Monitoring Results For Pharmaceuticals Are Released: Surveys Show Public Has Avoided "Stockpile" Drug Purchases

Months of tracking of pharmaceutical supplies by the Food and Drug Administration (FDA) and the Pharmaceutical Alliance for Y2K Readiness - a consortium of leading drug manufacturers, pharmacies and health care practitioners show that drug supplies are at normal levels and that the industry has taken necessary steps to prepare for the new millennium.

"Today's results mean that people need not have fears about Y2K-related drug shortages going into the New Year," said Secretary Shalala. "The kind of misguided stockpiling" of drugs that some had feared has not materialized, and we are now past the point where such buying might disrupt the nation's drug supplies. In fact, the U.S. has at least a 60 to 90 day supply readily available for nearly every category of medicine."

The positive results emerged from a yearlong study, involving surveys and audits of industry's readiness, which FDA carried out in anticipation of Y2K concerns. In addition, through a contracted survey, FDA monitored sales of prescription drugs in order to compare these data with data compiled from comparable time periods in recent years. The results have been reported weekly to FDA, with the most recent reports covering the period up to Dec. 17, 1999. In addition, a survey of physicians was recently conducted that monitored signs of consumer demand.

FDA's monitoring effort was augmented by communication efforts conducted by the Pharmaceutical Alliance for Y2K Readiness. Through regular meetings with its network of industry, pharmacy and health care professional groups, the Pharmaceutical Alliance was able to monitor pharmaceutical production and distribution patterns in the months leading into Y2K. Reports from this effort were freely shared with FDA and other interested parties.

Analyses of both of these major monitoring efforts revealed no notable problems with the drug supply - no stockpiling of drugs by a Y2K-anxious public, and no Y2Krelated production or distribution problems.

"FDA and the other elements of the Department of Health and Human Services, as well as the Department of Veterans Affairs and all the partners in the private health sector, are to be commended for the well coordinated approach they have taken to ensure that Americans have plentiful supplies of medicine," said John A. Koskinen, chair of the President's Council on Y2K Conversion. "This is a good example of how the public and private sectors can work effectively in meeting any challenge."

The positive news on the nation's supply of medicine follows other recent FDA reports indicating that other major aspects of the U.S. medical industry are ready for Y2K. FDA surveys and audits of the pharmaceutical, biologic and medical device industries revealed a very high level of readiness for Y2K.

Starting last spring, FDA surveyed companies in each of these industries with questionnaires about their Y2K readiness, then followed up with audits of priority companies to confirm information in the questionnaire.

FDA surveyed 4,228 pharmaceutical companies and focused its audits on a smaller number of priority companies, those that are sole source prescription drug manufacturers, manufacturers of the top 200 most often prescribed drugs, and companies that make orphan drugs. The audits confirm the positive results of the surveys.

The agency followed the same procedure with manufacturers of biological products, surveying a wide range of companies and then focusing on audits of priority manufacturers of vaccines, allergenic products, therapeutic products, and major blood producers. These audits likewise confirm the positive results of the surveys and that the industry is well prepared.

Although the vast majority of medical devices are not affected by the Year 2000 problem, FDA did two separate surveys of medical device manufacturers. In the first, FDA surveyed 3,070 makers of essential medical devices whose products are needed on a daily basis and could cause an interruption in critical care service to patients if there were shortages. The survey was done to determine the preparations made by industry to ensure the continued production of these important products. To verify the written survey responses, a sample of manufacturers was audited. Emphasis was placed on manufacturers that are the sole supplier of a product or that are among the few suppliers of an essential product. These surveys and audits confirm that manufacturers of essential medical devices are taking the necessary and prudent actions to be ready for Y2K.

In addition, FDA did an independent evaluation of computer-controlled medical devices that could present risk to patients if they had Y2K-related problems. The agency used a contractor who identified a sample of 80 of these manufacturers and conducted onsite audits. The audits confirmed the adequacy of steps the firms have taken to assure the safe functioning of their medical devices. The audits also confirmed that the Y2K product status information that companies have provided for FDA's Federal Year 2000 Biomedical Equipment Clearinghouse web site is accurate.

FDA will continue to monitor the companies' readiness through the rollover to Y2K.