Will FDA Soon Allow Drug Makers to 'Reserve' Drug Names?
Could a company with a good idea for a drug name "reserve" that name, preventing another company from using it or using another name similar enough to it to create confusion? While the idea has long been advanced by those in industry, the US Food and Drug Administration (FDA) now says it's willing to consider the idea as well, and is soliciting public input on the proposal.
Background
The process of naming a drug is considerably more difficult than the lay public might imagine. That name, known as a "proprietary" or "brand" name, makes the drug easily identifiable. For example, few would be able to tell you what drug sildenafil is, but nearly everyone would be able to recall its brand name, Viagra.
However, because brand names are generally shorter than the established non-proprietary name for a drug, the potential for confusion can exist. A May 2013 article in the New England Journal of Medicine noted that many drugs approved in the last few years have started with the letters ”X” and “Z,” potentially confusing patients. To name a few from the last few years: Xofigo, Xtandi, Xarelto, Xalkori, Xgeva, Zaltrap, Zytiga, Zelboraf, Zioptan and Zometa.
FDA regulators try to reduce the potential for confusion by approving final trade names submitted by companies, assessing them for similarity to other names. For example, if a company requested a proprietary name of "Simplus," but a similar drug was named "Simplos," regulators would almost certainly reject it based on the potential for mix-ups and errors.
And under a new draft guidance document issued in May 2014 by FDA, companies are supposed to subject any proposed name to real-world simulation studies, scenario-based testing, and an analysis of the name using a Phonetic and Orthographic Computer Analysis (POCA) system, which provides computational analysis of drug name similarity.
Benefits and Potential Pitfalls
So why might a company want to reserve a drug name? Because drug names are dispensed on a first-come, first-served basis, a company often has to come up with 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."
And then there are the international ramifications. Many drugs now seek approval worldwide, making it all the more important that they have the same brand name. The ability to reserve a name years in advance would help companies who launch drugs in smaller, foreign markets first in preparation for a US launch at a later date.
But such a system might also be problematic if implemented incorrectly. Entities could file reserve notices on hundreds of names, seeking to profit from them at a later date by selling them to companies. Alternately, it could become difficult to obtain approval if companies file dozens—maybe even thousands—of name reserve requests in anticipation of future approvals.
And because proposed drug names can sometimes be considered proprietary information (FDA cannot disclose the status of a drug filing unless the company chooses to do so), there are also concerns that companies might have an even harder time selecting a name to use.
Proposal and Questions
All the same, FDA says it is "interested in exploring the possibility of 'reserving' proprietary names for companies once the names have been tentatively accepted by the agency," presumably at the time of a drug's filing.
At the core of FDA's proposal is a guidance document developed by PhRMA, a US-based pharmaceutical trade group, which FDA is set to make available on 28 July 2014 through its Regulation.gov docket (FDA-2014-N-1008).
Based on that guidance, FDA also said it has several questions it wants answered by the public:
- Are there examples of drug market launches being delayed, or of drugs being launched without a proprietary name, because FDA’s determination that a proposed proprietary name would not be acceptable came too close to the date of product approval?
- Potential approaches for reserving proprietary names that would create more certainty for applicants than the current “tentative acceptance” process.
- Whether the “reservation” of a proprietary name for one applicant would be binding, even in situations in which such drug is ready for approval before that of the applicant for whom the name is “reserved.”
- A discussion of the application of the program to over-the-counter monograph products and drugs that are manufactured for a private label distributor, under an existing approved application.
- Data and information regarding:
- The number of applicants that would be interested in participating in a voluntary name reservation program.
- Whether applicants would be willing to participate voluntarily if “reservation” of a name is not guaranteed to prevent the use of the name by all other drugs that enter the U.S. market prior to the drug for which the name is “reserved.”
- In the absence of a binding name reservation program, what measures could be used to provide greater predictability to applicants about the likelihood that a name found tentatively acceptable will subsequently be approved? Can industry address this without FDA involvement, for example, through a voluntary posting of proposed names?
- Under current FDA regulations, information in an unapproved application, including proposed proprietary names, is generally not publicly available (see 21 CFR 312.130, 314.430, 601.50 & 601.51). What mechanisms could be used to provide notice to an applicant of possible confusion between its proposed proprietary name and other proposed proprietary names contained in pending applications?