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Fwd: Re: Judge Lamberth (FDA faces court ordered limits to its power)

>Xe.net>
>From: betty martini <bettym19@mindspring.com>
>Subject: Re: Judge Lamberth (FDA faces court ordered limits to its
>  power)
>
>Dear Barbara, 
>
>Wow!  My compliments to the Judge and I think we need to be in contact with
>the Washington Legal Foundation. The Foundation needs to know about the
>aspartame issue, and the bovine growth hormone issue too for that matter.
>And everybody needs to know about the Washington Legal Foundation.  There
>are a lot of issues up in the air right now.  The FDA would like to see
>such things as headaches and aging declared a disease so anything used to
>treat it can be declared a drug and taken out of the hands of the
>consumers.  The FDA just doesn't give up.  And this article makes it clear
>how the FDA operates as in the case of demanding that the Stevita Company
>burn cookbooks on Stevia and not allowing this safe herb to be used in
>manufacturer's products.  There is no law but the FDA appears to think it
>has no policing and can do what it wants until caught.  Looks like they
>were caught.  And the Washington Legal Foun dation may be able to help many
>issues that are now pending.  The FDA continues to overstep its laws or
>violate them.  As you remember, the late Dr. Adrian Gross, FDA toxicologist
>who tried to stop the approval of aspartame, told Congress that aspartame
>violated the Delaney Amendment and "if the FDA violates its own laws who is
>left to protect the public?"  Obviously, we have no protector.  The FDA
>does think it has universal power and I remember the persecution the FDA
>caused when there was the all out effort to get the dietary supplement bill
>passed to save vitamins and herbs.  You may remember when they went to Dr.
>Wright in Washington with guns and seized his equipment.  He had done
>nothing wrong.  There were parades in the street and one sign filmed said:
>"Dr. Wright Made Me Well, FDA Go To Hell".  
>
>There are attorneys on our Mission Possible list and I think this
>information on the Washington Legal Foundation should be distributed
>throughout the Internet.  I think its time for Dr. Arthur Hull Hayes who
>over-ruled a Board of Inquiry to approve aspartame  to answer a deposition.
>  He has refused to speak to the press since l983.  I think this foundation
>can help a lot of people.  
>
>Again and again, thanks so much.
>
>Regards,
>Betty
>
>
>>Dear Dave & Betty:
>>
>>Will ya look at this!!!  Here it is.  This is just a summary of what
>>went before the recent ruling.
>>
>>
>>FDA faces court-ordered limits to its power
>>
>>                                                      by Richard A. Samp
>>
>>
>>
>>
>>                                                     Executive summary:
>>
>>When the Washington Legal Foundation sued the FDA in 1994 over the
>>agency’s CME regulations, it was the first time in years that FDA
>>authority over
>>Rx communications had been challenged. The past three years have seen
>

>>evasive tactics by the FDA to keep the case from coming to trial. Now,
>>the chief
>>counsel of the WLF predicts resolution in the case which will more
>>clearly define industry’s First Amendment rights in the dissemination of
>>healthcare
>>information.
>>
>>
>>
>>Concerned about the health consequences of unrestricted off-label uses
>>of approved drugs and medical devices, the Food and Drug Administration
>>(FDA) in recent
>>years has been energetically restricting the dissemination of
>>information about off-label uses. But in its zeal to protect the
>>American public, the FDA apparently has
>>overlooked the very real First Amendment concerns created by its
>>policies. By attempting to suppress truthful information about
>>FDA-approved drugs and devices,
>>the agency appears to be infringing on the constitutional rights of
>>speakers to convey such information and of listeners (most of them
>>medical professionals) to receive
>>such information.
>>
>>The FDA’s policy has been under attack in a lawsuit filed in federal
>>court by the Washington Legal Foundation (WLF), a public interest law
>>firm. That suit, which
>>was filed on June 13, 1994, and has slowly been wending its way through
>>pre-trial procedures, has taken a number of unusual twists, including
>>the flat-out refusal of
>>former FDA Commissioner David Kessler to appear for a court-ordered
>>deposition.
