Two Pharmaceutical Companies File Lawsuits in Response to FDA’s DESI Decisions

May 04, 2011   

We recently reported the U.S. Food and Drug Administrations (“FDAs”) announcement of its intent to remove approximately 500 unapproved cold, cough, and allergy drugs from the United States market. As a result, on April 29, 2011, ECR Pharmaceuticals (“ECR”) and Laser Pharmaceuticals, LLC (“Laser”) filed Petitions for Review with the U.S. Court of Appeals for the District of Columbia Circuit pursuant to 21 C.F.R. § 514.235(b) and 21 U.S.C. § 355(h), which permits a direct appeal to an appellate court within 60 days after the entry of a relevant FDA order. The Petitions for Review requested the court to review and set aside the two final orders of March 3, 2011 that certain marketed unapproved cold, cough, and allergy drug products are not Generally Recognized as Safe and Effective (“GRASE”). The first order announced that all outstanding hearing requests pertaining to oral prescription drugs offered for the relief of cough, cold, or allergy symptoms had been withdrawn and any shipment of those products not approved under a new drug application (“NDA”) or abbreviated new drug application (“ANDA”) (other than an over-the-counter (“OTC”) product that complies with an applicable OTC monograph) is unlawful. In the second order, the FDA announced that it would take enforcement action against unapproved and misbranded oral cold, cough, and allergy prescription drugs and the persons who manufacture or cause the manufacture of those drug products.

As background, many of the drug products covered by the March 3, 2011 orders contain active ingredients that were originally introduced into the United States marketplace without a prior review as to effectiveness. The Federal Food, Drug, and Cosmetic Act (“FDCA”), as originally enacted, required the sponsor of a new drug demonstrate that the product was safe. New drugs did not have to demonstrate effectiveness. In 1962, Congress amended the FDCA and required new drugs to be proven effective, as well as safe. The amendment also require the FDA to conduct a retrospective evaluation of effectiveness for all drugs approved as safe between 1938, the year the FDCA was enacted, and 1962. To assist with the evaluation of effectiveness for over 3,400 products, the FDA contracted with the National Academy of Sciences/National Research Council (“NAS/NRC”). The NAS/NRC submitted reports to the FDA that were then published in the Federal Register. The FDAs implementation of the NAS/NRC reports was called the Drug Efficacy Study Implementation (“DESI”). Many of the active ingredients in the March 3 orders were reviewed for effectiveness through the DESI process.

All drugs covered by the DESI review are “new drugs” under the FDCA. If the FDA DESI decision classifies a drug as ineffective for one or more indications, that drug product and those drugs that are identical, related, or similar (“IRS”) to it can no longer be marketed for those indications and are subject to enforcement actions as an unapproved new drug.

In ECR Pharmaceuticals v. Commissioner of Food and Drugs, Case No. 11-1120, ECR states that its Lodrane® products are “identical, related, or similar (“IRS”) to the antihistamine/decongestant reformulation of Dimetapp Extentabs containing 12 mg of brompheniramine maleate and 75 mg of phenylpropanolamine hydrochloride in a controlled-release form.” ECRs Lorane® products are extended-release drug products that contain brompheniramine maleate alone or in combination with pseudoephedrine hydrochloride and are indicated as either an antihistamine or an antihistamine/decongestant drug product.

Laser Pharmaceuticals, LLC v. Commissioner of Food and Drugs, Case No. 11-1121, involves methscopolamine nitrate. According to the Petition for Review, The FDA has concluded that methscopolamine nitrate is not GRASE. In addition, the FDA has determined,

that products containing the active moiety in methoscopolamine nitrate that are marketed for the relief of cold, cough, or allergy symptoms are new drugs within the meaning of § 201(p) of the Federal Food Drug and Cosmetic Act, 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.

Both ECR and Laser cases were preceded with April 1, 2011 Petitions for Reconsideration/Petitions for Stay of Action. ECRs Petition for Reconsideration/Petition for Stay of Action asked the FDA to review and reverse its determination that ECRs Lodrane® products are not GRASE. If the FDA maintains its position, ECR ask the FDA to stay the effective dates for action for six months. ECRs Petition further adds that FDA has not appropriately considered all of the evidence and its actions fail to provide ECR with “the procedural protections in accordance with due process of law.” In Lasers Petition for Reconsideration/Petition for Stay of Action (CREATE A HYPERLINK), Laser requests that the 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.

The FDA has not responded to either Petition for Reconsideration/Petition for Stay of Action.