Unbiased Analysis of Today's Healthcare Issues
The government strictly regulates what information that pharmaceutical firms can share with payers. There is good reason for this. We don’t want drug companies making false claims that a drug can treat/cure a disease when there is no evidence to support that claim. Randomized controlled trials are the gold standard of clinical evidence and studies…
Stereotypically, the U.S. health system is seen as one that is expensive and inefficient, but one where patients do get the fastest access to new innovation. However, does that prove true in reality? A paper by Zhang et al. (2017) attempts to answer this question by looking at 45 oncology drugs approved by the FDA…
The Economist has an article on the evolution of FDA regulation of pharmaceutical treatments. Brining a drug to market costs billions of dollars. FDA commissioner Scott Gottlieb aims to cut this cost by expediting the drug approval process in three key ways. First, he wants the agency to rethink how much information the FDA demands…
How frequently are pharmaceuticals used off label? Perhaps more than you think. Although these figures are a bit dated, Tabarrok (2000) details the extent of off-label prescribing in the U.S. as follows: According to a study by the U.S. General Accounting Office, 56 percent of cancer patients have been given non-FDA-approved prescriptions, and 33 percent…
With the FDA’s introduction of new guidelines surrounding the use of real-world evidence (RWE) in medical device regulatory decisions, FDA Commissioner Scott Gottlieb advances the argument for the utility of RWE. In fact, the FDA is currently considering the role of RWE in evaluating pharmaceutical treatments. Despite much debate over what part RWE should play in…
When each drug is approved by the FDA, the drug is not approved to treat all patients. Each drug receives an “indication” which basically represents the types of patients the drug can treat. Giving the treatment to patients with said indication is known as “on label” prescribing. Drugs developed to treat one disease may sometimes…
Did you ever wonder what is is like having lung cancer? Or narcolepsy? What factors are most important to patients when receiving treatment for these diseases? The FDA is working to collect these answers to help guide their drug approval process. The FDA’s “Voice of the Patient” aims to “…more systematically gather patients’ perspectives…
The Duke-Margolis Center for Health Policy has a great overview of some of the issues related to off-label prescribing. Below is a summary of some key points from this article. What is off-label prescribing? Off-label prescribing and use can take many forms, such as use of an approved drug for an unapproved clinical indication, use at…
The FDA is planning to put additional scrutiny on the use and approval of opioids in order to prevent opioid abuse and addiction. Here is their plan: Re-examine the risk-benefit paradigm for opioids and ensure that the agency considers their wider public health effects Convene an expert advisory committee before approving any new drug application for an…
Typically, the FDA evaluates drugs and devices based on whether they are safe and effective. Patient treatment preferences play little to no role in whether a drug or device is approved by the FDA. However, times are a changing. On Wednesday, the FDA released draft guidance whereby they recommend the inclusion of patient preference information…