Policy Proposals

On this page, you’ll find our analysis on key state and federal pharmaceutical policy proposals, with a focus on providing the expected economic impact from these proposals.

Bringing a new drug to market now takes, on average, $2.6 billion and more than 10 years. Those numbers could shrink, and countless patients could benefit, if Food and Drug Administration regulators were less risk-averse. I know that from firsthand experience. Oct. 30 marks the 36th anniversary of the FDA's approval of human insulin synthesized in genetically engineered bacteria, the first product made with "gene splicing" techniques. As the head of the FDA's evaluation team, I had a front-row seat. Although...

Rarely is there bipartisan agreement that a tax cut won’t cost the federal government money. But, in the case of the medical device tax (a 2.3 percent tax on medical devices and products that was passed as part of the Affordable Care Act) this is true by definition because the tax is already suspended. The tax applies to medical devices such as pacemakers, advanced imaging technology (Cat Scan, MRI and ultrasound equipment), artificial joints, surgical gloves, and dental instruments. Devices that...

The controversial medical device tax hurts doctors, patients and manufacturers and should be repealed by Congress. The medical device tax imposes a 2.3 percent tax on such common items as pacemakers, CT scan machines, dental instruments, and artificial joints. It is currently suspended. Congress isn’t even collecting the revenue it anticipated, and it has also led to lower investment in research and development in new medical technology....

Although best-known for its peace-keeping in areas of conflict — where it enjoys a mixed record, at best — the U.N.'s agencies, programs, commissions and international agreements have a dismal record of accomplishment, especially while acting as the world's regulator-wannabe for all manner of products, processes and activities. The U.N. regularly panders to activists and, not coincidentally, adopts policies that expand its own scope and responsibilities. Science and free market principles routinely get short shrift. U.N. programs and projects inevitably become...

Last Friday, President Trump delivered a major speech from the White House Rose Garden on prescription drug prices. He announced several policies aimed at reducing the overall cost of pharmaceuticals and limiting patients’ out-of-pocket expenses. His reform agenda, entitled “American Patients First,” is largely excellent. It mostly harnesses the power of free-market competition, rather than government price controls, to drive down costs for patients while continuing to incentivize drug manufacturers to invest in innovative, lifesaving research. Contrary to popular belief, drug spending...

Health care is becoming less affordable every year. Over the past 10 years, national healthcare expenditures have grown 45 percent, but our economy has grown only 28 percent. This isn’t sustainable; and, solving this problem should be a top policy priority. However, “rounding up the usual suspects,” as Captain Renault might suggest, will not make U.S. health care system more affordable. One of the usual suspects is drug costs. Polling shows the American public blames pharmaceutical companies for high healthcare prices, perhaps...

Congress has undermined the Medicare drug benefit that millions of older Americans depend on – one of the few federal health care programs that's working well. The two-year federal budget deal passed recently shifts more of the program's costs onto drug manufacturers starting in 2020. In the process, the change eliminates one of the key features that has made the program – known as Part D – successful for over a decade. If the change stays in place, Part D could soon...

When it comes to the U.S. health insurance market, the adage about communist economics is apropos. In this instance, instead of being “they pretend to pay us, we pretend to work”, it is “they pretend to sell insurance, we pretend to buy it”. What we call health insurance in the U.S. is not insurance at all. In its simplest form, insurance is a financial transaction where an insurance company bears the financial risks associated with an unwanted event in return for...

Once again, budget negotiators in Washington D.C. are scrambling to put together a cogent spending plan for the federal government. And, once again, as part of this last-minute scramble, Congress is considering ad-hoc budget gimmicks to pay for spending instead of budgeting within the government’s affordability constraint. Or, as President Reagan might have said, “there they go again”. Employing budgetary gimmicks and pay-fors is one of the many reasons the federal government’s fiscal spending is out of control, and many problems...

President Trump's nomination of Alex Azar for secretary of Health and Human Services is encouraging news for free-market health reformers. Azar possesses precisely the combination of legal acumen, bureaucratic savvy, management experience dealing with a large workforce, and private-sector experience required to eliminate those parts of Obamacare that can be accomplished through administrative action. Azar's conservative legal credentials are impressive. He clerked for the late Supreme Court Justice Antonin Scalia. This alone suggests a healthy aversion to federal overreach — a welcome trait for a...

Effective health care reforms must reduce the excessive costs imposed by frivolous lawsuits. Studies have shown that medical tort reform could reduce total health care premiums between 1 and 3 percent. As estimated by the American Action Forum, this could mean “roughly $15 billion” in savings from effective (but partial) medical tort reform. Given the desperate need to bend the health care cost curve, implementing medical tort reforms that rein in over-zealous lawyers should be a no-brainer. But then again, this...

Tweaks do not turn bad regulatory proposals into good ones. Yet, with only minor modifications, Congress is once again considering the CREATES Act (Creating and Restoring Equal Access to Equivalent Samples Act of 2017), and its close cousin, the FAST Act (Fair Access for Safe and Timely Generics Act of 2017). Regulatory analyses quickly become detailed, and, frankly, quite boring. However, as the size and scope of the regulatory burden continues to grow, so does the negative impact on our economic...

In a unanimous and bipartisan vote, Arizona’s legislature passed the Free Speech in Medicine Act, which was signed into law about two months ago. Passing anything with bipartisan support is noteworthy in today’s hyper-partisan environment. Passing a bill with such important and positive implications for patients, even if the law is more symbolic than meaningful, is remarkable. Perhaps even more remarkable, the U.S. Congress now has an opportunity to replicate Arizona’s success at the federal level via the Medical Product Communications...

While ostensibly designed to help, often the regulatory state only makes matters worse. Unfortunately, this maxim applies to the impact from regulations on new technologies that could help lessen the nation’s large and growing opioid abuse crisis. The total healthcare costs of prescription opioid abuse in 2007, which have likely increased since the crisis has continued to worsen, was estimated to be as high as $55.7 billion. These costs include higher health care expenses, reduced productivity at the workplace, and more spending...

FDA officials apparently think that doctors aren't smart enough to understand the labels on the medications they prescribe. The agency recently released draft guidance for how the pharmaceutical industry should label "biosimilars," a new class of medicines. These guidelines state that biosimilars' labels should leave out critical information in order to avoid causing "confusion" among doctors. Omitting this data could harm — or even kill — patients. The FDA should reverse course — and urge drug manufacturers to give doctors all the information...