The Food and Drug Administration took issue with a series of draft bills on drug safety that the House Energy and Commerce health subcommittee is planning to mark up on Thursday.
Scheduled for consideration are bills to reauthorize the Prescription Drug User Fee Act and Medical Device User Fee and Modernization Act, a drug-safety bill, and several pediatric pharmaceutical and device bills.
Testifying before the health panel today, Randall Lutter, the FDA's deputy commissioner for policy and planning, said the agency was disappointed that the draft of the medical device user act didn't include modifications to the third-party inspection program.
The FDA has found significant problems with this program, and "a more robust third-party program would permit FDA to focus its resources on establishments and products posing the greatest risk to public health," he said.
In his opening statement, health subcommittee Chairman Frank Pallone (D-N.J.) said he didn't think changes were necessary to improve participation in the program. The draft of the prescription drug act authorizes an additional $225 million in user fees that would be used mainly for post-market safety activities. The proposal places the prescription drug act on a solid financial footing, Lutter said.
However, a proposal in the draft to fund new drug-safety activities with user fees may be inadequate, Lutter said. In addition, proposed requirements for risk evaluation and mitigation strategies in the draft drug-safety bill would be "unnecessarily burdensome," and would duplicate elements of the adverse event reporting system already required by the FDA, Lutter said. The full Energy and Commerce Committee is scheduled to mark up the bills sometime next week. -- by Jennifer Lubell