By Kurt R. Karst –
Earlier this week, sanofi-aventis U.S., LLC (“Sanofi”) filed a Complaint in the U.S. District Court for the District of Columbia against FDA in what appears to be a first-of-its-kind lawsuit. Sanofi alleges that FDA’s decision to make public a copy of the labeling approved on October 11, 2013 under NDA No. 020468 for the Over-the-Counter (“OTC”) use of Nasacort Allergy 24 HR (“OTC NASACORT”) for the temporary relief of symptoms of hay fever or other respiratory allergies (nasal congestion, runny nose, sneezing, and itchy nose) in adults and children ages 2 years and older violates the Administrative Procedure Act (“APA”).
Despite having approved a prior approval supplement (S-035) under NDA No. 020468 for the prescription-to-OTC use of NASACORT nearly a month ago, despite having received four Freedom of Information Act (“FOIA”) requests to release the labeling, and despite FDA policy, the Agency has failed to post on the CDER Internet Web Page (at Drugs@FDA) a copy of the approved labeling text.
FDA procedures have called for the prompt publication of approval information on the CDER Internet Web Page. For example, FDA Manual of Policies and Procedures (“MAPP”) 6020.8, titled “Action Packages for NDAs and Efficacy Supplements,” directs FDA staff to promptly compile and disseminate drug approval action packages. In particular, MAPP 6020.8 states that FDA Document Room Staff are responsible for “[e]nsuring that three copies of the action package are made and distributed according to the procedures in MAPP 4520.1, Communicating Drug Approval Information, upon notification by the project manager that the application has been approved.” MAPP 4520.1 is currently being updated and has been temporarily removed from FDA’s website; however, the most recent version of that MAPP stated the following policy:
Approved labeling text or final printed labeling for new drugs . . . will be made available on CDER’s Web Site and the CDER Fax-on-Demand system within the time frames specified in this MAPP, a period not to exceed three working days. [(emphasis added)]
The reason for FDA’s failure to timely post the OTC labeling along with the currently-posted approval letter for the NDA supplement was not entirely clear; however, there were suspicions that Sanofi was claiming proprietary rights to the OTC NASACORT labeling until Sanofi’s consumer healthcare division, Chattem, Inc., begins making the drug available next year (see here). Those suspicions were confirmed with the filing of Sanofi’s lawsuit. According to Sanofi, “FDA rejected Sanofi’s requests for confidentiality and advised Sanofi that it would post the approved labeling and packaging on FDA’s website on November 12, 2013.”
Sanofi alleges that the OTC NASACORT labeling is protected from public disclosure under FOIA Exemption 4. That exemption protects “trade secrets and commercial or financial information obtained from a person [that is] privileged or confidential.” According to Sanofi:
Until Sanofi’s labeling and packaging material is publicly disclosed, it constitutes proprietary information, the disclosure of which would cause substantial completive harm to Sanofi. Accordingly, the labeling and packaging information falls within Exemption 4 to the Freedom of Information Act and the Trade Secrets Act, 18 U.S.C. § 1905 until Sanofi chooses to make the labeling and packaging public in connection with the launch of the product.
So what’s all the hubbub really about? Competition of course! FDA did not grant Sanofi a period of 3-year new clinical investigation marketing exclusivity for the prescription-to-OTC switch of NASACORT. So some might say that the company’s efforts to prevent publication of the OTC labeling is a lifecycle management tactic that provides a limited period of de facto marketing exclusivity.
As Sanofi alleges in the Complaint:
Release of Sanofi’s approved labeling and packaging materials prior to its launch of the OTC version of Nasacort Allergy 24 HR will cause substantial competitive harm to Sanofi because it will provide generic manufacturers with advance knowledge of the labeling that they must match and thereby will enable them to launch their competing products sooner than would be the case if they must wait until Sanofi launches its product
Release of this information will also permit manufacturers of competing branded products to prepare advertising and promotion materials in advance of Sanofi’s launch of its OTC product.
The FDC Act requires that the labeling of a generic drug approved under Section 505(j) – whether for prescription or OTC use – be the same as the currently approved labeling of the Reference Listed Drug. Indeed, FDA and the Office of Generic Drugs (“OGD”) have recognized in guidance the need to promptly make labeling changes to meet these legal obligations, stating in relevant part that:
OGD believes that prompt revision, submission to the Agency, and implementation of revised labeling are important to ensure the continued safe and effective use of generic drug products. Because the regulations state that the labeling of the generic must be the same as the innovator, the revision should be made at the very earliest time possible.
Without access to approved labeling, however, generic drug sponsors may be unable to meet relevant legal and FDA obligations. (FDA has approved a single ANDA for a generic version of the prescription version of NASACORT – ANDA No. 078104, approved on July 30, 2009.) Prompt approval of an ANDA labeling supplement could result in the unusual situation where a generic version of a brand-name drug is available to consumers before the brand-name drug is available.
Sanofi requests that the court set aside FDA’s decision to make public the OTC NASACORT labeling as a violation of the APA, declare that FDA’s decision to make public the OTC NASACORT labeling because of the non-applicability of FOIA Exemption 4 violates the APA, and declare that the OTC NASACORT labeling falls within FOIA Exemption 4. In the alternative, Sanofi requests that the court remand the matter to FDA for reconsideration, and preliminarily and permanently enjoin FDA from publicly disclosing the OTC NASACORT labeling until Sanofi launches the product. (We'll update this post once Sanofi's injunction pleadings are available.)