Patient-safety advocates greeted a new law giving the Food and Drug Administration broader drug-safety authority with underwhelming support, saying the law doesnt go nearly far enough in actually promoting safe, effective drug use.
The new law, signed Sept. 27 by President Bush, allows the FDA to collect more fees from the companies it regulates to offset the costs of creating a clinical data-results registry and to increase focus on post-market drug surveillance in addition to monitoring drugs in development. The law also poses higher monetary penaltiesfrom $250,000 up to $10 millionon pharmaceutical companies that do not comply with data reporting regulations or with increased and timely side-effect warnings on their drugs.
But some are questioning if the law has teeth. Steve Nissen, chair of the Cleveland Clinics Cardiovascular Medicine Department, said the law is a good step forward, but he has modest expectations of both the law ensuring that drug companies comply with reporting requirements and of the FDA exercising its authority to force compliance.
This is a work in progress, said Nissen, who served as a medical adviser as legislators hammered out the bill on Capitol Hill. The law wont be enough to compel changethat starts with the leadership and culture of the FDA, and therein lies the problem, he said. Its the lack of authority and the lack of willingness to use the authority it does have that has created trouble for the FDA, Nissen said.
In September 2006 the Institute of Medicine issued a report that criticized the FDAs management and regulatory authority. The IOM stated that the FDA lacked clear, unambiguous authority and called for several improvements communicating adverse drug events to the public in addition to better drug monitoring.
The FDA responded to the IOM with its own report in February with plans for change (Feb. 5, p. 6).
The IOM report also recommended the FDA receive funding from federal appropriations, instead of user fees from the companies regulated through the authority to support increased drug surveillance. That, however, did not make it into the final legislation, which allows the FDA to collect at least $393 million annually from drug companies and $287 million by 2012 from medical-device manufacturers. The increased user fees will account for nearly a quarter of the FDAs budget, Randall Lutter, deputy commissioner for policy, said during a news conference.
Nissen, who advocated for funding to come from the U.S. Treasury rather than higher user fees, said collecting fees from companies that are regulated creates a conflict of interest. In addition, Nissen is not convinced the FDA will flex its new muscle, despite the increased funding.
Similarly, Leonard Lamkin, executive director of the Chicago Patient Safety Forum, an advocacy group, called the legislation a piece of the puzzle, but said there should be a stronger stick than just financial penalties. Theres no clout, Lamkin said of the FDAs power to penalize noncompliance. Were tinkering with the system rather than going in and overhauling it.
In order for the FDA to offer patients transparent drug-effect information, it needs to develop an easily accessible database where drugs and clinical results are clearly listed, instead of relying on its current MedWatch data repository, which uses self-reported information from pharmaceutical companies.
Calling MedWatch only one step up from useless, Nissen said the system does a good job of spotting clusters of adverse events, but added the FDA must explore the use of other data collection technology to create more meaningful analysis.
What the legislation does, and what IOM recommended in its report, is change the focus from getting drugs to market in quick turnaround, to ensuring new drugs are safe for patients while reviewing the continued safety of current drugs, and that in itself is a big shift, advocates agreed.
The FDA also will expand its existing clinical trials database and possibly create a new one.
The law also calls for establishing an independent, not-for-profit foundation, which will be named the Reagan-Udall Foundation, to identify and set priorities for unmet research needs involving FDA projects while forming partnerships with scientists outside the agency.
The greater amount of post-market surveillance will help patients better understand their choices, said Diane Pinakiewicz, president of the National Patient Safety Foundation, an advocacy group.
And despite a five-month lag in responding to the IOM report, the FDA did take those recommendations seriously and is implementing internal changes without waiting for federal oversight, according to agency officials.
The agency last week announced a program to streamline the generic-drug approval process, which allows it to hire review staff and work toward ensuring generic alternatives to brand-name drugs reach consumers faster.
The FDA also has awarded a two-year, $1.5 million contract to a consultancy, the Center for Professional Development, to help transform the agencys Center for Drug Evaluation and Research in leadership, empowerment and effective business practices.