Innovation

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On this page, you’ll find the Center’s analysis on how free-market policies can better balance the competing interests of medical innovation and competition. Here, you’ll find our research and commentary on such issues as patents, research and development spending, and reforms that will promote more robust competition.

November 23, 2021 Innovation

Millions of Americans may soon be able to hear a bit easier. The Food and Drug Administration just announced a new rule that would permit over-the-counter sales of hearing aids. Regulators are soliciting comments from the public. This move to liberalize the market for hearing aids is an unmitigated piece of good news. It recognizes that patients should have greater control over the care they receive, and it promises to increase competition in the market for hearing aids, saving consumers money...

September 30, 2021 Innovation

Dr. Henry Miller talks to the nationally-syndicated Lars Larson Show based out of Oregon about innovations in artificially constructed organs and tissue that could be used to make up for the shortage of organ transplants. Miller also talks about the use of genetically-engineered animals, and the regulatory issues with the FDA, to develop organs for transplant into humans. Lars Larson National Podcast · Lars Larson National Podcast 09-28-21...

September 27, 2021 Innovation

Modern medicine has produced many kinds of high-tech miracles, among them gene therapy to correct malfunctioning genes, electrical stimulation devices to restore significant function after traumatic spinal cord injury, and surgery performed by robots. Another medical area that desperately needs breakthroughs is transplantation of solid organs. We are making progress but are not quite there. Currently, donor organs — from a living donor or cadaver — must match the recipient's tissue type and size, and often, they are not perfect. By one estimate, approximately half of...

August 20, 2021 Innovation, Issues

The study of genetics has always been an attempt to understand our biologically determined fate. Many of us know of families with a predisposition to maladies like heart disease or breast cancer. There are many kinds of interventions that can modulate the effects of our genetic endowment, whether directly (as in highly sophisticated gene therapy for genetic diseases) or pharmaceutical treatments, such as human growth hormone for growth hormone deficiency. But even when such targeted interventions aren't possible, we can modulate...

July 9, 2021 Blog, Innovation, Policy Proposals

It’s time for your annual physical. You make an appointment with your doctor and mark the date on your calendar. But when the day arrives, you don’t set aside two to three hours or wait for a nurse to call your name in a sterile doctor’s office. You log onto your laptop from the comfort of your living room. The process takes less than 30 minutes. For many Americans, this was a reality amid the pandemic, when lots of care was delivered...

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...

June 3, 2021 Blog, Coronavirus-Alternate2, Innovation

On April 13th, citing "an abundance of caution," after the appearance of a few rare blood clots in the brain (cerebral venous sinus thrombosis, or CVST) following administration of the Johnson & Johnson COVID-19 vaccine, the FDA announced a "pause" in its administration. Regulators reversed course just ten days later, after confirming that the incidence of that adverse reaction was, indeed, extremely low, and that the benefits of receiving the vaccine overwhelmingly outweighed the risks. The decision to pause was precipitated...

May 28, 2021 Blog, Innovation

This week, lawmakers in the House and Senate introduced bills that could preserve access to telehealth for Medicare and Medicaid beneficiaries beyond the pandemic. The House measure would allow Medicare beneficiaries to continue receiving “audio-only” remote care — that is, by phone. The Senate bill would direct the federal government to come up with a list of telehealth services that state Medicaid and the Children’s Health Insurance Program should cover. This sustained enthusiasm for telehealth is great for patients. State and federal officials relaxed...

May 16, 2021 Innovation, Issues, Price and Costs

[vc_row css_animation="" row_type="row" use_row_as_full_screen_section="no" type="full_width" angled_section="no" text_align="left" background_image_as_pattern="without_pattern"][vc_column width="2/3"][vc_column_text css=".vc_custom_1621192674245{padding-right: 40px !important;}"]DOWNLOAD THE PDF In October 2019, the Center for Medical Economics and Innovation at the Pacific Research Institute released its second study documenting the savings potential enabled by biosimilars. Biosimilars are medicines manufactured in, or derived from, biological sources that are developed to be similar to FDA-approved reference products. Biosimilars are approved to compete in nine biologic drug classes in the U.S., and are available in seven of these drug...

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...

