The U.S. Food and Drug Administration just announced a series of measures designed to speed to market generic versions of complex drugs in an effort to address the rising cost of pharmaceuticals.
The measures, announced in a blog post by Commissioner Scott Gottlieb, stray into an area that has not previously been the FDA’s purview: drug prices. The agency has typically made its decisions based on safety and efficacy without regard to cost.
Gottlieb said the measures are designed to increase competition in the market by enabling generic competition to complex drugs, something he has long argued for.
Earlier this year, he announced the Drug Competition Action Plan to advance new policies aimed at bringing more competition to the drug market. The goal was to improve access consumers have to the medicines that they need. Access to medicine is a matter of public health. “If consumers are priced out of the drugs they need, that’s a public health concern that FDA should address, within the scope of its mandate and authorities.”
The plan has a number of different domains. Among them is a compilation of efforts to improve the efficiency of the generic drug approval process; and another is a group of policies aimed at closing loopholes that allow branded drug companies to game FDA rules in ways that forestall the generic competition that Congress intended.
One important group of policies is aimed at making it easier to bring generic competition to a category of branded drugs known as complex drugs. Thus the FDA announced a major new set of policies to advance these goals.
Complex drugs comprise high cost medicines like metered dose inhalers used to treat asthma, as well as some costly injectable drugs. These medicines generally have at least one feature that makes them harder to “genericize” under traditional approaches. As a consequence, these drugs can face less competition. In some cases, costly, branded drugs that are complex drugs have lost their exclusivity, but are subject to no generic competition.
The new policies just announced are aimed at ensuring that the FDA provides as much scientific and regulatory clarity as possible with respect to complex generic drugs. The new guidance provides information on requesting and conducting product development meetings, pre-submission meetings, and mid-review cycle meetings with FDA. These meetings will allow for enhanced communication between generic drug applicants and FDA early in the generic drug development process, allowing for more efficient generic drug development, review, and approval pathways.
The FDA commissioner says it will soon release other important policies aimed at spurring competition to complex drugs.