Author: Pacific Research Institute

It all sounds so simple: to hasten the end of the pandemic globally, suspend intellectual property protections on Covid-19 vaccines to allow swift production of low-cost copies the world over. The Biden administration has bought into exactly that strategy at the World Trade Organization. But some simple ideas are also simplistic, and this one is dangerously so. Waiving patent rights for Covid-19 vaccines will actually slow their availability in the developing world, thereby prolonging the pandemic. The production of these breakthrough Covid-19...

Reforms to the U.S. drug pricing environment are required, but to improve patients’ health outcomes, reforms must be grounded in a comprehensive understanding of the current drug pricing system. Otherwise, policymakers will make things worse, not better. Unfortunately, a March 2021 report by the Government Accountability Office (GAO) fails to live up to this goal. The title of the report, U.S. Prices for Selected Brand Drugs Were Higher on Average than Prices in Australia, Canada, and France, appears to confirm the narrative that U.S. patients...

A very bad regulation is coming. Here's the short of it. In 2016 Congress passed the National Bioengineered Food Disclosure Law. That law directed the U.S. Department of Agriculture to promulgate regulations for the mandatory labeling of "bioengineered" (or "genetically engineered") foods for human consumption. Consequently, the USDA issued the National Bioengineered Food Disclosure Standards (NBFDS) in December 2018. Although those regulations became effective in February 2019, the USDA allowed food manufacturers (the regulated entities) until Jan. 1, 2022, to come into full...

How the New Price Transparency Rules are Affecting Stakeholders May 13, 2021 Deborah Abrams Kaplan Although the hospital price transparency final rule took effect in January, it will take time for it to get its sea legs, whether that means 100% hospital compliance, inspiring patients to use it for their own healthcare decisions or for hospitals to reevaluate their pricing based on their competition. Eventually, though, “I think it will open up the market and, hopefully, reduce the cost of healthcare,” says Sally...

How the New Price Transparency Rules are Affecting Stakeholders May 13, 2021 Deborah Abrams Kaplan Although the hospital price transparency final rule took effect in January, it will take time for it to get its sea legs, whether that means 100% hospital compliance, inspiring patients to use it for their own healthcare decisions or for hospitals to reevaluate their pricing based on their competition. Eventually, though, “I think it will open up the market and, hopefully, reduce the cost of healthcare,” says Sally...

By Henry Miller, M.S., M.D., and Kathleen Hefferon, Ph.D The controversy over genetically engineered organisms (sometimes called “genetically modified organisms,” or “GMOs”) is genuine, not faux — but only because of uninformed, exaggerated concerns about the most recent techniques’ “newness.” What is faux and disingenuous are the arguments put forth by genetic engineering’s opponents. Humans have been modifying the DNA of our food for thousands of years (even though we didn’t know that DNA was mediating the changes until the 20th century). We call...

By Henry Miller, M.S., M.D. and Andrew I. Fillat Sometimes the sheer stupidity, posturing, and lack of insight by policymakers are breathtaking. As a form of virtue signaling, the Biden administration has just announced U.S. support at the World Health Organization (under TRIPS, the Agreement on Trade-Related Aspects of Intellectual Property Rights) for waivers of patents on COVID-19 vaccines. Patents are widely misunderstood. They do not so much permit the holder to do something; rather, they prohibit others from copying the patented “invention,” and, thereby, can...

By Robert Popovian, Pharm.D., MS, and Wayne Winegarden, Ph.D. Biologics are not natural monopolies, as certain individuals continually assert. This assertion threatens future innovations, greater healthcare affordability, and patient access. It is well understood that biologics have improved our ability to treat diseases such as cancer and autoimmune ailments. Biologics are also expensive; they now represent 43% of invoice spending, and spending has been growing 14.6% annually over the past five years. Until recently, originator biologics lacked any meaningful competition from less costly off-patent generic copies...

Watch PRI's Dr. Wayne Winegarden discuss the importance of improving competitions for biosimilars to increase access to these high value medications for more patients on two "Bending the Cost Curve" panel discussions hosted by State of Reform. https://youtu.be/oJTD34j-E-Y https://youtu.be/hu8sWIn3u_A...

As Congress once again takes up legislation to reduce drug prices, one of the most important yet overlooked areas for reform is rebate walls. Rebate walls, also known as rebate traps, block competition in parts of the U.S. prescription drug market, especially immunology, which is home to some of the costliest drugs. They can favor older, more expensive and even less effective drugs over newer, more effective, and often cheaper alternatives. Thanks to rebate walls, patients are routinely forced to “fail first”...

Dr. Henry Miller, M.S., M.D. joins the Lars Larson Show to discuss the impact of pesticides, GMOs, and agricultural chemicals and the role these products play in crop production. Miller talks about the umbrella term of pesticides, herbicides (removal of invasive plants), and insecticides (removal of harmful insects), and the impact of the environmental movement on how these products and practices are viewed. Lars Larson National Podcast · Lars Larson National Podcast 03-30-21...

By Robert Popovian and Wayne Winegarden The time has come for us to think about incremental, evolutionary, and targeted changes to the healthcare system to reduce costs rather than focusing on grand bargains. It is time for practical solutions that will likely have broad consensus amongst patients, providers, employers, and policymakers. While the debate over the merits of private sector healthcare solutions versus government control of healthcare continues, a group of policy experts with support from the Arnold Ventures and Tobin Center...

As the Biden administration engages the COVID-19 pandemic, a public tug-of-war has emerged over who should be nominated to run the Food and Drug Administration, a pivotal participant in the effort. An analysis of the two perceived front-runners illustrates that neither would likely introduce the kinds of reform needed at the agency. One candidate is acting Commissioner Dr. Janet Woodcock, a long-serving top FDA official with widespread institutional respect, both inside and outside the agency. To her (far) left is Dr. Joshua Sharfstein, who served briefly as...

By Henry Miller, M.S., M.D. and John Cohrssen 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. But for some other...

BY ROBERT POPOVIAN & WAYNE WINEGARDEN President Joe Biden should take advantage of a bipartisan opportunity to meaningfully reduce patients’ out-of-pocket spending on biopharmaceuticals. Seizing this opportunity requires the president to recognize that the drug cost problem exists because the current system inappropriately shifts too much of its expenditures to patients. Consider that hospitals’ total expenditure in 2019 was $1.2 trillion, or three times the total of the spend on pharmaceuticals. However, patients’ out-of-pocket spending on drugs in 2019 was $54 billion, or 50 percent higher than...

By Henry I. Miller and Shiv Sharma Even as the amazingly fast development of new high-tech COVID-19 vaccines enthralls the world, a simple piece of fabric has become the surprise emblem of the fight against one of the worst health crises in the nation’s history. The ordinary facemask has brought home a basic truth about public and personal health: simple and smart works. The lost jobs and monumental personal costs of widespread lockdowns have made simple, inexpensive means of deterring the virus’...

By Sarah Downey, Northern California Record With California now predicting it could take months longer than anticipated to vaccinate people ages 65 and older, a health policy expert said a wider distribution network could improve efficacy and help the state advance further in its economic recovery. California has received nearly 5 million COVID-19 vaccine doses but only 2.2 million have been administered, according to the latest data from the CDC. . . . . . “They need to get with the program and get the vaccines out there...