Although the FDA and industry leaders continue negotiations for reauthorization of the Prescription Drug User Fee Act (PDUFA), the agency released a budget synopsis Tuesday indicating that higher user fees are expected next year. PDUFA gives the FDA the authority to charge pharmaceutical and biotechnology companies fees for new drug applications (NDAs) and biologics license applications (BLAs) in exchange for quicker review times. PDUFA II, reauthorized in 1997, expires in September.

The increased user fees are part of Bush’s $2.13 trillion budget that includes a 9 percent increase for the Department of Health and Human Services (HHS). Of the total $489 billion proposal for the HHS, $429 billion would go to Medicare and Medicaid. Meanwhile, the FDA’s share is $1.727 billion, and the National Institutes of Health is in line to receive $27.335 billion.

The FDA anticipates collecting $295 million in user fees, including $272 million from PDUFA. Additional user fees are proposed for the continued implementation of the Mammography Quality Standards Act ($16.4 million), export certification program ($1.6 million) and the color certification program ($5.1 million), according to the FDA.

The anticipated $295 million in user fees apparently took some industry leaders by surprise.

“That $295 million may be on somebody’s wish list, but for right now it is a place marker,’” Jeff Trewhitt, spokesman for the Washington-based Pharmaceutical Researchers and Manufacturers of America, told BioWorld Today. “That final number is subject to two things: ongoing discussions between the FDA and industry, and final action by Congress.”

Trewhitt said the whole concept of raising user fees remains on the table for discussion. “This is all subject to ongoing talks,” he said.

In previous discussions, the FDA has said that it underbid PDUFA II and needs higher fees to keep the program running successfully. The application fee for NDAs and BLAs includes a base cost of $267,606 plus an inflation adjustment (cumulative since 1997 at 15.71 percent) to total $309,647 in fiscal 2001. (See BioWorld Today, Nov. 26, 2001.)

The lingering threat of bioterrorism has prompted the administration to look at spending more taxpayer dollars on counter-terrorism measures.

For the FDA, Bush proposes $159 million to protect agency-regulated products against willful contamination and to ensure the availability of medical products for the prevention or treatment of injuries caused by biological, chemical or nuclear agents. Also, according to the FDA, initiatives are under way to improve existing safeguards for the nation’s food system.

But the NIH is the big winner in Bush’s $37.7 billion homeland defense budget (the current fiscal year’s total is $19.5 billion).

In total, the president wants to fork over about $1.7 billion ($1.47 billion more than last year) to the institute for research on developing vaccines, tests and therapies to fight the likes of anthrax and smallpox. The NIH estimates that it will cost $977 million to fund bioterrorism research activities alone.

The government also intends to budget $851 million for stockpiling antibiotics and improving the smallpox vaccine.

About a month after taking office last year, Bush made a commitment to double the NIH’s fiscal year 1998 appropriation level in five years. Bush’s $27.335 billion proposal represents an increase of $3.902 billion, or 16.7 percent, over fiscal 2002. (See BioWorld Today, March 1, 2001.)

Aside from bioterrorism funding, the budget includes an extra $255 million (10 percent over last year) for a total of $2.77 billion in AIDS research dollars.

If approved, the president’s budget will allow the NIH to spend an estimated $5.5 billion in cancer research. A statement released by the NIH said increased financial support would be provided for large-scale studies on critical cancer control, prevention and screening questions.