New U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg says she is working toward earlier safety warnings to doctors as well as resolving some of the issues with the agency’s medical device division, reports The Wall Street Journal.
“There obviously have been some problems,” said Dr. Hamburg in an interview discussing the agency’s Center for Devices and Radiological Health, calling it “a high priority,” quoted the Journal. At the time President Obama named Dr. Hamburg as his pick to head the FDA, she announced plans to overhaul the ailing agency and restore confidence in the FDA, said the Journal previously.
The agency—responsible to ensure drugs, medical devices and products, some human and animal food products, cosmetics, and other consumer goods are safe to Americans—has been widely faulted for all manner of problems, including that had no permanent commissioner for the majority of former President Bush’s eight-year term.
Under the former administration, the FDA was accused of letting politics minimize science and, it was during that time, that some of the most notorious drug safety and food borne illness outbreaks and recalls originated, such as Medtronic Sprint defibrillator leads, Baxter infusion pumps, faulty heart stents, and squeaky hip replacements. In addition to countless drug and medical device recalls, there have been issues with toxic ingredients in consumer products, controversies over physician and researcher gifting by industry, inappropriate medical devices and medication marketing, and a system rife with corruption.
Former FDA Commissioner David Kessler described the device center as “dysfunctional,” and “in meltdown,” noting that he has spoken with Dr. Hamburg, said the Journal.
When President Barack Obama’s transition team was readying for office, some FDA scientists wrote begging for help, outlining a number of problems with an agency they described as “fundamentally broken,” according to an earlier Journal report. The group asked for restructuring and noted that, in addition to other ethical fiascos, FDA managers “ordered, intimidated, and coerced scientists to manipulate data in violation of the law,” the Journal said. “There is an atmosphere at FDA in which the honest employee fears the dishonest employee,” the Journal quoted, and noted that the letter gave specifics on details such as how scientists who differed in opinion from management were threatened with disciplinary action and that FDA’s regulation of medical devices was “corrupted and distorted by current FDA managers, thereby placing the American people at risk.”
Dr. Hamburg announced that she will look at the “division’s decision-making and” a fast-track “approval process for devices called 510(k),” said the Journal. Some devices, said scientists with the agency, have received 510(k) approval, but called for additional safety and efficacy information, explained the Journal. Industry disagrees, saying changes to the approval process could delay medical devices reaching patients, said the Journal, noting that the medical device sector represents a nearly $200 billion industry.
Earlier this year we reported that, according to the Project on Government Oversight, the Center for Devices and Radiological Health allows manufacturers and testing facilities to monitor their own compliance with federal regulations meant to ensure the safety of medical devices and that the FDA ignored federal Good Laboratory Practice regulations, a decision it called” stunning in its contempt for the protection of patients and its indifference to standards that comply with federal regulations.” Just prior, the Government Accountability Office issued a report that criticized the agency for failing to conduct appropriate medical device reviews.
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