WASHINGTON Biotechnology insiders hope the ever-changing list of hopefuls to lead the FDA narrows to one approvable candidate very quickly.
“Our hope is that one way or the other this is going to get done sooner rather than later,” Sharon Cohen, vice president for government affairs at the Washington-based Biotechnology Industry Organization, told BioWorld Today. “Our hope is that this will be one of the first appointments that the president makes. And we’re hoping for a good appointment someone with a strong science background and things of that nature.”
When the appointment will be made is anybody’s guess. Even Cohen admitted that the story behind the pending nomination is full of twists and turns.
Regardless, the task of naming a leader is part of BIO’s annual legislative agenda that was forwarded last week to President Bush.
Specifically, BIO says, “A new commissioner must reverse the trend of increased review times, demonstrate to Congress how the agency needs additional appropriations, lead on bioterrorism issues, and insist on quick action to extend PDUFA [Prescription Drug User Fee Act]. The worst-case scenario for our industry would be no nomination at all for several months or the nomination of a controversial figure that slows the confirmation process for months.”
Among the top candidates are Alastair Wood, a pharmacologist at Vanderbilt University in Nashville, Tenn., and Lester Crawford, a veterinarian who heads Virginia Tech’s Center for Food and Nutrition Policy in Alexandria, Va.
The president’s failure to name a permanent leader at the FDA could end up slowing negotiations for reauthorization of PDUFA, Cohen said.
PDUFA II (reauthorized in 1997) expires in September and government employees are trying to pull a proposal together to get the act reauthorized. PDUFA authorizes the FDA to charge biotechnology and pharmaceutical companies user fees when they submit drug applications. (See BioWorld Today, Nov. 26, 2001, and Dec. 10, 2001.)
At about $300,000 per drug application, the FDA has collected millions of dollars over the last decade to hire extra scientists to review the mountains of documents that are part of any drug application.
Even with the user fees, FDA officials are saying they can’t make ends meet and may need to raise the cost.
BIO hasn’t publicly stated whether it supports increasing the fee rate. Instead, Cohen said, “Our biggest concern is that there is legislation [to reauthorize PDUFA] and that it moves quickly and that it does not become available for unrelated extraneous things that can obviously slow it down. The priority here is to get this done; once everyone realizes this needs to get done, then we can talk about parameters.”
While PDUFA really helps companies that have drugs on the market or are close to getting products on the market, BIO is asking Bush to look out for companies still in the R&D phase.
“Many of the most promising biotechnology companies are hunkered down in the clinic trying to raise sufficient funds to see their product through to approval or to a point where they can partner it successfully with another company,” BIO’s legislative agenda says.
To better support some of the smaller companies, BIO asked the president to consider two proposals: one for net operating losses and the other for start-up capital gains. The former would allow eligible long-term research companies to claim a refundable tax credit in exchange for relinquishing their research-related losses and credits. The latter would set a zero-capital-gains tax rate for direct investments in the equities of entrepreneurial firms.
“The tax stuff is actually hugely important for the smaller, emerging companies those which don’t have any products in the marketplace,” Cohen said. “There are different tax incentives on the books today, the R&D tax credit for example. But for a company that doesn’t have any taxable income, the current IRS structure isn’t constructed to allow those companies to avail themselves of these existing tax incentives.”
And for orphan drugs, BIO recommends that the orphan drug tax credit be applied to clinical expenses before and after the drug received the designation from the FDA.
For a full view of BIO’s letter to President Bush, visit its website at www.bio.org.