Unbiased Analysis of Today's Healthcare Issues
That is the subtitle of a paper by Vreman et al. (2020). The authors look at all treatments approved by FDA and EMA that were subsequently reviewed by HTA bodies in both jurisdictions between 1995 and 2018. The authors used ICER as the US HTA body; European HTA bodies included IQWiG (Germany), NICE (UK), ZIN…
The answer to this question depends, not only on how well AI tools work, but also on how AI technologies are regulated by the FDA. Scott Gottlieb has some thoughts on preferred regulatory approaches in his recent article in JAMA Health Forum. Artificial intelligence tools with advanced analytical capabilities used in clinical practice, especially tools…
That is according to the FDA. Nature Reviews Drug Discovery summarizes the progress to date as follows. The FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) approved 57 new therapeutic drugs (NTD) in 2024. This is slightly above the average of 53 NTDs per year for 2014–2024,…
Recently, the Office of Management and Budget has released new procedures to assess government regulation (Circular A-4) and economic policies (Circular A-94). What is unique about this guidance is that it weights benefits and costs of new regulations and policies based on the income of the individuals impacted. The goal is to help reduce inequality.…
From the FTC’s press release out today: Today, the Federal Trade Commission brought action against the three largest prescription drug benefit managers (PBMs)—Caremark Rx, Express Scripts (ESI), and OptumRx—and their affiliated group purchasing organizations (GPOs) for engaging in anticompetitive and unfair rebating practices that have artificially inflated the list price of insulin drugs, impaired patients’…
As of 2007, about half of physicians had noncompete clauses (“noncompetes” for short) in their contracts. However, a recent FTC rule severely limits when they could be used. What specifically did the new FTC rule say about non-competes? Fuse Brown et al. (2024) provide a helpful summary. The final FTC rule declares all new noncompete clauses or…
What everyone wants is getting new, innovative medicines to market quickly, but at the same time insuring we have enough data to confirm that these medicines are safe and effective. How do we balance these two aims? A paper by Ollendorf et al. (2024) provides some guidance. Some of their suggestions are summarized below. Make…
In July 2018, FDA released the Biosimilars Action Plan (BAP), which outlined FDA’s approach for expanding access to biosimilars for the American public. The plan focused on 4 key areas: A recent FDA report reviews some of their accomplishments since then. Most of these efforts revolve around guidance documents, additional staff, education products and websites,…
According to the 2019 NSDUH survey, 27.7 percent of 18-22 year olds who are not enrolled in college full-time and 33.0% of 18-22 year old full-time college students reported binge drinking in the past month. Should society impose stricter restrictions on drugs and alcohol for younger individuals? On the one hand, drugs and alcohol harm…
For patients with serious illnesses, timeline access to efficacious medications is paramount. The European Medicines Agency (EMA) was created in part to help expedite drug approvals and insure these products are save and effective. As stated in a paper by Grünwald and Stargardt (2024): The EMA [European Medicines Agency] was founded in 1995 primarily to…