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Articles by John J. Cohrssen
Boosting the Biotech Economy
Recent Biden administration initiatives to boost the “bioeconomy” acknowledge an important fact: the government’s current biotechnology regulatory policies impose an unnecessary burden that slows the development of important products. A proposal to shift oversight of genetically engineered food animals to the Department of Agriculture, instead of its currently shared responsibility with the FDA, would help ease that burden.
Will the Biden Administration’s Attempt to Boost the ‘Bioeconomy’ Do the Opposite?
Recent Biden Administration initiatives to boost the “bioeconomy” are an acknowledgment that the government’s current biotechnology regulatory policies are unnecessarily slowing the development of important products and processes. They propose to correct that failure with bureaucratic make-work projects and the squandering of tax dollars. President Biden’s September 12 “Executive Order 14081 on Advancing Biotechnology and Biomanufacturing” seeks to grow the “bioeconomy” with new industrial policy.
Climate-Change Conference Devises Wrong Solutions
It’s often said that members of Generation Z are clueless, and the signs that these young people held at the November COP27 conference are evidence of that proposition. They fail to see the big picture. Let’s accept, for the moment, the premise of their advocacy: that human activities produce greenhouse gases (GHGs) such as carbon dioxide, which give rise to atmospheric warming, and thus to some degree of disruption and damage.
Biden's Biotech Executive Order Is a Bureaucratic Bonanza
Half a century ago, biotechnology became a marketing buzzword for the products and processes that used then-new techniques of genetic modification, such as recombinant DNA technology, or “gene splicing.” Today, that term has given way to “the bioeconomy,” the economic output from biotechnology, which President Biden’s September 12 “Executive Order 14081 on Advancing Biotechnology and Biomanufacturing” seeks to grow with new industrial policy.
Weapons Against Covid Need a Presidential Boost
John J. Cohrssen & Henry I. Miller City Journal December 27, 2021 Earlier this week, President Biden outlined new steps to confront the growing spread of Covid-19 from the new, more infectious Omicron variant, which, in only a few weeks, has soared from virtually nonexistent to 73 percent of all new cases.
Weapons Against Covid Need a Presidential Boost
Earlier this week, President Biden outlined new steps to confront the growing spread of Covid-19 from the new, more infectious Omicron variant, which, in only a few weeks, has soared from virtually nonexistent to 73 percent of all new cases.
Can 'fixing food' fix food regulation?
The Food and Drug Administration is “a slow-moving target that bleeds profusely when hit,” quipped a former agency head. Now, retired FDA food economist Richard A. Williams takes shots at the agency in his new book, Fixing Food: An FDA Insider Unravels the Myths and the Solutions. Reacting to exposés describing filthy food manufactured with inedible and unsafe ingredients, Congress first prohibited adulterated and misbranded food in interstate commerce in 1905.
Will the Biden Administration ‘follow the science’ on agricultural biotechnology regulatory reform?
The GLP Needs Your Help It is easier than ever for advocacy groups to spread disinformation on pressing science issues, such as the ongoing coronavirus pandemic. No, vaccines are not harmful. Yes, the use of biotechnology, GMOs or gene editing to develop antigens for treatments including vaccines are part of the solution. To inform the public about what’s really going on, we present the facts and challenge those who don't. We can’t do this work without your help.
Will Biden 'Follow the Science' on Regulatory Reform?
John J. Cohrssen & Henry I. Miller Nature October 4, 2021 (AP Photo/Ramon Espinosa) This year marks the 35th anniversary of the US Coordinated Framework for the Regulation of Biotechnology, a blueprint for federal agencies’ oversight of genetic engineering that was prepared by the White House and published by its Office of Science and Technology Policy (OSTP).
Biden’s Drug Price-Control Initiatives: What’s Possible
Health.mil President Joe Biden’s recent Executive Order 14036 contains initiatives intended to lower drug prices for patients, create more competition to increase wages for workers, promote innovation, and foster economic growth. As part of it, on Sept. 9 Health and Human Services Secretary Xavier Becerra proposed additional legislative and administrative actions.
Viewpoint: FDA’s overregulation of gene-edited animals hinders innovation and harms consumers
The GLP Needs Your Help It is easier than ever for advocacy groups to spread disinformation on pressing science issues, such as the ongoing coronavirus pandemic. No, vaccines are not harmful. Yes, the use of biotechnology, GMOs or gene editing to develop antigens for treatments including vaccines are part of the solution. To inform the public about what’s really going on, we present the facts and challenge those who don't. We can’t do this work without your help.
Suppressing Progress
FDA overregulation of genetic engineering has stalled innovation and hurt consumers.
