By Lisa Seachrist
WASHINGTON — The process by which regulated industries, advocacy groups and ordinary citizens can air their grievances to the FDA has caused such an administrative backlog that the agency is readying plans to alter the procedure.
An FDA source told BioWorld Today that the agency is looking to find a more cost-effective and less time-consuming means to address the concerns raised in the petitions. The agency will announce its planned changes in the next couple of weeks. Agency stakeholders have serious concerns that changes in the process could ultimately cost more, while severely limiting public comment to the agency.
"We believe that the general procedure works and it works quite well," said Jeff Trewhitt, media spokesperson for the Pharmaceutical Research and Manufacturers of America (PhRMA). "Basically, if it ain't broke, don't fix it."
The citizens' petition process creates a forum for debate within the agency, allowing stakeholders — whether industry or patient groups — to air their viewpoints. The process allows the agency to see the broad picture, which often includes competing interests. It also provides grassroots groups with one of their few means of communicating with the agency.
Much of the concern surrounding the increasing workload of the citizens' petition process is that individual pharmaceutical companies are abusing it to prevent generic competitors from entering the market. However, PhRMA took an informal look at the citizen petitions filed with the agency since 1990 and found that, of those concerning drugs and biologics, 45 came from the generic industry and 48 came from the brand-name industry, while 75 were filed by consumer advocacy groups.
"With 168 petitions since 1990, we don't see the process as bogged down," Trewhitt said. "The citizens' petition is a major avenue of communication for these consumer groups. [Does the FDA] really want to cut them off?"
The agency ultimately agreed with one-third of the citizens' petitions filed by industry, Trewhitt said. "Obviously, there are vested interests on both sides, but when the agency agrees with the petitioner more than one-third of the time, that indicates that these aren't frivolous filings," he said.
Petitions Often Prevent Litigation
More importantly, the petition may also serve to avoid litigation between the agency and the regulated industry. PhRMA claims that, in a significant number of cases, the party filing a citizen petition is signaling a belief that there are issues important enough to pursue in the court system, and the petition process often obviates the need for judicial review.
Even when it doesn't do that, Trewhitt noted, the petition process serves as an administrative record for any judicial review of agency decisions. With only a limited version of the petition in place, the agency would need to spend the time and the money to create that record.
"Any savings that the agency sees from changing the citizen petition procedure may just be money spent in lawsuits later," Trewhitt said.
A source at the agency said the FDA intends to reply to PhRMA's concerns in early December, and may propose the new rules shortly thereafter. *