By Lisa Seachrist
WASHINGTON — Nearly a year after passing FDA reform into law, the House Commerce Committee checked in with the agency and industry on Wednesday to make sure both the spirit and the letter of FDA changes were finding their way into the agency's efforts to implement the law.
Overall, the committee seemed pleased with the outcomes of the legislation that saw two years of rancorous, partisan debate in the 104th Congress before the legislators could use the Prescription Drug User Fee Act as a lever to pass the FDA Modernization Act of 1997 (FDAMA).
"I believe this legislation is one of the most notable achievements of this committee since I became chairman of this committee in 1995," Rep. Tom Bliley (R-Va.) said in his statement. "I am proud of what the committee and the Congress did in identifying problems and setting out solutions that do not compromise quality, but that do put patients first. I am pleased that FDA has, in large measure, followed this map and has proceeded to implement the law consistent with our goals."
Acting FDA Commissioner Michael Friedman assured the committee that "unequivocally, the agency has made an effort to follow the letter and the spirit of this legislation."
Nevertheless, committee members had concerns over the slowness in implementing incentives for pediatric drug testing, the guidance issued for dissemination of medical information, and the lack of guidance documents for the fast-track program.
In crafting the language of FDAMA, Congress required FDA to issue 17 regulations, 11 guidance documents, six notices and nine reports. Friedman pointed out that to date, FDA has issued a total of 9 final rules, two proposed rules, 28 guidance documents, 10 notices and one report.
The agency is under the gun to submit a guidance for industry on the fast-track program. FDA reform requires that guidance to be published in the Federal Register by Nov. 21, 1998, the one-year anniversary of the passage of FDAMA.
"We are working very hard to hit that deadline," said Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER). "We have a draft that we are working on. We are planning on releasing that document within the statutory time frame."
Bliley asked why so little progress has been made in implementing the incentives for testing drugs for use in children. Friedman said the agency can not simply request clinical studies in children. Instead, the FDA has to determine which protocols would give the desired dosage information in children.
William Schultz, deputy commissioner for policy, said the agency is "lacking the resources to move with more speed on this issue. We've concentrated our efforts on those provisions with statutory deadlines."
Friedman told the committee that some estimates indicate that the cost of FDA reform come to $50 million, yet the agency has received no additional resources.
Several members of the committee took issue with the proposed rule the agency published in the Federal Register on June 8 to describe the appropriate types of off-label information a drug company may provide. The Biotechnology Industry Organization (BIO) has identified this provision as the only one not consistent with FDAMA.
Rule On Off-Label Information Coming Next Month
Friedman said in his testimony that the agency held an open public meeting on July 8 to address concerns over the document, and had a comment period, which ended on July 23. Friedman said the agency is evaluating that input and plans to issue a final rule by Nov. 21.
BIO, in written testimony, noted that an August decision by Judge Royce Lamberth in U.S. District Court has complicated this issue by striking down the agency's current dissemination policy. BIO urged Congress to monitor the implementation of this provision.
Several consumer groups have complained that FDAMA has so weakened the FDA that dangerous drugs are making it to market, only to be pulled when they are proven to have deadly side effects. Several members of the committee asked whether FDAMA had indeed forced the agency to focus on "speed rather than safety."
Friedman said the issue is more of standards than speed. "We have not lowered our standards one iota," he said. "Every new product that gets added to the pharmacopoeia results in one more drug that can interact with other drugs. The burden for us is to follow those adverse events closely." *