An MD&DI January 1997 Column
The departure of David A. Kessler as FDA commissioner is being seen as cause for optimism in the medical device industry. Not much consideration has yet been given to the possibility that the selection process for Kessler's successor could be the precursor to a season of FDA-congressional warfare. If war does result, FDA device approvals could be logjammed, as they were the last time Congress (then in Democratic hands) applied pressure to the agency.
The importance of the search for FDA's next commissioner became obvious the day that Kessler's resignation was announced. Immediately, the Medical Device Manufacturers Association sought to have input on Health and Human Services Secretary Donna Shalala's selection criteria. Health Industry Manufacturers Association president Alan H. Magazine was pragmatic, however, about industry's chances of being allowed to give constructive input on the choice. Asked whether he really thought Shalala would grant it, Magazine answered simply, "No."
Industry's influence will likely be felt at the Senate Labor and Human Resources Committee, which confirmed its first FDA commissioner, Kessler, in a truncated, midnight preadjournment action on October 28, 1990. The committee, now in Republican hands, is certain to give Shalala's nomination a much more vigorous and prolonged examination.
The Republican majority is sure to want a commissioner as unlike Kessler as possible, one who will be content to focus on the agency's internal infrastructure, which is in need of reconstruction, rather than on bold new regulatory initiatives such as scientific upgrading of medical device regulation and Kessler's war on tobacco.
That the Republicans are ready to do battle with Kessler's FDA in the next Congress, whether or not Kessler is in charge or his legacy lives on under another leader, was readily apparent in the aftermath of the November election.
Although both industry leaders and House speaker Newt Gingrich called, on the day after the election, for more cooperation between Congress and the Clinton administration, the political undercurrents all pointed the other way.
The battleground may well be congressional probes into irregularities in FDA's management of staff travel expenses (especially those of lame duck commissioner Kessler, whose departure is expected shortly) and the alleged interactions of device center director Bruce Burlington and subordinates with ophthalmic laser sponsors Summit Technology and Visx. If either or both of these investigations by Texas Republican Joe Barton's House Commerce oversight and investigations subcommittee develop into full-blown, politically driven scandals, they may well choke the flow of FDA's day-to-day business and detract from workable reform efforts.
The precedent was set by the former Democratic majority. Less than five years ago, that same subcommittee under John Dingell (DMI), suspecting generic drugtype corruption in CDRH, launched such intrusive probes (including stationing a full-time investigator inside CDRH offices) that device approvals slowed almost to a stall.
The subcommittee's current investigations bear some broad similarities to that earlier probe. They also risk setting in motion a series of internal FDA reactions that could stifle the flow of product approvals.
The travel-expenses flap must have seemed irresistible to Barton. The weekend before the election, he issued a news release in which he described as "extremely serious" the allegations in an Associated Press report that Kessler may have improperly billed the government for his use of taxis, an airfare for his wife, and hotel accommodations. The reporter seemed to have been inspired by a plethora of publicly posted Freedom of Information requests for Kessler's records and contacts filed last year by a tobacco-funded Washington group.
In the intricate maze of government rules covering such small items, it's easy to stray from the straight and narrow. Former FDA commissioner Arthur Hull Hayes, Jr., found this out in 1983, when auditors faulted him for double-billing an airplane ticket and $59 worth of other irregularities, and he resigned rather than submit to partisan grandstanding over the affair.
Barton called that incident a "less serious" case than Kessler's, and demanded "a full explanation" from the current commissioner. "After I saw this article," Barton said of the AP report, "I immediately called Dr. Kessler to hear his side of the story. During our discussion, he acknowledged to me that there were some serious perception problems involved. ... That's putting it mildly. I am in the process of initiating informal discussions with [House Commerce Committee] Chairman Thomas Bliley [RVA], and [subcommittee members] Ron Klink [DPA] and John Dingell [DMI] to determine how best to proceed. Abuse of taxpayer funds is always a serious matter, and I intend to work immediately to get to the bottom of this in a bipartisan way."
According to close associates of Kessler, Barton's statement was an overreaction that illustrates well the famous malignancy of the Washington political environment. Kessler, they say, unlike Hayes, is a "stickler for propriety," but was blindsided by poor staff advice (he was first told by an ethics officer that he didn't need receipts for expenses under $25, then that he did, causing his immediate staff to generate such receipts after the fact). He supplemented their work using "the best of his recollection," but being somewhat absentminded, they say, did not do a good job of this.
Kessler apparently used his government credit card against regulations to pay for a plane trip his wife made to join him once in New York and forgot to pay it back. He also accepted a hotel room not knowing that it had already been paid for by an industry group instead of the government, another violation. When the AP reporter uncovered these transgressions and omissions, Kessler was so upset, sources say, that he immediately wrote a personal check for $850 to cover these and all other conceivable errors that might later emerge from further digging (the actual total by then was reportedly under $600).
To anyone in industry reading about these "violations" it must seem incredible that they could cost the job of the perpetrator, but that was clearly the implication of Barton's news release. Kessler's subsequent resignation, however, had more to do with his family's weariness of Washington and the wear and tear of six FDA years than it did with Barton's probe.
As Kessler prepared to leave Washington, Barton's attention seemed to be switching to his chief appointee in CDRH, Burlington, and the laser scandal. In this, Barton was treading on ground already occupied by a lethargic FBI investigation of the same scandal. A public hearing is thought likely to be called by Barton in January as the new Congress convenes.
The essence of this probe seemed to be that in their review of Summit Technology's excimer laser premarket approval (PMA) application, CDRH employees had too cozy a relationship with the sponsor, and that their activities simultaneously served to delay the review of Visx's competitive laser. Summit's laser was approved six months before Visx's, although Summit's PMA application was received by CDRH much later than Visx's. Additionally, there was the infamous leak by FDA of commercially sensitive Visx documents to Summit just after Summit's approval, along with other alleged leaks and charges of after-hours contacts between CDRH and Summit personnel. Then there is the persistent rumor, buttressed by third-hand accounts traced back to Summit CEO David Muller and hotly denied by everyone at FDA, including Burlington, that Senator Edward Kennedy (DMA) intervened somehow in Summit's approval. Burlington's role, if any, in such irregularities has never been made public, but on the theory that his desk is where the buck stops, he seems vulnerable.
What smells worst about these year-old allegations is the apparently unenthusiastic internal investigation of them that had to be turned over to the FBI when Barton became officially interested, and the subsequent failure of the FBI to come up with any closure--or, according to principal witnesses of possible wrongdoing, even to conduct interviews with those witnesses. Would it be partisan politics if Barton, exasperated in his long wait for something to emerge from the FBI investigation, decided to do whatever he could to uncover the possible cover-up?
In a Washington climate that by voter mandate deliberately pits one party against the other in the conduct of national affairs, logjam and stalemate may inevitably return to CDRH. This would be unfortunate, especially since there is a genuine desire by both FDA policymakers and device industry leaders to work together to achieve major reforms in the way FDA operates.
The big lesson learned from the failure of FDA reform legislation in the last Congress is that aggressive attempts from Capitol Hill to force change on FDA just won't work. FDA wasted a lot of its scarce resources fending off attacks, and with an even tighter budget this year is looking to work something out with the device industry, according to high sources. Whether such an effort can get past potential distractions remains to be seen.James G. Dickinson is a veteran reporter on regulatory affairs in the medical device industry.