Extending Rx Exclusivity Could Boost Study for Rare Diseases

Share this content:
Extending Rx Exclusivity Could Boost Study for Rare Diseases
Extending Rx Exclusivity Could Boost Study for Rare Diseases

MONDAY, Jan. 23, 2017 (HealthDay News) -- Extending the market exclusivity for existing drugs that are granted subsequent U.S. Food and Drug Administration (FDA) approval for a new rare disease indication would provide manufacturers with substantial compensation, often in excess of the cost of conducting the trials, according to research published in the January issue of Health Affairs.

Aaron S. Kesselheim, M.D., M.P.H., from Harvard Medical School in Boston, and colleagues examined the economic impact of the proposal to encourage rare disease research by providing six months of extended exclusivity for any existing drug that is granted subsequent FDA approval for a new rare disease indication.

The researchers found that from 2005 through 2010, the median projected cost of clinical trials leading to approval was $29.8 million for the 13 FDA-approved drugs that gained supplemental approval for a rare disease indication. The median discounted financial gain to manufacturers would have been $94.6 million if the exclusivity extension had been in place. Median net returns would have been $82.4 million; drugs with higher annual sales would have had higher returns.

"Extending market exclusivity would provide substantial compensation to many manufacturers, particularly for top-selling products, far in excess of the cost of conducting these trials," the authors write. "Alternative strategies to incentivize the study of approved drugs for rare diseases may offer similar benefits at a lower cost."

Full Text

Share this content:

is free, fast, and customized just for you!

Already a member?

Sign In Now »


Sign up for myCME e-newsletters


Drug Lookup

Browse drugs by: BrandGenericDisease

Trending Activities

All Professions

More in Home

ACOG: Shared Decision-Making Key to Breast Cancer Screening

ACOG: Shared Decision-Making Key to Breast Cancer Screening

Critically important for patient's value, preferences be factored into process, ACOG leader says

Three Lifestyle Interventions May Slow Cognitive Decline

Three Lifestyle Interventions May Slow Cognitive Decline

Cognitive training, management of hypertension, increased physical activity all help delay decline

CDC: Zika Can Be Found in Placental, Fetal Tissue at Birth

CDC: Zika Can Be Found in Placental, Fetal ...

Of 546 live births with possible maternal Zika virus, 11 percent proved positive

is free, fast, and customized just for you!

Already a member?

Sign In Now »