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FDA Feeling The Heat
By Evelyn Pringle (about the author) Page 1 of 4 page(s)
For OpEdNews: Evelyn Pringle - Writer
The Government Accountability Office has identified serious problems within the FDA. In an April 21, 2006, report, the GAO found the FDA's performance "disorganized," "bureaucratic," and undermined by infighting between drug evaluation administrators whose allegiance is with the pharmaceutical industry, and the Office of Drug Safety.
According to the GAO, the drug safety office is under-funded, lacks independence and lacks decision-making responsibility. It also criticized the way FDA scientists were prevented from speaking at advisory committee meetings on drugs they were studying.
Investigators point to a major conflict within the Office of New Drugs because it is not only responsible for approving a drug in the first place, it is also responsible for taking regulatory action related to the safety of drugs once they are on the market.
The GAO report said that day-to-day oversight of safety issues is still hampered by poor information, lack of legal authority to order drug company studies, and bickering between the powerful FDA bureau that reviews drugs for approval and a smaller safety office.
To improve postmarketing safety, the GAO recommends that Congress expand the FDA's authority to require drug companies to conduct studies when additional data is needed.
Another report was released on June 26, 2006, titled, "Prescription for Harm: The Decline in FDA Enforcement Activity," after an investigation was commissioned by the House Committee on Government Reform to evaluate the FDA's enforcement activities related to the pharmaceutical industry under the Bush administration.
When requesting the investigation, Rep. Waxman, wrote to the committee Chairman specifically asking for "attention to cases where career investigators believed official action to protect the public health was warranted but could not proceed."
For the investigation, in addition to reviewing the FDA documents, the investigators obtained information from current and former FDA officials and independent experts.
The experts consulted included Dr. Jerry Avorn, Professor of Medicine at Harvard Medical School; Dr. Michael Wilkes, Vice Dean of Medical Education at the University of California at Davis School of Medicine; and Sammie Young, former Director of Compliance at FDA's Bureau of Biologics and a 29-year veteran of the agency.
As to methods available for enforcement, when a serious violation of FDA standards is found during an inspection, the FDA has the statutory authority to seize or recall products, impose civil fines, or initiate criminal action.
However, most often the FDA will send the manufacturer either a "warning letter" or a "notice of violation," which is also called an "untitled letter." A warning letter notifies a company of violations, requires a written response, and warns that failure to correct the violations can lead to additional enforcement action.
Under FDA procedures, the agency must evaluate the response to a warning letter to determine whether the violations have been corrected. If the firm's response is inadequate, the agency must take other enforcement action "as necessary to achieve correction."
An untitled letter is less serious and informs a company of the violations but does not require a written response or warn that enforcement action may follow if violations are not corrected. An untitled letter also does not require an FDA follow-up.
The Prescription for Harm investigation found that there has been a sharp decline in FDA enforcement actions against pharmaceutical companies since December 2001. After reviewing the records, in a May 25, 2006, letter, Dr. Avorn told the Reform Committee, "In all of FDA's once-proud recent history, I cannot recall a time of greater concern about its work on the part of doctors, patients, and policy researchers."
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