E&C Health Takes Up PDUFA: The Energy and Commerce Health

Subcommittee holds hearings this morning on reauthorization of the bill that
governs the drug approval process, PDUFA. FDA reached a deal with industry
on the terms of the reauthorization in June, and it will make them public in
September. The written testimony (http://1.usa.gov/nol8T4) from the
witnesses shows that the hearings will try to drive home the point that the
FDA needs to speed up the approvals process. “I detect a lot of hunger in
industry to have some pressure on the FDA to remember the balance of their
mission,” said Ian Spatz, a senior adviser with Manatt Health Solutions.
“They believe very strongly that FDA has changed in the way it balances risk
and benefit” that disadvantages industry.

But Diana Zuckerman, President of the National Research Center for Women and
Families worries that the anti-regulatory attitude that currently dominates
the House. “There’s an attitude that we’re going to see in that room which
is very anti-regulatory and very anti-FDA, and I think it does not reflect
the best interests of our country. And I don’t think it reflects industry’s
interest in having an FDA that’s functioning well and that provides a level
playing field to all companies.”