From Health Affairs Today <[email protected]>
Subject Outcomes Of Negative Advisory Committee Votes For FDA-Approved Drugs
Date May 18, 2022 8:00 PM
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Forefront: How To Motivate Drug Development For Infectious Diseases
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Wednesday, May 18, 2022 | The Latest Research, Commentary, And News From
Health Affairs

Dear John,

Don't miss out on our health reform-focused newsletter written by
Katie Keith. The newsletter examines health policy developments-from
legislation to litigation-and explains what these changes mean for
patients, payers, providers, and other key health care stakeholders.

Sign up for the Health Reform newsletter today.

Advisory Committee Votes

In their paper published in this month's issue of Health Affairs, C.
Joseph Ross Daval and coauthors examine the 482 new drugs and biologics
approved by the Food and Drug Administration (FDA)

between 2010 and 2021.

In the article, the authors pay particular attention to the ten drugs
approved despite a negative advisory committee vote.

They find that the number of new approved drugs receiving advisory
committee review decreased from 59 percent in 2011 to only 6 percent in
2021.

The authors also note inconsistencies in the wording of FDA questions
posed to the advisory committees. Daval and authors propose that the FDA
provide clear and specific criteria for how it chooses to subject new
drugs to external scrutiny.

Read More

Elsewhere At Health Affairs

Today in Health Affairs Forefront, William K. Bleser and coauthors
examine how to advance equity through value-based payment models.

Beth Boyer and coauthors discuss how to overcome the weak incentives
pharmaceutical companies have

to invest in treating and preventing diseases like malaria and
tuberculosis.

The authors suggest a transferable exclusivity voucher program to
motivate drug development for infectious diseases.

Want to read more content like this? Bookmark Health Affairs Forefront
to never miss an article.

Daily Digest

Unwanted Advice? Frequency, Characteristics, And Outcomes Of Negative
Advisory Committee Votes For FDA-Approved Drugs

C. Joseph Ross Daval et al.

ACO REACH And Advancing Equity Through Value-Based Payment, Part 2

William K. Bleser et al.

How To Motivate Drug Development For Infectious Diseases

Beth Boyer et al.

 

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