Washington: US House of Representatives has passed a bill that provides greater flexibility in inspection of overseas drugs manufacturing facilities in countries like India and China that are approved by the US drug authority.
The bill now goes to the Senate, which is expected to vote on it next week, after which it would head to the White House for the President to sign into law.
Under the bill, the Federal Drug Administration (FDA) would have more flexibility to inspect US drugs manufactured in overseas facilities.
Of late more such facilities have opened in countries like India and China as the number of US drugs being manufactured overseas has doubled in the last decade.
"This is a jobs bill, and it's a medical innovation bill. And as we put this package together, our goal was to improve the predictability, consistency, transparency, and efficiency of FDA regulation," said the House Energy and Commerce Committee Chairman Fred Upton, in his remarks on the floor of the House.
"These reforms will help get new treatments to patients more quickly. They will help us not only keep jobs in Michigan and all across the country, but also to create new ones.
"In order to get it right, we turned to patients, innovators, and job creators who provided firsthand experience of how the current system is broken," he said.
The bill also includes provisions to modernise FDA's authorities with respect to the drug supply chain.
Congressman Henry Waxman said currently 80 percent of active ingredients and bulk chemicals used in US drugs comes from abroad and 40 percent of finished drugs are manufactured abroad.
"FDA has been trying to keep pace with this increasingly globalised drug supply change using an outdated statute. This legislation will give the FDA critical new tools to police this dramatically different marketplace," he said.
The legislation renews the user fee by drug companies to FDA, which will fetch the federal drug agency USD 6.4 billion in the next five years.
And for the first time the FDA would collect user fee from generic drug manufacturing companies.
"The bill before us Thursday provides the FDA with more than USD 6 billion over 5 years to pay for the timely and efficient reviews of medical products. Together, these agreements will ensure that Americans have access to safe and effective new medicines and medical devices," Congressman Frank Pallone said.
"It will reduce the drug costs for consumers by speeding the approval of lower cost generic drugs with the establishment of a new user fee programme for generic drugs and for lower cost versions of biotech drugs as well," he said.
The bill, Pallone said, also includes promising provisions that address the safety of the supply chain, help to foster the development and safe use of prescription drugs for children, increase efforts to address drug shortages, change conflict of interest rules so that the FDA has access to the best expertise on their advisory panels, and other provisions which are important to the pubic health of the US.
First Published: Friday, June 22, 2012, 00:39