The following article on FDA reform should have MAJOR consequences for Biotechs in general, and LGND in particular. In addition to the "fast track" designation for cancer, the legislation would allow LGND to talk about scientific articles that show Targretin, in clinical trials for cancer, also shows promise for Type II diabetes (and off-label use could skyrocket). Targretin is slated for NDA filing next year and initial clinicals for Type II diabetes (currently in Phase II trials in Europe) should be completed VERY soon.
Change in Drug-Approval Rules Is
Expected
By AARON ZITNER
c.1997 The Boston Globe
WASHINGTON -- A Senate committee appears ready to order
regulators to speed up the approval process for drugs made for
patients with the most serious illnesses.
The measure, if adopted by Congress and signed into law, would
require the Food and Drug Administration to grant ``fast track''
designation to drugs for patients with serious or life-threatening
diseases, or which show potential for addressing unmet medical needs.
The Senate Labor and Human Resources Committee Wednesday
agreed to include the provision in a broad bill that includes other new
FDA rules and funding for the agency, the office of Senator Edward
M. Kennedy said. A formal vote on the measure will be held next
week, Kennedy's office said.
Genzyme, of Cambridge, Mass., said it is developing products to fight
cancer, Huntington's disease, and Parkinson's disease that could be
eligible for the faster approval process. Henri Termeer, chief executive
of Genzyme, is also chairman of the biotechnology trade group that
pushed for the measure.
Under the proposed rule, drugs given fast-track designation would be
put at the top of the FDA's priority list in the approval process. In
addition, manufacturers could use a modified procedure to prove that
the drugs are effective.
Traditionally, the FDA requires manufacturers to show in clinical
studies that a drug saves lives or reduces illness. For diseases like
cancer, drug makers may have to show that the drug allows people to
survive for five years after treatment. That means a clinical trial can last
for five or seven years.
Under the proposed rule, drug makers could show instead that the
drug is effective on a ``surrogate endpoint'' that comes earlier in the
healing process. If the drug shrinks tumors or boosts the number of
immune cells, that may be enough to win approval.
Once the drug is approved, the manufacturer would have to conduct
more studies to show that smaller tumors or more immune cells in fact
lead to reduced illness or high survival rates five years after treatment -
the results that the FDA demands in its traditional approval process.
But while those studies are being done, companies could legally sell
their drugs to patients.
``It is especially important to the biotechnology industry, becase we
develop a disproportionate number of breakthrough drugs,'' Termeer
said of the provision.
Termeer also praised Kennedy for promoting the measure.
The broad FDA bill has become contentious, with some lawmakers,
including Kennedy, concerned about other provisions that might
loosen FDA scrutiny of pharmaceuticals and medical devices. For
example, the bill might allow drug makers to win approval for new
medicines after one clinincal trial instead of the usual two. A medicine
for one disease could be approved for new uses on the basis of
medical journal articles, rather than of FDA-approved clinical studies.
However, congressional aides predict lawmakers will overcome their
differences because drug makers need a separate provision of the bill
that is not controversial. That provision would continue a set of fees
that drug makers have been paying voluntarily. The fees pay for extra
medical reviewers, who speed up the drug-approval process.
(The Boston Globe web site is at globe.com )
NYT-06-12-97 1810EDT< |