CDC’s New Policy of No Quarantine After Vaccination Puts Great Stock in Speculation.
A just-announced policy change from the newly reinvigorated CDC specifies that persons who may have been exposed to COVID-19 no longer need to quarantine if they’ve been fully vaccinated within the previous 90 days.
FDA Overregulation Slows Biotech Progress
Over the weekend, the FDA issued an emergency-use authorization for Johnson & Johnson’s Covid-19 vaccine, clearing the path to market for the third coronavirus vaccine. The FDA had previously approved the Pfizer-BioNTech and Moderna Covid vaccines in record time—mere weeks after their makers submitted results of the clinical studies demonstrating safety and efficacy. When the FDA wants to, it can get desperately needed products expeditiously to those who need them.
COVID-19 Is Much Worse Than The Flu
Health.mil The World Health Organization has called attention to a COVID-19 “infodemic” – “an overabundance of information … that includes deliberate attempts to disseminate wrong information to undermine the public health response and advance alternative agendas of groups or individuals.” Part of that inaccurate information is the patently false and misleading claim that COVID-19 is like the flu, only less lethal.
Vaccine Documentation Will Be Important But A Hodgepodge
Yan Kennon Few could have imagined a year ago that by now our world would be so profoundly changed by a pandemic that has killed more than 300,000 Americans; been confirmed in over 16 million; gone undiagnosed in scores of millions more; and caused debilitating, persisting symptoms in many who have “recovered.” Certainly, no credible drug manufacturer would have claimed that a new vaccine for this emerging infectious disease could go through all phases of drug development and reach marketing...
Viewpoint: COVID won't subside in the US until 70% of us are immune. That means: 'Get a vaccine'
The United States is one of the most seriously COVID-19-impacted countries, faring the worst among the ten most-affected countries worldwide, as measured by new cases. The pandemic threatens both American lives and the economy. Credit: Johns Hopkins University Coronavirus Resource Center Even more worrisome, as shown below in this figure, the situation is deteriorating.
Coronavirus immunity verification could provide the needed incentive to get the shot
Relief from the scourge of COVID-19 in the United States may be in sight. Government and private sector initiatives should be able within months to provide enough safe, effective vaccines to begin to make a dent in COVID-19 cases, hospitalizations, and deaths. But for society to approach normalcy, people will need to be able to document that they are immune to COVID-19.
Resistance to Vaccination Could Prolong the U.S. COVID-19 Pandemic.
The United States is one of the most seriously COVID-19-impacted countries, faring the worst among the ten most-affected countries worldwide, as measured by new cases. The pandemic threatens both American lives and the economy. Even more worrisome, as shown below in this figure, the situation is deteriorating.
Unnecessary State Reviews of COVID-19 Vaccines Could Delay Distribution
November 22, 2020 By John J. Cohrssen and Henry I. Miller We are in the midst of a pandemic of historic proportions. COVID-19 has killed more than a quarter of a million Americans, caused pain and suffering to many more, damaged a thriving economy, and caused great public anxiety. And it promises to get worse before it gets better. The numbers of cases, the percentage of positive test results, and hospitalizations are all trending upwards.
Unnecessary State Reviews of COVID-19 Vaccines Could Delay Distribution.
We are in the midst of a pandemic of historic proportions. COVID-19 has killed more than a quarter of a million Americans, caused pain and suffering to many more, damaged a thriving economy, and caused great public anxiety. And it promises to get worse before it gets better. The numbers of cases, the percentage of positive test results, and hospitalizations are all trending upwards.
Biden Covid Plan Should Stick to Basics
Presumptive President-Elect Joe Biden’s transition organization has published an initial plan to “beat” the rapidly worsening Covid-19 pandemic. Though it is essential and not wholly unreasonable, some parts seem to have been highjacked by a political agenda that contains tangentially related issues. The plan’s sole focus should be on the difficult and complex problem of interrupting the runaway pandemic while maintaining a viable economy.
Viewpoint: This is no time to cut corners on regulation of COVID-19 vaccines
With COVID-19 cases, the percentage of positive test results, and hospitalizations reaching record levels in much of the nation, the Trump administration narrowed its focus for ways to blunt the effects of the pandemic.
Population Testing Is Critical to Managing the Coronavirus Pandemic.
With the United States gradually ramping up testing for the coronavirus, there has been a sharp, expected increase in the number of cases of COVID-19 disease. The individuals tested will learn whether they are infected, but, paradoxically, the public—and public health officials—will not know whether the total results are encouraging or discouraging. This is because the rates of the coronavirus infectivity and mortality will remain poorly understood.
