Watch Dr. Wayne Winegarden, director of PRI’s Center for Medical Economics and Innovation, discuss how the Biden plan to lower prescription drug costs is disappointing and would lead to less access and higher costs for patients with Scripps National News. https://youtu.be/IeokdBjtjqk...
Biden Plan May Require 2/3 of American Workforce to Either Get Vaccinated or Weekly COVID-19 Tests President Biden laid out a six-step plan to control the spread of the highly infectious coronavirus Delta variant and get more Americans vaccinated against COVID-19. “We have the tools to combat the virus,” he said during a press conference today at the White House. “If we can come together as a country and use those tools… we can, and we will, turn the tide on COVID-19.” ....
Listen to PRI President, CEO, and Thomas W. Smith Fellow in Health Care Policy Sally C. Pipes provide insight on how the full approval Pfizer-BioNTech Covid-19 vaccine might increase vaccinations and affect vaccine mandates on Real News with Rick Outzen on WCOA-AM in Pensacola, FL. ...
By Henry I. Miller, M.S., M.D. and Sheeva Azma, MS In spite of the wide availability of highly effective COVID-19 vaccines, only about half of eligible Americans are fully vaccinated. Partly as a result of that "vaccine hesitancy," the United States is experiencing a fourth wave of COVID-19 cases, with over 160,000 on August 18th, more than an order of magnitude higher than in mid-June. Deaths, a lagging indicator, have more than doubled since mid-July. Hospitals and healthcare providers in the...
Medical devices are something of an orphan sister to the glamour of drugs, but they include some of the genuine miracles of modern medicine, particularly for seniors: Pacemakers, artificial joints, insulin pumps, and CT, MRI, and radiotherapy machines are just a few examples. The United States is currently the global leader in medical device innovation, and it is one of the few major industries that both boasts a net trade surplus and is a job creator. The sector employs 400,000...
By Peter J. Pitts, Robert Popovian, and Wayne Winegarden What happens when regulatory ambiguity displaces sound scientific guidance, deterring the legislative intent of Congress? This is precisely the situation regarding the FDA changing the regulatory rules of the road regarding a biosimilar’s strength versus its potency. It is a distinction with a difference – with the potential unintended consequence of disincentivizing both the development and uptake of biosimilars. It is also important to consider the implications of the legislative intent of...
The Pioneer Institute and Pacific Research Institute hosted an educational webinar on the importance of protecting treatment access, innovation, and equity as Washington addresses drug pricing reforms on July 19, 2021. Pioneer Institute, PRI, and special guests explored the current policy landscape on treatment value and access and how policy proposals that lean on the Institute for Clinical and Economic Review, or ICER, and similar approaches could impact certain patients. William “Bill” Smith, PhD, Visiting Fellow in Life Sciences, Pioneer...
Rebates and discounts are generally viewed as important competitive tools that lower prices for consumers, and rightly so. But consumers should beware when discounts create competitive restrictions that reduces their choices and increases their costs. Such is the case when dominant drug manufacturers use rebates to keep lower-priced drugs off the market – practices referred to as “rebate walls” or “rebate traps.” Fortunately, the Federal Trade Commission in a recent report to Congress suggests its poised to shine a spotlight...
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...
Dr. Henry Miller, PRI senior fellow in health care studies, joins PRI's "Next Round" podcast with an update on the pandemic, the progress of vaccine distribution, and his perspective on the CDC’s pause on the use of the Johnson & Johnson vaccine. https://youtu.be/sMwlbxAjrNE...
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”...
Listen to PRI's Dr. Wayne Winegarden discuss the importance of increasing health care transparency and his recent Inside Sources op-ed with host Steve Noxon on "Talk of the Town" on WATR Radio in Waterbury, CT. Click here to listen to the interview...