House Committee passes prescription drug user fee act reauthorization legislation

The House Energy and Commerce Committee on Thursday voted 39-0 to approve nine bills that would expand FDA's authority to regulate prescription drug safety and increase user fees paid by drug and medical device companies, Dow Jones reports.

The legislation would reauthorize the Prescription Drug User Fee Act, which expires Sept. 30. The committee also voted to combine the bills into one omnibus measure (Corbett Dooren, Dow Jones, 6/21).

The legislation would grant FDA the authority to take major actions -- if deemed necessary -- against drug manufacturers, including requiring safety studies, limiting distribution of certain prescription drugs and ordering label changes. FDA would have the authority to decide which new drugs should be required to enter into postmarket risk-mitigation plans and would allow pre-review of direct-to-consumer advertisements by FDA. The agency would have the authority to recommend changes after review of the ads and could require disclosures in an ad to prevent it from being false or misleading.

Funding
FDA has proposed collecting $393 million from drug companies in 2008. The House version of the measure calls for an additional $225 million in fees from drug makers over five years, and the Senate version of the legislation (S 1082), approved last month, calls for an additional $50 million. Much of the additional money would be used to fund drug-safety monitoring programs. Both the House and Senate versions would allow FDA to collect $287 million over five years in fees from medical device manufacturers (Kaiser Daily Health Policy Report, 6/20).

An amendment to the bill, offered by Rep. Nathan Deal (R-Ga.), would lower the request for additional user fees if Congress appropriates more funding for drug safety provisions (Edney, CongressDaily, 6/22). However, appropriations from Congress are "unlikely in an era of tight budgets," Dow Jones reports (Dow Jones, 6/21). House Energy and Commerce Health Subcommittee Chair Frank Pallone (D-N.J.) said, "Practically thinking, and maybe I'm being a cynic, but I don't think there are going to be any appropriations" (CongressDaily, 6/22).

Fines
The committee also amended the omnibus measure to reduce the total amount FDA would be able to fine drug companies for violations (CQ Today, 6/21). The fines apply to postmarket studies, labeling changes and risk mitigation strategies, including restrictions and specific disclosures in DTC advertising (CongressDaily, 6/22). In the subcommittee's draft, FDA would have been able to fine companies up to $20 million for a single violation and up to $100 million for several violations.

The full committee reduced the fines to up to $250,000 for a single violation and up to $1 million for several violations. If a violation continues after a company has received notice from FDA, the company could be fined a maximum of $10 million for one violation or a maximum of $50 million for several violations, according to the amended legislation (CQ Today, 6/21).

Additional Amendments
A separate amendment to the legislation, offered by Rep. Bart Stupak (D-Mich.), would create safety goals for the agency, including requiring that FDA report to Congress if the agency does not accept a recommendation from a safety reviewer (CongressDaily, 6/22).

An amendment offered by Rep. Jay Inslee (D-Wash.) also was added to the measure that would lift a limit on the number of times a private inspector can be hired by the same company for medical device manufacturing plant inspections. The limit was intended to "prevent inspectors from returning positive inspections to get repeat business," according to CQ Today.

In addition, a manager's amendment would create a "unique identifier number" for all medical devices, which would allow FDA and health care providers to improve tracking of devices for malfunctions and safety (CQ Today, 6/21). The full House is expected to vote on the measure in July, after which it will be sent to conference committee to resolve differences with the Senate version of the legislation (Wall Street Journal, 6/22).