ROCKVILLE, Md. - Some industry representatives believe that if the FDA forces inconsistent rules and regulations on biologics' manufacturers, then the cost of producing breakthrough drugs will be even higher than it is today.
In an effort to find out what it's doing right and wrong in the manufacturing inspections process, FDA officials invited interested parties to a public hearing Wednesday to offer advice and feedback on the inspections approach referred to as "team biologics."
About 50 people showed up to listen as industry organizations and patient advocacy groups described successes, failures and real-life business situations impacted by government regulations.
"Nobody likes to be inspected but everyone knows that there should be a system of checks and balances," said Russell Madsen, senior vice president of science and technology at the Parenteral Drug Association in Bethesda, Md. "Some investigators appear to focus on building a case rather than objectively analyzing the facts of a situation. Inspection outcomes are often the result of how an individual interprets the good manufacturing practices."
Madsen addressed officials from the FDA's Center for Biologics Evaluation and Research (CBER) and the Office of Regulatory Affairs. Together, the organizations developed "team biologics" - groups of inspectors and investigators who examine blood and biologics manufacturing facilities (twice a year if possible). Wednesday's hearing was the outgrowth of the FDA's sweeping overhaul of manufacturing inspections process announced last August. (See BioWorld Today, Aug. 23, 2002.)
Even though the government requires dialogue with the industry and public, Richard Lewis, deputy director of CBER's Office of Blood Research and Review, commented, "We set up the public hearing because we wanted to find a way to evaluate ourselves."
Problems with inconsistent decisions made by inspectors have been raised before, and, as in the past, Madsen suggested better education and training of the employees.
But that's not the only problem. Madsen said he's heard complaints about FDA officials showing up for inspections without having read the biologics license application, therefore having no knowledge of the drug or the agreements between the company and CBER.
"I've had manufacturers say the inspectors have walked in and asked, What's the name of the drug we're looking at?'" he said.
The FDA pressed Madsen for a number on the amount of complaints he'd received. While Madsen couldn't pull a number out of his hat, he indicated that it was more than one.
He recommended the FDA consider an oversight program for investigators and a dispute resolution program for the companies.
Representatives of patients asked the agency to consider better ways of communicating with the public.
Miriam O'Day, the Immune Deficiency Foundation's special adviser for public policy, asked the agency to write an explanation of policy in lay terms for the general public. "It's very scary when you hear of a recall or that a facility has been shut down for compliance issues," she said. "A lay section on your web site would be helpful for some of these plasma users."
When an FDA official responded by saying the agency has such information on the Internet, Shannon Penberthy, senior director at Washington-based MARC Associates Inc., who spoke on behalf of the New York-based National Hemophilia Foundation, said oftentimes it's difficult to locate information on the FDA web site, and "even if you can find it, you may not understand it."
The FDA is accepting written and electronic comments on the effectiveness of team biologics until June 10. Written comments should be sent to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Md., 20852. Electronic comments can be sent to http://www.fda.gov/dockets/ecomments.