January 7, 2021 Innovation

By Henry Miller, M.S., M.D. and Kathleen Hefferon, Ph.D When was the last time you read an online magazine or newspaper, only to find yourself bombarded with shopping ads specifically targeted to your preferences and needs, seemingly by magic? How about the detection of fraud or the filtering of spam from your email inbox? Well, that was most likely the handiwork of "machine learning," a subset of artificial intelligence that uses computer algorithms that over time and multiple experiences, or iterations,...

December 16, 2020 Coronavirus, Coronavirus - Alternate, Innovation

By Henry I. Miller, M.S., M.D. and John J. Cohrssen 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...

December 15, 2020 Coronavirus, Coronavirus - Alternate, Innovation

To the editor of the Wall Street Journal: Your editorial contains the statement: "There's no evidence that a three-week review is needed." You know this how, exactly? Has anyone at the Journal seen the data (which run to hundreds of thousands of pages)? Has anyone at the Journal ever seen, let alone touched, an application for approval of a drug or vaccine? I have. As an FDA reviewer, I found extraordinary complexity, and sometimes shortcomings or inconsistencies, in many submissions ....

December 15, 2020 Coronavirus, CoronaVirusSlide3, Innovation

Public Health And Economic Growth Are Two Sides Of The Same Coin Vaccination of high-risk groups against SARS-CoV-2, the virus that causes COVID-19, has begun in earnest – and not a moment too soon because the trends in the United States are moving in the wrong direction. On December 13, records were set for 7-day averages of daily cases ((211,494), the number of people hospitalized (106,656), and daily deaths (2,427); and with the Christmas and New Year’s holidays approaching, we can expect worsening...

December 10, 2020 Blog, Innovation

By Henry Miller, Shiv Sharma Much of the progress in medicine during the past half-century has involved expensive, high-tech diagnostic tests and therapies.  The trend in this direction worries health economists and politicians because it has the potential to send already-high healthcare costs into the stratosphere. However, in both medicine and dentistry, there is an important role as well for ingenious, low-tech, less expensive approaches to improved health and increased longevity. The FDA last year approved a high-tech gene therapy drug, Zolgensma, for a...

November 25, 2020 Blog, Coronavirus-Alternate2, Innovation

By Henry I. Miller, M.S., M.D. and John J. Cohrssen 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. Two things about those trends are especially problematic: first, deaths are a lagging indicator, following chronologically behind cases and hospitalizations, so the death curve will continue upwards; and...

October 29, 2020 Coronavirus - Alternate, Innovation

For the more than 7 million Americans who inject insulin, Friday will mark an important anniversary: 38 years since the Food and Drug Administration (FDA) approved the use of human insulin synthesized in genetically engineered bacteria. This momentous event launched a revolutionary new era in pharmaceutical development, and, as the FDA medical reviewer of the product and the head of the evaluation team at the time, I had a front-row seat. To commemorate the event, I open a bottle of champagne every...

October 13, 2020 Briefs, Innovation, Price and Costs

A new brief released today by the Center for Medical Economics and Innovation at the nonpartisan Pacific Research Institute shows that counterfeit drugs put patients in harm’s way, hinder drug innovation, and lead to job losses. Proposals like drug importation or price controls, if implemented, would exacerbate the problem and result in more health and economic consequences. Click here to download the brief “Counterfeit drugs expose patients to potentially lethal contaminants, and may also increase public health risks by failing to effectively...

July 28, 2020 Coronavirus-Alternate2, Innovation, Issues

It's hard to find a silver lining in a pandemic. But one of the few may be the rapid rise of telemedicine. With people stuck at home, doctors retooled their practices to see patients via videoconference. Insurance companies and regulators expanded the number of services available via telemedicine—and made reimbursement for telehealth consultations on par with conventional in-person visits. The Federal Trade Commission has now called on officials at the Centers for Medicare & Medicaid Services (CMS)  to permanently extend the emergency...

July 9, 2020 Innovation

The COVID-19 crisis has tested America’s health care system like no other event in recent memory. One irony during this pandemic is that America has actually experienced the promise of health care innovation in an important way, namely through telehealth. Telehealth allows patients to talk with their doctors online using videoconferencing platforms. Doctors can see patients, discuss their symptoms, order tests, and even prescribe medication. Earlier this spring, as the coronavirus was becoming a serious problem across the country, Congress temporarily suspended regulations...