>>
>>When the FDA approves a drug or medical device, it also approves the
>>precise language of the product’s labeling — only those indications for
>>which the drug may
>>be used. But the medical community’s knowledge regarding the safety and
>>efficacy of FDA-approved drugs and devices inevitably outpaces
>>FDA-approved
>>labeling. In some specialties (e.g., oncology), the great majority of
>>medically-accepted treatments involve off-label use. In many cases,
>>doctors simply cannot treat
>>their patients properly without resorting to off-label uses.
>>
>>The FDA acknowledges the important role played by off-label uses.
>>Accordingly, it has not attempted to prevent healthcare providers from
>>engaging in such
>>practices. But what the FDA has done is to go to great lengths to
>>prevent manufacturers from doing anything that might result in a doctor
>>learning about off-label uses
>>of their products. The agency thus prohibits manufacturers from
>>providing financial support to CME programs which they know will include
>>discussions of off-label
>>uses, and from distributing reprints of peer-reviewed medical journal
>>articles that include such discussions. The FDA has thereby placed
>>itself in the anomalous
>
>>position of seeking to suppress information whose truthfulness and whose
>>value it does not seriously question.
>>
>>The FDA’s procedural defenses
>>Not surprisingly, the FDA has not been eager for the courts to decide
>>whether its policies regarding off-label information comply with the
>>First Amendment. Thus,
>>when the WLF filed a lawsuit challenging the constitutionality of the
>>FDA’s policies, the agency responded with a barrage of procedural
>>defenses designed to prevent

>>the court from ever reaching the merits of the WLF’s claims. The FDA’s
>>primary procedural defense was that its policies were not yet "ripe" for
>>review by the courts
>>because they had never been articulated in final form.
>>
>>At first blush, the FDA’s argument appears quite curious, because it has
>>issued several "guidance" documents that state very clearly the kinds of
>>manufacturer
>>conduct that is prohibited. Moreover, on numerous occasions the FDA has
>>sent "Warning Letters" to manufacturers that fail to adhere to those
>>"guidance"
>>documents, threatening strong enforcement action if such failures are
>>repeated. It has nonetheless been quite successful in past litigation in
>>using the "ripeness"
>>argument to fend off challenges to its policies. The FDA has convinced
>>many courts that its "Warning Letters" — no matter how threatening they
>>may sound — do
>>not constitute the official policy of the agency, and that manufacturers
>>may assert challenges to FDA policies only in connection with their
>>defense of an FDA
>>enforcement action.
>>
>>The FDA, of course, virtually never has to bring enforcement actions
>>against reputable manufacturers because — in light of its massive
>>enforcement weapons (such
>>as immediate seizure of a manufacturer’s entire inventory) and its
>>ability to deny new-product approvals sought by "troublemakers" — only
>>the most foolhardy of
>>manufacturers are willing to risk the agency’s wrath by ignoring
>>supposedly nonbinding Warning Letters.
>>
>>But the FDA’s winning streak when invoking its "ripeness" argument was
>>broken in the WLF’s lawsuit. Federal district judge Royce Lamberth ruled
>>that the FDA
>>did indeed have a final policy regarding dissemination of off-label
>>information, and that the WLF was entitled to challenge that policy
>>without awaiting an FDA
>>enforcement action against a manufacturer alleged to be in violation of
>>the policy. Judge Lamberth said a government "policy" is sufficiently
>>concrete to permit judicial
>>challenges to go forward whenever the only realistic choice of those
>>affected by the policy is to comply. The judge held that was precisely
>>the situation faced by
>>manufacturers here.
>>
>>Senior FDA officials (including former Commissioner Kessler) had made
>>clear in no uncertain terms (through speeches, journal articles, and
>>Warning Letters) that
>>they "expect[ed]" manufacturers to adhere to the informal "guidance"
>>documents issued by the agency regarding off-label information
>>dissemination. Under those
>>circumstances, Judge Lamberth ruled, a federal agency can be said to
>>have issued a "policy" that is ripe for review in the federal courts.
