[Commentary by Robert Steeves*] FDA’s relations with the Congress have not been as fractured as they are today in more than three decades. The Washington Times, never considered to be a liberal advocate, reporting on the House Energy and Commerce Subcommittee on Oversight hearing, said:
“Congress is simmering over the FDA’s approval of Ketek and apparent refusals to cooperate with lawmakers on the agency’s methods for sending new drugs to market.”
I consider that an understatement. Sadly, the indicators are pointing downward so the bottom is nowhere in sight. The previous adversarial, and sometimes downright hostile, relationship setting the low-water mark began a few years after passage of the Kefauver-Harris Amendments of 1962.
The issues then involved many of the same topics as today — FDA management being too close to the industry, cajoling its reviewers to approve drugs, among other things, and a group of FDA medical reviewers cooperating with congressional folks (today they would be considered “whistleblowers”). As tensions ratcheted up in the early 1970s, FDA’s Office of Legislative Affairs faced an average of one hearing a week — 50-plus hearings in a single year.
The situation could be even worse this time, since both congressional chambers shifted to Democratic control and the new leaders want to make up for what they consider six or more years of neglected oversight. And they also want to make the case that their party can run the government much better, more transparently, and more in the public interest than the Bush Administration or a new Republican President could.
With the current commissioner being a close friend of the President, the confrontation could be even harsher.
The subcommittee hearing began with statements by Chairman John Dingell (D-MI) and Joe Barton (R-TX), the ranking minority of the parent Energy and Commerce Committee. While not at all unusual to begin with the biggest guns you have, their presence at the kick-off hearing says that this is a serious effort with support of the heaviest hitters.
Chairman Dingell noted:
“Unfortunately, from time to time this Committee has had to expose problems at that agency [FDA]. It seems every so often the FDA loses its way, sometimes because of the work of scoundrels, sometimes because of poor management. But sometimes it is because of a more serious breakdown in the policies and procedures that are critical to assure the safety of the food, drugs, blood, and medical devices that are essential to the health of the American people.
“Today’s hearing will deal with just such a fundamental breakdown in policies and procedures for evaluating the safety of drugs.”
And he concluded with a stern warning:
“There are those who may be counseling the Secretary and Commissioner that Congress may not interview or call to testify Department of Health and Human Services (HHS) and FDA employees under any circumstances. There may even be those who are tempted to think that it is permissible to deliberately mislead us.
“I promise those in charge of HHS and any other department that chooses to deny this Committee the information and access to bring proper and needed oversight, as is our responsibility, that they will not succeed. There is an easy way to be investigated and there is a hard way and the hard way is not necessarily better.” [Emphasis added.]
Typically, Committee members of the President’s party will proffer a defense of the Administration — but the best that can be said for Congressman Barton’s is that he urged caution to not jump to conclusions before the whole story is complete:
“We on the Republican side of this subcommittee support this particular investigation.
“We must have an objective and balanced FDA. This agency serves the American people, and makes decisions every day affecting public health. Any credible concerns that FDA’s objectivity is in question must be examined.
“[The Ketek allegations are that] the company knew it, that the FDA knew it, and that although concerns were raised about the drug’s safety, the FDA approved the drug.
“These allegations go to the heart of FDA’s professionalism, integrity and the agency’s mission. * * *[T]his subcommittee needs to pursue these issues very carefully and not attack these delicate and complicated matters with a sledgehammer.”
We already know that Senator Grassley is more than “simmering” about FDA’s lack of responsiveness to his requests, and that members of the Senate HELP Committee, now chaired by Senator Kennedy, have felt misled or maligned by tactics used on Plan B, the confirmation of Lester Crawford, and that of Andrew von Eschenbach.
