Issues

The powers that be in Washington are renewing their campaign to gain greater control over Americans’ ability to access life-saving drugs. Lawmakers and regulators alike have decided to wage war on one of the few components of our health care system that works well — the Food and Drug Administration’s accelerated approval process. This regulatory pathway has saved countless lives by speeding groundbreaking medicines to market. Obstructing that pathway would be folly. The FDA created the accelerated approval pathway in 1992 in...

The quickest way to get less of something is to regulate it. Nowhere is that more apparent than in the health sector, which suffers from a chronic shortage of physicians, particularly in primary care. And it’s about to get worse. According to the Association of American Medical Colleges, the United States is facing a shortfall of up to 48,000 primary care physicians by 2034, especially in rural and historically marginalized urban areas. Many states are turning a blind eye to this looming shortage...

SACRAMENTO – Biosimilars competition saves patients and the health care system over $11 billion annually and could generate even more savings if the broken drug pricing system were reformed, finds a new issue brief released today by the Center for Medical Economics and Innovation at the nonpartisan Pacific Research Institute. “Patients living with cancer, autoimmune diseases, osteoporosis, and other illnesses are receiving revolutionary treatment from biologics,” said Dr. Wayne Winegarden, the Center director and the study’s author. “As our research shows,...

President Joe Biden returned from vacation in South Carolina this week to sign the Inflation Reduction Act into law. The country would have been better off had he stayed at the beach. The IRA includes a combination of massive tax increases, innovation-destroying price controls, and debt-funded spending commitments. That might be music to the ears of Democrats. But for American households struggling with spiraling prices, the future has rarely looked so dim. The new spending package comes at a moment of widespread pessimism about the future of...

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...

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...

Progressives claim that medical debt leads to financial ruin for hundreds of thousands of Americans each year. Sen. Bernie Sanders, I-Vt., recently argued that the high cost of health care is pushing so many people into bankruptcy that the government must cancel medical debt. It's the precursor to his call for a federal takeover of the entire health insurance system so that no one has to pay for medical care directly again. Medical bills can be onerous. But they account for a...

Some Illinois hospitals are keeping their prices secret from their patients. Only three out of a sample of 11 major medical facilities in the state are fully compliant with a federal rule requiring hospitals to publish the costs of common services, according to data from the nonprofit group PatientsRightsAdvocate.org. That includes hospitals in Chicago. Hospitals shouldn’t be able to get away with flouting the law like this. Price transparency empowers patients and payers to shop around for medical care — and ultimately...

The Democrats' budget reconciliation bill is winding its way through the Senate. Last week, Republican and Democratic senators met with the chamber's parliamentarian to discuss whether the bill's proposal for Medicare to negotiate the price of prescription drugs with manufacturers has a direct impact on government spending or tax revenue, as reconciliation rules require. But these are not negotiations. They're price controls. The bill's text sets maximum prices that the government will pay — and threatens confiscatory taxes for drug companies that refuse to...

CLICK HERE TO READ THE BRIEF Establishing an Efficient Health Insurance Market Cultivating an efficient health insurance market requires reforms that empower patients over payers, which can be achieved by: Making health expenditures and health insurance expenditures tax deductible;  Broadening the availability and usability of tax-free saving accounts to help patients cover the deductibles and out of pocket expenses that could arise should they require costly healthcare services; and Promoting price transparency and insurance competition to enable a more competitive pro-patient healthcare...

Late last month, the Food and Drug Administration advised COVID-19 vaccine manufacturers to develop booster shots aimed at the omicron variant of the virus. Regulators hope the shots will be ready by the fall. That will probably be too late to stop BA.5, the highly transmissible subvariant that has quickly become the dominant strain in the United States. It's been roughly six months since omicron caused COVID cases to spike. Yet the FDA waited until a new, more transmissible version of the virus was threatening a wave of cases...

Every month, it seems, the United States smashes another unenviable record when it comes to drug addiction and overdose statistics. According to the Centers for Disease Control and Prevention (CDC), the latest data show a jaw-dropping 108,000 overdose deaths in 2021. America’s families and communities are reeling — and the federal government needs to help. As part of a broader strategy to save lives, Congress and the Biden administration must embrace efforts to prevent addiction before it can begin. This means reducing the overprescribing of...

The following op-ed has been authored by a non-clinician, it does not constitute medical advice. In an effort to boost access to the antiviral Paxlovid, the Food and Drug Administration (FDA) will now allow pharmacists to prescribe the medicine; the agency announced this last week, on July 6. Previously, patients seeking the drug, which has proven highly effective at preventing severe illness and death from COVID-19, needed a prescription from a doctor. That hurdle never really made sense. Paxlovid must be taken no more than five days...

With inflation rising and midterm elections just months away, Democrats are desperate for something they can pitch to voters as a reason to keep them in control of Congress. They're hoping a watered-down version of their Build Back Better Act could do the trick. Sen. Joe Manchin, D-W. Va., who helped shoot the bill down last winter, has met repeatedly with Senate Majority Leader Charles Schumer, D-N.Y., in recent weeks in an effort to hash out a compromise on the massive spending package. Reports indicate a proposal to...

Imagine you’ve been diagnosed with chronic kidney disease, told by your physician that if it can’t be managed, you may eventually need a transplant or long-term dialysis. This scary situation is one faced by hundreds of thousands of Americans every year. Chronic kidney disease (CKD) is an illness that affects an estimated 37 million people in the U.S. That’s more than one in seven adults across the country, or nearly the entire population of California. Despite this alarming statistic, investment in kidney disease...

Proponents of prescription-drug importation notched a victory last week. The Senate Health, Education, Labor, and Pensions Committee green-lit a bill that would enable individuals to import medicines from Canada in the name of lowering out-of-pocket costs. It's not something Americans should welcome or support. Drugs imported from outside the United States will always pose a significant safety risk. Even if they didn't, importing medicines from countries with price controls on drugs would have devastating effects on medical innovation at home. It's an article of...

The House passed bipartisan legislation last week that could help reduce costs and ensure continued innovation for the future. While this legislation might not be covered as extensively as other issues, it nonetheless represents meaningful progress. This week, the Senate HELP Committee passed the Senate version, the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, a reauthorization of Prescription Drug User Fee Act (PDUFA), the Biosimilars User Fee Act (BsUFA), and the Generic Drug User Fee Amendments (GDUFA). These...

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...