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by Prof. Christopher M. Holman, UMKC School of Law
Orange Book Blog



Much of the current discussion surrounding the proposed follow-on biologics bills assumes that a "statutory path" is necessary before FDA can implement an abbreviated biologics license application (BLA) process for biotechnology-derived therapeutic proteins. In fact, FDA probably already has the authority to create such a process by regulation, but so far has declined to do so.

The argument that FDA requires a statutory path is based largely on the fact that the PHSA (the statute governing the regulation of most biotechnology-derived therapeutic proteins) does not explicitly provide an abbreviated BLA approval processes analogous to the FDCA's 505(b)(2) "paper NDA" and 505(j) abbreviated NDA (ANDA). But the FDCA explicitly requires clinical trials for the approval of an NDA, so FDA arguably needs explicit statutory authorization to implement an abbreviated process that dispenses with the requirement of clinical trials. As noted in the House Report published in connection with the passage of Hatch-Waxman, the only statutory difference between a NDA and an ANDA is the requirement of human clinical trials.

The PHSA, on the other hand, does not require clinical trials for approval of a BLA, and hence no explicit statutory path should be required for biologics. FDA's regulations require clinical trials to show safety and efficacy of biologics approved under the BLA process, but these are regulations dating back to the mid-1970s (well before the approval of any biotechnology-derived proteins), and could be updated by FDA to dispense with such a requirement in some instances, assuming the science would support such a revision, without requiring Congress to amend the PHSA.

In 1996, a district court specifically found that FDA has the statutory authority under the PHSA to approve a comparable biologic without requiring new clinical trials. Berlex Labs v. FDA, 942 F.Supp. 19 (D.D.C. 1996). Although that case dealt with a change in manufacturing process implemented by the original manufacturer, with respect to the question of statutory authority the court's rationale should apply equally to a comparable protein produced by a different manufacturer.

During recent Congressional testimony, FDA's representative Dr. Woodcock was questioned on the supposed need for a statutory path. She walked a close line, at one point indicating that a statutory path was required, but on closer questioning conceding that the PHSA does not require clinical trials, and that the only statutory requirement is that the FDA ensure the "purity, potency and safety" of biologics approved under the Act. Members of Congress also queried whether the rationale of Berlex Labs v. FDA should not also apply to biologics, but did not receive a direct answer. Earlier, in January 2007, Reps. Dingell and Stupak sent a letter to FDA questioning whether a statutory path was really necessary, and asking for a response from FDA no later than February. To my knowledge, FDA has not responded.

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RELATED READING:
- A somewhat more compelling take on biogenerics from Express Scripts
- Duke Study: Generic Biologics A Dumb Idea!
- Potential Trouble Ahead For Big Biotechs

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