February 16, 1995: Vol26n17: FDA boss says agency speeds approval process for drugs
Responding to recent public criticisms that his agency moves too
slowly in approving new drugs, Food and Drug Administration
Commissioner David Kessler told a standing-room-only crowd on UB's
South Campus that the FDA has dramatically increased access to
promising new drugs for patients with life-threatening diseases.
	 Kessler, who delivered the D.W. Harrington Lecture Feb. 9 in
Butler Auditorium, said the FDA has sped up the approval process for
new drugs and it has also increased patients' accessibility to new
drugs that are still in the clinical stages of testing.
	Kessler, who was appointed by President Bush in 1990, said the
advent of the AIDS epidemic changed the way the FDA handled the
approval process for new drugs offering potential treatments for
patients with terminal diseases. He said in today's world, it was
important for these patients to have the right to take a chance on a
new drug when, seemingly, all other treatments have failed.
	"Experimental sources of therapy, such as new drugs, represent
a rare source of hope for those people with conditions that have
seemed to outsmart medical science," Kessler said. He said he realized
the FDA must address the unique problems facing those patients who
have nothing to lose by trying experimental treatments. "In urgent
cases where people are dying and no effective therapy exists,
something more is required of the FDA," he added. 
	The FDA is the federal agency responsible for enforcing the
nation's food and drug laws and for overseeing the introduction of new
drugs into the marketplace. It has been criticized heavily during the
past few months for being overly bureaucratic and slow to approve new
treatments.
	The New York Times reported last Sunday that full-page ads
have recently appeared in national newspapers declaring: "If a
murderer kills you, it's homicide. If the FDA kills you, it's just
being cautious." The newspaper described how the FDA has become the
"prime target" of conservative groups which feel that government
over-regulation of drugs and medicine hurts American industry's
ability to compete globally and results in unnecessary deaths to
people who could have been helped by therapies currently awaiting FDA
approval.
	Kessler, however, disagreed and said there are widespread
misconceptions as to how long it takes for the FDA to approve a new
drug.
	"For most drugs, the average approval length is 13 months," he
said, "not seven years or 10 years like most people think."
	Sometimes the agency moves even quicker. Kessler, a graduate
of Harvard Medical School and the University of Chicago Law School,
said that in the past few years four new drugs-most notably a drug
called DDI, a possible treatment for AIDS patients-received approval
in less then seven months. Kessler said this kind of quick approval of
new drugs was one of the best ways the FDA can address the needs of
patients afflicted with life-threatening diseases.
	In 1992, he noted, the FDA also began granting conditional
approval to certain drugs before the agency has final confirmation of
direct evidence of their effectiveness.
	If a drug manufacturer can indirectly establish evidence of a
drug's effectiveness on a disease that would make it "reasonably
likely" the drug would successfully treat that disease, then it may
apply to the FDA for conditional approval. The drug then would become
available to the public much quicker than normal.
	Kessler said a drug receiving conditional approval is still
held to the same standards as a drug receiving full approval and that
the drug's manufacturer must conduct post-marketing studies of the
drug to ensure that it has the anticipated benefits. However, he noted
that "the less time a drug is in clinical trials, the less we will
know about it and the more risks we will take when we make it
available." Kessler said it was "not enough for the FDA just to get
new potential therapies to people who need them." It is also the FDA's
responsibility, he said, to "get answers" regarding the potential
benefits a drug may bring and the potential harm it could cause.
	"The challenge," he said, "is to strike the right balance
between access and answers." 
	Kessler warned that this challenge would be tested some day
when a drug that was introduced into the marketplace before all the
scientific research had been gathered, is found to be harmful.
	"One day we're going to make a mistake," he said. "But the
riskiest thing we can do is to not take risks. Especially since
patients have said that they are willing to take the risks."
	The magnitude of these risks depends on the precision of the
FDA approval process, which, in turn, Kessler said "is only as good as
the scientific research on which it is based." Most of that research
comes from the clinical studies of the drug's effects. Drug
manufacturers generally perform several phases of clinical trials,
sometimes covering a span of years. Until 1987, for most patients,
participation in one of these trials was the only way they could hope
to obtain some experimental drugs that could help in their treatment.
Many seriously ill patients were precluded from participating in these
trials, however, because they did not qualify physically or they were
limited by financial or geographic means.
	In 1987, however, the FDA opened the door for tens of
thousands of seriously ill people-mostly AIDS patients-to receive
drugs free of charge while the drugs are still in clinical trials.
Kessler said the FDA had to realized that while diseases such as AIDS
"have no geographical boundaries, access to cutting-edge medical
technology often does."
	He said, in 1992 this program was expanded to include even
more patients.
	"Today, drugs that show promise are being made available to
patients before they have received final approval from the FDA and
before they are marketed to the public," said Kessler.
 	The D.W. Harrington Lecture Series was established in 1896.
Speakers are chosen and invited by the faculty members of the School
of Medicine and Biomedical Sciences.