Author: Wayne Winegarden

Once wide coercive powers are given to government agencies…such powers cannot be effectively controlled. F.A. Hayek As part of the chorus calling for drug price controls, the New York Times editorial page has claimed that “Americans will need to accept a trade-off that other advanced nations long since come around to: Slightly fewer new drugs will come to market, in exchange for better prices on the medications that already exist”. There is not one part of this statement that is true. Worse, if the Times’...

“Three hundred forty-five billion dollars in savings versus the cost of eight to 15 fewer drugs over 10 years, I frankly think it’s worth it.” Rep. Darren Soto (D-FL), hearing before the House Energy and Commerce Committee In the above quote, Representative Soto is defending H.R. 3, the drug price control bill Speaker Nancy Pelosi is advocating. While the Congressman believes that the costs of price controls are “worth it”, patients living with diseases that lack an effective treatment may disagree. While there has...

In September 2018, the Centers for Medicare & Medicaid Services (CMS) sent an email announcing that it would no longer cover Auryxia®. Auryxia® is an FDA approved medicine that treats iron deficiency anemia (anemia) for patients with chronic kidney disease (CKD) but who are not on dialysis. People with CKD have damaged kidneys that no longer filter their blood properly. Currently, 30 million people in the U.S. are living with CKD, and for these patients, anemia is common. If left untreated,...

Despite their abysmal track record, government solutions are back in vogue. Ostensibly, government’s scale, leverage, and freedom from profit will unlock potential health care savings that are beyond the reach of the private sector. At their most extreme, reforms such as “Medicare for all” call for a complete government takeover of the health care system. Proponents of single payer reforms claim that only a complete government takeover of the health care sector can eliminate the health care sector’s inefficiencies and ensure 100 percent...

Biosimilars have the opportunity to bring significant savings to state Medicaid programs and consumers with commercial insurance according to a new study released today by Pacific Research Institute. “Every state would experience significant savings in the state Medicaid programs from expanding the use of biosimilars compared to the more expensive originator biologics,” said Dr. Wayne Winegarden, director of PRI’s Center for Medical Economics and Innovation and author of the new issue brief on biosimilars. “The same benefits will also accrue to...

When it comes to determining value, the U.S. health care system faces unique challenges. Without a better approach, the twin goals of continued innovation and broad-based drug affordability will be difficult, if not impossible, to maintain. Value assessment models are quickly becoming the approach du jour to overcome these challenges. However, value assessment models suffer from several flaws, but perhaps most importantly, as applied, these models assume that there is one number that accurately portrays the value of a medicine to all patients. Such an...

San Diegans and all Californians will pay a high price should a bill introduced by Assemblyman Jim Wood, a Democrat from Santa Rosa, become law. Proponents claim the bill is necessary to rein in anti-competitive practices by the pharmaceutical industry, but in reality, it will delay generic entry and raise the costs of medicines for Californians. The ostensible rationale for Assembly Bill 824 is to stop “pay-for-delay” tactics. “Pay-for-delay” refers to the practice of patented drug manufacturers paying off generic manufacturers for the sole...

Making medicines more affordable for patients promises to be a top policy priority for Congress when it returns from its August recess. Achieving this goal does not require new, elaborate, government programs or regulations. It requires reforms that will empower biosimilars to more effectively compete against originator biologics. To see why a little background is needed. Consider that the growth in spending on drugs that includes all discounts and rebates grew 3.5% annually between 2009 and 2018 according to IQVIA’s annual review of...

The Trump Administration's Department of Health and Human Services (HHS) has officially proposed legalizing the importation of drugs from Canada (e.g. the Safe Importation Action Plan). Canadians’ reactions provide an important perspective demonstrating why drug importation will harm the U.S. Despite assurances from Prime Minister Justin Trudeau, Canadians are worried that the U.S. proposal will impose severe costs on Canadians. Their concerns are well founded. Typical of their reaction, the Canadian Pharmacists Association (CPhA) has noted that the Canadian medicine supply is not equipped...

