FDA Actions On Drug Testing

Psychemedics Corporation (ticker: PMD, exchange: American Stock Exchange) News Release - 4-Dec-2003

CAMBRIDGE, Mass., Dec. 4 /PRNewswire-FirstCall/ -- Psychemedics Corporation (Amex: PMD), the only laboratory to have received FDA clearance on all of its assays for hair drug analysis, stated today that it strongly supports the recent actions by the FDA concerning drug-screening tests.

In a recent press release, FDA Commissioner Mark B. McClellan MD, PhD, clarified the FDA's position on the regulations governing laboratory and non- laboratory drug screening tests stating that the FDA intends to "... enforce the regulatory requirements fully."

The FDA began issuing public letters of concern to a number of laboratories stating, "... regulations require that, among other things, the screening tests used on the collected samples be approved, cleared, or otherwise recognized by the FDA as accurate and reliable." The FDA further advised the labs that, "Our records indicate that the drugs of abuse screening tests you are performing on hair samples obtained using your sample collection system have not been cleared, approved, or otherwise recognized as accurate and reliable by the FDA."

Raymond C. Kubacki, President and CEO of Psychemedics Corporation, stated, "We are pleased that the FDA has issued letters of concern to those labs that may have been unwilling or unable to demonstrate that their tests are accurate and reliable. We believe that some laboratories may have been misleading their clients for some time now on the need for FDA clearance."

Psychemedics Corporation is the world's largest provider of hair testing for drugs of abuse. Its client list includes over 2500 corporations, (over 10% of the Fortune 500), which use hair testing as part of their drug-free workplace programs. In addition, the country's largest police departments as well as schools and Federal Reserve banks also rely on Psychemedics' patented hair tests. Psychemedics Corporation is the only laboratory to have received FDA clearance on all of its assays for hair drug analysis.

Cautionary Statement for purposes of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995: From time to time, information provided by Psychemedics may contain forward-looking information that involves risks and uncertainties. In particular, statements contained in this release that are not historical facts (including but not limited to statements concerning anticipated increases in testing volume, revenues, anticipated business and marketing plans and anticipated filings with the FDA) may be "forward looking" statements. Actual results may differ from those stated in any forward-looking statements. Factors that may cause such differences include but are not limited to risks associated with development of markets for new products and services offered, the economic health of principal customers of the Company, government regulation, including but not limited to FDA regulations, competition and general economic conditions.

Contact:
William Thistle
SR VP and General Counsel
BillT at psychemedics.com