A KINDER, GENTLER FDA

Firms say new policies make it easier to handle

A new era is dawning at the U.S. Food and Drug Administration. Key
provisions of the 1997 FDA Modernization Act finally took effect last week,
capping a three-year battle on Capitol Hill to streamline the U.S. system
for approving new drugs and medical devices.

Biotech and medical devices companies say the changes, coming at a time of
rapid technology innovation, promise to help transform medical tools and
techniques. For patients, the new ``user friendly'' FDA law will mean
quicker access to cutting-edge drugs and devices. Although it will take
months for the FDA to translate the law into specific new procedures,
medical technology firms say the agency -- which began making some changes
while the law was being debated -- already is much easier to work with.

``I'm very happy with the changes,'' said Stuart Edwards, chief executive
at Somnus Medical Technologies Inc., who recently showed off his Sunnyvale
plant to U.S. Representative Joseph Barton, R- Texas, a leading
congressional champion of FDA streamlining. Somnus just won FDA approval,
after a mere 90-day review, for its latest ``Somnoplasty System'' -- a sort
of handheld microwave tool doctors can use to treat chronic stuffy noses.

``We demonstrated that we have a product that does the job, and the FDA
worked with us in a way that's been very beneficial,'' Edwards said.

But some consumer advocates worry that the FDA is getting too cozy with
companies it should be policing.

Maura Kealey, legislative advocate for the Ralph Nader-founded group Public
Citizen in Washington, D.C., helped lead the opposition to ``FDA reform''
on Capitol Hill. Now, Kealey warns that the FDA product-review system is
being systematically watered down. One of her main concerns is that many
product-makers will no longer have to track how new products work in actual
use. Another big controversy focuses on a plan to let manufacturers hire
private firms to test products.

``It's very scary,'' she said. ``The attitude now basically is, `Let's just
put stuff out quicker, with less review, and hope for the best.' ''
Defenders of the new system maintain that safety standards remain intact,
and that new timetables and disclosure rules merely eliminate unnecessary
delays in getting lifesaving products to patients.

Under the leadership of former FDA head Dr. David Kessler, the FDA was
world famous for its skeptical approach -- and notoriously difficult for
product makers, as well as many organized patient groups, to figure out.
``It was always a bit of a black box,'' recalled Ginger Howard, president
of the Silicon Valley-based vascular-products division of Guidant Corp.
``We didn't know what they would require, because we couldn't talk with the
agency.'' Her company received approval in October, following a 113-day
review, for a cardiovascular stent, a metal truss used to patch weak spots
within a blood vessel. It was only the second product of its kind to win
regulatory approval in the United States.

Because of the relative novelty of the product and the high risk of
fatalities should it fail, Howard said the company still had to conduct a
``very rigorous'' clinical study involving 1,040 patients.

``In today's environment (FDA reviewers) work with us collaboratively,''
Howard said, and try to reduce delays. ``They ask us a question today and
we answer it tomorrow and they keep on reviewing. So we don't lose a lot of
time.'' Whereas the FDA used to give few signals in advance, productmakers
now say they can find out early on just what kind of data they need to
gather to support an application. That has been the most profound change so
far, said William Starling, CEO at Cardiac Pathways Corp. in Sunnyvale.

His company submitted an application at the end of January for a new
electro-surgical device for treating a heartbeat abnormality called
ventricular tachycardia.

Although the review is only beginning, Starling was stunned to get a call
back within three days of filing: A senior reviewer just wanted to confirm
that the documents were received and that a timetable was being set for the
next steps.

``In the old days you would never have heard anything back from them,''
Starling said. ``Clearly they have a different attitude.'' In certain
cases, manufacturers now can use previously published medical literature as
a benchmark for comparing how well their products work. That eliminated the
need to conduct a whole new set of expensive, time-consuming studies.

Just because a product clears the FDA more quickly doesn't mean doctors
will necessarily adopt it, or more importantly, get it covered by
insurance.

In the past few years, the bottleneck holding back medical innovation has
shifted from the Washington regulators to the more complex landscape of
insurance and managed care.

``The big problem now is not getting something through the FDA, it's
getting it covered,'' said Don Freeman, head of Freeman Healthcare
Technology, a San Francisco consulting firm. ``You can have the greatest
product . . . and it can still be nearly impossible to get it reimbursed by
managed care and the Medicare program. The regulatory issues by comparison
are much easier to deal with.'' Nor have the regulations gotten so simple
that the lawyers have nothing to do anymore. They just switched from
fighting the FDA to explaining how the new system works.

``We have more work than ever before,'' said David Hoffmeister, a
specialist in FDA affairs at the Palo Alto law firm Wilson, Sonsini,
Goodrich & Rosati.

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WHAT'S NEW AT THE FDA

Most provisions of the 1997 FDA Modernization Act took effect last week,
although the FDA already had begun putting some changes into practice, and
still has to issue detailed rules.

Here's a summary of the main elements:

- -- New Mission: The FDA has a new ``mission statement'' that emphasizes
timely action along with careful study of safety and efficacy claims.

- -- Faster Reviews: Specific timetables are laid out for various stages in
the approval process. Agency reviewers must meet with applicants early on
to outline how clinical investigations should be carried out.

- -- Prior Studies: Previously published data may be used to support a
product application. International studies also may be used in certain
cases.

- -- Other Uses: Manufacturers must submit data only to support a product's
intended use, although the FDA can request more if other uses are likely.

Companies can distribute medical literature about unapproved uses of a
product, though several restrictions apply.

- -- Advertising: Although the Modernization Act didn't require it, FDA
policy now allows broadcast ads to mention a product's intended use without
a full recital of possible side effects. The law now lets manufacturers use
the phrase ``FDA-approved.''

- -- Third-Party Reviews: Independent product-testing labs can be used to
generate clinical data. Details on how this will be done are still being
worked out by the FDA.

- -- Product Tracking: Some mandatory tracking requirements for newly
approved products were eliminated, though the FDA can still require such
studies.

- -- Product Improvements: Small improvements can be made to an approved
product without triggering the need for a new review.

- -- Priority Treatment: Breakthrough technologies or devices that offer
significant improvements over current alternatives get priority in the
review process.

- --Expanded Access: Rules were streamlined for giving patients early access
to products before they are approved for full-scale marketing.

- --Global Harmony: FDA must strive to make U.S. product approval standards
conform where possible with internationally recognized standards.

c1998 San Francisco Chronicle