Without pro-market payment reforms, cutting edge medical treatments known as gene therapies run the risk of becoming the dance that no one attends. Gene therapies are not medicines, instead, they are akin to an organ transplant. These procedures typically use re-engineered viruses to repair, replace, or shut off malfunctioning genes that cause devastating diseases. For example, the newest gene therapy to obtain FDA approval, Zolgensma, could save the lives of people with spinal muscular atrophy (SMA), a fatal genetic disease. Children...

From the time we were toddlers, it has always been tempting to bang the square peg into the round hole. After all, there is always that one square peg that seems like it should just about fit into that round hole, and it would feel so satisfying if it did. Alas, square pegs don’t fit into round holes. The analogy is apropos for Congress’ current approach to drug prices. In the latest iteration, the Senate Health, Education, Labor and Pensions (HELP)...

Biosimilars have the potential to realize billions in savings for the health care system if reforms are enacted to incent their market share to grow, according to a new issue brief issued today by the Center for Medical Economics and Innovation at the California-based, free-market think tank, the Pacific Research Institute. “Biosimilars are innovative medications that can treat patients at lower costs,” said Dr. Wayne Winegarden, director of PRI’s Center for Medical Economics and Innovation and author of the issue brief. ...

The Trump Administration is proposing a litany of contradictory healthcare reforms. Some reforms will empower patients, improve incentives, and strengthen the healthcare system. Others empower bureaucrats, worsen incentives, and will restrict patients’ access to needed healthcare treatments. A better outcome will only emerge if the Administration jettisons the ill-advised proposals and focuses policy on eliminating the disincentives that pervade the current healthcare system. Starting with the bad, the Trump Administration is threatening to impose government-mandated price controls on pharmaceuticals. Of course, this...

Determining whether the prices for medicines are appropriate or not is critically important, which is why studies that attempt to answer this question must stand up to scrutiny. Studies that undervalue medicines jeopardize the development of future cures, while studies that overvalue medicines justify the imposition of excessive health care costs today. Judged against this goal, a recent World Health Organization (WHO) technical report is disappointing. In this report the WHO claims that the industry’s current pricing approach “makes cancer medicines...

The World Health Organization (WHO) is advocating that the price of cancer treatments are excessive, but its report that justifies this conclusion contains significant biases that drastically over-estimates the revenues multiple over research and development (R&D) costs, according to a new issue brief released today by the Center for Medical Economics and Innovation at the non-partisan Pacific Research Institute. “Cancer medications have revolutionized treatment, and it is unfortunate if the WHO’s flawed analysis jeopardizes patients’ access to these life-saving medicines” says...

The U.S. economy thrives on innovation. According to the U.S. Patent and Trademark Office, industries that intensively rely on intellectual property (IP) protections, which includes the biopharmaceutical industry, account for nearly 40 percent of the U.S. economy and are responsible for an outsized share of our overall economic growth. Beyond the growth benefits, innovations improve our lives in countless ways. From mobile technologies inaptly called “mobile phones” to cutting-edge medicines that treat formerly incurable diseases, innovation helps us live better lives. Within this...

The Senate Health, Education, Labor & Pensions (HELP) Committee has just released a bi-partisan bill authored by Senators Lamar Alexander (R-TN) and Patty Murray (D-WA) that would make health care more affordable and more transparent for patients. These reforms are not grandiose fantasies that are destined to fail, such as “Medicare for All”. Instead, the bill proposes modest “common sense” reforms that target specific inefficiencies and disincentives that plague the current health care system. For starters, the bill would promote greater...

The wrong model, no matter how hard you work it, will never provide the right answer. When it comes to how we pay for health care, the U.S. is using the wrong model. What’s worse, these financing inadequacies could threaten the viability of new therapies that will bring hope to patients who formerly had none. The well-being, and sometimes the lives of patients, depend on getting the health care financing model correct. New gene therapies will transform the treatment of devastating diseases. For...

There is a legal adage that “hard cases make bad law.” California may soon rediscover this wisdom. Assembly member Jim Wood has introduced a bill (AB 824) with the intention of discouraging “pay-for-delay” tactics. “Pay-for-delay” practices refer to a situation when a manufacturer of a patented drug pays the manufacturer of a generic drug to delay launching its competitive product in order to extend its exclusivity period. Undoubtedly, these practices are anti-competitive and violate the spirit of the entire patent system. Such...