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Washington Legal Foundation challenges the FDA oversteping their power



Dear Barbara, Thank you again and again.  I'm putting this one on all lists
too.

Regards,
BettyAt 05:57 PM 8/8/98 -0400, you wrote:
>Dear Dave & Betty:
>
>Get a load of this!
>Barbara M
>MPNJ
>
>
>What is the WLF and Why is it challenging the FDA?
>
>by William G. Castagnoli
>
>
>
>Executive Summary
>
>The Chairman of the Washington Legal Foundation (WLF) talks about its
>history, programs, philosophy, and criticisms of FDA in an exclusive
>interview
>with MM&M.
>
>"Will Anybody Sue FDA?" asked the headline of a column by James
>Dickinson in the October 3, 1993, issue of Medical Marketing & Media.
>Dickinson pointed out
>that for years the FDA has been expanding its regulatory authority,
>beyond what legal observers considered its legislative mandate,
>unopposed by the pharmaceutical
>industry. Almost in answer to the question, a citizens' petition was
>filed that same month challenging the FDA's proposed CME guidelines by
>the Washington Legal
>Foundation (WLF)—an organization little known to the rank and file in
>the Rx industry. The WLF took issue with FDA restrictions on "truthful
>speech" on off-label
>indications for drugs and medical devices in CME programs, arguing that
>FDA's position was in violation of the First Amendment.
>
>The WLF's petition was a bombshell at the FDA and to the health
>education firms, advertising agencies, publishing companies, medical
>organizations, and CME
>departments at manufacturers which, after wrestling with the FDA on the
>issue for two years, had assumed a workable compromise had been reached.
>In the face of
>the petition, FDA held up its final regulations, but chose not to
>respond to the WLF. When the statutory time limit for response to the
>citizens' petition had passed, the
>WLF took the next step and sued the FDA in June 1994 to block the
>regulations. The FDA then acknowledged the challenge by requesting
>additional comments on
>the regulations and, at the same time, going into court to have the WLF
>suit dismissed on technical grounds. Until now, notice of the WLF
>petition/suit had been
>confined to news items in the trade and business press and occasional
>squibs in the back pages of major newspapers. However, before dismissal
>of the suit came
>before a judge, the WLF was suddenly highly visible, with full-page ads
>in USA Today, The National Journal, Roll Call, The Wall Street Journal,
>and The New York
>Times, sharply critical of the FDA on much broader grounds than CME.
>
>Over a photo of two gravestones ran the headline, "If a Murderer Kills
>You, It's Homicide. If a Drunk Driver Kills You, It's Manslaughter. If
>the FDA Kills You, It's
>Just Being Cautious." Body text asserted that FDA delays in approving
>drugs and medical devices had cost thousands of lives. The signature
>line was, "The Problem
>with Health Care in America is the FDA." A second ad was illustrated by
>a casket with the headline, "The FDA Can Delay Medications and Safety
>Devices for
>Years. Too Bad It Can't Delay the Consequences."
>
>The advertising was attacked in a letter to the New York Times from the
>American Heart Association, and by syndicated columnist Anthony Lewis.
>Lewis found "the
>tone of the attacks on the FDA É uncommonly brutal" and termed WLF's

