The FDA has announced what its commissioner called “a major new set of policies” aimed at making it easier to bring generic competition to a category of branded medications known as complex drugs.
Such products include high-cost medicines like metered-dose asthma inhalers and some injectable drugs, FDA Commissioner Scott Gottlieb, MD, wrote in a blog post on the FDA website. ”These medicines generally have at least one feature that makes them harder to ‘genericize’ under our traditional approaches. As a consequence, these drugs can face less competition,” he said. Some of these drugs have lost their exclusivity but still face no generic competition.
Gottlieb said the agency’s new policies “are aimed at ensuring that we provide as much scientific and regulatory clarity as possible with respect to complex generic drugs.” Not only are they important to patients, he said, but they’re also “increasingly significant to the economic health of the generic drug industry.”
Complex drugs include products where the active ingredient itself is complex, Gottlieb said, citing the example of glatiramer acetate injection, a drug used in the treatment of multiple sclerosis. But the category is much larger, extending, for instance, to complex drug-device combination products. “This complexity, in turn, means that the scientific and regulatory pathways for approval of generic versions of these drug products are not as well traveled by generic drug developers,” he added.
Regulatory requirements affect both the direct and indirect costs of drug development, he noted: the time it takes to develop a drug and gain regulatory approval as well as costs associated with the research and development of experimental products that ultimately do not make it to market.
So the agency is “taking a number of new steps to support the development of high quality ANDAs [abbreviated new drug applications] for complex generic drugs,” Gottlieb said:
Source: FDA; October 2, 2017.