Lawmakers' Help for Drug Firm Tests Limits
By Dan Morgan and Marc Kaufman
pharmaceutical giant Bayer suffered a serious setback last year when a federal
administrative law judge backed a proposed ban on a drug used to fight poultry
infections at factory farms. The judge cited growing scientific evidence
suggesting that the practice was reducing the effectiveness of antibiotics vital
to human health.
Facing defeat in a three-year legal battle, Bayer
sought help in a new arena -- Congress. In a letter written in the office of
Rep. Charles W. "Chip" Pickering Jr. (R-Miss.), and with the assistance of a
Bayer lobbyist who was a longtime Pickering friend, 26 House members argued that
the poultry medicine was "absolutely necessary to protecting the health of
birds." It called on Lester M. Crawford, acting commissioner of the Food and
Drug Administration, to set aside the judge's decision regarding the class of
drugs. The Bayer product is known as Baytril.
The Baytril case provides
an unusual look at an attempt by lawmakers to influence the executive branch's
handling of an important public health issue involving parochial economic
interests and complex science. In stepping in, the congressmen entered a murky
area and overstepped legal limits on their involvement, FDA officials said.
While members of Congress frequently write to agencies as part of regular
oversight, they are not supposed to intervene in formal, trial-type proceedings.
Less than a month after the July 22, 2004, letter, the FDA informed the
legislators in writing that their attempt to sway Crawford violated federal
rules intended to shield him and other decision makers in similar quasi-judicial
proceedings from outside pressure. They admonished the lawmakers that they were
"not allowed" to communicate with Crawford because the lengthy public record of
testimony and documentary evidence was closed.
Pickering, who is vice
chairman of the House Energy and Commerce Committee, which has jurisdiction over
the FDA, strongly defends the letter. A statement from his office said he "acted
under legislative branch rules, representing his constituents and defending
their interests." The congressman, it added, "believes the medicine discussed in
the letter is vital to maintaining the jobs and businesses in Mississippi based
on poultry, and he stands by the content of the letter."
awaiting confirmation as FDA commissioner, is still considering Bayer's formal
appeal of the judge's decision upholding the proposed ban. The FDA has declined
to say whether he saw the congressmen's letter. Baytril is still being used in
the poultry business.
Federal rules require communications from outside
channels, such as the lawmakers' letter, to be made part of the public record of
the case so that all sides are aware of them. But in this case the letter was
not placed in the public docket until December, more than four months after it
was sent, because of what the FDA said was an "inadvertent oversight."
"They are weighing in on the side of parochial economic interests
against the public health, and that's disappointing," said Margaret Mellon,
director of food and environment programs at the Union of Concerned Scientists.
The October 2000 decision by the FDA's Center for Veterinary Medicine to
withdraw approval for Baytril was a milestone in the agency's attempts to
protect human health. It was the FDA's first formal withdrawal notice for an
animal drug based on concerns that it could make human drugs less effective. The
decision set the stage for current regulatory steps that could lead to bans on
other animal drugs, such as penicillin and tetracycline.
Baytril is a
fluoroquinolone antibiotic, among the strongest class available to treat humans
suffering from food poisoning and a broad range of bacterial infections,
including anthrax. When the FDA's veterinary division approved Baytril in 1996,
public health advocates warned that it could lead to an increase in bacteria
impervious to Cipro, Bayer's highly successful fluoroquinolone for humans.
In withdrawing approval, the CVM cited a study that found rising levels
of fluoroquinolone-resistant bacteria in supermarket chicken and in people who
prepared and ate chicken. Cipro-resistant bacteria, all but unknown in the
1990s, soared to 13 percent of the bacteria sampled in 1997. Follow-ups showed
resistance rising to 20 percent in 2002 before dropping slightly in 2003.
The FDA's findings and proposed action were supported by the Centers for
Disease Control and Prevention, the American Medical Association, the Union of
Concerned Scientists, and two agencies at the Department of Agriculture.
None of the research pointed to Baytril as the sole culprit. Public
health officials had long recognized that the overprescribing of antibiotics
increased resistance to the drugs in humans. But the data persuaded the FDA's
veterinary regulators to propose banning Baytril and SaraFlox, a similar product
from Abbott Laboratories. Abbott agreed to withdraw its product.
Bayer contended the FDA data were so flawed that there would be repercussions
for the entire animal-drug industry if they went unchallenged. Forty to 70
percent of U.S. antibiotics are used in agriculture.
spokesman for Bayer's Animal Health Division in Shawnee Mission, Kan., denies
that Baytril is a significant contributor to the spread of resistant bacteria,
saying there are "a lot of other factors at play." He added: "We don't feel
there's anything from a scientific standpoint that supports taking it off the
Bayer has argued that although only 2 percent of chickens were
treated with Baytril, the industry would lose millions of dollars a year if it
were removed as an option. The company noted that the incidence of human
infections resistant to Cipro-type medicines has declined sharply. The
congressmen's letter said cases in which Cipro did not work dropped from 3.28
per 100,000 in 1997 to 2.62 per 100,000 in 2001.
triggered a review that over the next 38 months produced thousands of pages of
documents and days of testimony before FDA Administrative Law Judge Daniel J.
Davidson. To wage the legal battle, Bayer HealthCare, the subsidiary that
oversees animal drug production, hired McDermott, Will and Emery of Chicago, the
world's 14th-largest law firm.
The Animal Health Institute (AHI), the
main trade group of animal-drug makers, quickly joined Bayer in contesting the
Bayer and AHI got little public help from the huge, vertically
integrated retail chicken producers that are the main users of Baytril. While
the broiler industry, as it is known, views Baytril as "a valuable medication
that ought to be available," said Richard Lobb, spokesman for the National
Chicken Council, many big companies that sell chicken under their own labels to
customers in supermarkets were unwilling to publicly embrace the use of
"It's not something we're up there banging away on" in
Congress, Lobb said.
