Here's more good news for Biotechs in general and LGND in particular:
By Jennifer Corbett Dooren Staff Reporter
WASHINGTON -(Dow Jones)- The Senate Wednesday overwhelmingly approved a bill
that is intended to speed the review of new medical devices, drugs and food
products.
The 98-to-2 vote caps a nearly three-year effort at overhauling the Food and
Drug Administration, the agency responsible for approving and monitoring the
safety of everything from pacemakers to aspirin.
A House panel is scheduled to approve similar legislation Thursday and the
measure expected to reach the House floor in the next few weeks.
Sponsors of the bill said it provides moderate, incremental reform of the
FDA.
"I believe this is an important step forward at ensuring a stronger and
efficient FDA," said Sen. James Jeffords (R., Vt.), chairman of the Senate
Labor, Health and Human Services Committee.
To help speed up review of medical devices, the legislation would allow the
FDA to expand an existing pilot program that allows private third-parties to
review some kinds of medical devices and it would create a "fast-track"
approval process for drugs intended to treat life-threatening illnesses.
The legislation would also give some seriously ill people access to
experimental drugs and it would renew the expiring Prescription Drug User Fee
Act. The popular law, which is credited with increasing drug approval times,
charges pharmaceutical companies fees to fund most of the costs of drug
safety and effectiveness reviews.
Linking FDA reform to the renewal of the drug user-fee act gave FDA reform
considerable momentum. Lawmakers have made various attempts to overhaul the
FDA during the past 20 years, but such efforts intensified when the
Republicans gained control of Congress in 1994.
The FDA bill was delayed for several weeks by Sen. Edward Kennedy (D.,
Mass.) and other liberal Democrats who objected to several provisions in the
bill ranging from cosmetics regulation to medical-device review. Kennedy and
Sen. Jack Reed (D., R.I.) voted against the bill.
Kennedy agreed Tuesday to end his filibuster of the bill. All but one of his
objections have been resolved over the past few weeks.
"Thirty sections of the 60 sections in this bill have been altered," said a
frustrated Sen. Dan Coats (R., Ind.) "(The bill) has been watered-down
substantially."
The remaining provision Kennedy objects to is one that would restrict Food
and Drug Administration testing of medical devices for uses other than those
spelled out on the manufacturer's label.
Supporters of the provision argue that the restrictions on the FDA are
designed to speed up the review process for medical devices.
The restrictions on reviewing devices for alternative uses doesn't apply to
new medical devices and would apply to devices that are similar to devices
already approved for use.
Critics had argued that the FDA, when considering an application for a device
that's similar to one already on the market, would be allowed to review the
device only for uses spelled out in the manufacturer's proposed labeling.
They said that would apply even if the device's technology clearly indicates
that it will be marketed for a use not included in the labeling.
Democratic lawmakers are expected to try to change the review restrictions
when the House Commerce Committee considers a similar FDA bill Thursday. They
are also expected to try to scale back or eliminate provisions that would
expand an existing pilot program that allows third-parties to review and
approve some medical devices.
The FDA legislation also contains food-related provisions that would allow
manufacturers to advertise and provide health and nutrient content
information claims that have been approved by another federal government
agency, such as the National Institutes of Health. Currently, the FDA must
verify such claims.
Regulation of the cosmetics industry was another contentious issue that
delayed passage. A provision, designed to make federal and state regulations
uniform, bars states from imposing their own competing rules and labeling
requirements for cosmetics and over-the-counter drugs.
Opponents complained the $20 billion cosmetics industry would be left with
little meaningful oversight. Under a compromise, states will continue to
regulate the safety of cosmetics and nonprescription drugs unless the FDA
imposes its own specific regulations. |
