D.C. Circuit is Asked to Review Two DESI “New Drug” Decisions

By Kurt R. Karst –      

FDA’s recent move to remove from the market hundreds of unapproved cough, cold, and allergy drug products has spawned two new lawsuits that might very well be one of the last hurrahs for court challenges to FDA Drug Efficacy Study Implementation-related decisions.  Last Friday, Petitions for Review were filed with the U.S. Court of Appeals for the District of Columbia Circuit on behalf of ECR Pharmaceuticals (“ECR”)  and Laser Pharmaceuticals, LLC (“Laser”) requesting that the Court review and set aside FDA’s March 3, 2011 decisions (here and here) that certain marketed unapproved drug products are not Generally Recognized as Safe and Effective (“GRASE”).  (Both FDC Act § 505(h) and FDA’s regulations at 21 C.F.R. § 514.235(b) permit a direct appeal to an appellate court within 60 days after the entry of a relevant  FDA order.) 

In ECR Pharmaceuticals v. Margaret Hamburg (Case No. 11-1120), which concerns extended-release LODRANE containing brompheniramine maleate alone or in combination with pseudoephedrine HCl, ECR contends that its products are Identical, Related, or Similar (“IRS”) to the antihistamine/decongestant reformulation of controlled-release DIMETAPP Extentabs containing 12 mg of brompheniramine maleate and 75 mg of phenylpropanolamine HCL.  “In its final order, [FDA] concluded that all extended-release drug products subject to the notice (e.g., Dimetapp Extentabs), and any IRS drug products (e.g., Lodrane products) to such extended-release drug products require approved new drug applications or abbreviated new drug applications prior to marketing, and are not [GRASE],” says the ECR Petition. 

Adding more color to the 2-page Petition for Review is an April 1st Petition for Reconsideration/Petition for Stay of Action submitted to FDA on behalf of ECR requesting that the Agency “review and reverse its determination that ECR's Lodrane® products are not [GRASE] drug products.  According to the ECR petition to FDA, “FDA's determination in this matter has not appropriately considered all of the evidence regarding these products.  In addition, the Agency's actions fail to provide [ECR] the procedural protections in accordance with due process of law.”  The ECR petition to FDA also asks the Agency to stay for 6 months the effective dates for action set forth in FDA’s March 3rd notice “[i]f upon reconsideration FDA maintains its position that the Lodrane products are not GRAS/E and may not obtain a hearing. . . .”

The second case, Laser Pharmaceuticals, LLC v. Margaret Hamburg (Case No. 11-1121), is similar to the ECR action, but concerns methscopolamine nitrate.  According to the 2-page Petition for Review, FDA concluded in the Agency’s March 3rd final order:

that methscopolamine nitrate is not [GRASE].  In addition, [FDA] determined that products containing the active moiety in methscopolamine nitrate that are marketed for the relief of cold, cough, or allergy symptoms are new drugs within the meaning of [FDC Act § 201(p)], and therefore require approved new drug applications or abbreviated new drug applications prior to marketing.  [FDA] further states that it intends to take immediate enforcement action against persons who market methscopolamine nitrate, as well as against those who manufacture the product or cause it to be manufactured or shipped in interstate commerce.

As with the ECR case, the Laser case was preceded by an April 1st Petition for Reconsideration/Petition for Stay of Action.  That petition requests that FDA “delay any enforcement action against [Laser] for the manufacture of drug products containing methscopolamine nitrate until January 1, 2012, and delay any enforcement action for the shipment of such products until February 28, 2012.”  Among other things, Laser alleges that FDA failed to consider important facts and ignored its own legal requirements in announcing its March 3rd  action with respect to methscopolamine nitrate.

FDA has not substantively responded to either of the April 1st Petitions for Reconsideration/Petitions for Stay of Action.  Both the ECR and Laser Petitions for Review were filed with the D.C. Circuit within the statutory 60-day period and appear to have been filed to protect the companies’ procedural rights.