to invest heavily in public-private partnerships without any conditions in place to guarantee affordable drug pricing and access." Over the past two weeks, the U.S. Biomedical Advanced Research and Development Authority (BARDA) has announced new agreements with Johnson & Johnson and Sanofi Pasteur to develop vaccines for the coronavirus. However, the Trump Administration has offered no indication that they will impose guidelines to ensure that these companies cannot monopolize the drugs and price them out of reach.   

The letter closes by asking President Trump not to break his promise to lower drug prices for the American people: "You have repeatedly called for action to lower drug prices and know that unjustifiably high drug prices are one of the most pressing public health concerns we face today. We should not grant any manufacturer a blank check to monopolize a coronavirus vaccine or treatment developed with public, taxpayer support. Without aggressive action to protect public health, we are fearful that Americans and people in lower- and middle-income countries will not be adequately protected against current and future coronavirus outbreaks." 

A signed copy of the letter is available HERE < https://schakowsky.house.gov/sites/schakowsky.house.gov/files/documents/U.S.%20House%20Letter%20to%20the%20President_Fair%20Drug%20Pricing%20to%20Fight%20Coronavirus_0.pdf> and complete text of the letter is below: 

February 20, 2020
The President 
The White House
1600 Pennsylvania Avenue, Northwest
Washington D.C. 20500

Dear Mr. President:

As the world works to confront the coronavirus disease 2019 (COVID-19) health threat, we are proud that the United States is a leader in developing a new vaccine and new treatments to protect patients. We write to ask you to ensure that any vaccine or treatment developed with U.S. taxpayer dollars be accessible, available, and affordable. That goal cannot be met if pharmaceutical corporations are given authority to set prices and determine distribution, putting profit-making interests ahead of public health priorities. Americans deserve to know that they will benefit from the fruits of their public investments.

Specifically, we urge the Department of Health and Human Services (HHS) not to provide an exclusive license to any private manufacturer for a coronavirus vaccine or treatment in any government grants, contracts, or licensing arrangements. Providing exclusive monopoly rights could result in an expensive medicine that is inaccessible, wasting public resources and putting public health at risk in the United States and around the globe. If HHS or any other federal agency moves forward with such a proposal, we urge you to instead issue a limited license and implement requirements that a vaccine or treatment be made available at an affordable price. You should also allow HHS to intervene if a manufacturer prices a COVID-19 vaccine or treatment at an excessive level. Such action is particularly critical for vaccines, which are most effective when the vast majority of the public is immunized; you must use every tool of the federal government to ensure a coronavirus vaccine is affordable and accessible.

Last month, Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID) indicated that a vaccine to prevent COVID-19 could begin initial clinical trials within three months. This rapid development is only possible because of public, taxpayer funding of NIH research on coronaviruses.[1] An investigative report released today revealed that while pharmaceutical companies have devoted startlingly little resources to research and development relating to coronaviruses, NIH has spent nearly $700 million on coronavirus research and development. While much of this funding focused on early-stage research, all six active coronavirus clinical trials that began prior to the COVID-19 outbreak received public and taxpayer support.[2] 

We are concerned that your Administration has already indicated its willingness to invest heavily in public-private partnerships without any conditions in place to guarantee affordable drug pricing and access. On February 4, 2020, the HHS Biomedical Advanced Research and Development Authority (BARDA) announced a partnership with Regeneron-a biotechnology company with the two highest paid executives in the entire pharmaceutical industry-to develop an experimental treatment for COVID-19.[3] Under the terms of the agreement, BARDA will pay for 80 percent of research, development, manufacturing costs for promising treatments.[4] BARDA has also already paid up to $8.9 million to Regeneron to support the development of a Middle East respiratory syndrome (MERS) coronavirus treatment, including packaging and labeling costs; Investigational New Drug Application costs, and clinical trial costs.[5] Although the U.S. government has utilized taxpayer resources to subsidize a large portion of Regeneron's work on coronavirus treatments in recent years, there must be guardrails in place to prevent Regeneron from monopolizing the medicine and maximizing profits.

You have repeatedly called for action to lower drug prices and know that unjustifiably high drug prices are one of the most pressing public health concerns we face today. We should not grant any manufacturer a blank check to monopolize a coronavirus vaccine or treatment developed with public, taxpayer support. Without aggressive action to protect public health, we are fearful that Americans and people in lower- and middle-income countries will not be adequately protected against current and future coronavirus outbreaks. 

We look forward to your response and to working with your Administration to ensure that the price of a coronavirus vaccine or treatment does not threaten public health by deterring access to these vital therapies both at home and abroad. 


CC:      The Honorable Alex M. Azar II, Secretary of Health and Human Services
      The Honorable Dr. Francis Collins, Director of the National Institutes of Health 
      The Honorable Dr. Robert Kadlec, Assistant Secretary for Preparedness and Response
Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases 
Dr. Rick Bright, Director of the Biomedical Advanced Research and Development Authority


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