Parker Waichman LLP

Rep. Waxman’s Letter Questions FDA Practices, Industry Ties

  FDA Practices Questioned. California Democrat Henry Waxman, head of the U.S. House of Representatives Oversight and Government Reform Committee, is questioning how the U.S. Food and Drug Administration (FDA) determines its priorities. The FDA has been at the center of a number of recent controversies over its handling of safety issues, including tracking tainted […]

FDA Practices

 

FDA Practices Questioned. California Democrat Henry Waxman, head of the U.S. House of Representatives Oversight and Government Reform Committee, is questioning how the U.S. Food and Drug Administration (FDA) determines its priorities. The FDA has been at the center of a number of recent controversies over its handling of safety issues, including tracking tainted foods, inspecting drug manufacturers, suicide risks linked to antidepressants and other medications, tainted batches of the blood thinner heparin, bacteria-tainted spinach and hot peppers, and the 2004 withdrawal of Merck & Co Inc.’s painkiller Vioxx after it was linked to heart problems, to name a few.

Waxman said the FDA seems to be giving priority to projects that benefit the pharmaceutical industry rather than helping consumers. For instance, a 2007 FDA list of top projects includes plans to offer advice to companies on promoting products and guidance on offering reprints of journal articles to physicians, according to FDA Commissioner Andrew von Eschenbach.  The FDA also plans to update regulations to protect device makers from lawsuits if their products are FDA-approved.  Waxman wrote that these steps “All appear to prioritize industry desires over consumer protection” and said that they also seem to have bypassed normal regulatory channels for quicker implementation.

Waxman also wrote that in a June 15, 2007 e-mail from then FDA Chief Counsel Sheldon Bradshaw, that Bradshaw planned to forward a list of agency priorities to the deputy secretary—Tevi Troy—at the U.S. Department of Health and Human Services (HHS). “I’ll send that list to the Deputy Secretary who, in turn, will send it back to the FDA as his list of priority projects. That will ensure that our projects are moved in a timely fashion,” Bradshaw said in one e-mail, according to Waxman. Bradshaw now represents the food and drug industry in private practice and claims the FDA’s priorities focused on public health, despite the fact that drug makers supported some practices.

pharmaceutical industry

In his letter, Waxman said Bradshaw and Troy have ties to the pharmaceutical industry. Prior to joining HHS, Troy worked for two companies with drug company ties and Troy’s brother works as a lawyer for GlaxoSmithKline Plc. Bradshaw maintains he never represented an FDA-regulated company before joining the FDA.  Notably, Troy was sworn in his position at HHS in August 2007, two months after Bradshaw’s e-mail.

FDA spokeswoman Heidi Rebello said the agency would review Waxman’s letter and respond to the congressman, adding that the FDA has an “ambitious agenda” that also includes tackling inspection reform and other safety issues. “It would be a mistake to think that the thousands of dedicated employees working on FDA issues cannot pursue a wide range of public health priorities concurrently,” she said.

The FDA has been criticized for its handling of a variety of drugs and medical devices pulled from the market and investigations revealed the FDA and drug companies were slow to react to problems; that the FDA tried to quiet agency doctors. FDA and drug-industry critics complain the relationship between medical researchers and drug companies is too close and that the industry has turned medical education seminars into drug-promotion campaigns.

Need Legal Help Regarding FDA Practices?

The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529).

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Positive: Professionalism , Quality , Responsiveness , Value MY CONTACT PARALEGAL WAS TINA MORACE, SHE WAS WAY BEYOND FANTASTIC IN ALWAYS KEEPING ME UPDATED WITH THE STATUS OF MY 911 VICTIMS RELIEF FUND CASE STATUS.
TONY P
6 months ago
5 Star Reviews 150
Julie Trinidad has been assigned to my case as my case manager - she’s wonderful. Answers all my questions & concerns. As well as JoAnne Stevens the Nurse who has been assigned to my case. Both ladies have been so informative so kind so professional so helpful!
Robert Metzger
5 years ago
5 Star Reviews 150
I had a very good experience with the people at PW. No issues at all
Peggy Corrigan
4 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038