The Trademark Approval Process of the Food and Drug Administration's Office of Postmarketing Drug Risk Assessment
The prescription pharmaceutical industry has matured rapidly with respect to its understanding of the value of trademarks. Ten years ago, it was uncommon to see advertisements for prescription medications. Today, with successes like Viagra® and Claritin®, one can hardly watch television or read a magazine without being exposed to an advertisement for the latest prescription medication. Prescription drug trademarks are important marketing tools that can add great value to a company.
However, the problems that can be created by similar prescription drug trademarks are significant. While confusingly similar trademarks can cause consumer confusion, confusingly similar drug trademarks can lead to fatalities. It is the role of federal agencies to screen trademarks in order to protect consumers from the sometimes serious consequences that result from the use of confusingly similar trademarks.
In seeking trademark protection, we normally think of the United States Patent and Trademark Office ("USPTO"), the federal agency that is responsible for reviewing trademark applications and issuing federal trademark registrations. However, companies that are in the business of developing and marketing prescription pharmaceuticals must also consider the policies of the Food and Drug Administration ("FDA") when it comes to selecting trademarks for their products. Thus, pharmaceutical companies are faced with additional federal administrative hurdles in developing trademarks for prescription drugs. It is unfortunate when a company obtains a federal registration of a trademark only to discover that the FDA will not approve the same mark for use with the company's product.
In October of 1999, the FDA opened a division called the Office of Postmarketing Drug Risk Assessment ("OPDRA"). This agency is a sub-group of the Center for Drug Evaluation Research ("CDER") and was created in response to the growing problem of medication errors caused by look alike and/or sound alike drugs. Despite the "postmarketing" part of the OPDRA name, the OPDRA is responsible for reviewing and either accepting or rejecting new drug trademarks (also know as proprietary names) before they hit the market.
Published guidelines, tentatively titled "Guidance for Industry," and official policies for the OPDRA review process were scheduled to be released by December 2001 but have been delayed until at least the end of 2002. When published, the guidelines should appear on the FDA's web site.
IMPORTANT NOTE: While the OPDRA may review the USPTO database in its evaluation process, the OPDRA's review is distinct from the USPTO examination of a trademark. Because the FDA's review criteria and concerns are different from those of the UPSTO, the existence of a federal trademark application or the grant of a trademark registration by the USPTO is of no real value in the OPDRA's review of the same mark and vice versa. However, the existence of a third party trademark application or registration in the USPTO for a similar mark may have a negative impact on the analysis of a sponsor's proposed name in the OPDRA.
Related reviews are conducted for labels and packaging by the Division of Drug Marketing, Advertising and Communication ("DDMAC"). Proprietary names for biologic products that are regulated by the Center for Biologics Evaluation ("CBER") are not generally reviewed by OPDRA but are instead reviewed by CBER's advertising, promotion and labeling staff ("APLS").
OUTLINE OF THE FDA/OPDRA REVIEW PROCESS
I. Request Submission
A request for review is submitted to the drug sponsor's reviewing division. The request format is informal and can be a simple letter to the reviewing division requesting the review of proprietary names used in connection with the sponsor's drug. The sponsor may submit up to two names for review in order of preference. If the first choice is approved, the second choice will not be reviewed.
Pointer: Any proposed product packaging and package inserts should be included with the request for review. The OPDRA recommends that empty vial sizes not be included on packaging but that final concentration after dilution be included in package inserts. The sponsor may also submit, if available, supporting studies and data.
The review process can begin between phase two and phase three of an investigational drug ("IND") application or new drug application ("NDA"). Proprietary names on abbreviated new drug applications ("ANDA") and supplemental new drug applications ("SNDA") are also subject to OPDRA review.
Pointer: When a review request is submitted, the sponsor should make sure that the indications for the drug are set. Such indications would be information normally contained in package inserts including dosage, delivery method and patient population. If indications are significantly changed after a name has been approved, the name may be subject to re-review based on the new indications.
Review requests for NDAs are given priority over INDs, and are reviewed on a first-come, first-served basis. The target time period for initial review of an NDA name is 60 days. Review requests for IND names can take considerably longer depending upon the backlog in the OPDRA.
