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.

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 The agency recently released draft guidance for how the pharmaceutical industry should label "biosimilars," a new class of medicines.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...