Bringing Real Life to the Table: Patient Reps Help FDA Review Products

By Meadows, Michelle | FDA Consumer, January-February 2002 | Go to article overview
Save to active project

Bringing Real Life to the Table: Patient Reps Help FDA Review Products


Meadows, Michelle, FDA Consumer


When Jim Anderson of La Plata, Md., became an FDA patient representative in 1997, he wasn't sure how much help he could be. In preparation for his first advisory committee meeting, the Food and Drug Administration sent him a new drug application (NDA) briefing package, which he describes as "10 pounds of paper."

"I couldn't pronounce half the words," he says, "and I was scared to speak ..."

But the fear didn't last long, says Anderson, who was diagnosed with prostate cancer in 1993. He recalls reviewing a drug that gave "a small chance to provide pain relief and a significant risk of heart failure," in his opinion. He was glad he spoke up about it because his concern prompted a serious discussion among the scientists and doctors.

Anderson was one of about 23 patient representatives who gathered in Rockville, Md. for an FDA training workshop in September. Since 1991, patient representatives have served on FDA advisory committees to help review products. Advisory committees provide a forum through which the FDA seeks advice from outside experts and consumers.

Patient representatives give the FDA and its advisory committees insight on issues and questions important for patients and family members living with serious and life-threatening illnesses. The patient representative program began after Congress passed legislation requiring consumer representation on advisory committees and HIV/AIDS advocates demanded to be included on advisory committees that review products affecting their lives. Over the years, the FDA saw the significant contribution HIV/AIDS patients made to the regulatory review process, and the distinct category of patient representatives was expanded to include other committees.

FDA experts in the areas of drugs, radiological health, medical devices, and biologics briefed those at the workshop on the agency's product review process. Among the workshop agenda topics was how to sift through the hefty NDA applications, which contain results from animal studies, clinical tests, and other drug information. Patient representatives should expect to spend at least 10 hours reviewing the material before an advisory committee meeting.

Patient representatives typically have experience with and are knowledgeable about a specific serious or life-threatening illness. They also typically have a formal affiliation with a patient advocacy organization. About 60 patient representatives now serve on the FDA's 32 advisory committees.

Most patient representatives serve on committees that review products related to HIV/AIDS and cancer. But additional diseases, such as arthritis, diabetes, lupus, and Parkinson's disease, are also included. Patient representatives are reimbursed for travel, lodging, and daily expenses. A modest honorarium is provided for each day of service at the meeting.

Critical Questions

During the fall workshop, Steven Hirschfeld, M.D., Ph.D., a medical officer in the FDA's division of oncology drug products, described the challenge of pinpointing the indicators that reasonably predict whether a drug will have a benefit.

The rest of this article is only available to active members of Questia

Sign up now for a free, 1-day trial and receive full access to:

  • Questia's entire collection
  • Automatic bibliography creation
  • More helpful research tools like notes, citations, and highlights
  • Ad-free environment

Already a member? Log in now.

Notes for this article

Add a new note
If you are trying to select text to create highlights or citations, remember that you must now click or tap on the first word, and then click or tap on the last word.
Loading One moment ...
Project items
Notes
Cite this article

Cited article

Style
Citations are available only to our active members.
Sign up now to cite pages or passages in MLA, APA and Chicago citation styles.

Cited article

Bringing Real Life to the Table: Patient Reps Help FDA Review Products
Settings

Settings

Typeface
Text size Smaller Larger
Search within

Search within this article

Look up

Look up a word

  • Dictionary
  • Thesaurus
Please submit a word or phrase above.
Print this page

Print this page

Why can't I print more than one page at a time?

While we understand printed pages are helpful to our users, this limitation is necessary to help protect our publishers' copyrighted material and prevent its unlawful distribution. We are sorry for any inconvenience.
Full screen

matching results for page

Cited passage

Style
Citations are available only to our active members.
Sign up now to cite pages or passages in MLA, APA and Chicago citation styles.

Cited passage

Welcome to the new Questia Reader

The Questia Reader has been updated to provide you with an even better online reading experience.  It is now 100% Responsive, which means you can read our books and articles on any sized device you wish.  All of your favorite tools like notes, highlights, and citations are still here, but the way you select text has been updated to be easier to use, especially on touchscreen devices.  Here's how:

1. Click or tap the first word you want to select.
2. Click or tap the last word you want to select.

OK, got it!

Thanks for trying Questia!

Please continue trying out our research tools, but please note, full functionality is available only to our active members.

Your work will be lost once you leave this Web page.

For full access in an ad-free environment, sign up now for a FREE, 1-day trial.

Already a member? Log in now.

Are you sure you want to delete this highlight?