FDA Holds Buyers' Club Drugs: Review of Access Issues

Since February 22, three packages of pharmaceuticals shipped
from Mexico to the PWA Health Group in New York have been
held by the Cincinnati office of the U.S. Food and Drug
Administration. On March 16, as this issue goes to press, one
of the three has been released; the other two are still being
held. The PWA Health Group has openly imported all three of
the drugs involved for several years; however, the FDA
insists that there has been no change in policy. (The drugs
are: albendazole -- now released -- used for treating
microsporidiosis, when nothing else works; tinidazole, an
anti-parasite drug which works more quickly than Flagyl; and
isoprinosine, an immune modulator which has shown good
results in a major Scandinavian trial with hundreds of
patients, but was never developed in the U.S. because
political disputes held it up until the patent ran out. The
PWA Health Group has long required a prescription for
albendazole and for tinidazole, but not for isoprinosine,
which is commonly sold over the counter.)

The current incident did not result from any problem with the
drugs, nor from any policy change. What precipitated it is
that the PWA Health Group switched to a different shipping
company, whose flights from Mexico to New York connect
through Cincinnati. Two agents in the FDA office there held
up the drugs. After the PWA Health Group called the Office of
AIDS and Special Health Issues, at the FDA headquarters near
Washington, to get the shipments released, the Cincinnati
agents called physicians who had written albendazole
prescriptions, "to warn the doctors about participating in a
'drug smuggling ring' with 'potential for criminal charges'
if they don't comply with the investigation," according to a
March 7 memo from the PWA Health Group. Sally Cooper,
executive director of the PWA Health Group, told us that the
physicians she talked to were outraged by this attempt to
interfere with their medical practice, when their use of the
drug is widely accepted as reasonable by experts in the
field. But they were unwilling to write or call the FDA about
it, apparently fearing that they might make enemies who could
hurt them in their profession. The PWA Health Group
complained to the FDA; but after an internal FDA meeting on
March 4, they were told that the AIDS office was no longer
handling this issue and they had to work through the Office
of Regulatory Affairs.

While the immediate problem may be resolved -- largely by
using other freight carriers, so that packages will no longer
be shipped through Cincinnati -- there are larger issues
around the edges. While it appears true that there has been
no change in official FDA policy, there are concerns that
this case, among others, may signal changes in attitude.
Problems cleared up years ago not only have returned, but
have been more difficult than expected to resolve.

Background: FDA Personal-Use Import Policy

The regulations involved in this case concern the much-
discussed FDA policy on importing small quantities of
pharmaceuticals, not available in the U.S., for personal use.
This policy was formalized in December 1989; it was modified
on May 25, 1993, in a letter from the FDA to AIDS buyers'
clubs, and is in force today. Because of considerable
confusion about the policy, we reproduce the key section,
dated December 11, 1989, from the Regulatory Procedures
Manual. (We also include the section which follows, on import
alerts, although it is not involved in the Cincinnati case.)

9-71-30 GENERAL GUIDANCE

Section C. Drugs, Biologics, and Devices

When personal shipments of drugs and devices that appear
violative are brought to FDA's attention by Customs, FDA
personnel will have to use their discretion to decide on a
case by case basis whether to sample or detain. Generally,
drugs and devices subject to the Import Alerts are not
amenable to this guidance. Devices to be used by
practitioners for treating patients should not be viewed as
personal importations subject to this chapter. Drugs subject
to Drug Enforcement (DEA) jurisdiction should be returned to
Customs for handling.

In deciding whether to exercise discretion to allow personal
shipments of drug or devices, FDA personnel should consider a
more permissive policy in the following situations:

* when the intended use is appropriately identified, such use
is not for treatment of a serious condition, and the product
is not known to represent a significant health risk; or

* when 1) the intended use is unapproved and for a serious
condition for which effective treatment may not be available
domestically either through commercial or clinical means; 2)
there is no known commercialization or promotion to persons
residing in the U.S. by those involved in the distribution of
the product at issue; and 3) the product is considered not to
represent an unreasonable risk; and 4) the individual seeking
to import the product affirms in writing that it is for the
patient's own use (generally not more than 3 month supply)
and provides the name and address of the doctor licensed in
the U.S. responsible for his or her treatment with the
product or provides evidence that the product is for the
continuation of a treatment begun in a foreign country.

Where there are any questions about the application of these
factors to any product, the product should be detained and
FDA personnel should consult with the appropriate
headquarters office.

Where a shipment is not detained or refused, FDA personnel
should "Release with Comment" and, as appropriate, advise the
recipient that 1) the drug (or device) that has been obtained
for personal use appears to be unapproved in the United
States; 2) the drug (or device) should be used under medical
supervision; 3) FDA may detain future shipments of this
product; and 4) the patient's physician should consider
enrolling the patient in an Investigational study or applying
for an Investigational New Drug (IND) exemption.

