Naming, Labeling, and Packaging of Pharmaceuticals

Disclosures

Am J Health Syst Pharm. 2001;58(21) 

In This Article

Naming a Drug

A marketed drug has three names: a chemical name, a generic name, and a brand name. A chemical name is given when a new chemical entity (NCE) is developed. The chemical name is a scientific name based on the compound's chemical structure (e.g., 6-thioguanine) and is almost never used to identify the drug in a clinical or marketing situation. The generic name is granted by the USAN Council and is commonly used to identify a drug during its useful clinical lifetime. The company that patents the drug creates the brand name (trademark). This name identifies the drug during the 17 years that the company has exclusive rights to make, sell, and use it under patent law.

The process for naming a marketable drug involves five steps: NCE submission and patent application, generic naming, brand naming, FDA review, and final approval.

A pharmaceutical company submits data on a newly discovered compound to FDA for classification as an NCE to gain permission for animal testing to determine any desirable and undesirable effects. Patent application is made before or at this time through a complex legal process taking two years on average.

The USAN Council is responsible for creating and assigning generic names to chemicals that appear to have potential as new drugs. The USAN Council is composed of representatives of USP, the American Medical Association (AMA), and the American Pharmaceutical Association (APhA), with FDA as a liaison member. After approval by the USAN Council, the name is sent to the World Health Organization for final approval.[8] At this point, the company begins animal testing for efficacy and toxicity.

The USAN Council has several criteria for a generic name. The name must be appropriate for the drug; short, easy to pronounce, and euphonic; and suitable for routine use both in the United States and internationally. The name cannot be misleading or confusing or imply efficacy or application to particular anatomical parts. The name often has a stem common to related drugs (e.g., angiotensin-converting-enzyme inhibitors end in "pril"). The USAN Council attempts to minimize similarities with other drug names, but it does not, at present, use objective methods for human factors evaluation (the effect of the name on practitioners).

If a new drug seems effective and safe after animal testing, the company files for an investigational new drug (IND) exemption to allow testing in humans. This application must include records of preclinical testing and a description of the proposed clinical trials. It is usually about 2000 pages long.[7]

Companies usually begin developing a brand name during Phase I of the IND process. No firm wants to get close to approval without a well-established brand name. A good brand name is important to marketing success in the highly competitive pharmaceutical business. Drug companies use several criteria in selecting a brand name. First and foremost, the name must be easy to remember. Ideally, it should be one physicians will like -- short and with a subliminal connotation of the drug. Some companies associate their drugs with certain letters (e.g., Upjohn with X and Glaxo with Z). If the drug is expected to be used eventually on a nonprescription basis, the name should not sound medicinal. There must be no trademark incompatibilities, and the company must take account of the drug's expected competition.

Each company's naming process is individualized, proprietary, and taken very seriously. Marketing departments are often very influential. An industry representative described the naming process as being "as complicated as a space shuttle launch; as you get down to the final countdown, you must have a very good reason to stop. . . . Marketing builds momentum for a name, and standing in the path of a good name is like standing in the path of a train: You do it only once."

In the standard approach, once several brand names have been selected and have passed an internal review, most companies hire outside consultants to screen for trademark incompatibilities and offer suggestions. The cost of the consultation depends on the number of names to be evaluated and ranges from $100,000 to $700,000. The company generally focuses on potential trademark disputes; these can be difficult to avoid because there are millions of trademarks. Human factors evaluation is conducted by a few companies, but the legal obstacles of the trademark process are the major concern. Brand names are sent to the U.S. Patent and Trademark Office (PTO) for approval. If a name is to be used globally (as most are), it is also sent to Europe's patent and trademark office. These efforts must be coordinated, and disagreements must be resolved. The goal of one global name is difficult to achieve. In the United States, the Lanham Act empowers the PTO and dictates what can be considered in the trademark process; it specifically forbids evaluation based on the potential for clinical confusion or human factors issues. The PTO process can take up to a year, and the name must still be published for public comment before final approval. If there is no objection, the brand name is attached to the product, often during Phase II of the IND process at FDA.

Chris Doninger, a former trademark examining attorney at PTO and currently a trademark and copyright attorney at Novartis, characterized the role of PTO at a 2000 roundtable on naming issues:

PTO is a federal agency that has been empowered by Congress under the Lanham Act to grant a company, organization, or person exclusive rights to a word, symbol, sound, color, product configuration, or other source indication as used on specific goods or services after it successfully passes an examination process. PTO is not authorized under the Lanham Act to determine how the trademark will be used in commerce, and it is not an enforcement agency. With regard to pharmaceutical trademarks, the trademark examining attorneys who review the applications are trained to evaluate marks so as to avoid look-alike or sound-alike problems, but they cannot, under the Trademark Manual of Examining Procedure, base a decision on what the mark for a prescription product might look like when scripted by a physician. . . . In fact, when a class 5 mark -- the international class for pharmaceuticals -- is processed, the examining attorney does not always know if it will be available on a prescription basis or as an over-thecounter product.

Before October 1999, the first human factors evaluation of a proposed brand name was conducted by the Labeling and Nomenclature Committee (LNC) of FDA, usually during Phase II or III of the IND process. This committee assumed this role in reviewing drug names in 1990. LNC was advisory only; FDA's 16 reviewing divisions had ultimate control, but LNC's recommendations were accepted about 95% of the time.

LNC considered whether a brand name looked or sounded like another, was too similar to the generic name, or had confusing prefixes or suffixes. The name could not encode or imply a dosage, imply efficacy, or suggest unapproved indications. In October 1999, the Office of Postmarketing Drug Risk Assessment, created the previous year, took over the review of proposed proprietary drug names.

After a drug has passed through IND, the company files a new drug application (NDA) with FDA. A typical NDA filing must contain all the scientific information a company has compiled and commonly runs to 100,000 pages.[8] At this point the drug is reevaluated and, if it is judged to be safe and effective, is approved for marketing and sale. Because there can be a several-year gap between the IND and NDA evaluations, the brand name is reevaluated during the NDA process.

In the 1980s, the IND and NDA processes at FDA averaged 8.3 years, with the IND process taking 5.5 years and the NDA process taking 2.8 years. During 1990-95, the time increased to 9.2 years.[7]

There has been considerable public, political, and industry pressure on FDA to shorten the regulatory process. Patient advocates (e.g., AIDS and cancer activists) have generated the strongest and most public political pressure, but they have been supported by a congressional majority that tends to be antiregulatory and by a large number of voters. This, coupled with pressure from the pharmaceutical companies to decrease preapproval time, has created significant change at FDA.

The 1992 Prescription Drug User Fee Act also had a major effect. It allowed companies to pay a fee to FDA to speed up the NDA process -- which fell from an average of 30.3 months in 1991 to 17.8 months in 1996. The concept of the new law was reaffirmed, and the fee per new drug was raised from $205,000 in 1999 to $256,338 in 2000 by the Food and Drug Administration Modernization Act of 1997. The statutory minimum duration of an NDA is 6 months; a knowledgeable source suggests that the average NDA is now less than 12 months.

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