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Smart Drugs & Nutrients:

How to Improve Your Memory and Increase Your Intelligence Using the Latest Discoveries In Neuroscience

VOLUME 1 in the Smart Drugs Series

by Ward Dean, M.D. & John Morgenthaler
$12.95 - 224 pages, softcover (Out of Stock)

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Section 2: Is All this Legal?

The fact that there are effective smart drugs and nutrients being manufactured today is good news. It is even better news that they can be purchased legally. How this is done, and what complications or qualifications may enter into such purchases is what this section is about.

Over-The-Counter Cognition Enhancement

First, the easy part. Some of the compounds we write about can be purchased over-the-counter from any source that specializes in the sale of nutritional supplements, including the sources we list in Appendix A (see page 165).

FDA Approved Drugs

Other compounds listed are FDA-approved drugs and can be purchased in this country with a prescription. It is im­portant to understand, however, what "approved" and "unap­proved" mean in FDA terminology. Under the Federal Food, Drug, and Cosmetic (FD&C) Act, a drug approved for marketing may be labeled, promoted, and advertised by the manufactur­er only for those uses for which the drug's safety and effectiveness have been established, and which the FDA has approved. These are commonly referred to as "approved uses." This means that adequate and well‑con­trolled clinical trials have documented these uses, and the results of the trials have been reviewed and approved by the FDA.

It is important to know that the FDA has no category for drugs that improve cognition in normal, healthy people. If a drug is to be approved at all, it must be approved for the treatment of a known disease such as Alzheimer's disease, multiple‑infarct dementia, or senility.

There are many drugs that are both safe and effective which are not approved for use in the U.S. Sometimes it is because the pharmaceutical company knows that it simply could not make a profit after going through the extraordinarily expensive and lengthy process required to obtain FDA approval. Another reason drugs might not receive approval is that pharmaceutical companies have little interest in working on any drug that cannot be patented. There are several natural compounds (such as choline) discussed in this book which have cogni­tive enhancing effects. But no one can patent a natural compound. Without a patent, the pharmaceutical company that spends the money to get FDA approval for a drug will then have to compete with other pharmaceutical companies who did not spend the approval money, but can now sell the approved drug.

Physicians should be aware that by FDA law they have the right to prescribe any medication they believe will be helpful to their patient. It does not matter if the prescription repre­sents a use for the drug that is not the FDA approved use.

Physicians are often reluctant to prescribe drugs for cogni­tive enhancement since it is not an "approved use". In April, 1982, the FDA issued a bulletin which included an impor­tant policy statement. The statement clarified the questions about prescribing drugs for "unapproved" uses, stating that physicians may prescribe drugs for unapproved uses in order to provide the best possible health care to the American public. The bulletin clearly stated that the use of "approved" drugs for "unapproved" uses is not only legal, but is one of the primary means of therapeutic innovation. It also said that, "valid new uses for drugs already on the market are often first discovered through serendipitous observations and therapeutic innovation." The term "unapproved uses" is misleading. It would appear that the FDA approves of the use of drugs for "unapproved" uses. Please see Appendix F for a reprint of this section of the April, 1982 issue of the FDA Drug Bulletin.

Overseas Drugs By Mail

The physician also has the right to prescribe drugs which have not been approved for any use in the U.S. Also, although it is not widely known, a July, 1988 FDA ruling now makes it quite legal for individuals to import effective drugs used elsewhere but not available in the U.S. The importation and mail shipment of a three-month supply of medications, for personal use, is now legal as long as they are regarded as safe in other countries. The new ruling, FDA Pilot Guidelines Chapter 971, was made as a result of heavy pressure from AIDS political action groups, which insisted that AIDS sufferers were denied access to potentially life-saving substances that were widely used abroad but were still unapproved for use in the U.S. You will find the text of these new FDA guidelines in Appendix G.

News of the FDA's policy change appeared in the New York Times as follows:

F.D.A. EXPANDS EARLIER STAND BY ALLOWING MAILING OF DRUGS

WASHINGTON, July 25 — When the Food and Drug Administration announced on Saturday that it would allow Americans to import unapproved drugs from abroad in small quantities, it was formalizing its long­standing practice of looking the other way when travelers brought back foreign drugs.

More significantly, it also stated for the first time that it would permit routine mail shipments of such drugs, making them potentially available to vastly more people than the few who venture abroad in search of treatments.

Certainly, both officials and critics agree that timely completion of human trials of potential drugs to determine which are truly effective is more important in the long run than the importation of unproved drugs. Despite recent pledges by officials from the F.D.A. and the National Institutes of Health to speed up the process of drug evaluation, there remains a wide gap in perceptions about the realistic chances of finding useful treatments soon.

The new policy was the direct result of pressure from desperate AIDS patients, who have only one approved treatment available in the country, AZT, or azidothy­midine, which is too toxic for many patients to take for long periods...

In cases where overseas shipments are stopped by U.S. Customs (which should be rare), the recipient will be sent a standard form letter and will have to sign a statement stating that the drug is for their personal use, and also to provide the government with the name of the physician responsible for his or her treatment with the product in the shipment.

The FDA has made it clear, however, that it will not toler­ate "commercial promotion" of unapproved drugs to U.S. citizens by overseas companies taking unfair advantage of the situation to promote unproven drugs to people in the U.S.

There are no guarantees that the FDA will not change its mind about the mail importation policy and act to reverse it. But at the time of this writing this is how the law and FDA policy stand. We have provided a list of mail-order sources in Appendix A (see page 165). We hope that the overseas compa­nies listed will have the good sense to comply with all FDA regulations, i.e., supplying only items which have been proven to be safe and have no abuse potential, and not commercializing their services (which we take to mean they must not advertise but merely supply to informed individuals). This will decrease the chances that there could be FDA action against them.

References:

Anderson, K., Anderson, L. Orphan Drugs. Los Angeles, CA: The Body Press, 1987, pp. VIII-XXVI.

Boffey, P.M., New York Times. July 25, 1988.

Food And Drug Administration. FDA Drug Bulletin. April 1982.

Food And Drug Administration. Regulatory Procedures Manual. Chapter 9-71.

James, J.S., AIDS Treatment News. July 29, 1988, Num­ber 61, pp. 1‑4.

Pelton, R., Pelton, T.C. Mind Food & Smart Pills. New York: Double­day, 1989.