New U.S. Legislation Introduced to Address COVID-19-related Pharmaceutical Manufacturing

U.S. Senator Warren, has introduced legislation titled, “COVID-19 Emergency Manufacturing Act” (Act).  The Act gives the federal government the power to manufacture certain goods, including pharmaceuticals needed to address the Covid-19 issue.  The Press Release states: 

Washington, DC - Today, United States Senator Elizabeth Warren (D-Mass.), a member of the Senate Committee on Health, Education, Labor, and Pensions, and Representative Jan Schakowsky (D-Ill.), Chair of the Energy and Commerce Consumer Protection and Commerce Subcommittee, introduced the COVID-19 Emergency Manufacturing Act to publicly manufacture personal protective equipment, prescription drugs, and other medical supplies necessary to combat the COVID-19 pandemic. The legislation authorizes the federal government to manufacture medical products, including by contracting with existing manufacturers, to ensure the nation has an adequate supply of critical materials to avoid rationing during this unprecedented crisis. It will also help the nation begin to prepare for the approval of a COVID-19 vaccine by dramatically increasing our capacity for development and distribution 

In 2018, Senator Warren and Representative Schakowsky introduced the Affordable Drug Manufacturing Act to radically reduce drug prices through public manufacturing of prescription drugs and re-introduced it in 2019. The COVID-19 Emergency Manufacturing Act of 2020 builds off of the lawmakers' original public manufacturing bill to ensure that the federal government harnesses its full manufacturing, contracting, and coordinating capacity during the pandemic. 

The legislation builds on an existing model in which the federal government contracts with private manufacturers to produce drugs critical to national security, and for which there is often a limited or non-existent commercial market. 

. . . The COVID-19 Emergency Manufacturing Act will:  

• Establish an Emergency Office of Manufacturing for Public Health to ensure an adequate supply of drugs, devices, biological products, active pharmaceutical ingredients, and other supplies necessary to diagnose, mitigate, and treat COVID-19 and to address shortages in products used to treat non-COVID conditions and illnesses.
• Require the Office to manufacture, or enter into contracts to manufacture, COVID-19 products and other critical drugs and medical devices in shortage. The Office will be required to provide COVID-19 products at no cost to federal, state, local, and tribal health programs and to sell COVID-19 products at cost to international and other commercial entities. The Office will be required to sell the additional products it manufactures at a transparent and reasonable price to domestic and international entities.
• Direct the Office to begin manufacturing, or enter into contracts to manufacture, PPE, diagnostic test materials, COVID-19 treatment drugs within one month of the Act's passage. The Office will prioritize production of items that have most impact on public health and the economy, that address shortages, and that alleviate demographic disparities in COVID-19.

• Direct the Office to begin constructing, or enter into contracts to construct, vaccine and therapeutic manufacturing facilities to ensure the immediate production, at-scale, of COVID-19 vaccines when such vaccines become available.
• Provide transparency into the Office's activities by mandating Inspector General reviews of all of the Office's contracts, requiring periodic reports to Congress, and forcing the Office to publicly post its prices for COVID-19 and other products as well as any licensing agreements. 

Novartis, the Good Samaritan

As discussed in a previous post, the Covid-19 pandemic is an excellent opportunity for the pharmaceutical industry to demonstrate its commitment to serving the world through philanthropy.  Novartis recently stated that it will “donate up to 130 million doses” of a generic drug which may be a good treatment for coronavirus.  The Press Release further outlines Novartis’ other efforts to combat Covid-19.  Notably, Gilead Sciences received a significant amount of criticism for its attempt to get a potential treatment for Covid-19 orphan status under U.S. law—which it has since withdrawn.  Professor Lisa Larrimore Ouellette has an excellent analysis of the situation, here.  The Novartis Press Release states, in part:

Basel, March 20, 2020 - Novartis announced today its commitment to donate up to 130 million doses of generic hydroxychloroquine to support the global COVID-19 pandemic response. Hydroxychloroquine and a related drug, chloroquine, are currently under evaluation in clinical trials for the treatment of COVID-19. Novartis is supporting ongoing clinical trial efforts, and will evaluate needs for additional clinical trials.

When supported for use in COVID-19 infected patients by regulatory authorities, Novartis intends to donate up to 130 million 200 mg doses by the end of May, including its current stock of 50 million 200 mg doses. The company is also exploring further scaling of capacity to increase supply and is committed to working with manufacturers around the world to meet global demand.

Novartis Sandoz division currently only holds a registration for hydroxychloroquine in the U.S., and will pursue appropriate regulatory authorizations from the U.S. FDA and the European Medicines Agency. Novartis will work with stakeholders including the World Health Organization to determine the best distribution of the medicine to ensure broad access to patients most in need of this medicine globally. The company aims to ensure that patients currently depending on this medicine are not impacted by the donation.

