WASHINGTON - The FDA for the first time revealed its industry-negotiated vision for the next iteration of the Prescription Drug User Fee Act (PDUFA), and as expected, costs are on the rise to fund a wide set of activities beyond the drug approval process itself.
The agency proposes increasing annual user fees to $392.8 million, representing $87.4 million in growth over the current baseline. That escalation translates to new drug application costs of about $1.1 million apiece, up from the current fee of about $900,000 per submission. And while the bulk of that total is devoted to funding drug reviews, much of the proposed increase is tabbed for spending beyond the law's original intent.
Steven Galson, director of the FDA's Center for Drug Evaluation and Research (CDER), said the increased costs would fund a number of "important program enhancements." Among them, he said during a conference call Thursday, the extra money would "significantly broaden and upgrade our drug safety program."
Specifically, $29.3 million of the increase would be used for post-approval safety monitoring of drugs for as long as they remain on the market, which would involve the hiring of an additional 82 employees. It also would help buy external databases to mine for safety signals as the FDA works more broadly to adopt new scientific approaches and improve the use of existing tools to detect and prevent adverse events. That longer post-approval surveillance through user fees would require congressional approval to lift the current three-year limit on such activities.
The drug safety initiative meets a lot of recommendations put forth in last fall's Institute of Medicine report on the agency's post-approval oversight capabilities, said Amit Sachdev, executive vice president of health for the Biotechnology Industry Organization (BIO). While conceding that plans to beef up the FDA's safety program wouldn't please everyone, he stressed that plans to change the framework should be done "in parallel" with congressional work on the initial proposal for PDUFA IV, as this new version is known. He added that drugmakers are wary of potential additions to the bill that call for an independent safety office within the FDA, apart from CDER, risk-management plans for all drugs, provisional approvals and limitations on off-label use.
The measure faces a "fairly tight deadline," Sachdev told BioWorld Today. Even though the legislation must be renewed in principle before the current version expires on Sept. 30, agreement on a final draft needs to be reached by late May to allow the FDA to budget its staff needs for the next government fiscal year.
Going forward, there is a public vetting on the proposal, including a Feb. 16 meeting here. The FDA then will evaluate the comments and make any changes before sending its final version to Congress.
Key players at that point include the Senate's Health, Education, Labor and Pensions Committee and the Energy and Commerce Committee in the House. Their final version would be forwarded to President Bush.
Other PDUFA IV program enhancements call for $4.6 million in new user fees to improve the drug review process. That includes expediting drug development through guidelines on clinical trial designs and other topics such as predictive toxicology and biomarker qualification, as well as clarifying Phase IV commitments and timelines.
The FDA also plans to add 20 employees as part of a broader pledge to practice good review management principles and speed its review of proposed trade names. Sachdev said drugmakers especially are pleased with those commitments.
An additional $4 million is tabbed for improving the information technology activities for human drug review by moving the agency and drugmakers toward an all-electronic environment. Under that goal, the FDA would commit to develop a five-year plan to lay out a technical approach for achieving a more integrated, standards-based electronic regulatory submission and review environment.
The FDA also wants to increase user fees to stabilize PDUFA IV's financial base line, including $20 million in additional fees and 87 new employees to cover increases in drug review workloads incurred but not compensated for under PDUFA III. That refers in part to meetings for special protocol assessments and other development-related discussions with drug companies.
Since the 2002 fiscal year, the number of meetings per commercial investigational new drug applications has increased by almost 30 percent, and the number of special protocol assessments is up more than 90 percent. There were 1,800 meetings in 2005 alone, said Theresa Mullin, the FDA's assistant commissioner for planning. That's an average of seven per day, and their popularity is expected to continue.
Another $17.7 million is included for adjusting the base amount for inflation and supporting salary and benefit increases, and $11.7 million to ensure that the fees cover a share of higher facility costs for the agency.
For the first time, the FDA also proposes charging a fee for drug advertising. Through a separate user fee program the agency would collect money from companies seeking advisory reviews of their direct-to-consumer television ads. The FDA expects to collect $6.2 million in the first year to support 27 new employees to carry out the function.
The drug user fee program was first authorized in November 1992, and in the background of the current reauthorization, the FDA and interested parties, such as BIO, are continuing to press the White House and Congress for more money to offset an over-reliance on user fees. At present, the agency is being funded at last year's levels, as is most of the federal government, because Congress failed to pass the president's spending bills for the current fiscal year. His budget proposal for the coming fiscal year is expected in a few weeks.