New CEI Study: Promising Treatments Delayed by FDA

Charging that outgoing FDA Commissioner David Kessler has left a legacy of increased bureaucracy and deadly overcaution, the Competitive Enterprise Institute will release a new study which presents a list of promising drugs and devices currently unavailable or delayed in the U.S.

"While many are singing Kessler's praises for supposedly speeding up drug and device approvals, we want to remind the public that FDA continues to prevent life saving therapies from coming to this country," said Julie DeFalco, CEI Policy Analyst and author of the new study, Treatment Delayed, Treatment Denied: Therapeutic Lag and the FDA's Performance.

Some of those drugs and medical devices include:

• TAXOTERE: An important breast cancer treatment for women who have exhausted all other options, Taxotere was kept in the FDA approval queue for two years. Its FDA approval came a year after taxotere became available in Canada, and six months after it was approved in Europe, even though Taxotere was submitted for approval at the same time in all places.

• CITICOLINE: Treating stroke-related disability, Citicoline represents a major improvement over current treatment. Citicoline has been available in 20 countries, including France, Switzerland, and Japan, for more than three years.

• VASOSEAL: Vasoseal is a small plug used to seal the arterial wall after catheterization. By the time Vasoseal was approved in the U.S. in January, 1997, it had already been available in Canada, the Netherlands, and Australia since 1994. It took the FDA over four years to approve Vasoseal.

"The FDA claims that it is approving more therapies faster than ever, and that is clearly not true," said DeFalco. "The FDA also alleges that important new therapies are not being kept from Americans, an assertion which, sadly, is false as well."

For more information, contact Greg Smith at (202) 331-1010 or gsmith@CEI.org [2].