Week 5 Reflection Writing
Word Count: 400+ words.
Requirement:
You need two parts of this reflection writing,
Part 1:
The key points from the readings (View Attached below)
Part 2:
The remaining questions of the class activity, lectures, etc.
Reminder:
You should cite all readings given, there are four.
Make clear of your parts.
Below is this weekàlearning:
5. FDA Regulation for Pharmaceuticals (February 27)
The FDA is the most important regulatory entity with respect to innovation in clinical technologies, with
the mandate to ensure the safety and efficacy of new therapeutics while not imposing undue burdens on
product development and innovation. This session will provide an overview of the FDA process for
authorizing market access for new drugs in the US, with a focus on the evolution towards accelerated
review and a )fe cycle-onitoring of performance based on both pre-market clinical trials and postmarket real world evidence. As a case study we will consider aducanumab for Alzheimeràdisease.
Recorded lectures:
?
?
FDA: The Framework of Regulation
FDA Market Authorization for Drugs
Readings:
?
?
?
?
AL Gassman et al. FDA Regulation of Prescription Drugs. NEJM 2017;376:674-682.
http://www.nejm.org/doi/full/10.1056/NEJMra1602972?af=R&rss=currentIssue
CG Alexander et al. Revisiting FDA Approval of Aducanumab. New England Journal of
Medicine, July 28, 2021. https://www.nejm.org/doi/10.1056/NEJMp2110468?url_ver=Z39.882003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed
B Dunn et al. Approval of Aducanumab for AlheimeràDisease: The FDA Perspective. JAMA
Internal Medicine, July 13, 2021. https://pubmed.ncbi.nlm.nih.gov/34254984/
JC Robinson. Why is Aducanumab Priced at $56,000? Lessons for Drug Pricing Reform. New
England Journal of Medicine 2021; 385(22):2017-2018.
https://www.nejm.org/doi/10.1056/NEJMp2113679?url_ver=Z39.882003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed
Class activity:
The class will begin with an instructor-led discussion of key points and remaining questions from
lectures, readings, and student reflections.
The class then will divide into breakout groups to discuss the tradeoffs between potential over-regulation
and potential under-regulation and FDAàstreamlined review process. FDA must offer or withhold
market authorization early in the drugàmarket life cycle, when the available evidence of safety and
effectiveness is limited. The agency is under constant pressure from industry to reduce evidentiary
requirements to accelerate authorization, from patient advocacy groups to increase evidentiary
requirements to ensure safety, and from political interest groups to promote transparency, accountability,
and efficiency.
Product is safe & effective
Accelerated review, with
streamlined evidentiary
requirements
Thorough review, with high
evidentiary requirements
Efficient regulation.
Accelerated review gets products
onto the market cheaply and
rapidly. Patients benefit.
Innovation is rewarded.
Over-regulation. FDA stringent
regulation adds cost and delay
without improving patient
outcomes. Innovation is
reduced. Future generations of
patients suffer.
Product is unsafe and/or
ineffective
Under-regulation. AgencyÊaccelerated review allows unsafe
and/or ineffective products onto
the market. Patients suffer.
Efficient regulation. Rigorous
demands for evidence identify
unsafe and/or ineffective
products prior to launch.
Patients benefit. Industry faces
incentive for meaningful, not
incremental, innovation
One team will be assigned to develop the policies that promote innovation (reduce over-regulation) by
FDA accelerating review, offering broad Medicare coverage, and allowing firms to set launch prices
based on expected future value of the new therapy. The other team will be assigned to develop policies
that will most effectively moderate spending (reduce under-regulation) through comprehensive FDA
review, Medicare ïverage with evidence development and launch pricing based on the actual
documented value of the new therapy (which typically is much lower than the expected future value).

Purchase answer to see full
attachment