If a name passes through the initial review, the sponsor is given provisional approval of the name. A second review is conducted approximately 90 days before the final NDA approval. The second review is intended to intercept any intervening approvals for newly marketed drugs that may be problematic.
Pointer: If final NDA approval is delayed beyond 90 days from final review and acceptance of the proposed name, the name must be re-evaluated.
Pointer: Status update requests should be directed to the reviewing division project manager, not to the OPDRA.
III. Mechanics of the Review
- Clinical Sampling - The OPDRA puts together a sample group of approximately 100 health care professionals from various units of the FDA including physicians, pharmacists, and nurses. These sample groups analyze and interpret handwritten and verbal test prescriptions. The sample submissions include the proposed name as well as dosage, delivery method, and course of therapy. These submissions are then analyzed by the OPDRA and compared against existing proprietary drug names for look alike and sound alike problems.
- Analysis Factors - The OPDRA analyzes the proposed name and packaging using the following, non-inclusive, factors:
- Are any clinical promises supported?
- Are indications proven?
- Is there a problematic alpha or numeric prefix or suffix?
- Pointer: Avoid names that end in letters or numbers that may be confused with prescription dosage abbreviations or acronyms. For example, a name that ends in "QID" may be confused with the acronym q.i.d. (four times daily).
- Is the dosage encoded in the name?
- Pointer: Encoding dosages in proprietary names is discouraged because dosages can change. Thus, such names can be confusing and lead to medication errors.
- Is the name generic?
- Pointer: As is the case for federal trademark registration in the USPTO, drug names that are generic will not be acceptable to the OPDRA.
- Risk/Benefit Analysis - The indications for the proposed drug name are evaluated by an FDA safety evaluator who weighs the risks and benefits of such factors as overlapping strengths, dosage forms and recommendations, use and indications, storage, labeling, and packaging. The evaluator also runs a literature search. Recently, more staff have been added to the reviewing division resulting in more in-depth literature searching.
- Computer-Assisted and Reference Analysis - A database review is conducted to compare the proposed name against names on other applications undergoing FDA product review. The review system is currently being developed to include searches for spelling and phonetic similarities in proprietary drug names. The OPDRA medication error staff also conducts a search of several reference texts and FDA databases including MICROMEDEX Healthcare Intranet Series which includes DrugDex, Poisindex, Martindale, Index Nomunum, and PDR/Physician's Drug Reference; American Drug Index; Facts and Comparisons; COMIS database; The Established Evaluation System database; Labeling and Nomenclature Committee database; New Drug Approval database; FDA Orange Book, and the USPTO database. The common name associated with the subject drug application is also checked for published reports of medication errors. The proposed name is compared against other proprietary names that are associated with reported medication errors for the same drug type.
- Risk Assessment - The OPDRA puts the above information into a report, called a "Consultation Response," conducts a risk assessment of the same, and prepares a summary of any safety issues. If the risk assessment is positive, the sponsor is given provisional approval of the submitted name. Part of the report includes issues raised by group discussions of the OPDRA's medical error staff and a DDMAC representative. These discussions focus on safety concerns and nomenclature issues raised by the proposed name. In this evaluation, the group relies on professional and clinical experience as well as standard references discussed above.
If a proposed name is rejected, the sponsor may appeal the decision by presenting persuasive evidence relevant to the concerns raised in the OPDRA risk assessment evaluation. One commentator on the subject set the appeal success rate at 50%.
Pointer: The appeal is made to the sponsoring division, not directly to the OPDRA. The sponsoring division hears the evidence at a meeting attended by, in most cases, an OPDRA representative and sponsor representatives.
There are no additional federal agency filing fees associated with the OPDRA's review of proprietary drug names.
As noted, FDA approval of a prescription drug trademark does not have any bearing on federal trademark registration. To avoid potential conflict with third party marks, the owner of a prescription drug trademark should seek approval by both the USPTO and the FDA. It may seem daunting to have to go through two different government agencies to establish a viable prescription drug trademark. However, the consequences of having to change the name of a product once it is in the marketplace and/or defending a trademark infringement action are much more burdensome.
*article courtesy of The Food and Drug Law Institute.