Sanofi is trying to force a period of exclusivity for its recently approved OTC switch Nasacort Allergy 24HR by suing FDA to block disclosure of labeling prior to the product’s launch in 2014.

In what attorneys say seems to be a first-of-its-kind complaint filed Nov. 6 in the U.S. District Court for the District of Columbia, Sanofi-Aventis US LLC argues that FDA should not be allowed to post the packaging and labeling for OTC Nasacort on the agency’s website until the drug launches OTC in 2014 because it is proprietary information that was submitted to FDA confidentially as part of its application to switch the product from Rx to OTC status.

FDA approved the first-in-class switch Oct. 11 for the temporary relief of symptoms of hay fever, nasal congestion, runny nose, sneezing and itchy nose in adults and children 2 years and older Also see "Sanofi’s Nasacort First-In-Class Switch Receives FDA Approval" - Pink Sheet, 11 October, 2013.. However, it did not grant Sanofi three years of market exclusivity for new clinical investigation associated with the Rx-to-OTC switch.

On Oct. 18, the company requested FDA not publish the labeling and packaging until after its subsidiary Chattem Inc. launches the product in 2014.

The agency notified Sanofi Nov. 1 that it was denying that request and that it would post the labeling on its website Nov. 12.

Sanofi holds that because the label was submitted as privileged or confidential information it meets the fourth exemption of the Freedom of Information Act that protects trade secrets and commercial or financial information.

Sanofi argues in the complaint that FDA’s decision to dismiss its confidentiality request and post the labeling and packaging on the agency’s website prior to the launch of Nasacort is “arbitrary, capricious, an abuse of discretion” and violates the Trade Secrets Act.

However, it did not detail an argument of how the decision was arbitrary, capricious or a violation of the law.

FDA likely denied Sanofi’s original request because it is the agency’s policy to post approved labeling text or final printed labeling for new drugs on its website within three working days of the approval. FDA says in guidance that the prompt publication of this information is necessary for generic drug makers to meet their legal obligation to provide identical labeling as the branded product.

However, the back-and-forth between the company and agency regarding whether Sanofi has proprietary rights to the labeling likely has delayed publication up to this point, Kurt Karst, an attorney with Hyman, Phelps & McNamara, notes in an FDA Law Blog post Nov. 8.

Karst also noted that FDA is updating its publication policy, but four Freedom of Information Act requests to release the labeling likely influenced the agency’s ultimate decision to publish the labeling.

While the court is unlikely to act before Nov. 12, which is when FDA said it would post the labeling, the suit should give the agency pause to consider whether the labeling really is confidential or not, said John Fuson, a partner at Crowell Moring in Washington. If FDA posts the label and the court later decides it was a trade secret and that the agency violated confidentiality protections under the Trade Secrets Act, individuals at the agency could face criminal penalties, Fuson says.

With this in mind, he said the agency might delay publication until the court rules on the case just to be on the safe side.

Marketing Exclusivity Crux Of Matter

The likely motivation for the case is to create a period during which Sanofi can market Nasacort prior to facing generic competition.

If Sanofi succeeds in blocking the publication of Nasacort’s label, it could squeeze out a period of exclusivity on store shelves before private label competition hits by delaying generic manufacturers’ ability to create product labels. Under section 505(j) of the Food Drug and Cosmetic Act the relevant labeling of a generic drug must follow the currently approved labeling for the reference listed drug. There are a few exceptions to the rule, such as listing different manufacturers or expiration dates.

If Sanofi loses, and the label is published prior to Nasacort’s launch, competitors could get a jump-start preparing their labeling and be ready to launch more quickly, if not the same day as Nasacort.

Sanofi argues posting the labeling on FDA’s website prior to its launch of branded OTC Nasacort “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.”

Without market exclusivity, if the labeling is released prior to the launch of Nasacort, generic competitors feasibly could launch the same day as the branded product if their labeling follows Nasacort’s and if FDA approves their abbreviated new drug application quickly, as was the case when Perrigo Co. PLC’s generic OTC cetirizine product launched before McNeil Consumer Healthcare’s branded Zyrtec reached store shelves Also see "Perrigo Fuels “Growth Engine” With Spending On New Product Pipeline" - Pink Sheet, 11 February, 2008..

Sanofi Sues FDA To Stop Publication Of Nasacort Labeling Before Launch

More from United States

More from North America