Population Testing Is Critical To Managing The Coronavirus Pandemic
As the United States ramps up rapid testing for the coronavirus, the results will surely show a sharp uptick in the number of cases of coronavirus-caused COVID-19. Those tested will learn whether they are infected, but, paradoxically, the public – and public health officials – will not know whether the overall results are encouraging or discouraging, because the rates of the coronavirus infectivity and mortality will remain poorly understood.
China’s Stranglehold On Pharmaceuticals Threatens Americans’ Health And U.S. National Security
Health.mil As the cases of the Wuhan coronavirus (formally 2019-nCoV) continue to increase, and China and other countries aggressively perform screening, isolation, treatment and tracking of patients’ contacts, demand for various essential medical items is unprecedented, and shortages have been reported. For example, American dentists, who go through large numbers of surgical masks daily, are already finding their supply chain interrupted.
Viewpoint: How politics pollutes the FDA's genetically modified animal regulations and stifles innovation
Dogs bark, cows moo, and regulators regulate,” former U.S. Food and Drug Administration commissioner Frank Young once quipped to explain regulatory agencies’ expansionist tendencies. There may be no better example than the FDA’s oversight of genetically engineered animals. This oversight misguidedly extends a regulatory regime designed specifically for the approval of new animal drugs to the regulation of the animals themselves.
Commentary: Drug companies over-rely on base components from China
By Henry I. Miller and John J. Cohrssen/Los Angeles Times Thursday Dec 12, 2019 at 6:40 PM China has become the world's largest producer and exporter of "active pharmaceutical ingredients," the base components drug companies use to manufacture most of the medications we rely on. China's dominance puts both the health of Americans and our national security at risk.
Commentary: Drug companies over-rely on base components from China
By Henry I. Miller and John J. Cohrssen/Los Angeles Times Thursday Dec 12, 2019 at 6:40 PM China has become the world's largest producer and exporter of "active pharmaceutical ingredients," the base components drug companies use to manufacture most of the medications we rely on. China's dominance puts both the health of Americans and our national security at risk.
Commentary: How drug companies over-rely on China
China has become the world’s largest producer and exporter of “active pharmaceutical ingredients,” the base components drug companies use to manufacture most of the medications we rely on. China’s dominance puts both the health of Americans and our national security at risk.
Commentary: How drug companies over-rely on China
China has become the world's largest producer and exporter of "active pharmaceutical ingredients," the base components drug companies use to manufacture most of the medications we rely on. China's dominance puts both the health of Americans and our national security at risk.
How Drug Companies Over-Rely on China
(Los Angeles Times) - Thursday, December 12, 2019 at 9:48 pm | י"ד כסלו תש"פ China has become the world’s largest producer and exporter of “active pharmaceutical ingredients,” the base components drug companies use to manufacture most of the medications we rely on. China’s dominance puts both the health of Americans and our national security at risk.
Let’s Let Market Forces Lower Drug Prices
The Trump Administration on July 31 announced steps that could lead to the importation of prescription drugs from Canada, where prices are lower. This strategy is favored by President Trump but has long been opposed by many Republicans.
Let's Let Market Forces Lower Drug Prices: Reciprocity of drug approvals between FDA and foreign counterparts and more accelerated approvals could increase competition in the marketplace
The Trump Administration on July 31 announced steps that could lead to the importation of prescription drugs from Canada, where prices are lower. This strategy is favored by President Trump but has long been opposed by many Republicans.
A smarter way to curb drug prices | Opinion
The Trump administration last week announced steps that could lead to the importation of prescription drugs from Canada, where prices are lower. It is a goal supported by President Donald Trump, but long opposed by many Republicans. This latest initiative would allow states, pharmacies, and drug makers to seek federal approval for demonstration projects to import drugs that are similar or identical to drugs already approved by the U.S. Food and Drug Administration.
OPINION EXCHANGE | Reciprocity of regulatory approvals: A smarter way to curb prescription drug costs
The Trump administration last week announced steps that could lead to the importation of prescription drugs from Canada, where prices are lower. It is a goal supported by President Donald Trump, but long opposed by many Republicans. This latest initiative would allow states, pharmacies and drugmakers to seek federal approval for demonstration projects to import drugs that are similar or identical to drugs already approved by the U.S. Food and Drug Administration.
A better way to reduce U.S. drug prices
By HENRY I. MILLER and JOHN J. COHRSSEN The Trump administration last week announced steps that could lead to the importation of prescription drugs from Canada, where prices are lower. It is a goal supported by President Donald Trump, but long opposed by many Republicans.
