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Regulatory News | 03 April 2015 | By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) plans to study whether including pricing information on the label of a pharmaceutical product affects how consumers view the safety and efficacy of drug products, especially when comparisons are made between two drugs.
Pharmaceutical advertising and labeling in the US are regulated by FDA, which ensures that certain information related to the safety and efficacy of a product is conveyed appropriately. The ultimate goal, regulators have frequently said, is to keep drug advertising—and especially advertising targeted at the public—balanced. That means that a drug's benefits should not be overstated, its potential harms should not be understated and its comparative effects should portrayed accurately.
While this might sound simple in theory, FDA's advertising regulators—the Office of Prescription Drug Promotion (OPDP)—have frequently expressed interest in studying areas in which obscure factors might skew the way in which a consumer understands the benefits and harms of a drug.
For example, if a company uses a "composite score" to promote a drug, do most consumers understand what that means? If a drug is promoted toward adolescents, does the drug need to emphasize its risk factors more to account for the target audience? And what happens to consumers when they see the same drug ad multiple times?
OPDP has undertaken studies on all of these topics (and more) in recent years.
Read our accounts of all OPDP's drug advertising studies conducted since January 2012 here.
Now OPDP has expressed its interest in another study on the effects of drug advertising on consumers’ decision-making and benefit-risk assessment.
In an FDA announcement on 3 April 2015, OPDP said it plans to study what happens when two or more drugs are compared using price comparison information.
"In prescription drug advertising, sponsors are permitted to include truthful, non-misleading information about the price of their products in promotion," FDA explains in the notice. "This may extend to price comparison information, wherein sponsors may include information about the price of a competing product in order to make advantageous claims."
The problem, FDA notes, is that few drugs—with the exception of generic chemical drugs—are easily comparable. Instead, companies marketing similar drugs must account for differences in safety and efficacy when making price comparisons between two or more products.
FDA said it is concerned that even with "the inclusion of this additional [safety and efficacy] information," that information might not be sufficient to "correct the impression that the products are interchangeable and that price is the main factor to consider."
As a result, OPDP said it plans to assess the issue in an upcoming study on consumers and physicians.
The main study will assess 1,500 diabetic patients, as well as 1,440 general practitioners. The study participants will view one of three possible advertisements for a fictitious prescription drug for diabetic neuropathy. One advertisement will compare pricing between the two drugs; the second advertisement will have a price comparison as well as additional context, and the third advertisement will include only price information and will not compare the drug to any other product.
The study has been sent to the Office of Management and Budget (OMB) for its approval, FDA said.
Federal Register notice
Tags: Drug Advertising, Pharmaceutical Advertising, OPDP, Office of Prescription Drug Promotion, Price Comparisons in Drug Advertising