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

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

Issue	OIG Recommendation	HHS/FDA Response
Antibacterial Draft Guidance	FDA should clarify the role of draft guidance	Draft guidance is not binding and is provided to enable public comment on ideas FDA is considering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 QIDP	FDA 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 sponsor	Approval date	Indication*	Priority review?	Fast track designation?	QIDP exclusivity?
Dalavance             Allergan	5/23/14	ABSSSI	Yes	Yes	Yes
Sivextro (2 dosage forms) Merck	6/20/14	ABSSSI	Yes	No; not requested	Yes
Orbactiv The Medicines Company	8/6/14	ABSSSI	Yes	No; not requested	Yes
Zerbaxa Merck	12/19/14	IAI; UTIs	Yes	Yes	Yes
Avycaz Allergan	2/25/15	IAI; UTIs	Yes	Yes	Pending
Cresemba Astellas	3/6/15	Invasive fungal infections	Yes	Yes	Yes

* 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.