Issues

SACRAMENTO – Nevada taxpayers could face millions in new bureaucratic costs and patients will likely see less access to life-saving drugs if state government mandates so-called “Maximum Fair Price” price controls on prescription drugs, finds a new brief released today by the Center for Medical Economics and Innovation at the nonpartisan, California-based, free-market think tank, the Pacific Research Institute. “Some Nevada lawmakers want to enact government price controls on prescription drugs in the name of lowering costs for patients,” said Dr....

READ THE PDF A California appellate court invented out of whole cloth a new and troubling theory of tort liability. Specifically, the court held that drug companies have a duty to develop and bring to market drugs that are supposedly safer and more effective than another, FDA-approved drug the company sells already. The claim rested on factual premises contradicted by all publicly available information, the acceptance of which could seriously disrupt the FDA approval process. This disruption gives rise to an...

On Jan. 17, just days before leaving office, the Biden administration announced the next 15 prescription drugs dispensed through Medicare Part D that will be subject to price controls on Jan. 1, 2027, under the terms of the Inflation Reduction Act. Among them is the blockbuster semaglutide, a prescription medication sold by Novo Nordisk under the brand names Ozempic, Wegovy, and Rybelsus for the treatment of Type 2 diabetes and obesity. The IRA required the federal government to publish the list...

On this Wednesday and Thursday, two powerful Senate committees will hold confirmation hearings for Robert F. Kennedy Jr., President Trump's nominee to lead the Department of Health and Human Services. RFK Jr. is no stranger to controversy. But his most radical policy position may be one that relatively few people are talking about. Politico recently reported that RFK Jr. has "expressed openness" to seizing drug companies' patents and relicensing them to generic manufacturers—a move that would effectively implement roundabout price controls on...

Just three days before President Biden left office, his appointees tried to tie incoming Trump staffers' hands on a health policy decision that affects millions of Americans and tens of billions in federal spending. On January 17, the Centers for Medicare & Medicaid Services announced a new list of 15 drugs under Medicare Part D that will be subjected to price controls under the Inflation Reduction Act on January 1, 2027. The list was announced this month despite the IRA not...

California State Senator Scott Wiener, D-San Francisco, recently introduced a bill aimed at reining in pharmacy benefit managers (PBMs), the middlemen largely responsible for the dysfunction plaguing our nation’s prescription drug market. Wiener’s effort should attract the support of lawmakers on both the left and right. By cracking down on the activities of PBMs, they can deliver real savings for patients at the pharmacy counter. Read the op-ed here....

CMS recently announced the next 15 drugs that will be subject to price negotiations under the Inflation Reduction Act of 2022 (IRA). These are negotiations in name only because CMS can levy penalties on any manufacturer that fails to comply with the process. Since the penalties include an excise tax up to 95% of a drugs total U.S. sales revenue, the law essentially empowers CMS to set its desired prices (e.g. price controls). Price controls discourage R&D spending. With less investment...

PRI’s scholars responded to today’s action by the Centers for Medicare & Medicaid (CMS) announcing 15 additional drugs under Medicare Part D that will be subject to government price setting effective January 1, 2027.  The action was authorized by the Inflation Reduction Act signed by President Biden in August 2022. According to Sally C. Pipes, PRI President, CEO, and Thomas W. Smith Fellow in Health Care Policy and author of the soon-to-be published book The World’s Medicine Chest: How America Achieved...

READ THE PDF Executive Summary Reforms that will strengthen the biosimilar market and expand savings opportunities include: Reforming (ideally repealing) the Inflation Reduction Act’s price control measures. Improving the incentives underlying the current buy-and-bill system to better align the financial incentives of providers, payers, and patients. Promoting greater transparency to the opaque drug rebating system including addressing the rebate wall problem through comprehensive reform or prohibiting the anti-competitive rebating practices that are generally outlawed in other markets. Given biosimilars’ demonstrated ability to...

The Centers for Medicare & Medicaid Services has proposed a rule expanding Medicare and Medicaid patients’ access to anti-obesity drugs such as GLP-1s. Congress is also considering such a move. Expanding coverage to these patient groups makes sense. Read the op-ed here....

