By Dara Katcher Levy –
How many lawsuits will it take before FDA starts exercising better judgment on imports? On October 25, 2010, Amphastar Pharmaceuticals Inc. (“Amphastar”) filed suit against FDA seeking declaratory judgment and injunctive relief with regard to FDA’s detention of two entries of semi-purified heparin. According to the Complaint, the entries, proposed for import in May 2010 in the Los Angeles District, were intended for use in the manufacture of starting material for the development of active pharmaceutical ingredient - the subject of a pending Abbreviated New Drug Application for generic LOVENOX (enoxaparin). The material, heparin (which is used in the manufacture of enoxaparin), from an Amphastar-owned facility in China, was intended to qualify the manufacturer as an alternate source of raw material, and was intended for laboratory testing purposes only, not for use in humans or animals.
Both entries of material were tested by FDA in June 2010 and released in July 2010. FDA rescinded both releases a week later, and two weeks after the recission of the releases, alleged the products were misbranded due to the manufacturer not being a registered facility. This allegation was apparently incorrect, as the Chinese facility was a registered establishment. After FDA was notified of this, the Agency then alleged the product lacked adequate directions for use, notwithstanding the fact that the material was not intended for use in humans, was for laboratory testing purposes only, and even if it were a drug for human use, would be subject to the exemption from adequate directions for use for bulk drugs intended for further processing pursuant to 21 C.F.R. § 201.122(c).
The products remain detained despite Amphastar notifying FDA of these issues. Although the first shipment passed FDA testing, FDA still has not completed testing of the second shipment. FDA notified Amphastar on October 18, 2010 that testing would not be completed until November 17, 2010 – approximately 5 months after FDA initially sampled the product.
Although FDA has broad discretion over imports, it is expected that FDA’s allegations of violations have some merit, and that they be made in a timely manner. It appears that FDA is using the misbranding allegations as “place-holders” until FDA completes testing of the second shipment. For FDA to take five months to test the shipment is extraordinary, and even more so given that the product is not intended for human use. It will be interesting to see FDA’s response to this Complaint.