House votes to give FDA more power
The House of Representatives has overwhelmingly passed legislation that is expected to give the federal drug regulators significantly more money and power to ensure the safety of the nation’s drug supply, as reported in The New York Times.
After an all-night negotiating session, the House passed it 405 to 7. The bill grants the agency the power to require drug makers to undertake clinical trials of medicines that the agency has already approved and to fine those who refuse, which can be used to finance the agency’s operations, according to The Times.
The House also voted to reauthorize the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA). The two programs review the safety and efficacy of drugs and account for nearly one quarter of the FDA's annual budget.
In a statement issued on the FDA website, Andrew von Eschenbach, FDA Commissioner, applauded the actions of the Congress. “These programs are vitally important to the agency and its continued ability to protect and promote the public health. We look forward to working toward implementation of this legislation,” he said.
The bill is expected to quickly pass through the Senate and be signed into law by the President, in order to prevent dismissal notices for some 2,000 employees of the FDA.
After an all-night negotiating session, the House passed it 405 to 7. The bill grants the agency the power to require drug makers to undertake clinical trials of medicines that the agency has already approved and to fine those who refuse, which can be used to finance the agency’s operations, according to The Times.
The House also voted to reauthorize the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA). The two programs review the safety and efficacy of drugs and account for nearly one quarter of the FDA's annual budget.
In a statement issued on the FDA website, Andrew von Eschenbach, FDA Commissioner, applauded the actions of the Congress. “These programs are vitally important to the agency and its continued ability to protect and promote the public health. We look forward to working toward implementation of this legislation,” he said.
The bill is expected to quickly pass through the Senate and be signed into law by the President, in order to prevent dismissal notices for some 2,000 employees of the FDA.