The FDA Needs Out Help

By: Red Hot Mamas

Published: July 13, 2010

Based on a new release for 2009 budget plans, recent congressional deliberations and other news popping up recently (New York Times article “The F.D.A. in Crisis”, Sunday, February 3, 2008), consumers should be aware that the FDA and the US Food and Drug Administration is in a crisis due in part to a lack of funding, a limited staff, lack of scientists, and an inefficient computer system–they are in desperate need of help.

Last Tuesday, the FDA’s former chief counsel, Peter Barton Hutt, addressed a Congressional panel declaring the agency was barely hanging on by its fingertips. “This is a fundamentally broken agency and it needs to be repaired.” Our nation’s public health protection agency isn’t getting enough money to do their job? This is a very alarming statement!

In a time where our country so readily outsources the manufacturing of drugs outside the United States, I hope the FDA and other regulatory agencies have what they need to ensure nothing slips through the cracks. Just recently, a pharmaceutical producer in China was flagged for accidental drug contamination when some 200 leukemia patients in China were harmed from a leukemia drug.

Chinese authorities have recently taken appropriate action by closing the facility and detaining two company officials related to the incident. Coincidentally, the same company (but in a different factory) is the U.S.’s sole supplier of the abortion pill, RU-486. Evidently, the FDA inspected the RU-486 factory several times in the past few months and everything checks out fine. Still, the incident drives home the importance of quality control and diligent monitoring.

The importance of the FDA is indisputably vital to our nation’s health and safety. They serve as our government watchdog ensuring our food, drugs, medical devices, cosmetics and products are regulated to meet a certain standard. The past few decades have been tough for the agency and many government officials, industry and consumer groups feel it has been neglected.

The Government Accountability Office (GAO) has raised grave concern. They discovered the FDA is currently (amongst other problems) unable to conduct timely inspections of foreign manufacturing facilities due to a lack of staff and inadequate computer systems. According to current GAO reports, the agency’s workload has greatly increased in the past decade while staff and funding have not kept pace.

In recent years, Congress has put increasing demands on the FDA without giving them proper support, including funds and personnel support. Some units, including regulatory of food, dietary supplements and cosmetics are in “a state of crisis”. Red Hot Mamas suggest you urge Congress to strengthen the FDA to protect the lives of Americans now and in the future. Write your representative and voice your concerns.

References:

Drug Safety: Preliminary Findings Suggest Weaknesses in FDA’s Program for Inspecting Foreign Drug Manufacturers. Government Accountability Office Testimony 1 November 2007: 28pp.

FDA’s Food Protection Plan Proposes Positive First Steps, but Capacity to Carry Them Out Is Critical. Government Accountability Office Testimony 29 Jan. 2008: 19pp.

Gibb, Gordon. The FDA: Barely Hanging On by its Fingertips. Lawyers and Settlements 4 Feb. 2008.

Medical Devices: Challenges for FDA in Conducting Manufacturer Inspections. Government Accountability Office Testimony 29 Jan. 2008: 30pp.

The FDA in Crisis: Another Danger Made in China. Editorial. The New York Times 3 Feb. 2008: Opinion.

The FDA in Crisis: It Needs More Money and Talent. Editorial. The New York Times 3 Feb. 2008: Opinion.

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