Commentary: A smarter way to curb drug prices
The Trump administration last week announced steps that could lead to the importation of prescription drugs from Canada, where prices are lower. It is a goal supported by President Trump, but long opposed by many Republicans. This latest initiative would allow states, pharmacies and drugmakers to seek federal approval for demonstration projects to import drugs that are similar or identical to drugs already approved by the U.S. Food and Drug Administration.
Commentary: A smarter way to curb drug prices
The Trump administration last week announced steps that could lead to the importation of prescription drugs from Canada, where prices are lower. It is a goal supported by President Trump, but long opposed by many Republicans. This latest initiative would allow states, pharmacies and drugmakers to seek federal approval for demonstration projects to import drugs that are similar or identical to drugs already approved by the U.S. Food and Drug Administration.
We Need Reciprocity Of Drug Approvals To Address Critical Drug Shortages
Peretz Partensky We hear a lot about rising drug prices, but largely ignored is a far more acute and worrisome problem: widespread shortages of critical medications, many of which are essential in medical practice. University of Chicago researchers last year surveyed 719 pharmacists at large and small hospitals across the country and found that all of them reported experiencing at least one drug shortage in the past year, and 69% had experienced at least 50 shortages in that time.
A Market-Based Solution to Rising Drug Prices: More Competition
President Trump and high-ranking officials in his administration, including Health and Human Services Secretary Alex Azar, Council of Economic Advisers Chairman Kevin Hassett and acting White House chief of staff Mick Mulvaney, are scheduled to meet tomorrow for a strategy session on how to moderate drug prices. The president is frustrated over recent price increases that have occurred in spite of his publicly pressuring and shaming drug companies.
FDA Doubles Down On Failed Animal Biotechnology Regulation
Some bureaucrats in the Trump administration seem not to have gotten the memo about deregulation being good for innovation, the economy, and public health. Far from deregulating, FDA Commissioner Dr. Scott Gottlieb has doubled down on his agency's failed policy toward an entire sector of biotechnology — the production of genetically engineered animals.
FDA Doubles Down on Failed Biotech Regulation
FDA Doubles Down on Failed Biotech Regulation AP Photo/J. Scott ApplewhiteIt seems some bureaucrats in the Trump administration didn't get the memo about scientific, evidence-based regulation being good for innovation, the economy, the environment and public health.FDA Commissioner Dr. Scott Gottlieb has doubled down on his agency's failed policy for regulating an entire sector of biotechnology — the production of genetically engineered animals.Read Full Article »
OPINION: The FDA Doubles Down On Failed Animal Biotechnology Regulation
It seems some bureaucrats in the Trump administration didn’t get the memo about scientific, evidence-based regulation being good for innovation, the economy, the environment and public health. FDA Commissioner Dr. Scott Gottlieb has doubled down on his agency’s failed policy for regulating an entire sector of biotechnology — the production of genetically engineered animals.
Drug Reciprocity Could Save Lives in the U.S.
President Trump recently signed legislation permitting terminally ill patients to obtain experimental drugs directly from manufacturers, without having to wait for full approval. The medicines in question have completed only the most basic safety testing—Phase 1, usually performed on a small number of healthy volunteers.
Why not genetically engineered organic foods?
USDA’s arbitrary rules about what is permitted for the “organic” designation prohibit important advances in agriculture and food production, and they unnecessarily restrict consumer choice. That could be remedied by expanding what is permitted under the federal National Organic Standards, and this would be an opportune time.
Viewpoint: FDA regulations 'a disaster' for genetically modified animal research | Genetic Literacy Project
Contrary to Article I of the U.S. Constitution, which vests all legislative power in the Congress, federal agencies can expand their jurisdiction by forcefully pushing policy initiatives into regulatory regimes for which they were never intended. Congress has established limited controls over runaway agency rule-making, such as a public notice-and-comment process and judicial review of regulations.
Prescription-Drug Price Control: Reciprocity Is the Key | National Review
To control escalating U.S. drug prices that seem to be disconnected from research, development, and manufacturing costs, an array of politicians, policy wonks, and pundits have proposed a spectrum of government interventions. The Senate Special Committee on Aging is the latest to weigh in, with a report that makes various recommendations.
Drain The Regulatory Swamp, Let Agriculture Bloom
Worry about slow economic growth has shifted the mood of America from "hope and change" eight years ago to "drain the swamp,” which is at least in part a realization that government regulation needs major fixes to spur innovation and job creation.
Zika Virus Mosquito - Obama Won’t Act to Eradicate It
The bad news about Zika continues. The epidemic that has spread from Brazil to the rest of Latin America is now raging in Puerto Rico, with thousands of residents infected every day, and the first locally transmitted cases have been reported in the United States — more than a dozen during the past week or so in south Florida.
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