Issues

Home > Issues (Page 9)

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 Coronavirus-Alternate2

Dr. Henry Miller joins the John Batchelor Show to discuss the FDA's footdragging on COVID-19 vaccines for continued use and the nuances of what the emergency use declarations mean. Miller talks about the data behind full vaccine approval and what it would take for the FDA to issue a final approval. ...

July 19, 2021 Coronavirus

Two months, one week, and five days. That's how much time has passed since Pfizer and BioNTech filed for approval from the U.S. Food and Drug Administration for their Covid-19 vaccine. The agency has not hinted when that decision might be coming. Moderna formally asked the FDA for approval of its vaccine seven weeks ago. There's been no word on when the agency will complete its review. Experts say the FDA will likely grant the applications "priority review." Translating from the bureaucrat-ese, that's within six months of...

July 18, 2021 Coronavirus - Alternate

It's been about six months since the Food and Drug Administration allowed the distribution of the first COVID-19 vaccines via emergency use authorizations, which are preliminary approvals during a public health emergency based on lower standards of safety and efficacy than for a normal, or "full," approval. As of July 13, 48.1% of the U.S. population had been fully vaccinated. However, uptake has been inconsistent among different groups and locales, the earlier momentum for vaccination has waned, and there are surges of...

July 18, 2021 Industry Trends

Millions of people have canceled doctor’s appointments and postponed elective surgeries over the past 18 months. But now that the pandemic has largely subsided, many patients feel it’s once again safe to seek care. A Gallup poll conducted in May found that nearly 17% of Americans had gone to a hospital, doctor’s office, or treatment center in the previous 24 hours, up from just 6% the year before. Whether patients actually receive the care they’re seeking, though, depends entirely on where they...

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...

July 7, 2021 Issues, Policy Proposals

The myth about endangered, disappearing honeybees lives on — with potentially dire implications. Rep. Earl Blumenauer, an Oregon Democrat, just reintroduced “Save the Bees” legislation that would eliminate farmers’ most advanced and effective defenses against crop-destroying pests in the name of preventing imaginary bee declines and preserving food security, which the bill would actually undermine. According to Blumenauer’s press release, “The United States lost an estimated one-third of its honeybee colonies between 2016 and 2018.” This sounds scary, except the Department of...

July 5, 2021 Blog, Coronavirus, Policy Proposals

America’s vaccination campaign is stalling. In late June, pharmacists and other providers were administering roughly 800,000 shots a day — down 80 percent from a peak of more than 4.6 million in mid April. Because of this precipitous decline, the Biden administration recently admitted it would miss its self-imposed goal of vaccinating at least 70 percent of American adults by Independence Day. So far, only 66 percent have gotten the jab. The Centers for Disease Control and Prevention (CDC) deserve much of...

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 24, 2021 Industry Trends

Dr. Henry Miller talks about potential life-saving medical technology with organ transplants on the nationally-syndicated Lars Larson Show. Dr. Miller talks about advances in 3-D printing for liver, gallbladder, and even heart transplants and why the FDA is slow to test and approve these groundbreaking practices. Dr. Miller's segment begins at the 48-minute mark. Lars Larson National Podcast · Lars Larson National Podcast 06-22-21...

June 22, 2021 Policy Proposals

The Kaiser Family Foundation recently surveyed more than 300 companies with more than 5,000 employees — and found that 83% believed that “a greater government role in providing coverage and containing costs would be better for their business.” They’re gravely mistaken. A health care system that features even more government control than the status quo would mean higher taxes and bigger recruitment challenges for companies — not to mention lower-quality care for their employees. Government could tighten its grip on our health...

June 22, 2021 Industry Trends

Demand for doctors is far outstripping supply. The United States will face a shortage of up to 124,000 physicians by 2034, according to projections out this month from the Association of American Medical Colleges. Already, many Americans are struggling to get the care they need. About 35% of patients had trouble finding a doctor in the past several years, according to a 2019 survey. That's up from 25% in 2015. This physician shortage disproportionately affects Americans in rural and historically neglected urban areas. Medical schools are taking...

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...

June 16, 2021 Coronavirus-Alternate2

PRI's Dr. Henry Miller talks about the misleading claims about national vaccine rates versus progress by each state, and how the vaccine rates breakdown by region with the nationally-syndicated Lars Larson Show. Dr. Miller also discusses statements about vaccines by President Joe Biden during his run for the presidency and it's impact on current vaccination rates. Lars Larson National Podcast · Lars Larson National Podcast 06-15-21...

June 10, 2021 Coronavirus - Alternate

The COVID-19 vaccines have been nothing short of miraculous. Life is returning to normal in many places. But ACSH advisor Dr. Henry Miller argues that we will still need effective medical treatments for COVID-19. COVID-19 vaccines are the miracle that has significantly suppressed the pandemic in a number of countries, including the United States, where the current seven-day moving averages of cases and deaths are at levels not seen since March of 2020.  With continued aggressive vaccination, we can further suppress the numbers – getting us...

June 10, 2021 Blog, Industry Trends

Dr. Henry Miller, physician, molecular biologist, and senior fellow with PRI, talks to the Lars Larson Show about the new Alzheimer drug approved by the FDA. Dr. Miller gives the history of Alzheimer drug approvals and the controversy around it. Larson and Dr. Miller talk about the approval process used by the FDA, costs, and how additional testing for the drug would work. Dr. Miller's segment begins at the 47-minute mark.  Lars Larson National Podcast · Lars Larson National Podcast 06-08-21...