FDA revises ICH Q8 guidance

June 11, 2009

The FDA has revised its guidance on ICH Q8, adding an annex that clarifies the original document and adds the principles of quality by design (QbD).

The US Food and Drug Administration’s (FDA) guidance states that different drug delivery methods will have varying CQAs, such as adhesion properties for transdermal patches, but raw materials such as excipients and intermediates are common factors.

Using the framework devised by the International Conference on Harmonisation (ICH) the guidance details the importance of identifying CQAs and using knowledge of them to guide product and process development.

Source: in-pharmatechnologist


FDA hoping fake ads help monitor real ones

August 7, 2008

Drug regulators plan to produce commercials for a make-believe blood-pressure medicine to test whether images in ads distract attention from required safety warnings.

The U.S. Food and Drug Administration wants to use the internet to survey 2,400 consumers ages 40 and older on responses to the simulated ads, according to a notice posted yesterday on the agency’s website. The study has been submitted to the Office of Management and Budget for approval.

Drugmakers spend $30 billion a year marketing products in the United States, triple what they did a decade ago, according to a study last year in the New England Journal of Medicine. Dozens of companies are warned each year about ads and marketing materials the FDA says mislead consumers that drugs are safer or work better than proven. The new study would show what techniques in commercials add to misperceptions.

The FDA is “responding to criticism of many of us that the risk information is underplayed” in ads, said Steve Findlay, a health care analyst in Washington for Consumers Union, the publisher of Consumer Reports. “It’s unfortunate that this has taken so long, but I think we’ll probably learn some valuable things from this.”

Drugmakers use different techniques to convey the mandatory information about their products’ dangers, from recitations by actors dressed as doctors to the phrases that stream across an animated blue landscape in a commercial for Pfizer’s painkiller Celebrex.

The FDA intends to create a number of ads for the fictitious drug for high blood pressure using different images and text on the screen while a narrator reads the risk information. Some of the visuals will focus on the benefits of the drug, to see if that diverts attention from the safety warnings. Participants will be asked questions about the ads and their attitudes toward the purported new medicine.

The study was first proposed by the agency last August as a survey of 1,020 consumers in shopping malls. The FDA made “extensive modifications to the study’s methodology” as a result of comments received on the proposal, including changing the mode of surveying and the type of questions asked.

Get the story at the Star-Ledger