Bayer and AHI pursued other avenues. AHI filed
petitions with the FDA and the CDC under a new business-friendly law, the Data
Quality Act, seeking a "correction" of the information the agencies were putting
out about Baytril. And in 2002, AHI hired former senator Robert W. Kasten Jr.
(R-Wis.), paying him $75,000 a year to facilitate contacts with top officials at
the Department of Health and Human Services on the Baytril matter. The
department was the FDA's parent and was then led by former governor Tommy G.
Thompson, a longtime Kasten political ally.
AHI was "writing letters and
not getting answers back," Kasten said. He said he arranged meetings with "legal
people around the secretary" and may have mentioned the matter to Thompson. He
also recalled at least one meeting with Crawford, then number two at the FDA.
Separately, Bayer HealthCare hired lobbyist Wayne Valis to work with
administration officials on the validity of the government data on
fluoroquinolones. Valis recalled setting up one or more meetings with officials
at the White House office that oversees regulatory issues, as well as with
officials from the FDA and several other agencies.
unsuccessful in getting the corrections it sought from the FDA or the CDC,
however, and in March 2004, Davidson strongly backed the veterinary division's
proposed ban in a 68-page decision. He said the evidence "does not establish
that the social and economic benefits [of this class of antibiotics] outweigh
the risks to public health."
Davidson cited recent studies of bacteria
in chicken showing increased levels of drug resistance. A 1999-2000 sampling of
retail meat in the Washington area also mentioned in his ruling found that 35
percent of the suspect bacteria was resistant to Cipro-type drugs.
then, Bayer had already begun looking for help in Congress.
Myrick, a lobbyist hired by Bayer in early 2004, had a long-standing connection
to Pickering. They both grew up in Jones County, Miss., and their families knew
each other well, attending church and school together, according to the
congressman's office. When Pickering -- whose father was a federal judge and
former state GOP chairman -- decided to run for a House seat in 1995, Myrick was
one of his first contributors.
Myrick, a former Senate staff member, has
been counsel to pharmaceutical giant Wyeth/American Home Products Corp., and has
held leadership posts on trade associations, including AHI, according to his
In March 2004, he attended a small Pickering fundraiser for drug
company representatives at the 116 Club, a Capitol Hill favorite of southern
lawmakers that serves home-style catfish on request, along with chicken,
dumplings and crab.
The event raised $11,000, Pickering spokesman Brian
Perry said. Lobbyists for Merck, Pfizer, Abbott Laboratories and
Hoffmann-LaRoche chipped in, campaign finance records show. Myrick contributed
$1,000, and two partners in his lobbying firm, Larson, Dodd, Stewart &
Myrick, donated to Pickering then or later in the year.
Myrick did not
return a phone call seeking comment.
Bayer representatives met with
Pickering's congressional staff on June 17 and 23, according to his office.
Perry identified the participants as Myrick and Julie Spagnoli, Bayer
HealthCare's new chief Washington representative. Bayer, he said, "produced
verbiage" for the letter and "brought in a lot of the material."
together a kit to educate members of the media on the issue. It's most likely
that is what she [Spagnoli] shared with them," said Walker, the spokesman for
Bayer's Animal Health Division. "But I must stress generation of the letter was
not due to Bayer writing it."
Pickering's office said a senior House
Democrat, Rep. Bobby R. Etheridge (N.C.), and members of the House Agriculture
Committee were given a chance to make changes. In all, 18 Republicans and eight
Democrats signed. Among them were the House's third-ranking Republican, Whip Roy
D. Blunt (Mo.); John A. Boehner (Ohio), second-ranking Republican on the
Agriculture Committee; and Nathan Deal (R-Ga.), who recently became chairman of
the Energy and Commerce Committee's health panel.
explained his stance by saying, "The poultry industry is a $1.77 billion
industry in Missouri's 7th District, creating nearly 16,000 jobs for Congressman
Ten of the 26 signers, including Pickering,
Etheridge and Blunt, received campaign contributions from Bayer's political fund
in 2003 and 2004.
Rep. Sherrod Brown (Ohio), ranking Democrat on the
Energy and Commerce Committee health panel, said he learned of it only when told
about it in March.
The lawmakers, who did not mention either Bayer or
Baytril by name, urged Crawford to "go the extra mile" to ensure FDA action on
fluoroquinolones was based on valid science. But last Aug. 17, the FDA responded
that the Code of Federal Regulations prohibited such contacts at that stage. The
code, however, specifies no criminal penalties.
In defending the
decision to send the letter while Crawford was reviewing the case, Pickering's
office cited a 1970 advisory opinion of the House ethics committee saying a
member may contact a federal agency to "call for reconsideration of an
administrative response which he believes is not supported by established law,
federal regulation or legislative intent."
Lawyers specializing in
ethics issues say Congress's oversight duties give members considerable leeway
to contact officials, but there are limits during formal proceedings such as
those the FDA is conducting. The House Ethics Manual states, "Since 1976, the
Government in the Sunshine Act has prohibited anyone from making an ex parte
communication to an administrative agency decision-maker concerning the merits
of an issue that is subject to formal agency proceedings."
intrusion amounts to "unfair and undue congressional interference in a judicial
proceeding," said Stanley Brand, a former chief counsel of the House.
Donald Kennedy, a former FDA commissioner, said: "I never received any
letters like that when I was in the position of making a quasi-judicial
decision, and should not have. It is clearly improper."
Washingtonpost.com and Pharmecutical