The Pharma Marketing Glossary

FDA requires that drug product claim Direct-to-Consumer (DTC) ads must include "All the risks of using the drug." Under certain circumstances, however, ads can give only the most important risks. This is referred to as "Important Safety Information" or ISI for short.

In broadcast radio and TV ads (and telephone), ISI is referred to as the "major statement," which consists of the drug's most important risks. The major statement must be presented in a clear, conspicuous, and neutral manner. The risks are generally similar to the risks required for "fair balance" in print ads.

Omission or minimization of risk information is the most frequent violation of the regulations cited in advertising and promotion enforcement letters sent to sponsors, and illustrative research in one of the areas this guidance covers, direct-to-consumer prescription drug advertising, has shown that 60 percent of patients believe ads directed at them do not provide enough information about risks, 60 percent of physicians believe that patients have little or no understanding from these ads about what the possible risks and negative effects of the products are, and 72 percent of physicians believe that patients have little or no understanding from these ads about who should not use the product.

• FDA: "Guidance for Industry Presenting Risk Information in Prescription Drug and Medical Device Promotion"

The process of getting a drug approved by the FDA -- the investigational new drug ("IND") process -- is costly and time-consuming. The IND process typically has three separate phases.

1. "Phase I" trials, evaluate the safety of the medication by studying the effect of the drug and are designed to determine the metabolic and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.
2. "Phase II" trials are designed to obtain preliminary data on the effectiveness of the drug for a particular indication or indications in patients with the disease or condition.
3. "Phase III" trials, are intended to gather additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug.

Many drugs, like chemotherapy for an example, have deeply deleterious -- sometimes even fatal -- side effects, and part of the FDA approval process is weighing the potentiality for those side effects against the disease process the drug is designed to treat. The sponsor's goal at the end of the IND process is an approved New Drug Application ("NDA").

• Source: Bender's Health Care Law Monthly - April 2009 (accessed 7 November 2011)