READ THE PDF Executive Summary The Inflation Reduction Act’s price controls discourage biosimilar development. Payment system inefficiencies, such as the buy-and-bill payment system and rebate walls, disincentivize the use of lower cost biosimilars. Despite the savings biosimilars have already enabled, there are barriers to further progress. First, the price controls from the Inflation Reduction Act (IRA) disincentivize biosimilar development. Second, the convoluted pricing system discourages greater use of lower cost alternatives. How the payment system disincentivizes their use varies depending on whether...

The Pacific Research Institutehas filed an amicus curiae brief in a case before the California Supreme Court that has the potential to devastate innovation in future life-saving medications. The Gilead Tenofovir Cases surround questions of the liability of pharmaceutical companies over their decisions on drug development timelines. In the case, the plaintiffs filed cases against the Gilead pharmaceutical company over the company’s failure to bring an alternative medication used to treat AIDS, hepatitis, and other diseases to the marketplace called TAF under...

READ THE PDF Executive Summary Since 2019, biosimilars have obtained a majority share of most markets where they compete. The combination of lower prices (both biosimilar and originator) and rising market share could have generated up to $35 billion in savings in 2024 dollars compared to an all-originator baseline based on PRI’s latest analysis. These savings demonstrate that, just like with small molecule medicines, biosimilars strike a beneficial balance between incentivizing innovation and promoting affordability. Lower-cost Biosimilars Are Gaining Market Share The share...

“On the other side of the political spectrum is Wayne Winegarden, Ph.D., the Senior Fellow in Business and Economics at Pacific Research Institute, and Director of PRI’s Center for Medical Economics and Innovation. “He and his colleagues believe that patients are not in control of the health care system and that we suffer from an opaque and complex pricing structure that harms patients. “Winegarden’s free market approach means he advocates for doing away with the Obamacare subsidies that Congress must consider, as...

Low-cost biosimilars generated $19 billion in savings value in today’s dollars in 2023. But obstacles in the current drug pricing system meant that billions of dollars in potential savings were left unrealized. Join the Pacific Research Institute’s Center for Medical Economics and Innovation and panel of experts for a brief, informative webinar discussing how potential reforms can improve competition, generate more savings, and better serve patients and taxpayers. https://www.youtube.com/watch?v=-m7lNXr_dAw...

READ THE PDF Executive Summary In the competitive biologic markets, biosimilars have reduced average prices by 56 percent. The lower prices have reduced total expenditures by 51 percent in the competitive biologic markets even though total use is higher. Developing biosimilars is a long and costly endeavor that can take up to 9 years and $300 million. Market conditions should encourage uptake and appropriate reimbursement for physicians and manufacturers. Biologics – innovative medicines made, or derived, from biological processes – treat devastating...

Last week, a House subcommittee held a hearing on pharmacy benefit managers and their impact on the prices patients pay for prescription drugs.The hearing speaks to voters' concerns. Republicans and Democrats alike have identified the cost of prescription drugs as their No. 2 health care concern, according to polling this month from KFF.And PBMs deserve congressional scrutiny. These middlemen have used their enormous influence in the drug market to make prescription medications unaffordable for a sizable share of patients. Read the...

In a patently politicized press release, Senator Bernie Sanders (I-VT) who is  Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, claims that the U.S. price of Ozempic is too high. As evidence, he cites generic companies that claim they can sell Ozempic for less than $100 a month, an inherently flawed JAMA study that claims that these same diabetes drugs can be profitably produced for less than $5 a month, and inaccurate price comparisons with other countries. Debunking...

It's easier to have a car or refrigerator shipped to your home these days than a prescription. To get even the most common prescription drug still requires a visit to the doctor, a trip to the pharmacy, and a convoluted series of negotiations between insurers, middlemen, and pharmaceutical companies. Fortunately, that's starting to change. In recent months, drug companies Pfizer and Eli Lilly have begun rolling out direct-to-consumer programs that let patients purchase basic prescriptions remotely. Read the full article at Forbes...

The Inflation Reduction Act (IRA) effectively imposed price controls on a portion of the pharmaceutical market. Worse, by design, the reach of these price controls will expand every year. The intended consequence of the policy is to reduce overall spending on drugs, but all regulations have unintended consequences, too. While these consequences may be unintended, they need not be unexpected. In the case of the IRA, these unintended impacts now threaten to undermine the entire purpose of the policy. Read the full...