In the House hearing, it was stunning that discussions of changes in the present FDA management and culture were so openly discussed without dissent and with general agreement. Starting with one of the earliest charges of management manipulation of science and staff work — Rezulin — on through the current products in question, there seemed to be agreement on both sides of the dais as well as among the witnesses that management at the top and two or three layers below needs to be changed if effective reform of the policies, practices, and culture at FDA are to change at all.
In another unusual wrinkle, Senator Grassley appeared as a witness at the hearing. Senator Grassley has been probing FDA’s handling of several drugs, and protecting the “insider” whistleblowers who brought him the early information:
Senator Grassley said:
“My investigations of FDA issues have also revealed a deeply troubling disregard for Congress’s responsibility to conduct oversight of the executive branch of government. The FDA and the Department of Health and Human Services have put up so much resistance to my effort to find out what happened inside FDA with a relatively new antibiotic call Ketek that I can only wonder what there is to cover up.
“Every excuse under the sun has been used to create roadblocks, even in the face of Congressional subpoenas requesting information and access to FDA employees.
“In denying access to documents responsive to the subpoenas, the department and FDA have claimed “prosecutorial deliberative process,” “confidential communications,” and agency prerogative to determine who will be interviewed or testify before a jurisdictional committee. Yet during my years in the Senate, my investigators have obtained access to every single one of these categories of so-called confidential information from HHS as well as other executive branch agencies.
“Furthermore, I asked the Congressional Research Service to look into the department’s policies regarding this matter and the CRS told me that there is ‘no legal basis’ for the department’s executive branch assertions.
“Nevertheless, the department and FDA not only withheld documents that do not appear to be privileged, but they also won’t say what has been withheld and why. The subpoenas compel a privilege log, but the department and FDA will not provide one.
“The department and FDA say that they have been responsive to the Finance Committee’s Ketek investigation because they made available millions of pages of documents to the committee. But what they provided is quantity, not quality.”
We can only hope that the President and the commissioner realize, quickly, that they are on a collision course with both chambers of the United States Congress that could destroy the FDA as it now exists. Chairman Dingell gave fair warning: “There is an easy way to be investigated and there is a hard way and the hard way is not necessarily better.” If FDA is playing a sophisticated game of chicken, there will be no second chance.
* Attorney-pharmacist Robert Steeves is FDA Webview's Washington commentator and was formerly economic and program policy director in FDA's Office of Orphan Products Development.
| 02/16/2007 8:23 AM | |
Mr. Steeves, because of his lengthy and varied private and public service career, is well qualified to make these observations. Since the start of this Administration, other than through the efforts of Senator Grassley, there has been very little oversight/investigation of the FDA. Yet, during this period there have been numerous examples of FDA mismanagement, waste, and abuse both at headquarters and in the field. The return of Congressmen Dingell and Waxman to Committee/Subcommittee Chairs and the possibility of serious and effective oversight/investigation of FDA performance is a welcome opportunity for FDA improvement. If the FDA reputation for excellence is to be restored, it must accept the possibility that a good "audit" of its performance will identify the weaknesses that will enable it to implement a "corrective and preventive action" plan that the public, through Congress, can monitor and evaluate. Just as regulated industry can benefit from such internal/external audits so can the FDA. Too bad that during the last several years the FDA has not undertaken to objectively audit its own performance.
Welcome to the "Brave New World" of a Congress which has the opportunity and responsibility to perform the function that taxpayers expect from their Congressional "Board of Directors" in return for the investment it makes to assure excellent performance by the FDA.
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| 02/16/2007 1:25 AM | |
When exactly did the FDA's reputation of excellence occur, to which we are restoring it? If Steeve's article is taken as fact, then the mismanagement of the FDA is recent - the last 6 years. However, a more keen eye (and historical perspective) would be able to discern that the FDA has been mismanaged for the past 2 decades and overlooked by Congress since the 1970s. The quick-fix mentality of the Clinton Administration created an attitude of "We know how to fix our own problems" but only succeeded in throwing money at problems and hiring unqualified staff to resolve issues that required creative thinking and aptitude.
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