New Drug Applications; Refusal to File; Change in Procedures to Include Industry Representatives in Meetings of the Review Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 92N-0371]

New Drug Applications; Refusal to File; Change in Procedures to

Include Industry Representatives in Meetings of the Review Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a change

in the review process conducted by the Center for Drug Evaluation and

Research's (CDER's) Refusal to File (RTF) review committee. The new

procedures will permit applicants that have received an RTF to attend

the meeting at which the RTF review committee evaluates the RTF imposed

on its application. This change, which will be implemented on a trial

basis, may enhance understanding of and participation in the RTF review

committee process. Additional changes to the procedures may be useful

and comments are requested.

DATES: Comments may be submitted at any time.

ADDRESSES: Submit written comments on this change in procedures to the

Dockets Management Branch (HFA-305), Food and Drug Administration, rm.

1-23, 12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Janet M. Jones, Center for Drug

Evaluation and Research (HFD-014), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-594-5445.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 18, 1993 (58

FR 28983), FDA announced the establishment of a standing committee in

CDER's to conduct periodic review of the CDER's RTF decisions. The

committee was established on a 1-year trial basis. Initially, the

committee invited companies to submit requests for review of RTF's that

they considered to have been made inappropriately. The RTF review

committee consists of senior CDER officials, a senior official from the

Center for Biologics Evaluation and Research, and FDA's Chief Mediator

and Ombudsman.

CDER created the RTF review committee because it believes that a

clear, well-understood, and consistently applied RTF policy may improve

substantially the efficiency of the new drug evaluation process. The

practice of submitting an incomplete or inadequate application and then

providing additional information during an extended review period is

inherently inefficient and a waste of agency resources. In addition, it

is unfair to those applicants who fulfill their scientific and legal

obligations by submitting complete applications to have the review of

their applications delayed while other incomplete applications

submitted earlier undergo review and repair.

FDA regulations on filing applications, including grounds and

procedures for RTF's, are found in Sec. 314.101 (21 CFR 314.101). In

the past, some CDER review divisions refused to

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file applications only where the deficiencies were extreme while other

divisions applied the regulation more broadly. When deciding whether to

file an application, CDER exercises discretion, considering in

particular whether the application is for a medically important drug.

The RTF procedure is used in the context of CDER's effort to promote

rapid development and review of applications.

Although an RTF is not a final determination, it is a significant

step that delays full review of an application. The applicant who

receives an RTF notification may request an informal conference with

FDA and thereafter may ask that the application be filed over protest

as described under Sec. 314.101(a)(3). CDER believes that an RTF

decision is, in general, of benefit to applicants as an early signal

that the application has major deficiencies.

When the RTF review began, FDA invited companies to request review

of RTF decisions that they wanted FDA to reconsider. As explained in

the Federal Register of September 21, 1994 (59 FR 48440), in January

1994, the RTF review committee began to meet bimonthly and to review

all of the RTF decisions that CDER makes, rather than only some of

them, and requests by drug companies were no longer necessary. CDER

decided to review all of the RTF decisions because the number of those

decisions had decreased over the previous year and because RTF

decisions have other effects related to user fees. Under section

736(a)(1)(D) of the Prescription Drug User Fee Act of 1992 (21 U.S.C.

379h(a)(1)(D)), FDA is authorized to retain 25 percent of the total

user fee assessed for each NDA that it refuses to file. If the agency

incorrectly refuses to file an application, FDA needs to identify and

correct the error promptly so that the application may be filed and a

review initiated and so that incorrectly retained fees may be returned

to the applicant.

To increase the understanding of and participation in this process,

the RTF review committee has decided to invite each company whose

application has been refused for filing to the committee meeting

scheduled to review that RTF decision. The committee usually will

review no more than four RTF's per meeting. At the RTF review meeting,

the CDER division that made the RTF decision will present to the

committee the deficiencies present in the application and will explain

the RTF decision. The applicant will not attend this portion of the

meeting as the discussion generally involves, among other things,

predecisional deliberations and internal management issues. After the

division's presentation, the applicant will be invited to give a brief

presentation (approximately 10 minutes), and may be asked questions by

the committee. For the reasons specified above, the applicant will not

remain for the committee deliberations on the appropriateness of the

RTF, but will be advised of its decision. The agency also may send

followup correspondence to the applicant after the meeting. Because the

presentations may deal with confidential commercial information,

applicants will not be permitted to be present during presentations

made by other companies.

The change in the procedures will be implemented on a trial basis

at the next meeting to review RTF decisions. Additional changes to the

procedures may be appropriate, and comments are requested.

Interested persons may, at any time, submit to the Dockets

Management Branch (address above) written comments regarding this

change in procedures. Two copies of any comments are to be submitted,

except that individuals may submit one copy. Comments are to be

identified with the docket number found in brackets in the heading of

this document. Received comments may be seen in the office above

between 9 a.m. and 4 p.m., Monday through Friday.

Dated: June 26, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95-16205 Filed 6-30-95; 8:45 am]

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