On Oct. 10, 1973, the Food and Drug Administration (FDA) published an official notice warning that progestins — synthetic sex hormones — had never been proven effective in preventing miscarriages and had been implicated in causing birth defects. The labels to physicians carry warnings along such lines at the present time.
Yet in 1975, about 500,000 prescriptions for these drugs were written by physicians for pregnancy-related purposes. SUCH EXAMPLES are numerous and are feeding a growing consumer demand for easily understandable printed material warning patients about such harmful effects of drugs to be provided both in the physician’s office and the pharmacist’s store.
While the FDA has slowly moved toward requiring patient package inserts for a few drugs, such as birth control pills, the agency is balking at requiring more patient information for many prescription drugs to be given by physicians to patients at the real point of purchase — the doctor’s office.
FDR’s outgoing chief, Alexander M. Schmidt, has doubts about the agency’s legal authority to require doctors to transmit such printed information. Although he recognizes merit in such a rule, he has not aggressively asked Congress to give FDA the authority he thinks the agency needs.
Here is an illustration of how a patient information requirement would work. Thousands of pregnant women would receive a progestin fact sheet in their doctor’s office. On the sheet in clear language would be a warning against use in pregnancy due to the possibility of birth defects. The sheet would also note that the drug is not approved for any pregnancy-related conditions. Thus informed, the patient may start asking her physician why the drug is being prescribed in the first place.
Such objective information based on the best available scientific tests would enable the patient to achieve a more genuine kind of informed consent which can reduce the prevalence of medical malpractice associated with negligent or uninformed physicians.
Even so mild a man as FDA’s Schmidt is “appalled” at the widespread misprescribing of drugs by physicians throughout the country. The results are tens of thousands of serious or fatal injuries every year.
MANY PEOPLE do not realize that the FDA only approved drugs for specific purposes. But once these drugs are on the medical market they can be prescribed for other, unsafe purposes. The massive over prescribing of amphetamines for weight control is a current case in point. In rare instances, a physician may be able to show that a drug should be prescribed for a particular patient in order to achieve an unapproved use. But the abuses are far more prevalent.
Consumers may wish to write to the Food and Drug Administration, Wash., D.C., for material on the patient package insert controversy. The FDA is interested in hearing about complaints that patients have concerned the harmful effects of prescribed drugs.
The issue, which is most strenuously opposed by the drug companies and the American Medical Association, is the proposal by some consumer groups that printed warnings be available in physicians’ offices. That is an additional reason why the FDA needs to hear from you.