By Kurt R. Karst –
First, FDA gets hit with a June 27th preemptive lawsuit over approval of generic versions of CRESTOR (rosuvastatin calcium) Tablets; and then, on June 28th, a second lawsuit is filed by Lannett Company Inc. and Lannett Holdings, Inc. (collectively “Lannett”) challenging FDA’s recent rescission of Lannett’s ANDA 202750 for the oral chemotherapy drug Temozolomide Capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, and 250 mg. It looks like it may not be much of an Independence Day Holiday for some of FDA’s attorneys.
Lannett’s five-count Complaint was filed in the U.S. District Court for the District of Columbia and challenges FDA’s May 17, 2016 approval rescission of ANDA 202750 for Temozolomide Capsules, which the Agency had approved on March 23, 2016. According to FDA, the Agency approved the ANDA in error. You see, ANDA 202750 apparently identifies Chinese company Chongqing Lummy Pharmaceutical Co. Ltd. (“Lummy”) as the manufacturer of the active pharmaceutical ingredient for the drug product. FDA inspected Lummy in mid-March 2016. On April 19, 2016, the Agency placed Lummy on Import Alert, pointing to concerns over the company's Current Good Manufacturing Practices (“CGMPs”) as the reason for the Import Alert; and on June 21, 2016, FDA issued a Warning Letter to Lummy summarizing significant CGMP deviations.
Lannett says in the Complaint that on April 1, 2016, FDA sent the company a “General Advice” letter “indicating that Lummy would not be releasing any new Temozolomide active pharmaceutical ingredient into the U.S. market until FDA deemed the Lummy facility acceptable.” FDA’s letter requested a call with Lannett to discuss two issues: first, a commitment by Lannett not to distribute any Temozolomide drug product (or to recall drug product already distributed by Lannett; and second, a “necessary withdrawal” of Lannett ANDA 202750. After some further correspondence in which FDA gave Lannett three options – (1) request FDA to withdraw approval of the ANDA; (2) agree to immediate rescission of the ANDA approval; and (3) provide FDA with information demonstrating that the compliance status at Lummy was acceptable as of March 23, 2016 – FDA issued an “ANDA Approval Rescission” letter on May 17, 2016. According to Lannett:
The letter stated that while some FDA officials had information at the time of the ANDA approval indicating that Lummy’s compliance status was unacceptable, the “information was not adequately conveyed to the FDA officials making the final decisions about the ANDA approval.” The letter also stated that the approval was a mistake. It stated that the agency had authority to rescind the ANDA, because the procedures of 21 U.S.C. § 355(e) do not apply, such that there is “no applicable statute displac[ing] FDA’s inherent authority to correct its mistake.” The agency concluded that “FDA is correcting its error and rescinding the approval letter issued for ANDA 202750 on March 23, 2016.”
Lannett alleges in the Complaint that FDA’s rescission of ANDA 202750 violates the Administrative Procedure Act (“APA”) and the Fifth Amendment’s due process right to a hearing in connection with deprivation of a property right. Lannett asks the court to, among other things, set aside and declare as unlawful FDA’s ANDA approval rescission, and to enjoin FDA from revoking the approval of ANDA 202750 without a hearing and the procedures established at FDC Act § 505(e).
Various disputes concerning mistaken ANDA approvals and withdrawal (or suspension) of ANDA approvals have cropped up over the past few years. There’s Armenpharm, Ltd.’s recent opposition to FDA’s efforts to suspend the approval of the company’s ANDA 060851 for Chloramphenicol Capsules, 250 mg (see our previous post here). Also, a couple of years ago, Mallinckrodt Inc. sued FDA after the Agency downgraded the company’s ANDA 202608 for generic CONCERTA (methylphenidate HCl) Extended-Release Tablets. Among other things, Mallinckrodt argued that the downgrade was tantamount to withdrawal of ANDA approval (see our previous posts here and here). There’s also the short-lived lawsuit Novartis Pharmaceuticals Corporation filed back in 2010 after FDA mistakenly approved ANDA 078278 for a generic version of FAMVIR (famciclovir) Tablets (see our previous post here). And who could forget the litigation surrounding FDA’s decision to strip Ranbaxy Laboratories, Ltd. of tentative ANDA approvals for generic VALCYTE (valganciclovir) Tablets and NEXIUM (esomeprazole magnesium) Delayed-release Capsules (see our previous post here).
But perhaps the closest parallel to Lannett’s lawsuit is decades old. Way back in 1989, FDA issued a letter to American Therapeutics, Inc. (“American Therapeutics”) rescinding approval of the company’s ANDA for Chlorzoxazone because of CGMP concerns, and shortly after the ANDA was approved. American Therapeutics argued before FDA that the rescission is “an illegal action in violation of the FD&C Act, the Administrative Procedures Act, and [the company’s] fundamental due process rights guaranteed by the U.S. Constitution.” Ultimately, American Therapeutics sued FDA (in D.C. District Court). In February 1990, in American Therapeutics v. Sullivan, 755 F. Supp. 1 (D.D.C. 1990), the court ruled for FDA in a short decision:
There is no regulation or statutory provision that contemplates rescission of an approval issued by mistake. . . . FDA is entitled to some deference when its actions are examined. This was a good faith mistake promptly discovered and corrected, nothing more. There is authority that suggests an agency must be given some leeway to remedy mistakes. No precedent from this circuit has been cited that indicates a contrary approach. It is not the function of a district court under these circumstances to intervene where an unresolved issue of statutory interpretation and administrative law within the exclusive jurisdiction of the Court of Appeals is presented. [(Citations omitted)]
Where will the cards fall here given the American Therapeutics decision? We’ll see soon enough.