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Another Bloody Season in the FDA-Congress Wars?

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

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.

Copyright © 1997 Medical Device & Diagnostic Industry

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