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U.S. Regulator Criticized on Oversight of Heart Devices
By Barry Meier, The New York Times
Thursday, September 15, 2005
Two U.S. lawmakers have said they plan to increase their scrutiny of the way the Food and Drug Administration monitors the safety of critical medical devices like heart defibrillators and pacemakers once they are on the market.
The two, Senator Charles Grassley and Representative Edward Markey, issued separate statements on Wednesday criticizing what they described as the regulator's failure to alert the public to data it gets from makers of implantable heart devices about product problems.
Makers of defibrillators and pacemakers must file detailed reports with the agency annually showing why and how often those products fail. The reports, which the agency treats as confidential, contain far more comprehensive product safety information than the data that manufacturers provide to doctors.
The lawmakers' actions follow a New York Times report this week disclosing that the agency received a regular annual filing in February from Guidant, a maker of heart devices, showing that one of its widely used defibrillators was short-circuiting at the rate of about one unit a month. A month later, a young man who had a flawed device died of cardiac arrest.
A spokeswoman for the agency, Julie Zawisza, said on Wednesday that while the agency had a policy of reviewing within 90 days annual reports from makers of critical products like cardiac devices, she could not say what percentage of those reports actually were reviewed within that time because the agency did not track that data.
Also late Wednesday, the agency said it was reviewing, among other things, the way makers of critical medical devices filed their yearly reports.
"Guidance is being developed which will ensure that companies provide information about device failures and problems in a way that facilitates prompt, efficient review by FDA," it said. The agency did not go into details but said it was changing the way producers reported manufacturing fixes.
In May, The New York Times reported that Guidant had not told doctors for three years that one of its defibrillators, the Ventak Prizm 2 DR, had a manufacturing defect that made some units prone to short-circuiting. The company also continued to sell potentially flawed models even after it began making an improved version of the model in 2002.
After that article appeared, the food and drug agency began an investigation of Guidant that is continuing. In recent months, Guidant has issued recalls covering the Prizm 2 DR as well as tens of thousands of other defibrillators and pacemakers. Guidant executives have said that they did nothing wrong.
A defibrillator sends out an electrical jolt intended to interrupt a potentially fatal heart rhythm. A pacemaker regulates a heart that is beating too fast or too slowly.
Markey, a Massachusetts Democrat who serves on the House Energy and Commerce Committee, sent a letter on Wednesday to Lester Crawford, the agency commissioner, containing questions related to the way the agency reviewed product performance data in annual filings from makers of heart devices.
Grassley, the Iowa Republican who is chairman of the Senate Finance Committee, released a letter on Wednesday disclosing that members of his staff had held a meeting in mid-August with agency officials concerning the Guidant investigation. The release containing that letter also contained a request for internal Guidant documents.
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