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October 21, 2021 Coronavirus - Alternate

Whether it was flip-flops on the effectiveness of masks, seemingly inane restrictions on certain activities, or crass politicization of the use of ineffective drugs, the past 20 months have provided numerous reasons to question what we were told. Significant numbers of people are resisting employer mandates to get the COVID-19 vaccine and thereby jeopardizing their jobs. Still, there is a useful but misunderstood and underused mitigation tool — rapid-result antigen tests , which detect pieces of the SARS-CoV-2 virus's proteins — that can...

October 4, 2021 Policy Proposals

By Henry Miller, M.S., M.D. and John Cohrssen This year marks the 35th anniversary of the US Coordinated Framework for the Regulation of Biotechnology (https:// usbiotechnologyregulation.mrp.usda.gov/ biotechnologygov/about/about), 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). Click here to read the full article....

September 27, 2021 Coronavirus

As the Food and Drug Administration contemplates booster shots and a myriad of other regulatory issues related to the COVID-19 vaccine, it is essential to reiterate the importance of a vaccine that is available and recommended for every age group at no cost to the patient — the influenza vaccine. Throughout history, influenza has been responsible for far more mortality than any other individual ailment. And in the 2018-2019 flu season, the year before the COVID-19 pandemic, the Centers for Disease...

September 10, 2021 Coronavirus - Alternate

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.” ....

August 19, 2021 Coronavirus, Issues

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...

August 16, 2021 Industry Trends

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...

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...