fda-1
carmendorin / iStockphoto.com
14 September 2017Americas

FDA clears orphan drug backlog

The Food and Drugs Administration (FDA) has cleared the backlog of orphan drug designation requests, one month early.

Three months ago, the agency promised to eliminate the backlog of around 200 orphan drug designation requests that were older than 120 days by September 21, 2017.

The requests were completed by August 28, according to Scott Gottlieb’s, commissioner of the FDA, in a blog post published on Tuesday September 12.

According to the FDA, the orphan drug designation programme provides “orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the US.”

The agency also promised that this backlog would never occur again.

According to Gottlieb, the FDA is planning to increase the speed of the process by reorganising its review staff to improve workload efficiency.

Earlier this year Gottlieb announced that although the FDA doesn’t have a direct role in drug pricing, it planned to target the barriers to generic drug competition.

The agency will do so by “facilitating increased competition in the market for prescription drugs through the approval of lower-cost, generic medicines” through its drug competition action plan.

The FDA also revealed plans to increase competition in the US market for prescription drugs, as well as to facilitate the entry of generic drugs into the market.

Gottlieb said on the matter: “No patient should be priced out of the medicines they need, and as an agency dedicated to promoting public health, we must do our part to help patients get access to the treatments they require.”

In a speech Gottlieb delivered to the Regulatory Affairs Professionals Society on Monday September 11, he stated that the time between the discovery of the science behind new treatments and the adoption of such treatments has shrunk.

But at the same time, in the period between 2003 and 2013, the overall cost of development has risen by 145%, according to the Tufts Center for the Study of Drug Development, an independent research group at Tufts University in Boston.

Gottlieb said: "By front-loading the cost of drug discovery, the broader biomedical community is making it harder to advance new ideas. It’s economically harder to capitalise the cost of an early stage drug programme, relative to funding a later stage project. So frontloading the costs are a recipe for reducing amount of new ideas that can be advanced."

Did you enjoy reading this story?  Sign up to our free newsletters and get stories like this sent straight to your inbox.

Sign up for our latest webinar, Biotech patentability issues in Europe.


More on this story

Americas
3 January 2018   The US Food and Drug Administration revealed additional steps aimed at encouraging generic competition today.
Americas
28 February 2018   The US Food and Drug Administration has introduced a pilot scheme for processing orphan designation requests more efficiently, as part of its commitment to support and expedite the development of rare disease products.
Big Pharma
23 May 2021   The US House of Representatives has passed a bill to amend exclusivity laws for drugs on the US Food and Drug Administration’s orphan drugs list.

More on this story

Americas
3 January 2018   The US Food and Drug Administration revealed additional steps aimed at encouraging generic competition today.
Americas
28 February 2018   The US Food and Drug Administration has introduced a pilot scheme for processing orphan designation requests more efficiently, as part of its commitment to support and expedite the development of rare disease products.
Big Pharma
23 May 2021   The US House of Representatives has passed a bill to amend exclusivity laws for drugs on the US Food and Drug Administration’s orphan drugs list.