Unbiased Analysis of Today's Healthcare Issues
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…
That is the title of a very interesting paper by Casey Mulligan (2023) [NBER WP version]. The full title includes the phrase “Peltzman revisited”. This refers to a paper by Peltzman (1973).When speaking of the 1962 “Drug Efficacy Amendment” (EA) to the Federal Food, Drug, and Cosmetic Act a key piece of research was Peltzman…
Diversity in clinical trials Recently, the FDA’s Center for Drug Evaluation and Research’s (CDER’s) released its 2020 Drug Trials Snapshots Summary Report. Part of the report examines the demographics of participants in clinical trials for the 53 drugs that FDA approved in 2020 either as new molecular entities (NMEs) under new drug applications (NDAs) or…
How do you evaluate treatment efficacy and safety outside of the clinical trial setting? This is not just a question of academic interest. In last week’s JAMA, Rubin 2021 writes about some of the challenges of evaluating COVID-19 vaccines outside of a clinical trial setting. In an interesting, two-day workshop last week, the Duke Margolis…
The FDA approval process is slow. Even for COVID-19 vaccines, the process can be time consuming. However, regulators around the world do have some expedited programs. However, a number of countries have programs that expedite review, particularly for the diseases with unmet need, orphan drugs, or when new treatments represent a significant advance over the…
In many cases, the answer is ‘no’. At least that is the findings from a paper by Ryan and Sood (2019). As reported in FiercePharma: Sood and Ryan reviewed 166 drug pricing laws passed between 2015 and 2018 and found that 35 bills in 22 states included transparency mandates. Only seven of the laws were…
Not surprisingly, the answer is yes, but not by as much as one might guess. In part due to a measles outbreak at Disneyland, California outlawed non-medical exemptions for vaccinations. An NBER working paper by Richwine et al. (2019) provides background on the situation in California prior to enacting the ban. Prior to the policy…
That is the title of my recent piece in STAT News. Earlier this month, the Food and Drug Administration announced the creation of Project Facilitate. This pilot program facilitates access to innovative treatments for cancer that have not yet been approved by individuals who aren’t able to enroll in clinical trials. This move suggests that the…