>claim of the number of lives lost by FDA delay "dubious." WLF responded
>with a
>statement defending the ads as providing the public with information
>"they were not getting from the FDA" and citing its "dubious" facts as
>originating with an
>American Heart Association spokesperson. Out of nowhere, the Washington
>Legal Foundation had become a major player in the debate on FDA's
>regulatory
>practices. In discussing the CME suit and the WLF's advertising, many in
>the industry had questions about the source of these hard-hitting,
>anti-FDA actions. "Who
>are these people?" was a typical reaction.
>
>MM&M makes a house call
>
>To find out more about the WLF, I visited its headquarters in Washington
>in mid-February and talked with its chairman and general counsel, Daniel
>J. Popeo. The
>organization's home is a town house at 2009 Massachusetts Avenue N.W.
>off the DuPont Circle. Mr. Popeo picked me up in the downstairs
>reception, and as we
>proceeded upstairs to his office, he explained that the building, which
>WLF owns, had once been the home of Teddy Roosevelt's daughter Alice and
>her husband
>Nicholas Longworth, a noted Speaker of the House of Representatives (a
>Congressional office building is named for him).
>
>The WLF is using what once must have been comfortable, refined suites as
>offices, reference libraries, conference rooms, and press briefing
>halls, complete with
>electronic hardware. However, the high ceilings, classic moldings, and
>graceful stone staircases remain, lending it a historic atmosphere.
>
>Popeo showed me around the building with understandable pride, since he
>explained that he had founded the organization just seventeen years ago
>with "a hundred
>dollars worth of furniture."
>
>In his office, I asked him about the WLF, and he began with a formal
>definition—"a 501(C)(3) charitable on-profit organization," then went on
>to explain it is a
>"proÐfree enterprise, public-interest law and policy center." Adding
>color to the description, he concluded, "I like to think of us as a
>small business version of the
>American Civil Liberties Union. Only our stress is on economic civil
>liberties."
>
>Essential to understanding the WLF, is that it is a legal organization.
>Its governing body is a "legal policy advisory board" of 55, comprised
>almost entirely of lawyers
>and judges and including legal academics from Harvard, Northwestern,
>Yale, and the Universities of Virginia, Chicago, and Indiana. Of its
>staff of 18 to 24 people
>(depending on work load), six are full-time lawyers.
>
>Not surprisingly with such an array of legal talent, the WLF is immersed
>in litigation. It sends its legal staff and pro bono volunteers into
>court on a broad range of
>cases. Forty-eight firms donated professional services to the WLF in
>1993, among them such prestigious names as Arnold & Porter, Covington &
>Burling, and
>Vinson & Elkins. In addition to the Litigation Division, the WLF program
>is rounded out by its Legal Studies Division, which publishes on legal
>matters in a number of
>formats from one- and two-page bulletins to comprehensive monographs.
>

>The WLF in court and in print
>
>A sampling of cases and regulatory proceedings that the WLF has recently
>participated in expresses its pro-business philosophy and the breadth of
>its activities. The
>WLF has supported the rights of home owners to display signs on private
>property, supported claims that permit fees imposed by a city for hotel
>conversion
>constitute compensatable taking of property, opposed efforts by
>environmental groups to limit logging in California's timber industry
>based on concerns for the
>spotted owl, supported the right of a Hispanic student to compete for an
>academic scholarship without regard to race, opposed damage awards based
>on fear of
>cancer, supported the rights of those injured by illegal lawyer
>solicitation to sue for damages, and supported regulations barring drug
>users from sensitive positions in
>nuclear power plants.
>
>Some titles of recent WLF publications also reflect the group's range of
>interest: How to Survive an OSHA Inspection in Today's Regulatory
>Climate, More
>Openness Needed in EPA Violations of Paperwork Reduction Act, Balancing
>Endangered Species Regulations and Antitrust Law Concerns, and Supreme
>Court
>Decisions Reaffirm Need to Provide Commercial Speech Full Constitutional
>Protection.
>
>The WLF is also concerned about the legal profession itself. Its SCALES
>(Stop the Collapse of America's Legal Ethics) project is aimed at
>"litigation [that] imposes
>monetary liability grossly disproportionate to any harm caused by a
>defendant's conduct." Accordingly, it is involved with contingency fees,
>attorney advertising, tort
>reform, frivolous litigation, and judicial ethics.
>
>Overall, the WLF is dedicated to defending business against governmental
>regulation, but it also finds time for the rights of voters, taxpayers,
>and crime victims,
>federal sentencing policies, and the proper functioning of the legal
>system. The philosophy that melds these wide-ranging interests was
>stated by Popeo in the WLF's
>1993 Annual Report:
>
>"Most of the problems we have in America today, from cost-prohibitive
>government regulation to unchecked violent crime, can be traced back to
>activist lawyering
>by well-entrenched organizations committed to promoting an agenda
>through court action, new regulation, and enforcement activity, and
>advocacy-educational
>campaigns."
>
>I asked Popeo about the WLF's finances. He told me the annual budget is
>approximately $3,000,000 and that the money comes from over 500
>companies and
>foundations and many individual contributors, with no concentration of
>support for any particular industry. He was emphatic that the WLF is not
>a spokesperson for
>the drug or medical devices industry, or for any sector of business. The
>WLF is ready to fight for any business against excessive governmental
>regulation. Greatly
>supplementing the work of its staff is the pro bono help it receives
>from the legal community—time and brainpower which increases its
>operational effectiveness many
>times beyond the basic $3,000,000 budget.
>
>WLF's beginnings
>

