The Food and Drug Administration ‘lacks a clear and effective process’ for monitoring the safety of drugs once they have been approved for marketing, and its powers should be extended to force drugmakers to carry out post-marketing clinical trials, according to the USA’s Government Accountability Office.
In a just-published report, the GAO maintains that the FDA “lacks clear and effective processes for making decisions about, and providing management oversight of, post-market safety issues.” It also points to a lack of transparency in how decisions are made, insufficient managerial oversight and disputes between the Office of New Drugs and the Office of Drug Safety, which comes under the OND’s jurisdiction.
The current structure causes a conflict of interest because officials who have previously deemed a new drug safe for marketing may be reluctant to reverse their decisions later, it is alleged.
At present, the FDA has no authority in law to force companies to complete post-marketing studies, but a bill that would give it this power has been introduced in the US Congress by Senators Chuck Grassley and Christopher Dodd.
This bill, which has been languishing in the Senate since last April, would give the FDA the power to order drugs off the market, require changes to warning labels without a lengthy negotiation process, and create a new department focused on drug safety and post-marketing surveillance of the new medicines.
The GAO report on the FDA’s approach to drug safety was made at the request of Senator Grassley and House Energy and Commerce Committee chairman Joe Barton, amid allegations that the FDA is tardy in removing potentially unsafe drugs, such as Merck & Co’s painkiller Vioxx (rofecoxib), from the marketplace. Vioxx was withdrawn in 2004 after it was linked to an increased risk of heart attack and stroke.
Tthe FDA recently launched its own internal investigation into its handling of post-marketing studies, also known as Phase IV testing. This probe, conducted by independent audit firm Booz Allen Hamilton, got underway earlier this month and is expected to take around a year to complete. The agency is also participating in an Institute of Medicine investigation of its safety monitoring activities, with a verdict due in July.
In its report, the GAO recommends that the FDA “systematically track post-market drug safety issues, revise and implement its draft policy on major post-market safety decisions, improve the dispute resolution process, and clarify the ODS’ role in scientific advisory committees.”
The FDA said that the GAO’s conclusions, seen in draft form, were reasonable, but the agency has not yet delivered a public statement on the recommendations made in the final document.
At a press conference to release the results of the GAO report, Grassley said the report would add some momentum to his bill, which would increase transparency at the FDA. The agency is under-funded and “lacking in independence [and] decision-making responsibility,” he maintained.
If the Grassley/Dodd bill goes through, the new independent regulatory body, provisionally called the Drug Safety Board, would have the power to stop the drug development process at any time, and demand additional safety studies once a medicine was already on the market.
But opponents of the bill maintain that demanding larger and more complex post-marketing studies runs counter to the FDA’s efforts to streamline clinical research, through the widespread use of predictive biomarkers and measures such as the new Critical Path initiative, which aims to develop and use tools to identify unsafe drugs at the earliest possible stage of preclinical or clinical development.