FDA ENACTS REFUND PROGRAM FOR UNAPPROVED DRUGS

The FDA has sent a notice to consumers of a restitution program for purchasers of three Lane Labs products that were marketed without agency approval.

A federal court in New Jersey ruled that the company marketed BeneFin, MGN-3 and SkinAnswer as treatments for cancer, HIV and skin cancer without FDA approval and has ordered Lane to provide consumers with refunds. The company was under fire from the agency for mislabeling last year, facing a penalty of disgorgement. Disgorgement can result in hundreds of millions of dollars in losses by requiring that all of a company's profits associated with a violation be paid to the government.

Under the U.S. District Court for the District of New Jersey's decision, consumers who purchased these products between Sept. 22, 1999, and July 12, 2003, are eligible for a partial refund of the purchase price and any shipping and handling costs.