martes, 14 de marzo de 2017

FDA Law Blog - GAO Issues Report on Qualified Infectious Disease Products

Posted: 13 Mar 2017 09:14 PM PDT
By Alexander J. Varond & Kurt R. Karst –
The U.S. Government Accountability Office (GAO) recently issued a January 2017 report to the Senate Committee on Health, Education, Labor, and Pensions.  The GAO report examines:
  • The steps FDA has taken to encourage the development of antibiotics to treat serious or life-threatening infections since the enactment of title VIII of the Food and Drug Safety and Innovation Act, which is commonly referred to as the Generating Antibiotic Incentives Now (GAIN) provisions; and
  • Drug sponsors’ perspectives on FDA’s efforts to encourage the development of antibiotics to treat serious or life-threatening infections since the enactment of GAIN.
GAO analyzed FDA data on requests for QIDP designation since the enactment of the GAIN provisions as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) on July 9, 2012 through December 31, 2015. GAO also interviewed ten industry sponsors on FDA’s efforts to encourage the development of antibiotics to treat serious or life-threatening infections since July 9, 2012.     
GAO’s report provides a helpful overview of the QIDP program, an accounting of the drugs that have been granted QIDP designation, and findings related to FDA’s antibiotic development guidance documents. GAO also issued two recommendations, discussed below.
GAO Recommendations/FDA Response
IssueOIG RecommendationHHS/FDA Response
Antibacterial Draft GuidanceFDA should clarify the role of draft guidance
Draft guidance is not binding and is provided to enable public comment on ideas FDA is considering
Written Guidance on QIDPFDA should develop written guidance on the QIDP designation to help drug sponsors better understand the designation and its associated incentives
HHS indicated that FDA intends to proceed promptly with developing written guidance on the QIDP designation, the process for requesting fast track designation, and the criteria for determining whether an application qualifies for the 5 additional years of QIDP market exclusivity
Key Findings
  • Since 2012, FDA has granted 101 of 109 (93%) requests for QIDP designation.
  • Despite their eligibility, many drug sponsors with QIDP designation have not applied for fast track designation. Of the 101 QIDP-designated products, sponsors submitted only 61 (60%) requests for fast track designation. FDA granted all 61 (100%) of these requests.
  • Six drugs with QIDP designation have been approved (see table below).
Drugs Approved with QIDP Designation
Drug name and sponsorApproval dateIndication*Priority review?Fast track designation?QIDP exclusivity?
Dalavance            
Allergan
5/23/14ABSSSIYesYesYes
Sivextro
(2 dosage forms)
Merck
6/20/14ABSSSIYesNo; not requestedYes
Orbactiv
The Medicines Company
8/6/14ABSSSIYesNo; not requestedYes
Zerbaxa
Merck
12/19/14IAI; UTIsYesYesYes
Avycaz
Allergan
2/25/15IAI; UTIsYesYesPending
Cresemba
Astellas
3/6/15Invasive fungal infectionsYesYesYes
* ABSSSI = acute bacterial skin and skin structure infections; IAI = intra-abdominal infections; UTI = urinary tract infections
Additional Findings
  • QIDP designation typically increased communication between FDA and sponsors and expedited the review of QIDP-designated drug applications.
  • Sponsors noted FDA’s receptivity to considering new approaches to the design of clinical trials for antibiotic products.
  • As of August 2016, FDA had coordinated the release of 14 updated or new guidance documents on antibiotic development; however, half of these guidance documents are in draft form.
  • Sponsors expressed concerned regarding how much they could rely on FDA’s draft guidance documents and the lack of guidance describing the QIDP designation and its requirements.