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Summary

Congress has been considering legislation that would expand regulatory activities of the Food and Drug Administration (FDA) by opening a pathway for the approval of follow-on biologics. A biologic is a preparation, such as a drug or a vaccine, that is made from living organisms. A follow-on biologic is similar to the brand-name (innovator) product made by the pharmaceutical or biotechnology industry. In contrast to a biologic, most commonly used drugs are synthesized via a chemical process. The new regulatory pathway would be analogous to the FDAs authority for approving generic chemical drugs under the Drug Price Competition and Patent Term Restoration Act of 1984 (P.L. 98-417). Often referred to as the Hatch-Waxman Act, this law allows the generic company to establish that its drug product is chemically the same as the already approved innovator drug, and thereby relies on the FDAs previous finding of safety and effectiveness for the approved drug. The generic drug industry achieves cost savings by avoiding the expense of clinical trials, as well as the initial drug research and development costs that were incurred by the brand-name manufacturer. The cost of speciality drug products, such as biologics, is often prohibitively high. For example, the rheumatoid arthritis and psoriasis treatment Enbrel costs $16,000 per year. It is thought that a pathway enabling the FDA approval of follow-on biologics will allow for market competition and reduction in prices, though perhaps not to the same extent as occurred with generic chemical drugs under Hatch-Waxman. In contrast to chemical drugs, which are small molecules and for which the equivalence of chemical composition between the generic drug and innovator drug is relatively easy to determine, a biologic, such as a protein, is much larger in size and much more complex in structure. Therefore, comparing a follow-on protein with the brand-name product is more scientifically challenging than comparing chemical drugs. In many cases, current technology will not allow complete characterization of biological products. Additional clinical trials may be necessary before the FDA would approve a follow-on biologic. This report provides a brief introduction to the relevant law, the regulatory framework at the FDA, the scientific challenges for the FDA in considering the approval of follow-on biologics, and a description of the proposed legislation. Bills introduced during the 110th Congress on this topic include H.R. 1038/S. 623, H.R. 1956, H.R. 5629, S. 1505, and S. 1695.

Related Legislation:
• H.R.1038
• S.623
• H.R.1956
• H.R.5629
• S.1505
• S.1695

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