>>
>
>>Judge Lamberth has also permitted the WLF to go forward as the sole
>>plaintiff, suing on behalf of WLF members who are physicians. The judge
>>accepted the
>>organization’s argument that the First Amendment protects those seeking
>>to receive information just as fully as it protects the right of those
>>wishing to speak, and thus
>>that the WLF has "standing" to sue in order to vindicate the right of
>>its members to receive information.

>>
>>Tangled First Amendment defense
>>Once the district court finally disposed of the FDA’s procedural
>>defenses, the WLF was permitted to go forward with information discovery
>>efforts. The depositions
>>revealed an agency still trying to come to grips with the First
>>Amendment implications of its own policies. On the one hand, FDA
>>officials stated repeatedly under
>>oath that they recognize the great importance to the medical community
>>of accurate information about effective off-label uses of approved
>>products. On the other
>>hand, they insist that a manufacturer can simply never be trusted to get
>>involved in the dissemination of such information regarding its own
>>products because it will
>>always be tempted to distort the information for commercial gain. But
>>then again, these same witnesses admit, it is all right for a
>>manufacturer to discuss proven
>>off-label uses of its products in response to outside inquiries, so long
>>as those inquiries are totally unsolicited.
>>
>>But the moment that the FDA admits that there is value to disseminating
>>off-label information and that such information is often truthful, it
>>has all but lost the First
>>Amendment battle. Even in the context of commercial speech (which is
>>entitled to somewhat less First Amendment protection than is
>>noncommercial speech), total
>>suppression of truthful speech is almost never permitted by the courts.
>>It is certainly not permissible when there are available alternatives
>>that are less restrictive of
>>speech rights, yet still take account of the FDA’s concern that
>>manufacturers might be tempted to distort off-label information
>>regarding their products. FDA
>>witnesses could not adequately explain, for example, how the public
>>could be harmed if manufacturers were permitted to distribute to doctors
>>reprints from the New
>>England Journal of Medicine or other peer-reviewed medical journals. In
>>the absence of evidence of such harm, the First Amendment does not
>>permit the
>>suppression of information which the FDA has no reason to believe is not
>>truthful.
>>
>>Commissioner Kessler’s deposition
>>The FDA’s crackdown on the dissemination of off-label information is a
>>relatively recent phenomenon. It began in earnest in 1991, soon after
>>David Kessler was
>>named FDA Commissioner. Indeed, the depositions conducted by the WLF
>>soon revealed that Dr. Kessler played a major role both in initiating
>>the crackdown and
>>determining its details. But when the WLF requested that it be permitted
>>to depose Dr. Kessler for up to two hours, the FDA refused the request.
>>
>>The WLF then asked Judge Lamberth to permit the deposition to go
>>forward. After extensive briefing by the parties, the judge last summer
>>ordered Dr. Kessler to
>
>>appear for a two-hour deposition — ruling that while depositions of
>>agency heads generally are not permitted, the WLF had made an adequate
>>showing regarding
>>why a deposition was warranted in this case. The FDA did not give up
>>quietly. After failing in its effort to get Judge Lamberth to reconsider
>>his decision, the agency

>>appealed to the federal appeals court. In a sweeping decision issued
>>last November that significantly strengthens the ability of litigants to
>>depose senior federal
>>government officials, the U.S. Court of Appeals for the District of
>>Columbia Circuit denied the appeal and directed the deposition to go
>>forwarded immediately.
>>
>>So how did the FDA — an agency that insists that the pharmaceutical
>>industry scrupulously adhere to federal food and drug laws — react to
>>this legal mandate? It
>>simply refused to comply. It made clear that Dr. Kessler would not be
>>appearing for a deposition under any circumstances. Dr. Kessler stepped
>>down from his post
>>on March 1, 1997, having served the final 3 1/2 months of his tenure in
>>open defiance of a federal court order.
>>
>>When it became clear that the FDA had no intention of complying with the
>>court order, the WLF filed a motion in January to impose sanctions
>>against the agency.
