On September 29, Congressman Henry Waxman (D-CA-30), the co-author of the 1984 Hatch-Waxman amendments, introduced H.R. 6257, “The Access to Life-Saving Medicine Act” – the first major legislation authorizing a new abbreviated approval pathway for biological products licensed under the Public Health Service (PHS) Act. The Senate companion to the Waxman bill, S. 4016, was introduced by Senators Charles Schumer and Hillary Clinton (D-NY), Patrick Leahy (D-VT) and Debbie Stabenow (D-MI).
Historically, biological products such as cytokines and monoclonal antibodies, have been marketed through licensure under biologics license applications (BLAs) granted under section 351 of the Public Health Service Act (PHS Act). However, a number of biological products, such as insulin, human growth hormone, and menotropins, have been regulated as drugs and approved as new drugs under New Drug Applications (NDA) under section 505 of the Food, Drug and Cosmetic Act (FD&C Act). While the latter products are subject to potential competition through abbreviated approval pathways for generic drugs under Abbreviated New Drug Applications (ANDAs) as well as NDAs under section 505(b)(2) of the FD&C Act, “the PHS Act has no similar provision.”
The bill sponsors intend the Access to Life-Saving Medicine Act to redress the absence of such an abbreviated approval pathway for biological products licensed under the PHS Act. This, they claim, will enable “FDA… to approve lower cost copies of biotech drugs”. Absent such a statutory pathway, the sponsors, generic drug industry, and a number of health care payors argue that “manufacturers of biotech drugs can charge monopoly prices, indefinitely.” The claim that substantial savings would accrue from the creation of an abbreviated approval pathway for BLA-licensed products is hotly contested by innovators, who believe that demonstrating comparability – much less interchangeability – of different biological products is not possible absent extensive clinical investigations and proof of suitable manufacturing capacities. Leading companies and scientists involved in the development and marketing of innovative biological products maintain that only a full complement of clinical evidence can suffice to demonstrate the safety and effectiveness of follow-on biotechnology products.
While the legislation will not receive further consideration in the remaining days of the 109th Congress – unless as an amendment offered in committee markup of unrelated legislation, such as patent reform or prescription drug safety bills – it is certain to be the focus of intense activity in 2007.