FDA Follies

Folly – noun (pl. –ies)

1. foolishness. 2. foolish act, behavior, idea, etc, 3. fanciful ornamental building created for display.

– Oxford Dictionary

News and Analysis Concerning Pharmaceutical Impact on Women and Girls

FDA circa 21st century could be considered laughable, if one could disregard the body count.

Bipartisan criticism for FDA

“Imposing user fees on an industry, it is charged with regulating, will only increase industry influence at the FDA.”

— Rep. Rosa L. DeLauro, D-Conn.

FDA Woes

AARP Bulletin, Volume 47 No.5, Page 11

“The thing that is really screwy, is they have a huge backlog of generic drugs and yet they (FDA) are not asking for any more money.”

— Rep Jo Ann Emerson, R-Mo

FDA Woes

AARP Bulletin, Volume 47 No.5, Page 11

“A lot of people are nervous about what is in their medicine cabinet, and for good reason. The FDA has become too cozy with the industry it regulates…That’s not a recipe for full trust and faith among consumers.”

— Sen. Chuck Grassley, R-Iowa… A leading agency critic

FDA Woes

AARP Bulletin, Volume 47 No.5, Page 10

“We have to make certain we have a balance of experts, [including] people who deal with the complications and side effects.”

Steven Nessen, M.D.
Ohio’s Cleveland Clinic
Former chair of the FDA’s Cardiovascular Drugs Advisory Panel

 Dr. Nessen is co-author of the JAMA article calling on the FDA to reject a drug for which the manufacturers failed to provide an accurate measure of the medications risk factors.

FDA FACTOIDS

  • The FDA regulates companies that account for 25% of the US economy.
  • The FDA gets more than 20% of its $2-billion annual budget from industry user fees — fees paid by companies seeking the FDA’s approval to market new products.
  • The fees, mandated by a 1992 law to speed up the approval process, account for nearly half of the new drug office budget.
  • Under 3% of agency funds are devoted to monitoring drug side effects.
  • Generic drugs account for 56% of all prescriptions.

AARP Bulletin, Volume 47 No.5, Page 11

PG

Author: H. Sandra Chevalier-Batik

I started the Inconvenient Woman Blog in 2007, and am the product of a long line of inconvenient women. The matriarchal line is French-Canadian, Roman Catholic, with a very feisty Irish great-grandmother thrown in for sheer bloody mindedness. I am a research analyst and author who has made her living studying technical data, and developing articles, training materials, books and web content. Tracking through statistical data, and oblique cross-references to find the relevant connections that identifies a problem, or explains a path of action, is my passion. I love clearly delineating the magic questions of knowledge: Who, What, Why, When, Where and for How Much, Paid to Whom. My life lessons: listen carefully, question with boldness, and personally verify the answers. I look at America through the appreciative eyes of an immigrant, and an amateur historian; the popular and political culture is a ceaseless fascination. I have no impressive initials after my name. I’m merely an observer and a chronicler, an inconvenient woman who asks questions, and sometimes encourages others to look at things differently.