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# FDA Reducing Hurdles for Generic Complex Drugs: Gottlieb
- URL: https://www.fdaweb.com/fda-reducing-hurdles-for-generic-complex-drugs-gottlieb/
- Published: 2017-11-28T12:00:00.000Z
- Updated: 2026-09-14T23:03:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140217

FDA is ramping up its efforts to improve the process for developing generic copies of complex drugs, according to commissioner **Scott Gottlieb**. These are products that involve a complex formulation or a complex active ingredient, and include inhaled drugs and eye drops that can’t be easily measured in the blood. “Traditional bioequivalence and bioavailability studies aren’t adequate to support approval,” he said in [remarks delivered](https://www.fda.gov/newsevents/speeches/ucm586643.htm?ref=fdaweb.com) at the agency’s generic drug day in White Oak, MD 11/28.

“The hurdle to approval can also be higher when the drug is delivered through a complex device like a metered dose inhaler, or an auto-injector,” Gottlieb said. “In these cases, the branded drug maker may still hold IP \[intellectual property\] on certain features of the device. In such a circumstance, the drug can be an old medicine, but the device can be hard to copy since new patents protect its key features.”

In certain situations, a generic sponsor may propose differences to the device in an effort to avoid infringing its patents, Gottlieb said. These raise complicated scientific and regulatory questions on whether the proposed generic will have the same clinical effect and safety profile to allow substitution for the branded drug product.

Gottlieb said that a new guidance is being finalized that will provide parameters to generic applicants in addressing these issues. “The guidance lays out how generic applicants should consider when design differences between a generic version of a branded drug could impact the clinical effect or safety profile of the generic product, and thus the substitutability of the generic medicine,” he said. The document will also clarify new policies to allow a generic product to have certain labeling differences from the branded product in situations that permit design differences.

“In other words,” Gottlieb explained, “under this guidance, as long as the generic applicant is able to demonstrate with data, where appropriate, that differences in the design of the generic product do not affect the clinical effect or safety profile when the generic is substituted for the branded product, the generic product can be approved as a competitor to the branded drug where all other requirements for generic approval are met.”

Another guidance being developed will clarify “sameness” requirements for ANDAs. “Going forward, we’ve committed to put out guidance laying out how a generic firm would copy a particular complex drug at least two years in advance of the first potential generic entrant,” Gottlieb said. “This will make it easier for generic firms to plan how they can copy complex drugs. But we also need to continue to improve the science for demonstrating sameness in these settings.”

These are the latest issues Gottlieb and the agency are adding to their plate in order to increase generic drug availability and ultimately lower drug prices. [Earlier this month](https://www.fdaweb.com/fda-wants-to-reduce-companies-gaming-rems/), the agency said it is looking at steps it can take to reduce the likelihood that branded drug companies can use the existence of a Risk Evaluation and Mitigation Strategy (REMS) as a way to slow the entry of generic competition. In a [statement](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584259.htm?ref=fdaweb.com), Gottlieb said the effort is part of a broader strategy, including finding ways to encourage the use of shared system REMS between all innovator and generic companies producing a drug.