Some familiar with Food and Drug Administration practices say no one should be fooled by agency claims that it has accelerated and reformed its drug approval processes.

They say improvements are largely illusory and accuse the agency of fudging the numbers.

• It has changed from reporting mean approval times, to median approval times -- which makes the process appear to move more quickly.

• To calculate approval times, the FDA traditionally measured from the time of submission of a drug candidate to permission granted.

• But it now measures to the point of issuance of an "approvable" letter -- appreciably reducing the time involved.

Analysts say that the total time required for drug development has more than doubled since 1964. Also, bringing a new drug to market now costs about $500 million, by far the highest price tag in the world.

One result is that not many new biotech drugs are in the development pipeline. The FDA approved only two new biotech drugs in 1994, one in 1995, and none during the first nine months of 1996 -- not counting duplicates of drugs already on the market sold by other companies.

Source: Henry I. Miller (Hoover Institution), "How Healthy Is Biotechnology?" Washington Times, January 28, 1997.

For more FDA delay of drug approvals, see the new NCPA study http://www.ncpa.org/studies/s208/s208.html