FDA's first steps in drug competition plan: get more generics approved
- The Food and Drug Administration on Tuesday unveiled a listing of branded drugs that currently lack generic competition and announced a policy change aimed at ushering copycat products to market faster as part of a wider initiative to increase competition across the pharmaceutical industry.
- The list includes marketed products that don't have any FDA-approved generic counterparts even though their patents and market exclusivity have run dry. The agency plans to refresh the list every six months.
- On the procedural end of things, the regulator updated its priority review rules for Abbreviated New Drug Applications (ANDAs) — the filings drugmakers use for generic treatments. Now, a copycat can qualify for priority review if the branded drug it references has less than three other approved generics and no blocking patents or exclusivity.
Newly minted FDA Commissioner Scott Gottlieb has made it clear one of the first issues the agency tackles under his leadership will be boosting competition in a bid to address rising drug costs. While the FDA has no direct say in drug pricing, Gottlieb believes the FDA can still play a role.
In fact, Gottlieb penned a blog post just last week announcing the Drug Competition Action Plan, a measure that, while far from fleshed out, seeks to reform agency protocols and prevent companies from "gaming" regulations.
The revamped priority review rules and the list are the first steps of that plan.
"Getting safe and effective generic products to market in an efficient way, being risk-based in our own work and making sure our rules aren't used to create obstacles to new competition can all help make sure that patients have access to more lower-cost options," Gottlieb said in a June 27 statement.
If nothing else, Gottlieb's directive is timely. Consumers have become increasingly outraged at the large price tags associated with essential medicines, while state and federal lawmakers are introducing a growing agenda of legislation looking to curb drugmaker's ability to gouge prices or hide pricing decisions. With controversy as a backdrop, the pharmaceutical industry's reputation has taken hit after hit.
In response to concern over rising prices, the FDA is hoping to entice drugmakers to bring more generics to market.
The new list, for instance, is broken down into two parts. The first section lays out branded drugs — such as butenafine hydrochloride or verteporfin, the active ingredients in Bayer's anti-fungal agent Lotrimin Ultra and Bausch + Lomb's eye care treatment Visudyne — the agency could accept an ANDA for without any prior discussion. A second section, however, includes products that could pose legal or scientific issues to potential generic versions. Drugmakers looking to file copycats of those medications should talk to regulators first, the FDA cautioned.
Moving forward, the agency is also holding a meeting on July 18, asking to public to provide "input on places where the FDA’s rules – including the standards and procedures related to generic drug approvals – are being used in ways that may create obstacles to generic access, instead of ensuring the vigorous competition Congress intended," according to Gottlieb.
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