>The WLF opened its doors in September 1977, founded by Popeo, who had
>left a job as a federal trial lawyer to set up the organization. Popeo
>is a Georgetown
>law graduate who, after college, worked in the Nixon White House before
>moving to the Justice Department and there representing the government
>in court. What
>prompted leaving federal service and the creation of the WLF? "My last
>case for the government did it. I represented the Interior Department,
>and we closed down a
>one-man mining operation because there was no two-man stretcher or
>two-way radio in the shaft. That was just too much."
>
>Had anything in his family background inclined him toward his
>pro-business philosophy? No, just the opposite, he said, describing
>himself as having a "working-class
>background."
>
>I asked about a New York Times (February 12th) story linking the WLF by
>implication with an anti-FDA, conservative coalition ("FDA Becomes
>Target of
>Empowered Group"). The article singled out the Progress and Freedom
>Foundation (which funds Newt Gingrich's college video course), the
>Competitive Enterprise
>Institute, Citizens for a Sound Economy, and other "conservative
>advocacy groups" and displayed a WLF ad. It also highlighted the
>donations to conservative causes
>of the John M. Olin, David Koch, and Smith Richardson foundations. Popeo
>did not like being associated with any coalition or funding source and
>again emphasized
>that WLF's independence is assured by the breadth of its financial
>support. He thought the article was an example of a pro-FDA prejudice in
>the media. However,
>although lumped with a coalition he maintains he is not part of, he did
>not object to the use of the ad in the news story since, as he sees it,
>the message obtained
>additional exposure.
>
>WLF vs. the FDA
>
>Turning to the ads, I asked their objective. Popeo said they were
>intended to educate the American public, to call attention to the
>"abysmal" performance of the
>FDA. What about the shrill tone? That was needed to gain attention and
>"to raise the level of public discussion" on important issues.
>Commenting further, Popeo said,
>"We did not do these ads for the elite of the advertising industry or
>the healthcare business. We did them to reach the American public."
>
>Budget for the campaign? "We do as much as we can where we can," he
>said.
>
>Creative work on the ads was from Tim Kenney Design Partners, a
>full-service agency in Bethesda, Maryland. Popeo hints that the WLF
>provided the central
>themes. Proximity to Washington has gained advocacy campaigns for Kenny.
>In the past, it has worked for Common Cause and Green Peace, and lately
>the
>Republican Party on the Contract for America.
>
>As to the response to the advertising, Popeo considers it successful.
>"We've struck a nerve," he says. "I've had mail bags of letters from
>ordinary citizens agreeing
>with us, and I've heard from some top health people, as well, who feel
>that their industry groups have been too polite to the FDA. We could be
>forcing some trade
>groups to be more aggressive." As for the criticisms? "Again, we hit a
>nerve," he says smiling, "one that was very tender for obvious reasons!"

