Washington Editor

Had Congress not acted last week to pass legislation intended to provide the FDA with more authority and funding, the agency's commissioner would have terminated up to 2,000 employees vital to the product-approval process, said Sen. Edward M. Kennedy (D-Mass.).

Had the 2,000 employees left the agency, he said Friday in a speech on the floor of the Senate, "the consequences would have been with us for years in terms of slower access to medicines for patients, weaker safety oversight and loss of America's competitive edge in the life sciences."

In a voice vote Thursday evening, the Senate unanimously passed the FDA Amendments Act of 2007 and sent the bill to President Bush.

The House passed the legislation on Wednesday in a 405-7 vote. (See BioWorld Today, Sept. 21, 2007.)

The legislation renews the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA), programs that call on firms to pay fees to the agency to help support the review of approval applications.

The legislation provides more than $400 million in fiscal year 2008 for the review of drugs, biologics and medical devices, and more than $50 million for safety reforms "to give these talented professionals the tools they need to do the job we are counting on them to do," said Kennedy, who led the Senate's fight to reform the FDA.

"FDA has an urgent need for these funds," said Kennedy, chairman of the Senate Health, Education, Labor, and Pensions Committee.

In a statement, FDA Commissioner Andrew von Eschenbach said he was pleased that Congress acted to renew PDUFA and MDUFMA, programs that account for nearly one-quarter of the FDA's annual budget.

Since its inception in 1992, noted Jim Greenwood, CEO of the Biotechnology Industry Organization, PDUFA, which was set to expire on Sept. 30, has provided the FDA with the resources necessary to review more than 1,100 new medicines, and to reduce review times for innovative drugs and biologics, "providing patients and doctors with earlier access to breakthrough treatments."

The legislation, Kennedy said Friday, means more than additional funding for the FDA.

"It is a strong and comprehensive measure to improve the safety of the medicines we rely on," he said.

Under the legislation, the FDA has the power to force manufacturers to include warning information in product labeling and to conduct post-market safety studies. The agency can impose civil penalties of up to $10 million for violators.

The legislation also requires manufacturers to list information about all clinical trials in a public registry. The government's currently available online trial database, clinicaltrials.gov, does not include information about all studies.

Sen. Charles Grassley (R-Iowa), who has criticized the FDA since the withdrawal of Vioxx (rofecoxib) from the market in 2004, called the legislation a "positive step toward restoring public trust in the FDA."

However, the Iowa lawmaker said he was disappointed that the final bill failed to fix the imbalance between the FDA's Office of New Drugs (OND), the office that approves new drugs, and the Office of Surveillance and Epidemiology (OSE), which monitors safety of drugs and biologics after approval.

Grassley has called OND "too cozy" with the drug industry, and has accused that office of impeding OSE's efforts.

"With the enactment of this legislation, there should be no excuse for future FDA failure to quickly and aggressively protect the public from unsafe drugs," Bill Vaughan, senior policy analyst for the watchdog Consumers Union, said in a statement.

Left out of the bill passed by Congress last week is legislation that would create a regulatory pathway for FDA to approve follow-on biologics.

Rep. Henry Waxman (D-Calif.) has pledged to move that bill forward as a separate piece of legislation.

However, he noted at a recent conference, the follow-on biologics bill would have had a better chance for passage had it been attached to the FDA reform bill. (See BioWorld Today, Sept. 7, 2007.)