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July 28, 2021 Issues, Policy Proposals

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...

July 21, 2021 Multimedia

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...

June 24, 2021 Policy Proposals

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...

June 21, 2021 Coronavirus

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...

June 16, 2021 Innovation

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...

May 28, 2021 Policy Proposals

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...

May 16, 2021 Industry Trends

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...

May 13, 2021 Blog

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...

May 12, 2021 Industry Trends

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...

May 6, 2021 Innovation

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...

April 28, 2021 Industry Trends

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...

April 19, 2021 Multimedia, Policy Proposals, Resources, Value

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...

April 9, 2021 Industry Trends

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”...

April 1, 2021 Coronavirus-Alternate2

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...

March 24, 2021 Policy Proposals

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...

March 22, 2021 Blog

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...

March 4, 2021 Coronavirus

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...