The U.S. Food and Drug Administration has issued new guidelines for the marketing of drugs.
The rules will be enforced by the agency’s Office of Regulatory Affairs.
Here are five things to know.
The drugs must contain a single, clear, medically-defined term that describes the drug’s intended use, benefits, and risks.
The new rules will help define what it means to “buy a medicine” and how it must be marketed.
The drug must be labeled with the FDA’s logo, a picture of the drug, and the drug company’s name and a generic name that is at least 50% identical to the name of the original drug.
The generic name must be “brand-specific.”
The FDA must consider whether a drug’s generic name is a generic term or a registered trademark, or whether a generic trademark is a registered term.
The latter is the most common scenario.
A generic name should contain at least one of the following: the generic name, an abbreviation of the generic term, the generic drug’s brand name, or the generic brand name of a brand-name drug.
The company that created the generic product must have at least a 25% market share in the U.s. generic drug market.
The brand-specific label can only be used if the company’s brand and/or the brand name is used on the product.
The label must be at least 30% smaller than the actual size of the product, and must be consistent with the product’s generic label.
The guidelines are part of a larger effort by the FDA to simplify the process for drug approval.
The agency has issued its first generic drug rules in the United States since 2008.
The Food and Drugs Administration (FDA) has said the rules will improve transparency and accountability.
Read more about the FDA rules and drug marketing.