All Clarivate websites use cookies to improve your online experience. They were placed on your computer when you launched this website. You can change your cookie settings through your browser.

More information on our cookie policy.

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
  • Special reports
    • Artificial intelligence
    • Coronavirus
    • IVDs on the rise
    • Top Biopharma Trends of 2021
    • Top Med-tech Trends of 2021
    • Premium reports
      • BioWorld Financings Reports
      • Disease Incidence & Prevalence Summaries

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Thursday, June 30, 2022
Home » Blogs » BioWorld Perspectives » Hamburg: Society needs to weigh in

BioWorld Perspectives
BioWorld Perspectives RSS FeedRSS

BioWorld / Oncology

Hamburg: Society needs to weigh in

April 10, 2014
By Mari Serebrov
No Comments

Blog 4-10-14Including the patient voice in the drug approval process could produce a fundamental shift in the risk-benefit equation of a new drug. But first, the FDA has to figure out how to do it, and that may take a broader societal discussion, FDA Commissioner Margaret Hamburg said.

Speaking at the annual meeting of the Pharmaceutical Research and Manufacturers of America, Hamburg ticked off a few issues that we as a society must address. For instance, in the absence of a cure, patients with chronic or terminal diseases want a better quality of the life they have left. But the FDA tends to judge a potential drug’s merits on survival endpoints rather than quality-of-life factors.

Are we willing to invest in drugs that improve a dying patient’s life or make life easier for someone with a chronic condition? If we answer yes, how does the FDA, which is so used to weighing objective scientific data, quantify subjective patient-reported outcomes as a component in the assessment of a drug candidate?

This isn’t the only conversation we should be having, Hamburg said. We need to be shaping a national strategy seizing the potential of personalized medicine. Again, that discussion is much broader than the FDA alone, she said. It needs to consider intellectual property, economic policies, scientific investment and reimbursement issues.

You must login or register in order to post a comment.

Report Abusive Comment

Popular Stories

  • Free access to BioWorld coronavirus articles

    BioWorld

    The articles in this collection are from BioWorld’s ongoing coverage of the COVID-19 coronavirus outbreak. Note that we have added three critical tables which are...

  • Today's news in brief

    BioWorld
    BioWorld briefs for June 29, 2022.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech's briefs for June 29.
  • Enhertu.png

    Swing low, sweet Enhertu: Astrazeneca, Daiichi ASCO data carry HER2 message home

    BioWorld
    The “showdown” at the American Society of Clinical Oncology (ASCO) meeting foreseen by one analyst between breast cancer drugs from Gilead Sciences Inc. and...
  • Novavax-COVID-19-vaccine-vial

    Novavax vaccine shows its chops

    BioWorld
    Given that Novavax Inc.’s COVID-19 vaccine will be a latecomer to the U.S. scene if it gets FDA authorization, it’s been cast in a supporting role to the lead...
black cortellis ad

BioWorld Premium

Enjoy extended coverage for the most complete market view with BioWorld, BioWorld MedTech, and BioWorld Asia in a single, easy to access subscription.

Subscribe
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • Archives
    • Today's news
    • Search BioWorld Science
    • About
  • More
    • About
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
Follow Us

Copyright ©2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing