Scientists who have worked at the FDA and criticized agency decisions are now helping Congress fashion legislation to tighten product-safety rules.
The scientists include David Ross, who said in an interview that FDA supervisors forced him to retract a recommendation that the antibiotic Ketek, made by Sanofi-Aventis, was probably too dangerous to be used for treating two common respiratory infections. The drug was approved in 2004 and had $148 million in sales in 2005.
Ross is one of four current or former employees of the FDA who are working with Congress on bills intended to create more stringent drug safety rules. One change being proposed would create a new office to monitor the safety record of drugs after they're on the market. Next week, several of the critics may describe their concerns at a congressional hearing on the FDA.
``I felt like if I didn't do something and people got hurt, I wouldn't be able to stand it,'' said Ross, 48, who worked at the FDA for a decade before resigning in November. ``I'm getting a chance to say what the problems are, and I'm getting a chance to fix them.''
Legislation proposed by Senators Charles Grassley, an Iowa Republican; Edward Kennedy, a Massachusetts Democrat; and other lawmakers would give the FDA greater authority to restrict the use of drugs with side effects and require the registration of drug-company clinical trials.
More at Bloomberg
The scientists include David Ross, who said in an interview that FDA supervisors forced him to retract a recommendation that the antibiotic Ketek, made by Sanofi-Aventis, was probably too dangerous to be used for treating two common respiratory infections. The drug was approved in 2004 and had $148 million in sales in 2005.
Ross is one of four current or former employees of the FDA who are working with Congress on bills intended to create more stringent drug safety rules. One change being proposed would create a new office to monitor the safety record of drugs after they're on the market. Next week, several of the critics may describe their concerns at a congressional hearing on the FDA.
``I felt like if I didn't do something and people got hurt, I wouldn't be able to stand it,'' said Ross, 48, who worked at the FDA for a decade before resigning in November. ``I'm getting a chance to say what the problems are, and I'm getting a chance to fix them.''
Legislation proposed by Senators Charles Grassley, an Iowa Republican; Edward Kennedy, a Massachusetts Democrat; and other lawmakers would give the FDA greater authority to restrict the use of drugs with side effects and require the registration of drug-company clinical trials.
More at Bloomberg
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