Unbiased Analysis of Today's Healthcare Issues
The year 2022 was a good, but perhaps not great year for innovation. According to the FDA’s Center for Drug Evaluation and Research’s (CDER) New Drug Therapy Approvals 2022 report, there were 37 novel drugs approved in 2022. This number is down from the historical rate of approvals between 2013-2021 (43.4 approvals per year) and…
The primary reasons is that it is much faster and less expensive to repurpose an existing drug for a new disease than trying to identify a new therapeutic agent. A paper by Islam et al. (2021) explains why: Available information. A repurposed drug has an extensive portfolio of knowledge relating to human pharmacokinetics, bioavailability and…
That is the takeaway according to a November-December 2022 survey by PhRMA of 25 large pharmaceutical manufacturers. Among respondents, it was clear the IRA price setting provisions are already impacting, and are expected to have a growing impact on, R&D plans moving forward:• 78% expect to cancel early-state pipeline projects.• 63% said they expect to…
A ViewPoint by Richman and Adashi in JAMA this week provides a nice overview of the pharmacy benefit manager (PBM) marketplaces as well as some considerations for the Federal Trade Commission (FTC) to consider. Below I summarize some of the developments in the PBM market in recent decades. Of particular note is that PBMs have…
This is the paraphrased title of a paper by Fusco et al. (2023). The authors conduct a systematic literature review of studies published between 2010 and 2020 and find that among the 79 articles screened: The majority of publications found that, regardless of disease area, increased cost-sharing was associated with worse adherence, persistence, or discontinuation.…
That is the title of an FTI White Paper published this year where I was a co-author alongside Antoine Mialhe, Sabiha Quddus, Anne-Sophie Deman, Suhail Thahir and Agnes Sipiczki. The role of Intellectual property (IP) in the development of COVID-19 vaccines and therapeutics became a central tenant in discussions on how to ensure access to…
A paper by Birg (2022) aims to examine how mandatory increases in rebates for pharmaceutical products impacts the use of parallel imports. She uses a policy change from 2010 in Germany which mandated increased pharmaceutical rebates to identify the impact of this change. What are parallel imports? Parallel imports are drugs that are imported from…
As part of The 21st Century Cures Act, FDA is required to consider additional mechanisms to expedite access to new drugs, including those currently under investigation. In fact, the 21st Century Cure Act mandates that pharmaceutical manufacturers have to post their policies on expanded access (a.k.a. “compassionate use”) for investigational drugs by: (1) the first…
Antibiotic resistance is an increasing problem. My own research shows that when infections are antibiotic resistance, the risk of complications rises as does the cost to treat the infection. According to the CDC, antimicrobial resistance is a major public health problem: …killing at least 1.27 million people worldwide and associated with nearly 5 million deaths…
That is the title of a article yesterday in Kaiser Health News. What is your initial reaction to this title? That pharmaceutical firms are making unfair profits here? Likely so. However, if you keep reading, you will see the following: In the United Kingdom, where health care is generally free and Takeda sells the drug…