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December 29, 2021 Blog, Policy Proposals

By Henry I. Miller, M.S., M.D. and Jeff Stier When President Joe Biden nominated Obama-era Food and Drug Administration Commissioner Dr. Robert Califf to return to his old post, he made what is widely seen as a safe, if uninspired, choice. Califf is a distinguished cardiologist and clinical trial specialist, but the day-to-day regulatory decision-making happens at the organizational levels below the commissioner. The FDA, a huge and critically important but dysfunctional organization, now needs a bold, clear-thinking reformer, but Califf, the...

December 24, 2021 Blog, Coronavirus - Alternate, Policy Proposals

By Henry I. Miller, M.S., M.D. and John J. Cohrssen Earlier this week, President Biden outlined new steps to confront the growing spread of Covid-19 from the new, more infectious Omicron variant, which, in only a few weeks, has soared from virtually nonexistent to 73 percent of all new cases. Unfortunately, Biden’s plan failed to include what could be the most important action of all: an all-out effort to make safe and effective anti-viral Covid-19 pills available—two of which have now...

December 21, 2021 Price and Costs

Wayne Winegarden, PhD, Discusses the Value of an Interchangeable Designation for Adalimumab Biosimilars December 19, 2021 Skylar Jeremias The Center for Biosimilars® interviewed Wayne Winegarden, PhD, senior fellow in business and economics at Pacific Research Institute (PRI) and director of PRI’s Center for Medical Economics and Innovation. Click here to watch. Winegarden talked about how interchangeability designations are more important for biosimilars referencing adalimumab (Humira) because they would not administered by a physician in a clinic, unlike oncology biosimilars, which pharmacists do not interact with...

December 16, 2021 Industry Trends

Last week, President Joe Biden emphasized the importance of the drug pricing proposals in the Democrats' roughly $2 trillion Build Back Better spending package. "I think it's safe to say that all of us, all of us, whatever our age, wherever we live, we can agree that prescription drugs are outrageously expensive in this country," Biden said. "Under my Build Back Better bill, which has passed the House of Representatives, it won't be the same way." Build Back Better would make significant changes to drug pricing...

December 13, 2021 Coronavirus

Good public health policy is welcome, even when long delayed. So we should cheer the Biden administration's announcement earlier this month that Covid-19 rapid-result antigen tests (RATs), which tell you in as little as 15 minutes whether you're infected, will be covered by private insurance. For uninsured Americans, the government would make 50 million free tests available, to be distributed through health clinics and other sites in rural and underserved communities. Assuming that they can detect the new Omicron variant along with...

December 9, 2021 Industry Trends

The Center for Biosimilars® interviewed Wayne Winegarden, PhD, senior fellow in business and economics at Pacific Research Institute (PRI) and director of PRI’s Center for Medical Economics and Innovation. Winegarden said that because of the high costs associated with Humira (reference adalimumab) and Enbrel (reference etanercept), biosimilars of these agents are needed to establish a competitive marketplace and to drive down costs. He said the long exclusivity periods that the makers of Humira and Enbrel have secured must end to allow greater affordability;...

November 23, 2021 Coronavirus

An overwhelming consensus on any topic is very rare these days. But many Americans, whatever their political leanings, seem to feel that the policies, communications, and actions of the public health "experts" and politicians about the COVID-19 pandemic have been confusing, sometimes contradictory, and in some cases, inconsistent with the scientific evidence. Whether it was flip-flops on the effectiveness of masks, seemingly inane restrictions on certain activities, or baseless advocacy of ineffective drugs, the past 20 months have provided numerous reasons...

November 18, 2021 Blog, Coronavirus

Dr. Henry Miller and John Batchelor talk about the coverage around COVID-19 surges in Europe and elsewhere and what that could mean for lockdowns and vaccinations. They discuss how the United Kingdom is handling a potential new surge including masking, vaccinations, and the arrival of new surges. Miller also talks about the various surges, especially related to the delta variant and the impact of long COVID symptoms. ...

November 17, 2021 Blog, Industry Trends, Issues

By Wayne Winegarden and Celine Bookin Billionaire investor Mark Cuban’s pharmaceutical company, the Mark Cuban Cost Plus Drug Company, is hoping to disrupt the pharmaceutical benefit management (PBM) industry with a new venture that seeks to address some of the most criticized practices of the industry. These include PBMs pocketing rather than passing on negotiated rebates and not being transparent in how they negotiate said rebates. PBMs traditionally contract with governments and businesses to manage drug formularies, determine co-pays, administer plans, and negotiate...

November 2, 2021 Policy Proposals

Allowing the federal government to negotiate drug prices is a politically winning talking point. According to polling, Americans from across the political spectrum support this government intervention. However, the talking point is only a political winner if it is presented without context. Americans back the policy if it leads to direct savings in their pocketbooks while not diminishing access to life-saving therapies — whether through less investment in research and development by the pharmaceutical industry or restricted access to approved treatments. That this...

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...