FIGHTING CHANCE

Speeding FDA's approval process a win for dying patients

It's not often that Congress gets praised for acting in the interest of the
American people. But Congress deserves applause for passing legislation
that will speed the Food and Drug Administration's process for approving
lifesaving drugs and medical devices.

Changes in the way the FDA conducts its approval process have been long
overdue. For years the agency's process has been criticized by a chorus of
detractors as being too slow, contradictory and totally confusing.
Competitively, U.S. pharmaceutical and medical device manufacturers have
lost ground and money to European companies whose products were making it
to the marketplace in far less time.

For suffering patients and those near death, the snail's pace of the FDA's
approval process was unconscionable. Physicians were hard pressed to
explain to desperate and dying patients why they could not prescribe a drug
or recommend a medical device that might save their lives. Unfortunately,
this forced many patients to go to great measures to get access to
lifesaving drugs or medical devices, often in other countries.

With the passage of this legislation, lawmakers took the mystery, not to
mention the misery, out of the process. The bill did not pass without
contention. Consumer advocate groups decried it, warning that public health
would be compromised if offlabel promotions and thirdparty reviews were
allowed. Both are legitimate concerns addressed in the legislation. There
are reasonable safeguards in the legislation that will help to ensure that
safety comes before profit. Even with the quicker process, the FDA
ultimately retains final approval over drugs and medical devices.

While some worry that lawmakers have put profits ahead of patient safety by
passing this legislation, a dying patient needing access to a lifesaving
drug or medical device has the compelling vote in this argument.

With this bill, which we urge President Clinton to sign, doctors can now
look their dying patients in the eye and tell them they at least have a
fighting chance. Before, that was not even an option.