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FDA Feeling The Heat
By Evelyn Pringle (about the author) Page 2 of 4 page(s)
"It is unlikely," Dr Avorn advised, "that the behavior of the regulated industries improved so much during these years to account for a reduction of 300 warning letters per year."
Another expert consulted for the investigation, Dr. Wilkes, stated in a June 10, 2006, letter to Rep. Waxman:
"Today the snake oil salesman need not travel in horse and cart nor even in automobiles - they use the internet and the mail to make the same outrageous claims with products that contain sometimes dangerous ingredients and often inert useless ingredients.
"And the Food and Drug Administration seems unable and unwilling to step in to protect the American public."
The Report cites examples of serious problems that were ignored, including a GlaxoSmithKline plant in Puerto Rico, where the FDA's field inspectors found several violations between 2002 and 2004, and even recommended that the facility be closed. Yet it was not until 2005, that the FDA censured Glaxo, and even then it did not impose a fine, shut down the plant, or order a recall of the products it was unable to seize.
In some cases, the Report states, FDA headquarters rejected the recommendations of field inspectors despite findings that violations led to multiple deaths or serious injuries. Internal agency documents obtained during the investigation reveal that in at least 138 cases over the last 5 years, the FDA failed to take actions recommended by field inspectors.
The problems identified by inspectors in these cases included 110 where drug labeling and new drug application requirements were violated; 99 cases where manufacturing standards were violated; and 2 cases where firms failed to report adverse drug events. And over 40% of the files, the report said, involved multiple types of violations.
In nearly half of the cases, the FDA took no enforcement action against the firm and in the remaining cases, it took action that was weaker than recommended by the field inspectors.
Most interesting is the fact that during the Congressional investigation, the FDA provided no records from the Office of Chief Counsel, even though a previous investigation had attributed a sudden decline in enforcement actions to the issuance of a change in FDA policy by then Chief Counsel, Mr Daniel Troy, in September 2001, that required all warning letters and untitled letters to be approved by his office before being issued.
According to the revised procedures, the Chief Counsel is required to "state in writing the reason for nonconcurrence" whenever it objects to an enforcement action. Yet when the FDA was asked to explain why there were no records from Mr. Troy's office, FDA staff claimed that the Office of the Chief Counsel does not maintain copies of its decisions or recommendations, or even a record of which files it has reviewed.
The FDA was slammed again when the Institute of Medicine released a September 22, 2006, report that said that the nation's drug safety system is impaired by "serious resource constraints that weaken the quality and quantity of the science that is brought to bear on drug safety; an organizational culture in [FDA] that is not optimally functional; and unclear and insufficient regulatory authorities particularly with respect to enforcement."
The report listed the agency's lack of stable leadership in recent years, and the detrimental effect on personnel; the failure to provide the agency with the necessary authority to regulate post-marketing assessments and enforce compliance; the undue influence caused by the agency's dependence on user fees; and the impact of stacking advisory committees with members that have clear conflicts of interest.
A recent session of the Senate Committee on Health, Education, Labor, and Pensions, gave the Democrats the first opportunity to show how they intend to deal with the major problems at the FDA, so aptly identified by investigations over the past year.
A November 17, 2006, hearing was held to push forward Senate Bill 3807, the "Enhancing Drug Safe and Innovation Act of 2006," previously introduced by outgoing chairman, Senator Michael Enzi (R-WY), and incoming chairman, Senator Edward Kennedy (D-MA), who began working on the bill shortly after the Vioxx disaster.
At the hearing, critics called for stricter conflict of interest rules for advisory panels. Merrill Goozner, Director of Integrity in Science Center for Science in the Public Interest, testified about the conflicts of interest involving the expert panel that reviewed the COX-2 inhibitors, and how the panel decided that Vioxx was safe enough to stay on the market, even though its maker, Merck, had already removed it from the market.
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