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January 26, 2023 Issues, Policy Proposals, Price and Costs

A group of 25 senators, led by Sen. Elizabeth Warren (D-MA), requested that HHS Sec. Xavier Becerra exercise march-in rights for Xtandi (enzalutamide), a prostate cancer therapeutic. March-in rights give the government the right to take a license for itself if it helped to fund the product owner's research . . . “Net prices, which take into account discounts and rebates, have been going down for several years,” Wayne Winegarden, Ph.D., senior fellow, business and economics, Pacific Research Institute, told BioSpace. “Gross...

November 14, 2022 Innovation, Issues

By Wayne Winegarden, Robert Popovian & Peter Pitts Biosimilars, to date, have achieved the promise of reducing prices and drug spending in the United States. The unquestioned safety and efficacy of biosimilars have given providers, patients, and employers, amongst many others, the confidence that savings will be even more robust as we embark on the primary target: the launch of Humira (adalimumab) biosimilars. Humira is by far the all-time biopharmaceutical revenue generator, with more than $15 billion in US sales in 2021.[1] Adalimumab biosimilars will also be...

August 9, 2022 Issues, Policy Proposals

By Henry Miller & Stanley Young Are you confused about conflicting “research” findings on certain foods’ effects on our health? It would hardly be surprising. First, butter is the enemy; then, it’s solid margarine. Is caffeine good or bad for your heart? For a time, beta-carotene supplements are thought to prevent cancer — until they are found to increase the risk of lung cancer in smokers. And finally, does a woman’s diet at conception determine the sex of her fetus? When you do a...

August 2, 2022 Coronavirus, Issues

By Henry Miller and Josh Bloom President Biden’s bout with COVID-19 is illustrative of the debate currently raging about “Paxlovid rebound” — the recurrence of symptoms and of testing positive for SARS-CoV-2 after a seemingly successful five-day treatment course of Paxlovid. This phenomenon is not unusual, and it suggests that regulators should modify the terms of the drug’s Emergency Use Authorization. When he headed the Food & Drug Administration, Dr. Frank Young used to admonish his minions that sometimes regulations need to...

June 14, 2022 Coronavirus, Issues

By Henry I. Miller and Josh Bloom Decades ago, a case report (relating the experience with a single patient) was published which described how a person’s flu symptoms improved after a bowl of chicken soup, but then reappeared. The article was meant as a kind of parody of the old maxim that chicken soup is the best cure for a cold. Pediatricians occasionally see a similar phenomenon when children are treated with an antibiotic for an ear infection; they may then...

May 4, 2022 Coronavirus

By Henry I. Miller and Jeff Stier The two-years-plus of the COVID-19 pandemic should be a wakeup call that there is something very wrong – irreparable, even – at the chronically inept World Health Organization (WHO). Two recent transgressions show that the bureaucrats there are not getting any smarter. The first is almost inconceivable. Medicago, a Canadian company, developed a COVID-19 vaccine synthesized in the Nicotiniana plant, a relative of tobacco. In clinical testing, it showed efficacy against all variants studied prior to the emergence of Omicron of 71%, and for...

March 1, 2022 Blog

By Henry Miller and Melissa Hart We're learning more every day about the SARS-CoV-2 virus, but it will likely present surprises. The best strategy is still to prevent new infections. Donald Rumsfeld, the two-time secretary of defense (Gerald Ford and George W. Bush administrations), is perhaps best remembered for a response he gave to a question during a 2002 news conference: As we know, there are known knowns; there are things we know we know. We also know there are known unknowns; that is...

February 22, 2022 Issues, Multimedia, Policy Proposals

Watch PRI’s Wayne Winegarden, director of our Center for Medical Economics and Innovation, discuss efforts by the Federal Trade Commission to considering ordering large pharmacy benefits managers to study the competitive impact of contractual provisions, reimbursement adjustments, and other practices affecting drug prices on Scripps National News. https://youtu.be/DQsjKM44ScQ...

February 1, 2022 Innovation

By Henry Miller and Kathleen Hefferon Much of the world is preoccupied with the ongoing coronavirus pandemic, but there are other global challenges, including climate change, food security, and degradation of the environment. Interestingly, and perhaps ironically, there is some good news regarding the latter three from a recent breakthrough in microbiology.   Plants depend upon beneficial interactions between roots and root-associated microorganisms for growth promotion, disease suppression, and nutrient availability. Crops require nitrogen to grow, and although there is an abundance of...

January 10, 2022 Blog

By Henry I. Miller and Drew L. Kershen It's no secret that Congress sometimes does things – including creating laws – that make little sense and that are contrary to the public interest. One of the most egregious of those laws has just taken effect. The subject – labeling of foods that have been "genetically modified," or "bioengineered" — is somewhat obscure, but the measure, in the form of a Department of Agriculture regulation that was mandated by the law — affects...

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...