Washington Editor

New legislation passed by the House this week would give the FDA stronger authority to demand, rather than ask, manufacturers to make changes to prescription drug labeling and conduct post-marketing safety studies.

The legislation includes compromises from bills passed earlier this year by the House and the Senate.

In a 405-7 vote, the House Wednesday passed the long-awaited FDA bill, which not only would give drug regulators new powers, but also reauthorize the Prescription Drug User Fee Act (PDUFA) for five more years.

The House vote came a little more than a week before PDUFA was set to expire. As of early Thursday evening, senators had not yet passed the final version.

The Senate was expected to pass the same legislation, with action there expected no later than today. President Bush has signaled that he would sign the bill.

Earlier this year, lawmakers had pledged to quickly reauthorize PDUFA. But negotiations between the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor, and Pensions to reconcile the differences between the two bills waned throughout the summer, nearly leaving the FDA without needed funds to pay the salaries of drug reviewers.

PDUFA, first passed by Congress in 1992, was created to allow firms to pay user fees to the FDA to help support the agency's process for reviewing applications for new drugs and biologicals, and established performance goals for the agency, including completing its review of a certain percentage of applications within certain time frames.

The user fees supplement the FDA's funds allocated by Congress and are intended to decrease the amount of time the agency takes to complete pre-marketing reviews of applications for product approval.

PDUFA had twice been amended and reauthorized, in 1997 and 2002.

Under the PDUFA provision passed by the House, drug manufacturers would pay $392.8 million in fiscal year 2008, an $87.4 million increase over the current base. The legislation also expands the amount and scope of fees devoted to post-market safety. The bill also contains a measure that would require firms to pay an additional $225 million in user fees over five years for drug-safety activities.

The legislation passed this week also would reauthorize the user fee program for medical devices.

In addition, the bill would establish a new program to assess, collect and use fees for the voluntary review of prescription drug direct-to-consumer television advertisements. The legislation renews a provision under the Best Pharmaceuticals for Children Act that grants manufacturers six months of marketing exclusivity for a product in exchange for FDA-requested pediatric studies and reports to determine safe use of the products in children.

Some House members had sought to cut the exclusivity to three months, but that proposal ultimately was overridden.

Under the drug safety provisions in the bill, the FDA would have stronger authority to require labeling changes and to impose civil monetary penalties of up to $10 million for violators.

The legislation would require manufacturers to work with the FDA to develop risk-evaluation and mitigation strategies (REMS) before a drug is approved. The REMS are intended to help firms and regulators better assess post-marketing adverse-event reports and more efficiently communicate risk information to the public after a drug is approved.

The legislation also is giving the FDA the power to review television advertisements about drugs and biologics before the commercials are aired.

Currently, the FDA reviews commercials submitted on a voluntary basis before they air or warns advertisers when the agency becomes aware of false or misleading information in an advertisement that has already aired. However, those warnings generally come after the advertisement has appeared for several weeks.

The bill also includes a measure directing the FDA to establish an active post-market drug surveillance infrastructure.

The FDA's current system, the Adverse Event Reporting System, or AERS, relies on voluntary reports from clinicians and the public.

Regulators have acknowledged that AERS is overloaded and outdated.

The FDA legislation also would require all clinical trials on drugs, biologics and devices to be registered in a publicly accessible trial registry.

The public advocacy group Consumers Union called the clinical trials measure "one of the biggest consumer victories" in the bill.

"It will be harder for drug companies to fudge or hide the results of their clinical trials," said Bill Vaughan, senior policy analyst at Consumers Union.

The group noted in a statement this week that the passage of the FDA bill came nearly three years to the day after Vioxx was yanked suddenly from the market in September 2004.

Since the Vioxx debacle, regulators have been criticized by lawmakers and consumer groups for being too slow to warn the public about safety concerns about other nonsteroidal anti-inflammatory drugs, antidepressants and, most recently, GlaxoSmithKline plc's diabetes drug Avandia (rosiglitazone).

But Jim Greenwood, CEO of the Biotechnology Industry Organization, called lawmakers' criticism of the FDA an "overreaction" to some of the drug safety concerns "that really could have been very harmful to the industry" had earlier measures in the bill passed.

"We avoided some of the worst potential outcomes," he told BioWorld Today.

Greenwood praised lawmakers for passing the FDA bill before PDUFA expired.

"It was imperative to get this done," he said.

BIO, Greenwood said, was concerned that lawmakers would "jam" a measure into the bill that would create a regulatory pathway for FDA to approve follow-on biologics - authority the agency currently does not possess.

However, the House did not include the provision in the final FDA bill.

"All in all, I think it is a good outcome," Greenwood said, adding that BIO is "glad to have this long fight behind us so that we can move on to the next challenges."