The commitment announced today builds on the previously announced commitments of a USD 20 million Novartis COVID-19 Response Fund, drug discovery collaboration efforts, support of clinical trials for existing Novartis medicines, and the Sandoz commitment to maintain stable prices on a basket of essential medicines that may help in the treatment of COVID-19.

Novartis intends to work closely with other manufacturers to scale up production of hydroxychloroquine as necessary to support global supply, and encourages industry, governments and international institutions to ensure adequate global supply of medications to treat COVID-19 patients.

Will the US Government, California and Health Insurers Produce Treatments for Covid-19 for the World?

Neil Wilkof wrote on the IPKat blog today that the Israeli government has essentially issued permits under Israeli law to import generic versions of a drug into Israel for the purpose of treating Covid-19 infected patients despite patents covering that drug in Israel.  Neil notes that there is a dwindling supply of the drug and that the Israeli government is acting quickly to acquire supply.  

Notably, one issue that exists is the production of useful treatments for coronavirus.  Prior to the pandemic, there was already a concern with the lack of production of many generic drugs.  The State of California as well as health insurers are looking into manufacturing generics.  Moreover, the U.S. Congress has legislation before it concerning the federal government’s ability to have generics manufactured on its behalf or to manufacture those generics itself. (Here's a nice list of the US FDA's actions concerning the virus.) Additionally, on Tuesday of this week, President Trump invoked the Defense Production Act.  This Act apparently allows the federal government to direct, to an extent, private industry concerning the production and pricing of items necessary for national defense, in part.  It will be interesting to see if President Trump uses this power to push the manufacture of treatments for coronavirus for the United States, and hopefully, the world, and if California and Congress move fast to produce and incentivize more potential treatments. (If they did, this could lead to the development of much stronger US based generic manufacturing.)

Legislation Introduced to Raise Manufacturing of Active Pharmaceutical Ingredients in the United States

On March 11, 2020, Senators Blackburn and Menendez introduced a bill, Securing America’s Medicine Cabinet, designed to raise the manufacturing of active pharmaceutical ingredients in the United States to stem reliance on China.  The Press Release notes that part of the reason for doing this is concerns with the safety and quality of active pharmaceutical ingredients from China.  The Press Release states: 

Blackburn, Menendez Lead Bipartisan Bill to Increase US Prescription Drug Manufacturing 

WASHINGTON, D.C. – Senators Marsha Blackburn (R-Tenn.) and Bob Menendez (D-N.J.) have introduced the Securing America’s Medicine Cabinet (SAM-C) Act to increase American manufacturing of active pharmaceutical ingredients (APIs), the building blocks of prescription drugs. Currently, only 28% of API-producing facilities are in the United States and the number of Chinese facilities has more than doubled since 2010. “When confronted with a serious challenge such as the corona virus, it is important to take stock, look at lessons learned and build upon them in order to respond better the next time,” said Senator Blackburn. “Currently, we are too reliant on foreign manufacturing of critical APIs. The SAM-C Act is one step on the right path to strengthen our drug supply chain.” “The COVID-19 is a real health emergency and we have to do everything in our power to increase our preparedness and response,” said Senator Menendez. “This bipartisan proposal will do that by encouraging drug manufacturers to partner with our best minds in higher education on new advancements, creating good jobs and increasing the national production of vaccines and drugs that can save lives. With New Jersey’s concentration of pharmaceutical companies and institutes of learning, we can lead the way and make a difference.” The corona virus outbreak has heightened concerns about dependence upon China and India for prescription medications. On February 27, 2020, the FDA announced the shortage of one drug used to treat patients with coronavirus. They attributed the shortage to difficulties obtaining the API from a site in China affected by coronavirus. Additionally, in its 2019 report to Congress, the U.S.-China Economic and Security Review Commission revealed “serious deficiencies in health and safety standards in China’s pharmaceutical sector.” Dependence upon China and others for prescription drugs combined with safety concerns needs to be addressed. This urgent health event provides an impetus to improve our pharmaceutical supply chain. The SAM-C Act will encourage pharmaceutical drug manufacturers to spur innovations similar to those in other industries such as automotive, aerospace and semiconductors and bring drug manufacturing back to the United States, where ingredients and processes can be more easily verified.  The legislation would expand upon the Emerging Technology Program within the Food and Drug Administration to prioritize issues related to national security and critical drug shortages, as well as bring pharmaceutical manufacturing jobs to the United States. In addition, the SAM-C Act authorizes $100 million to develop centers of excellence in advanced pharmaceutical manufacturing in order to develop these innovations as well as train the workforce needed in this industry. These centers will be partnerships between institutes of learning and the private sector.  RELATED Last month, Senator Blackburn wrote about how the coronavirus outbreak exposes the U.S.’s pharma supply chain vulnerability: “Without intervention, the FDA expects the pharmaceutical industry will continue to rely on Chinese companies to make active pharmaceutical ingredients… The status quo has made us vulnerable. The fix, however, is sitting right in front of us.”