FDA Releases PhRMA Proposal on How Drug Names Could be Reserved Prior to Launch
Posted 21 August 2014 | By
US regulators have finally released the text of a 2009 industry proposal that is set to form the basis of discussion at an upcoming meeting on whether companies should be allowed to "reserve" drug names for late-stage investigational drugs.
As Focus reported in July 2014, FDA recently issued a notice indicating that it was exploring allowing companies to reserve drug names.
Because drug names are dispensed on a first-come, first-served basis, companies often generate several proposed names for a drug at the time of filing. Drug names aren't approved, however, until the time that the drug itself is. And because a company has no idea of the names other companies have requested from FDA, its proposed name could be knocked out of commission by a product that wasn't even approved at the time of its submission—what FDA calls an "intervening entry into the US market."
Complicating matters further, companies generally seek worldwide approval for their drugs. If a product has been approved under one name in most regions, but fails to get approval for that same name in the US, that can potentially cause confusion for healthcare providers and patients alike, who may be familiar with a drug's other name.
Missing in Action
Accordingly, FDA and members of industry have been interested in building a more predictable mechanism for approving new drug names.
Most notably, in 2009 the US pharmaceutical trade group PhRMA sent FDA a working draft of a guidance document that outlined its then-preferred system for approving drug names. In FDA's July 2014 meeting notice, the agency said PhRMA's guidance would be one of the primary focuses of its meeting, and implied it might potentially be used as the basis for future agency guidance.
But since FDA first posted its meeting notice, industry analysts have been missing one important detail: PhRMA's guidance. Requests by Focus to obtain the guidance were declined by PhRMA, which said in a statement that what it had submitted in 2009 was "a bit outdated," and that it would not be making it "available publicly" as a result.
But after several rounds of requests, FDA has finally posted the document to its public docket, affording the public a glimpse at what could become the basis for the future drug name reservation system.
As PhRMA's guidance explains, "the lack of early final approval of proprietary names gives rise to a system that is time and resource intensive for both the Agency and the applicant, and creates unnecessary delays and uncertainty in the approval process."
What the trade group would like to see instead is a voluntary system in which sponsors could reserve a drug name once a product has cleared Phase II clinical testing. At present, companies can request a name at this stage, but can only receive "tentative" approval for the name—not binding approval.
To guard against name hoarding, PhRMA's guidance anticipates that any names not used within 18 months of an initial request will then be available for use by other companies, or subject to an 18-month extension that would also make the drug name and release date available on FDA's website. Withdrawn names can be re-submitted to the agency, but can no longer be reserved.
While this system might otherwise release confidential commercial information (CCI), because the system is voluntary, it should avoid potential issues, PhRMA said.
Notably, the system calls for FDA to publish all proprietary names on FDA's website, along with the date the name reservation is expected to end. FDA "will not disclose the name of the applicant" or any other details about the drug, according to the guidance.
Focus reached out to PhRMA for comment on the guidance, but did not receive a response by the time this article was first published.