The Biotechnology Industry Organization is preparing to seek a broad overhaul of FDA's regulatory approach to product review as part of a push to encourage more drug development.

"The FDA review process has become too unpredictable, too time-consuming and too expensive, BIO President Jim Greenwood said June 28 during his state of the industry address at the association's international convention in Washington, D.C.

"Regulatory science hasn't kept up with the frontiers of innovation. And, the agency has been given too many conflicting missions - and not enough resources to perform them," he said.

Among the proposals is "creating a progressive approval pathway so that even before final approval, patients can have earlier access to promising new therapies," Greenwood said.

With the Avastin fight still fresh on policymakers' minds (see Also see "CDER Attacks Genentech's Plans For New Confirmatory Trial At Avastin Hearing" - Pink Sheet, 28 June, 2011. ) getting such a pathway created may be a tall order, however.

"Won't Be Easy To Sell"

The association developed the proposal over the last year with the help of former National Institutes of Health Director Elias Zerhouni, who subsequently became Sanofi's global head of R&D (Also see "BIO Creating "Game-Changing" Legislative Proposal To Boost R&D" - Pink Sheet, 21 March, 2011.).

BIO will also offer legislative proposals addressing the challenges that its energy and agricultural firms face.

"Every day, our products reduce suffering, save lives, and provide hope and healing. But for us, that's just not good enough. If we really intend to leave our children a world with less disease, less hunger and less pollution, then we have to face the reality that our time is running out," Greenwood said.

"That's why we're proposing big ideas. Clearly, our ideas for unleashing the promise of biotechnology won't be easy to sell on Capitol Hill. But, the facts are on our side, and the science is on our side," he said.

The fundamentals of BIO's proposals have been discussed in Washington on-and-off over the years, but Greenwood's focus, and upcoming renewal of the user fee program mean that they will be debated anew.

The user fee act expires during an election year, and the last time those two events aligned (in 2002) the result was clean, swift reauthorization legislation.

The political dynamics are different this time around; there's a divided Congress and it's a presidential election year. But the relatively short timeframe the BIO has in order to educate senators and representatives on its proposals may mean that its more ambitious ideas are left off the PDUFA train.

A More Independent, More Product-Focused FDA

BIO is not yet offering specifics, but Greenwood's speech outlined the broad contours of the proposals. Regulatory ideas include:

* "Making the FDA an independent agency;

* "Updating the FDA's mission statement to give the agency a clear mandate to encourage the development of innovative products;

* "Providing greater continuity of leadership by giving the FDA commissioner a fixed term of office that doesn't change over with every new presidential administration.

* "Giving the agency a chief innovation officer to ensure that forward thinking, cutting-edge science is integrated into agency operations at all levels;

* "Giving the agency new ways to bring in top-notch external scientific and medical advice and more input from patients."

A "Patent Box" And Other Capital Ideas For Capitol Hill

Greenwood also argued that "Our tax laws need to include incentives to encourage, not punish, more investment in biotech innovation." BIO's capital formation proposals include:

* "A new 50% angel investor tax credit for companies with fewer than 500 employees;

* "A new research and development partnership structure;

* "A provision to make investments in small biotechs eligible for a reduced capital gains tax rate;

* "Matching federal grants to venture capitalists that fund small innovative companies;

* "New net operating loss provisions;

* "Incentives for multinational companies to return overseas funds and invest them in small biotechs;

* "A 'patent box' providing reduced corporate rates on income derived from certain kinds of intellectual property."

-M. Nielsen Hobbs (n.hobbs@elsevier.com)

BIO's "Big Ideas" Include Expanding FDA's Mission, Allowing "Progressive Approval"

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