Forefront: Moving Toward Broader Value
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Thursday, June 23, 2022 | The Latest Research, Commentary, And News From
Health Affairs

Dear John,

Health Affairs is publishing a theme issue on disability and health
in October 2022.
Content will include original research, analyses, and commentaries that
provides a multidimensional perspective on disability and health.

As part of Health Affairs' commitment to supporting and raising
awareness of disabilities and health, we will launch a video component,
as well as unique artwork and digital assets, alongside the research to
set the foundation of the issue.

We invite participants to submit their responses
to the proposals
for video production and artwork and digital assets by July 15.

Fixing The FDA's Orange Book

In this month's issue of Health Affairs, Scott Hemphill and Bhaven
Sampat argue in a Perspective that the regime for balancing innovation
and competition

in pharmaceuticals needs updating.

Their article is in response to a paper by William Feldman and coauthors
analyzing how manufacturers limit generic competition through the use of
patents

and other exclusivities granted to inhalers approved by the Food and
Drug Administration.

Feldman and coauthors find that of the sixty-two inhalers for asthma and
chronic obstructive pulmonary disease that were approved during
1986-2020, only one contained an active ingredient with a new
mechanism of action.

In their companion Perspective, Scott Hemphill and Bhaven Sampat argue
for updating the system for competition between brand-name and generic
drugs, with a focus on challenging invalid or irrelevant patents.

"We agree with Feldman and colleagues that the four-decade-old
Hatch-Waxman machinery is due for an update," the authors write.

Feldman recently wrote an essay for the Health Affairs Today newsletter

to discuss the research. We frequently include curated newsletters on
topics like this as part of the Health Affairs Insider

program.

To read more from the June issue of Health Affairs, consider becoming a
subscriber.

Purchase The Issue

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Elsewhere At Health Affairs

Today in Health Affairs Forefront, Beth Beaudin-Seiler and coauthors
argue that, through strategies such as the use of real-world data, we
can gain a better understanding of the value of health care resources
across the entire spectrum of care
,
including procedures, screenings, and other services.

Yuna Lee and Ingrid Nembhard write that while COVID-19 brought much
devastation, it also showed the creative potential of the health care
industry to address serious problems
.

Peter Nelson discusses how President Biden's proposed regulatory fix
to the so-called family glitch

in the Affordable Care Act contravenes the relevant statutory
provisions.

Doug Badger argues Congress alone has the institutional capacity

to weigh the upsides and downsides of "fixing" the "family glitch" and
the constitutional authority to amend the statute.

Rachel Sachs delves into the Verifying Accurate Leading-edge IVCT
Development (VALID) Act
,
which would provide the Food and Drug Administration with greater
authority to regulate diagnostic tests.

Elevating Voices: Pride Month: As part of the Borders, Immigrants &
Health
theme
issue, C. Nicholas Cuneo and coauthors examine data about people seeking
asylum in the US from El Salvador,

Guatemala, and Honduras who presented to a medical clinic in Boston.

The authors find a total of 5.3 percent of their sample identified as
LGBTQ and that the most common type of asylum claim was based on
membership in a particular social group, such LGBTQ identity.

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Daily Digest

Fixing The FDA's Orange Book

C. Scott Hemphill and Bhaven N. Sampat

Moving Toward Broader Value: Expanding Value Assessment Beyond Clinical
Drug Trial Data
Beth
Beaudin-Seiler et al.

COVID-19 Inspired Creativity In Health Care: Lessons For Management And
Policy

Yuna S. H. Lee and Ingrid M. Nembhard

Biden's Proposed Fix To The "Family Glitch" Illegally Sidesteps
Congress

Peter J. Nelson

FDA User Fee Reauthorization: Contextualizing The VALID Act

Rachel Sachs

 

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mailto:[email protected]

About Health Affairs

Health Affairs is the leading peer-reviewed journal
at the intersection of health,
health care, and policy. Published monthly by Project HOPE, the journal
is available in print and online. Late-breaking content is also found
through healthaffairs.org , Health Affairs Today
, and Health Affairs Sunday
Update .  

Project HOPE is a global health and
humanitarian relief organization that places power in the hands of local
health care workers to save lives across the globe. Project HOPE has
published Health Affairs since 1981.

Copyright © Project HOPE: The People-to-People Health Foundation, Inc.

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