9-71-40 IMPORT ALERTS

FDA personnel should recommend to HFC-131 the issuance of an
import alert if they encounter:

* personal importation of products that represent either a
direct or indirect risk;

* the promotion of unapproved foreign products for mail-order
shipment; or

* repeated importation of products that represent a health
fraud.

This policy was updated in the May 1993 letter to buyers'
clubs (see AIDS TREATMENT NEWS #176, June 4, 1993, for
portions of that letter, and for an interview with Randy
Wykoff, M.D., head of the FDA's Office of AIDS and Special
Health Issues). The letter interpreted the 1989 policy to
address three major concerns of the FDA: lack of physician
involvement in the care of people getting products through
alternative mechanisms; promotion and commercialization of
products; and drugs from unknown sources.

Neither the original policy nor the clarification requires a
prescription for drugs to be imported. Instead, from the
letter to buyer's clubs:

"Documentary evidence should be available for immediate
review onsite, demonstrating that any patient importing
products for personal use has a licensed physician who is
accepting responsibility for the patient's care, including
the administration of the imported product. FDA does not
believe that the best interests of any individual are served
by having access to drugs for serious conditions without
adequate physician oversight."

Comment and Recommendations

The PWA Health Group appears to have more than met the
requirements of the personal use policy. The policy does not
require a prescription, only evidence that a physician is
supervising the treatment -- a matter which activists fought
hard for in 1989, when the policy was developed. The PWA
Health Group does require a prescription for albendazole and
tinidazole.

Persons should be aware, however, that the personal-use
import policy allows discretion by the FDA, and provides
guidance to agents on using that discretion. It does not
create a legal right to import drugs in every case, but
attempts to formalize procedures for making case-by-case
decisions.

The issue, then, is one of discretion. During the last
several years the FDA has made important efforts to avoid
being an obstacle to persons with AIDS or other serious or
life-threatening conditions obtaining treatment which is
medically appropriate. And usually the problem now is no
longer the FDA, but the lack of interest by pharmaceutical
companies in developing products for AIDS, and especially for
opportunistic infections, since the U.S. market for each
infection is likely to be small.

The Cincinnati incident has precipitated fears that the FDA
may be diluting its commitment to avoid blocking patients'
access to unapproved but medically appropriate care for
serious conditions for which no adequate approved therapy is
available.

The FDA appears to be concerned that if it uses its
discretion in favor of persons with life-threatening
conditions -- and AIDS in particular -- then promoters of
health foods or questionable remedies can argue in court that
they are victims of discriminatory enforcement, that the FDA
is giving special breaks to people with AIDS that it is not
giving to them. In fact, under the laws and regulations, the
FDA is clearly given areas of discretion, and is expected to
exercise this discretion in the furtherance of medically
rational policies. But attitudes toward AIDS in some parts of
the country are such that the promoters' discriminatory-
enforcement argument could have influence, regardless of
laws, regulations, or rationality. We understand that the FDA
recently lost a case in which that argument was raised --
apparently a bizarre case which started by accident but
turned into a decade-long crusade. The FDA may also be
concerned that overruling local officials' moves against AIDS
groups may damage morale -- even though the regulations
plainly state that local officials should seek guidance from
FDA headquarters when questions arise.

Meanwhile, the recent events are raising fears about whether
the AIDS community can still defend itself. Many people have
died, and there is widespread discouragement due failures in
treatment research; will people still mobilize if necessary
to maintain access to medically appropriate treatments, when
their access is under political attack? This is why the small
incident in Cincinnati invokes issues which will not go away.

We have two suggestions -- not for the immediate case, but
for building strength to be used if necessary in the future.
First, we can begin groundwork on what could be a powerful
response to official obstacles to medically accepted
treatments -- actions for wrongful death, raising the issue
in the courts, Congress, the media, and otherwise, in cases
where the lack of treatment appears to cause or contribute to
the death. The way to prepare for this possibility is for
organizations to do the advance work to handle the obstacles
-- legal, financial, technical -- to such actions. If the
preparations are thorough and professional, then all that
will be necessary, when an appropriate case arises, is for
the family or other representative -- or for the deceased
themselves, through a will -- to say, "Yes." It would not
take many such cases to have an impact.

Our other suggestion for building community strength is much
broader. AIDS and treatment organizations need to make
certain changes in how they operate, in order to be able to
grow into a mass movement. (AIDS may not be a mass movement
in itself, but needs to be able to function as part of one,
in coalition with others.) The main problem is that most
organizations do not offer a workable path for new people to
approach the group and get plugged in -- an easy, appealing
way to volunteer, or just to hang out for a while with as
little or as much commitment as they want to give, and see
what develops for them. AIDS organizations which do offer a
clear, unambiguous path (such as the Walkathon, etc.) often
get tens of thousands of volunteers; people are ready to
help, but organizers must do their job first to make it
possible for them to do so. The elitism and ego fights, which
can occur in any organization, can poison the development of
the mass-movement style which may become necessary for our
survival.