Generic firms appear to have avoided most, but not all, of the reporting requirements for ClinicalTrials.gov, though winning complete privacy protections appears as though it will require congressional intervention.

The ¹ draft definitions posted on ClinicalTrials.gov indicate that most bioequivalence trials conducted in support of an ANDA would be considered Phase I trials and thus exempt from expanded public reporting requirements created in the FDA Amendments Act passed last year.

Generic firms have been concerned that being required to disclose such studies on a public Web site would expose their pipelines to scrutiny by brand firms (² Also see "Pipelines Of Generic Drug Firms May Become More Transparent Under FDAAA" - Pink Sheet, 1 December, 2008., p. 19).

However, the way the definition is structured, trials for locally acting drugs or other products where traditional bioequivalence techniques cannot be used would not be exempt and would have to post their studies on the Web site. Two areas where this may be of immediate concern are antibiotics and orally dissolving drugs (see ³ Also see "FDA Finalizes ODT Guidance, Sticks To More Restrictive Recommendations" - Pink Sheet, 5 January, 2009.).

Specifically, the definition states, "Bioequivalence or comparative bioavailability studies that fall within the scope of the studies described in 21 CFR § 320.24(b)(1), (2), and (3) share many of the characteristics of Phase I clinical investigations as described in 21 CFR § 312.21(a), and therefore will be considered to be Phase I trials" and exempt from disclosure.

"However, bioequivalence or comparative bioavailability trials that fall within the scope of 21 CFR § 320.24(b)(4) do not share the characteristics of Phase I trials as described in 21 CFR § 312.21(a), and thus would not be considered to be Phase I trials."

Generic firms might be able to get the definition changed when it is finalized, but FDA has already heard the arguments and decided the other way. The best hope for industry would seem to be getting legislation passed that would more broadly exempt them from the disclosure requirements.

Hyman, Phelps & McNamara attorney Kurt Karst observes that "under a Maine law that is still in effect (and that might not be pre-empted for a few years)," all trials, including bioequivalence studies, must be posted for approved products.

While the policy does not appear to open a window for brand firms to pounce on generic studies before approval, it would give brand firms some insight into the generic approval process in general.

- M. Nielsen Hobbs (n.hobbs@elsevier.com)

Generics Avoid Many, Not All, Disclosure Requirements For ClinicalTrials.gov

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