>>The WLF asked that the FDA be held in contempt of court and that, as a
>>sanction against the agency, certain key allegations of the WLF’s
>>lawsuit should be deemed
>>to have been admitted. At this point, the WLF is far more interested in
>>having sanctions imposed against the FDA than it is in undertaking the
>>deposition of a former
>>FDA commissioner whose testimony would no longer be binding on the
>>agency and would be of limited admissibility at trial. As of press time,
>>the WLF was still
>>awaiting a ruling on its sanctions motion.
>>
>>Once the sanctions motion is ruled on, WLF says it will seek a
>>rejudgment. The period permitted for depositions and pre-trial discovery
>>of opposing parties’
>>documents has long since expired. Assuming that Judge Lamberth rules on
>>the sanctions motion by the beginning of the fall, a ruling on the
>>merits is not likely for at
>>least a month thereafter.
>>
>>The WLF and the FDA have already agreed that they will each file what is
>>known as a "summary judgment" motion. Such a motion asks the court to
>>assume that
>>one’s opponent’s factual allegations are all true but argues to the
>>court that — even assuming such facts — one nonetheless is entitled to
>>win the case as a matter of
>>law. Because there are few significant factual disputes between the
>>parties, the judge is likely to decide the case on the basis of the
>>summary judgment motions,
>>without conducting a full-fledged trial.
>>
>>Still a long way off
>>If Judge Lamberth decides that a trial is necessary, it may be 1998
>>before one can be scheduled. But regardless of how long the FDA is able
>>to continue to drag out
>>this lawsuit, the fact remains that sometime within the next year the
>>courts are going to rule on whether the FDA’s off-label policy complies
>>with the First Amendment.
>>
>>Win or lose, such a ruling will be a significant development. Up to now,
>>the FDA has frustrated efforts to obtain judicial review of the agency’s
>
>>regulation of
>>manufacturers’ speech. Once there is a First Amendment judicial decision
>>on the books, the agency will finally be forced to face the fact that
>>its speech regulation

>>powers are subject to strict constitutional limits. Whether Judge
>>Lamberth ultimately agrees with the WLF that the FDA has exceeded those
>>limits in this case, by
>>merely articulating those limits Judge Lamberth will go a long way
>>toward reining in the FDA’s seemingly unlimited regulatory power.
>>
>>
>>
>>
>>
>>Richard A. Samp is Chief Counsel of the Washington Legal Foundation. He
>>can be reached at: 2009 Massachusetts Ave., N.W., Washington, DC 20036.
>>202 588-0302; fax: 202 588-0386; e-mail: litigation@wlf.org.
>>
>>
>>
>>                                     ©1997 CPS Communications, Inc. All
>>rights reserved. Site comments? webmaster@cpsnet.com
>>
>>     Return to top
>> 
>z***************************************************************************
>** 
>1. Take the 60-day No Aspartame Test and send us your case history. 
>Mission Possible International
>5950-H State Bridge Rd.  #215
>Duluth, GA 30097  USA 
>2. Tell your doctor and all of your friends! 
>3. Return Asparcidal food to the store.
>(anything with Monsanto's NutraSweet/Equal/Spoonful/Benevia/NatraTaste) 
>VISIT http://www.dorway.com/possible.html Get links to over 30 sites 
>VISIT http://www.holisticmed.com/aspartame/   ..FAQs & Cases
>VISIT http://www.notmilk.com Exposing Bovine Growth Hormone 
>Disability and Death are not acceptable costs of business!
> 
z***************************************************************************
** 
1. Take the 60-day No Aspartame Test and send us your case history. 
Mission Possible International
5950-H State Bridge Rd.  #215
Duluth, GA 30097  USA 
2. Tell your doctor and all of your friends! 
3. Return Asparcidal food to the store.
(anything with Monsanto's NutraSweet/Equal/Spoonful/Benevia/NatraTaste) 
VISIT http://www.dorway.com/possible.html Get links to over 30 sites 
VISIT http://www.holisticmed.com/aspartame/   ..FAQs & Cases
VISIT http://www.notmilk.com Exposing Bovine Growth Hormone 
Disability and Death are not acceptable costs of business!