>
>I next asked Popeo about WLF's suit on FDA's CME regulations. A common
>question in the industry has been what had sparked the citizens'
>petition and the
>eventual court challenge? Popeo could not fix a crucial conversation or
>triggering event. As a partial explanation, he pointed out that the WLF
>has always monitored
>the FDA. Given the WLF's mission and its watchdog role on governmental
>regulation, the collision between FDA and the WLF on CME appears, to me,
>to have
>been inevitable. The CME guidelines were sure to appear on the WLF's
>radar screen, and given the organization's philosophy, an intercept
>becomes understandable.
>
>On February 14, 1995, the case went before Judge Royce Lamberth, U.S.
>District Court of the District of Columbia. The FDA had contended that
>no regulations
>had been issued and that the WLF did not have proper standing to bring
>the suit and had asked that it be dismissed. Judge Lamberth ruled March
>9, 1995, against
>dismissal, and the suit will now go to trial.
>
>WLF and FDA reform
>
>With the suit and the WLF's advertising in mind, I asked Popeo what
>changes he would like to see at FDA. Was he in the de-regulation camp
>that would dismantle
>the agency? His response was a clear no. "All I want is for the FDA to
>stop acting like a dysfunctional federal bureaucracy and do its job
>right."
>
>The WLF has no proposals for FDA reform, and Popeo sees no need for
>structural change. He urges managerial changes, however, and is
>particularly incensed with
>what he calls FDA's "autocratic style." Dr. Kessler should change his
>regulatory philosophy, says Popeo. "He doesn't understand his function.
>He has the
>master/servant relationship mixed up. Look, he's making life-and-death
>decisions." Isn't that the FDA's job? I asked. "Yes, it is," said Popeo.
>"All we want is that
>what they do be openly examined and that they are held accountable for
>what they do. That the FDA holds some unquestionable expertise that
>places it above
>scrutiny is a powerful lie."
>
>A key WLF executive and FDA critic, Alan Slobodin has moved to the
>Commerce Committee of the House of Representatives as counsel. Does the
>WLF plan to
>testify at anticipated oversight hearings on FDA? There will be a role
>for the WLF, says Popeo, in compiling a record on FDA and in presenting
>the facts it has
>collected from the public on FDA's performance.
>
>>From Popeo's statements and the activities of his organization, it is
>clear that the WLF is in tune with the Republican movement to reduce
>governmental regulation.
>Leaving no doubt as to his allegiance, Popeo, on the day of the
>interview, was wearing a red, white, and blue tie patterned with
>flag-draped GOP elephants. The
>WLF, although independent and with a long record of opposing big
>government, will, undoubtedly, be an active player in the antigovernment
>tide which has engulfed
>Washington since the November elections.
>
>In the WLF, Kessler's FDA has met a formidable adversary. The
>organization is well-connected ideologically with the Republican
>majority in Congress and will
>speak out in the upcoming examination of the Agency. It is firm in its

>beliefs in a free enterprise system and skilled in antiregulation
>litigation to advance its beliefs.
>Regardless of the aggressive tone of its advertising, it is also
>experienced in advocacy campaigns, as evidenced by the splash it made
>with the ads which registered
>their message well beyond the amount of space purchased. The WLF knows
>the value of ads which are picked up by the media and generate
>additional PR for their
>sponsor.
>
>Additionally, when the WLF suit comes to trial, the WLF will act as
>accuser of the FDA as an abuser of the Bill of Rights. Based on past
>performance, the FDA will
>undoubtedly try to paint pharmaceutical and devices promotion as so
>irresponsible and dangerous to public health that it has to keep the lid
>on. In the absence of
>another thalidomide tragedy, it will be hard for the FDA to make a
>credible case. In the process, however, the industry will experience
>some adverse publicity as past
>promotional mistakes are exposed yet again.
>
>Popeo may not be aiming at drastic changes at FDA, but success of the
>WLF suit on CME may have greater impact than he anticipates. If the
>court rules against
>FDA on CME, its powers over other aspects of medical
>communication—including advertising and promotion—will be subject to
>further reinterpretation and
>challenge. It would not be the first time that the courts—consider civil
>rights and abortion, for example—have reshaped our institutions.
>
>
>                                           Mr. Castagnoli is MM&M's
>contributing editor.
>
>
>1995/1996 © CPSNET, INC., Boca Raton, FL 33433, e-mail:
>webmaster@cpsnet.com
> 
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