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In Washington this month, administration scandals proliferate as newly empowered committee chairs brandish their subpoena powers, presidential candidates vie for support, and federal health care agencies-as always-go about their business.
The FDA has also announced it is beginning a safety review of over-the-counter cough and cold remedies marketed to children, with special concern for products labeled for use in children under 2 years of age. Most of the ingredients in these remedies were approved by the FDA years ago, at a time when safety standards were not as strict as they have since become.
The FDA has also taken action against the numerous criticisms of biased advisory committees.
Under newly proposed guidance, advisors who received money from a pharmaceutical or device manufacturer might be unable to cast a vote regarding approval of that company's products. Furthermore, any doctor who receives more than $50,000 from a company might not be able to even serve on the committee that discusses the company's product, or competing products.
The FDA's advisory panels took criticism after drugs such as Vioxx were approved by board members with financial ties to drugmaker Merck. When Vioxx was pulled from the market as a result of causing heart attacks in many patients, the advisory panel's actions were called into question.
"FDA is committed to making the advisory committee process more rigorous and transparent so that the public has confidence in the integrity of the recommendations made by its advisory committees," said Randall Lutter, PhD, FDA's acting deputy commissioner for policy.