Subject: The FDA vs. the First Amendment 
Date: Published: 2/13/92 (174 lines)
Source: Wall Street Journal. Copyright Dow Jones & Co. Inc.

    The FDA vs. the First Amendment
    ----
    By John E. Calfee

    The AIDS crisis has brought national attention to the Food
 and Drug Administration's slow pace in approving new drugs.
 Less attention has been paid to its dangerous, ill-advised
 campaign to restrict the dissemination of information about
 how drugs can be used.
    Many drugs find their greatest value in uses that never
 receive formal FDA approval, but FDA policy prohibits
 pharmaceutical industry promotion of such "off-label" uses
 regardless of how well established those uses are.  Since the
 summer of 1991, the FDA has conducted a wide-ranging attack
 on the promotion of off-label uses.  This will greatly reduce
 the speed with which practicing physicians learn of the
 newest and best ways to treat such illnesses as heart disease
 and cancer.
    The problem of unapproved uses arises from the
 peculiarities of the FDA's drug approval process.  The FDA
 approves new drugs only for specified applications -- to
 treat a particular form of cancer, for example.  But
 physicians are free to prescribe approved drugs for any use,
 so research continues in search of other uses.  These new uses
 are almost never submitted for FDA approval, because the
 millions of dollars and years of effort needed for a second
 approval cannot be justified for a drug whose patent life has
 already been abbreviated by the original lengthy approval
 process.
    The extent of off-label use of approved drugs is unknown
 because physicians do not have to tell pharmacists why a drug
 is being prescribed.  But crude estimates are that unapproved
 uses account for at least one-fourth of all prescriptions.  A
 recent government survey of cancer chemotherapy treatments,
 in the Journal of the American Medical Association, found
 that almost all the surveyed drugs were sometimes prescribed
 for off-label uses and that over half of all patients had
 received drugs for off-label uses.
    The potential value of off-label applications is
 unquestioned.  Many eventually make their way to the basic
 medical compendiums published by the American Medical
 Association and other groups.  Some states (including New York
 and Michigan) have explicitly stopped using FDA approval as
 the sole basis for judging which pharmaceutical uses are
 valid.
    The parties in the best position to inform physicians
 about new uses are often pharmaceutical firms.  They have the
 knowledge (from sponsoring research that reveals new uses),
 and they have the incentive to make their knowledge available
 to others.  Nonetheless, the FDA will not allow manufacturers
 to promote any off-label use.  Information cannot move through
 the usual and most efficient channels:  product labels, ads
 and salespeople.
    This led some years ago to the creation of a "gray market"
 in information, in which drug firms found ways to provide
 information to physicians without directly offending the FDA.  
 Popular methods included press conferences, teleconferencing,
 distribution of journal reprints, newsletters and,
 especially, symposiums or seminars in which experts presented
 the latest results to physicians.  These were expensive but
 effective ways to move information quickly from the lab to
 everyday medical practice.  Drug firms willingly covered the
 costs and even sponsored symposiums in which they had
 essentially no control over what speakers said.
    These financial arrangements made eminent economic sense.
 The pharmaceutical firm knew better than anyone else whether
 the latest information was worth this expense.  If the
 information was as valuable as the firm thought it was, the
 cost of providing it was likely to be recouped through
 increased sales; if the information was worthless, the cost
 was borne by the firm.
    In the past six months or so, the FDA has largely
 dismantled this system by cracking down on the promotion of
 off-label uses.  Cancer newsletters have been shut down.
 Symposiums have nearly been brought to a halt.  In a classic
 Catch-22, the FDA has prohibited firms from covering
 physicians' travel expenses while also prohibiting firms from
 repeating the same symposium in multiple locations.  Press
 conferences announcing new applications (usually from
 controlled clinical trials) are for the most part eliminated.
    Doctors are even being encouraged to call an 800 number to
 report pharmaceutical representatives who engage in
 "suspicious" behavior (such as telling a physician that the
 National Cancer Institute endorses an off-label use).
