Advertisement
ProteinSimple
ProteinSimple

FDA May Fast-track Needed Drugs

New congressional proposals would allow drug makers to bypass traditional clinical trial requirements for drugs that address rare diseases.

By | November 18, 2011

FLICKR, CANDY

As part of the renewal of pharmaceutical licensing fees, Congress is considering two proposals for the US Food and Drug Administration to fast-track drugs that address rare diseases or conditions for which no approved cures exist.

Senator Kay Hagan, a democrat from North Carolina, and the Biotechnology Industry Organization have developed plans that would allow pharmaceutical companies to skip traditional clinical trial requirements for drug approval, in essence broadening the accelerated approval program used for cancer and AIDS drugs to include rare disorders.   According to the proposal, drugs that may qualify would address one of 7,000 conditions that affect fewer than 200,000 people per year in the country, Bloomberg News reported. Currently, only about 360 drugs are approved for those conditions, according the National Organization for Rare Disorders.

But the FDA already has an orphan drug program and existing methods to fast-track drugs for rare diseases, an FDA spokesperson told Bloomberg. For example, patients can access unapproved drugs if they enroll in a clinical trial or if their doctor submits an application. Since 2006, three quarters of the 85 treatments for rare diseases were approved based on limited clinical trial data, John Jenkins, the director of the Office of New Drugs, told Bloomberg.

Advertisement
ASM
ASM

Add a Comment

Avatar of: You

You

Processing...
Processing...

Sign In with your LabX Media Group Passport to leave a comment

Not a member? Register Now!

LabX Media Group Passport Logo

Popular Now

  1. The Mycobiome
    Features The Mycobiome

    The largely overlooked resident fungal community plays a critical role in human health and disease.

  2. Antibody Alternatives
    Features Antibody Alternatives

    Nucleic acid aptamers and protein scaffolds could change the way researchers study biological processes and treat disease.

  3. Circadian Clock and Aging
    Daily News Circadian Clock and Aging

    Whether a critical circadian clock gene is deleted before or after birth impacts the observed aging-related effects in mice.

  4. Holding Their Ground
    Features Holding Their Ground

    To protect the global food supply, scientists want to understand—and enhance—plants’ natural resistance to pathogens.

Advertisement
Advertisement
Life Technologies