DELAYS IN PASSING ON PRODUCTS
Report of the Council on Pharmacy and Chemistry
The Council has adopted the following report and authorized its publication.
W. A. Puckner, Secretary.
The Council frequently receives inquiries—some of them accompanied by expressions of impatience—concerning articles, reports on which appear to be delayed. It therefore seems advisable to make a statement of some of the factors which enter into this problem.
The Council fully realizes the importance of giving prompt information to the profession with regard to proprietary medicines under consideration. It therefore acts as soon as sufficient information is available to justify a definite judgment, and publishes its conclusions as soon as possible. When adequate information is available at the outset, there is no delay in the publication of the Council’s conclusions.
Unfortunately, but very naturally, there are many cases in which the information available at the time the product is submitted is not sufficient to justify the Council in coming to definite conclusions for or against the preparation. In some cases the manufacturer possesses the required information, but to obtain it from him takes time; in other cases the manufacturer does not possess the information—perhaps he did not realize the inadequacy of his evidence until the subject was brought to his attention by the Council.
Such cases might be dealt with in either one of two ways: The Council might at once reject the article because the claims for it are not supported by adequate evidence; or, the Council might suspend judgment and give the manufacturer an opportunity to supply the information.
The first method—immediate rejection—would obviously be felt by manufacturers as a hardship. To afford the fullest possible opportunity for the presentation of the case, the Council follows the second method; that is, it suspends judgment and withholds publication of a report until reasonable time has been afforded for furnishing the required information, provided the manufacturer or agent appears to be making honest and diligent efforts to supply it. The collection and compilation of such information is sometimes a lengthy process, especially when the products are of foreign manufacture.
Although it would be easier for the Council to render an immediate decision than to assist manufacturers to supply the data necessary for the formation of an authoritative judgment, the Council cannot yield to importunities for hasty action. It must rely on the medical profession to bear in mind that the character of a product under consideration by the Council has not yet been determined. The Council holds that, during this stage, a product is suitable, at most, for experimental use.—(From Reports of Council on Pharmacy and Chemistry, 1915, p. 119.)