 Finally, the FDA has threatened to seek criminal prosecutions
 of physicians and pharmaceutical employees who cross what the
 FDA considers to be the line separating promotion from
 information.
    All this takes place in the context of a regulatory regime
 of breathtaking rigidity.  The FDA position is that mentioning
 any unapproved use, no matter how well established, is
 inherently misleading to physicians.  If you are dying of
 cancer and a pharmaceutical salesman making his rounds knows
 that one of his firm's drugs had been shown in a double-blind
 controlled clinical trial to be effective in fighting your
 condition, the salesman would risk his career and perhaps his
 freedom by giving this information to your oncologist.
    The FDA's crackdown has ripple effects.  Reimbursement
 authorities balk at paying for therapies that the FDA
 believes should not even be mentioned by manufacturers.
 Physicians then feel compelled to drop unapproved therapies
 in favor of less effective approved uses, or physicians may
 simply put patients in a hospital, where prescriptions are
 not so closely scrutinized by insurance companies.
    Worst of all are the effects on information.  A leading
 support group for cancer patients has strongly objected that
 the new policy will keep patients from receiving the best
 therapies.  Oncologists have declared that patients will die
 because practicing physicians will not learn of efficacious
 treatments.  The director of the National Cancer Institute's
 Division of Cancer Treatment has objected specifically to the
 shutting down of newsletters from pharmaceutical firms,
 saying "what really matters is the content of the report" on
 new research results.  Ultimately, research designed to
 discover uses will slacken.  Why find a better mousetrap if
 you can't tell anyone how it works?  
    Drug firms put up with these absurdities because the FDA
 staff has so much discretion in the approval process that
 only a foolhardy pharmaceutical executive would do anything
 to offend that staff.  Over and over again, individual firms
 and the entire industry have agreed without a fight to the
 most onerous of staff demands, even forsaking their First
 Amendment right to tell practicing physicians about the
 results of clinical trials or about the therapeutic
 recommendations of the National Cancer Institute.  In a draft
 set of guidelines on medical symposiums, the FDA proposes to
 regulate the content of all industry-supported symposiums
 regardless of whether the sponsoring firms have any control
 over the content of the presentations.
    The FDA thinks the solution to all this is simply to
 approve more uses.  Commissioner David Kessler has announced a
 plan to identify, study, select and eventually approve some
 of the off-label uses that have achieved coinage among
 physicians.  But this complex plan will be undertaken by the
 same bureaucracy that caused the problem.  The process will be
 glacially slow, leaving the information problem unsolved.
 Moreover, the FDA staff will probably point to the new plan
 as justification for even tighter scrutiny of what it
 considers to be promotion of off-label uses.
    The solution is to move regulation of promotion to the
 Federal Trade Commission, which possessed such authority as
 recently as 1962.  The FTC has a far better understanding of
 market processes.  More important, the FTC would not have the
 extra power to approve new drugs.  It would therefore be
 forced to permit the rough-and-tumble airing of views that
 should always accompany major policy initiatives such as the
 current onslaught on promotion.
    As things stand now, the transmission of crucial medical
 information is crippled by an agency whose distrust of market
 processes seems to know no bounds.  Exorcising the profit
 motive from information about drugs makes no more sense than
 removing profits from the development of drugs in the first
 place.  The FDA even doubts the intelligence and motives of
 American doctors, who are presumed to lose either their
 desire or their ability to make rational decisions whenever a
 pharmaceutical firm provides them with a reprint from the
 Journal of the American Medical Association.
    In its refusal to recognize the disciplining role of
 markets and physician common sense, the FDA seems prepared to
 sacrifice sound medical practice and freedom of speech.
    ---
    Mr. Calfee, an associate professor of marketing at Boston
 University, worked from 1980 to 1986 at the FTC, where he
 dealt with the regulation of food and drug ads.  This is
 adapted from a longer piece to appear in the March-April
 American Enterprise.

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