CQ TODAY ONLINE NEWS
June 18, 2012 – 11:13 p.m.
Agreement Reached on User Fee Bill
By Emily Ethridge, CQ Staff
House and Senate leaders announced a bipartisan deal Monday on a five-year reauthorization of the Food and Drug Administration’s user fee programs, hoping the chambers will clear the negotiated agreement by the end of the month.
The House is expected to vote on the new text, added as an amendment to the Senate measure (
“I hope that the House and Senate will act to approve it soon, so we can send it to the president for his signature without delay,” said Sen.
The agreement takes elements from both bills, which each won broad support in their respective chambers. But certain provisions, including a national drug tracking and tracing system sought by some groups to improve safety of prescriptions throughout the supply chain, were left out of the final deal.
The leading industry group, the Pharmaceutical Research and Manufacturers of America (PhRMA), backed the agreement in a written statement but noted the absence of any language addressing the tracking and tracing issue.
“Protecting American patients from counterfeit and adulterated medicines is a public policy priority for PhRMA, Congress, FDA and a multitude of stakeholders, and we commend Congress’ efforts to address this issue,” the group’s CEO, John J. Castellani, said.
Quicker Generics Approval
The bill includes language from the House measure that would reduce the amount of time the FDA has to make administrative decisions in hopes of getting cheaper generic drugs to market more quickly, which the Congressional Budget Office said would reduce government spending. It would give the agency 150 days, rather than 180, to respond to citizen petitions requesting a stay on pending generic applications, including those for generic biologic drugs.
The bill also would set a time limit of 270 days for the agency to respond to petitions related to generic drug approval. Currently, the FDA does not have a time frame for responding to petitions after the agency denies a generic drug application because its original reference drug was withdrawn for safety or effectiveness reasons.
The negotiated measure does not contain language from the Senate bill that would have earned savings by prohibiting brand-name companies with a Risk Evaluation and Mitigation Strategy from denying samples of their drugs to generic companies.
In addition, it would require the FDA to withdraw its guidance documents on when companies must notify the agency of modifications made to medical devices and prevent any new guidance from being issued until the agency turns in a report to Congress. That provision was included in the House bill.
But the negotiated version includes language from the Senate bill that would allow the agency to stop a clinical trial of a device if it determines that the device poses an unreasonable risk to subjects’ safety.
Senate negotiators also won a limitation on which antibiotics will qualify for an additional five years of marketing exclusivity. Under the negotiated measure, new products that treat serious or life-threatening conditions will receive the incentive, whereas the House bill would have given it to antibiotics used to treat conditions for which the agency determined new treatments were needed.
Agreement Reached on User Fee Bill
The bill contains several provisions to combat prescription drug shortages, including requiring the secretary of Health and Human Services to maintain a publicly available, updated list of all drugs experiencing shortages.
In addition, it would require HHS, within 18 months, to collaborate with other agencies and publicly post a proposed strategy for regulating health-related applications on mobile devices, as proposed in the House bill. A July 2011 draft guidance on apps caused consternation in the industry.
The bill would reauthorize for five years the FDA’s ability to collect user fees for its prescription drugs and medical device approval process. It also would create two new user fee programs, one for generic drugs and the other for generic biologic drugs. The current reauthorization (PL 110-85) expires Sept. 30.