‘Holy Cow!’: FDA Approves Record Number Of Generics This Year
By moving more generic drugs into the marketplace, the Trump administration hopes to create more competition and lower-cost alternatives.
Stat:
A 'Holy Cow' Moment: The FDA Approved A Record Number Of Generics
As the Food and Drug Administration attempts to foster more competition in the prescription drug market, the agency appears to be making good on one key effort — approving more generics. In fiscal year 2017, which ended Sept. 30, the agency approved a record number of applications — 763 in all. That beat the previous high of 651 in fiscal year 2016, and worked out to a monthly average of 63 approvals. (Silverman, 10/12)
The Hill:
New Campaign Launched For Low Cost Generics
Patients for Affordable Drugs is launching a new campaign to pass a bill aimed at easing hurdles to bringing lower cost generic drugs to the market. The group wants the CREATES Act passed, viewing it as a measure for decreasing the costs of prescription drugs. (Roubein, 10/13)
In other news —
The Washington Post:
FDA Advisers Urge Approval For First Gene Therapy For Inherited Disease
A Food and Drug Administration advisory committee unanimously endorsed an experimental gene therapy Thursday for patients with a rare kind of hereditary blindness, setting the stage for a historic approval. If the agency agrees with the recommendation, the one-time treatment would be the first gene therapy cleared in the United States for an inherited disorder. (McGinley, 10/12)
NPR:
First Gene Therapy For An Inherited Disorder Gets Expert Endorsement
Gene therapy, which has had a roller-coaster history of high hopes and devastating disappointments, took an important step forward Thursday. A Food and Drug Administration advisory committee endorsed the first gene therapy for an inherited disorder — a rare condition that causes a progressive form of blindness that usually starts in childhood. (Stein, 10/12)
