Would You Balk at Disclosing Confidential Information to Your Competitors?

February 18, 2015

By Kurt R. Karst –       

Without even knowing what we’re talking about, it’s probably safe to say that any company would immediately answer “Yes!” to the question posed in the title to this post.  But that’s exactly what FDA is asking some ANDA applicants to do to facilitate the creation of a single, shared Risk Evaluation and Mitigation Strategy (“REMS”). 

FDC Act § 505-1 provides FDA with the authority to require a proposed REMS from an NDA sponsor if the Agency determines that such a strategy “is necessary to ensure that the benefits of the drug outweigh the risks of the drug.”  A REMS may include various elements, such as a Medication Guide, patient package insert, and/or communication plan.  In addition, under FDC Act § 505-1(f), FDA may require that a REMS “include such elements as are necessary to assure safe use of the drug, because of its inherent toxicity or potential harmfulness.”  The Elements To Assure Safe Use (“ETASU”) of such a drug include, among other things, certain restricted distribution, procurement, and dispensing systems. 

ANDAs for generic versions of RLDs with an approved REMS must have the same Medication Guide (if there is one) and the same or a comparable ETASU REMS.  Specifically, FDC Act § 505-1(i)(1)(B) states:

A drug that is the subject of an [ANDA] and the listed drug shall use a single, shared system under [FDC Act § 505-1(f)].  The Secretary may waive the requirement under the preceding sentence for a drug that is the subject of an [ANDA], and permit the applicant to use a different, comparable aspect of the elements to assure safe use, if the Secretary determines that—

(i) the burden of creating a single, shared system outweighs the benefit of a single, system, taking into consideration the impact on health care providers, patients, the applicant for the [ANDA], and the holder of the [RLD]; or

(ii) an aspect of the [ETASU] for the applicable listed drug is claimed by a patent that has not expired or is a method or process that, as a trade secret, is entitled to protection, and the applicant for the [ANDA] certifies that it has sought a license for use of an aspect of the [ETASU] for the applicable listed drug and that it was unable to obtain a license.

ETASU REMS have been a difficult pill for some ANDA applicants to swallow.  Such REMS have resulted in litigation over the ability of some generic drug companies to obtain product sample to conduct bioequivalence testing (see our previous post here).  And once those studies are conducted, the baseline requirement for a single, shared REMS has further complicated things (see our previous post here).

FDA has apparently taken on the role of facilitator in negotiations for a single shared system.  But before FDA will facilitate such negotiations, the Agency is asking ANDA applicants for permission to disclose certain information to the NDA RLD sponsor, and to hold FDA harmless for any repercussions such disclosure might cause.  That’s a lot to ask of an ANDA sponsor. 

A copy of the disclosure letter FDA has been asking ANDA applicants to sign is provided below.  Although it asks for permission to share only the existence of an ANDA number, it’s the following sentence about which folks might have the greatest concern: “FDA may not be able to withhold information and documents containing such information under 5 U.S.C. 552(b)(4) or FDA’s regulations.”  Of course, almost any document an ANDA applicant sends to FDA contains the application number.  So it seems that the potential exists for almost any ANDA correspondence to become public.

FDA Letter to ANDA Applicants     

Instructions to ANDA applicant: Prepare the following disclosure authorization letter on applicants letterhead. Prominently identify the submission containing the disclosure letter with the following wording in bold capital letters at the top of the first page of the submission:


John R. Peters, M.D.
Acting Director, Office of Bioequivalence
Office of Generic Drugs
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

        RE:  FDA Sharing of Non-Public Information concerning [ANDA NUMBER] with [NDA SPONSOR] and ANDA applicants]

Dear Dr. Peters:

On behalf of [ANDA APPLICANT], the applicant of the above-referenced regulated product(s), I authorize the United States Food and Drug Administration (FDA) and its staff to share the information described below with [NDA SPONSOR] and any abbreviated new drug application (ANDA) applicants for [DRUG] for the purpose of facilitating the development of a single shared system REMS for [DRUG].  I understand that the information may contain confidential commercial information within the meaning of 18 U.S.C. § 1905 and 5 U.S.C. § 552(b)(4) that is exempt from public disclosure.  I agree to hold FDA harmless for any injury caused by FDA’s sharing the information with thc parties referenced above.

Information to be shared: The existence of [ANDA NUMBER].  I understand that, after disclosure, FDA may not be able to withhold information and documents containing such information under 5 U.S.C. 552(b)(4) or FDA’s regulations.

Authorization is given to FDA and its staff to disclose the above-mentioned information without deleting confidential commercial information.  As indicated by my signature, I am authorized to provide this consent on behalf of [ANDA APPLICANT] and my full name, title, address, telephone number, and facsimile number is set out below for verification.

(Printed name)
(Telephone & Facsimile Numbers)