An MD&DI January 1997 Column

WASHINGTON WRAP-UP

The departure of David A. Kessler asFDA commissioner is beingseen as cause for optimism in the medical device industry. Not muchconsideration has yet been given to the possibility that the selection processfor Kessler's successor could be the precursor to a season of FDA-congressionalwarfare. If war does result, FDA device approvals could be logjammed, as theywere the last time Congress (then in Democratic hands) applied pressure to theagency.

The importance of the search for FDA's next commissioner became obvious theday that Kessler's resignation was announced. Immediately, the Medical DeviceManufacturers Association sought to have input on Health and Human ServicesSecretary Donna Shalala's selection criteria. Health Industry ManufacturersAssociation president Alan H. Magazine was pragmatic, however, about industry'schances of being allowed to give constructive input on the choice. Asked whetherhe really thought Shalala would grant it, Magazine answered simply, "No."

Industry's influence will likely be felt at the Senate Labor and HumanResources Committee, which confirmed its first FDA commissioner, Kessler, in atruncated, midnight preadjournment action on October 28, 1990. The committee,now in Republican hands, is certain to give Shalala's nomination a much morevigorous and prolonged examination.

The Republican majority is sure to want a commissioner as unlike Kessler aspossible, one who will be content to focus on the agency's internalinfrastructure, which is in need of reconstruction, rather than on bold newregulatory initiatives such as scientific upgrading of medical device regulationand Kessler's war on tobacco.

That the Republicans are ready to do battle with Kessler's FDA in the nextCongress, whether or not Kessler is in charge or his legacy lives on underanother leader, was readily apparent in the aftermath of the November election.

Although both industry leaders and House speaker Newt Gingrich called, onthe day after the election, for more cooperation between Congress and theClinton administration, the political undercurrents all pointed the other way.

The battleground may well be congressional probes into irregularities inFDA's management of staff travel expenses (especially those of lame duckcommissioner Kessler, whose departure is expected shortly) and the allegedinteractions of device center director Bruce Burlington and subordinates withophthalmic laser sponsors SummitTechnology and Visx. If either or bothof these investigations by Texas Republican Joe Barton's House Commerceoversight and investigations subcommittee develop into full-blown, politicallydriven scandals, they may well choke the flow of FDA's day-to-day business anddetract from workable reform efforts.

The precedent was set by the former Democratic majority. Less than fiveyears ago, that same subcommittee under John Dingell (D­MI), suspectinggeneric drug­type corruption in CDRH, launched such intrusive probes(including stationing a full-time investigator inside CDRH offices) that deviceapprovals slowed almost to a stall.

The subcommittee's current investigations bear some broad similarities tothat earlier probe. They also risk setting in motion a series of internal FDAreactions that could stifle the flow of product approvals.

The travel-expenses flap must have seemed irresistible to Barton. Theweekend before the election, he issued a news release in which he described as "extremelyserious" the allegations in an Associated Press report that Kessler mayhave improperly billed the government for his use of taxis, an airfare for hiswife, and hotel accommodations. The reporter seemed to have been inspired by aplethora of publicly posted Freedom of Information requests for Kessler'srecords and contacts filed last year by a tobacco-funded Washington group.

In the intricate maze of government rules covering such small items, it'seasy to stray from the straight and narrow. Former FDA commissioner Arthur HullHayes, Jr., found this out in 1983, when auditors faulted him for double-billingan airplane ticket and $59 worth of other irregularities, and he resigned ratherthan 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. "AfterI saw this article," Barton said of the AP report, "I immediatelycalled Dr. Kessler to hear his side of the story. During our discussion, heacknowledged to me that there were some serious perception problems involved.... That's putting it mildly. I am in the process of initiating informaldiscussions 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 taxpayerfunds is always a serious matter, and I intend to work immediately to get to thebottom of this in a bipartisan way."

According to close associates of Kessler, Barton's statement was anoverreaction that illustrates well the famous malignancy of the Washingtonpolitical environment. Kessler, they say, unlike Hayes, is a "stickler forpropriety," but was blindsided by poor staff advice (he was first told byan ethics officer that he didn't need receipts for expenses under $25, then thathe did, causing his immediate staff to generate such receipts after the fact).He supplemented their work using "the best of his recollection," butbeing somewhat absentminded, they say, did not do a good job of this.

Kessler apparently used his government credit card against regulations topay for a plane trip his wife made to join him once in New York and forgot topay it back. He also accepted a hotel room not knowing that it had already beenpaid for by an industry group instead of the government, another violation. Whenthe AP reporter uncovered these transgressions and omissions, Kessler was soupset, sources say, that he immediately wrote a personal check for $850 to coverthese and all other conceivable errors that might later emerge from furtherdigging (the actual total by then was reportedly under $600).

To anyone in industry reading about these "violations" it mustseem incredible that they could cost the job of the perpetrator, but that wasclearly the implication of Barton's news release. Kessler's subsequentresignation, however, had more to do with his family's weariness of Washingtonand 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 beswitching to his chief appointee inCDRH, Burlington, and thelaser scandal. In this, Barton was treading on ground already occupied by alethargic FBI investigation of the same scandal. A public hearing is thoughtlikely 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 SummitTechnology's excimer laser premarket approval (PMA) application, CDRH employeeshad too cozy a relationship with the sponsor, and that their activitiessimultaneously served to delay the review of Visx's competitive laser. Summit'slaser was approved six months before Visx's, although Summit's PMA applicationwas received by CDRH much later than Visx's. Additionally, there was theinfamous leak by FDA of commercially sensitive Visx documents to Summit justafter Summit's approval, along with other alleged leaks and charges ofafter-hours contacts between CDRH and Summit personnel. Then there is thepersistent rumor, buttressed by third-hand accounts traced back to Summit CEODavid Muller and hotly denied by everyone at FDA, including Burlington, thatSenator 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 apparentlyunenthusiastic internal investigation of them that had to be turned over to theFBI when Barton became officially interested, and the subsequent failure of theFBI to come up with any closure--or, according to principal witnesses ofpossible wrongdoing, even to conduct interviews with those witnesses. Would itbe partisan politics if Barton, exasperated in his long wait for something toemerge from the FBI investigation, decided to do whatever he could to uncoverthe possible cover-up?

In a Washington climate that by voter mandate deliberately pits one partyagainst the other in the conduct of national affairs, logjam and stalemate mayinevitably return to CDRH. This would be unfortunate, especially since there isa genuine desire by both FDA policymakers and device industry leaders to worktogether to achieve major reforms in the way FDA operates.

The big lesson learned from the failure of FDA reform legislation in thelast Congress is that aggressive attempts from Capitol Hill to force change onFDA just won't work. FDA wasted a lot of its scarce resources fending offattacks, and with an even tighter budget this year is looking to work somethingout with the device industry, according to high sources. Whether such an effortcan get past potential distractions remains to be seen.

James G. Dickinson is a veteran reporter on regulatoryaffairs in the medical device industry.

Copyright © 1997 Medical Device & Diagnostic Industry