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FDA reform plan edges closer to realisation
World Report
FDA reform plan edges closer to realisation A bill that gives the US Food and Drug Administration much new heft in addressing drug shortages and drug and device approvals has cleared House vote. Vivien Marx reports.
www.thelancet.com Vol 379 June 9, 2012
paid in the past 5-year stretch of user fees. Around $1·6 billion would stem from new fees from generic drug manufacturers. While requiring fees from traditional pharmaceutical companies, drug manufacturers, and device makers is not new, the reform legislation institutes fees for generic drug makers for the first time.
“The bill passed by the House requires drug companies to quickly report drug shortages...” According to a Congressional Budget Office estimate, the user-fee programmes will reduce the federal deficit over a 10-year period by $247 million in the 2013–22 period and $72 million in the 2013–17 timeframe. User fees were first put in place at the FDA in 1992 and are provisions that must be renewed every 5 years. The current term is set to expire at the end of September. The funds will allow the FDA to hire additional scientists to help with the drug and device safety review process. The bill passed by the House requires drug companies to quickly report drug shortages to the government. In the past, manufacturers have had problems producing cancer drugs and anaesthetics, leading to shortages across the USA. Federal officials must act in the case of shortages to assure ample supply from other sources. Much behind the scenes wrangling, which extended from policy makers to industry, accompanied the evolution of these bills, which changes the process of drug and device approval at the FDA. Industry has been lobbying extensively for a more transparent evaluation and approval process for drugs and medical devices. The two bill versions are not identical but
have many elements in common. For example, both bills mandate that drug companies inform the FDA if drug shortages loom but differ in approaches to tracking drugs to curtail counterfeiting. The House legislation addresses tainted drugs by giving the FDA more power to inspect not only US factories but also manufacturing and packaging plants anywhere in the world. Drug companies are also supposed to police their suppliers more intently. According to one estimate, around 80% of the ingredients in drugs sold in the USA are made in India and China. The House bill also increases the penalty for drug counterfeiting from a 3-year to a 20-year prison sentence, which could be brought to bear in a case under investigation about a fake version of the cancer drug Avastin that reached the USA in February from Turkey with middlemen in Egypt Switzerland, Denmark, and the UK. In April, another fake Avastin batch reached the USA also from Turkey through the UK wholesaler Richard’s Pharma—a case which the UK’s Medicines and Healthcare products Regulatory Agency is investigating.
For more on the Senate bill http://www.help.senate.gov/ newsroom/press/ release/?id=e1bfeed3-75b84945-81bdFor the Congressional Budget Office report see http://www. cbo.gov/publication/43268
Vivien Marx
Manuel Balce Ceneta/AP/Press Association Images
In a 387–5 vote, the US House of Representatives in Washington, DC, passed its version of the Food and Drug Administration (FDA) Reform Act last week. “This vote signals support for innovation and access to safe and effective medical products”, FDA Commissioner Margaret Hamburg said in a statement after the House vote. Unlike the country’s previous budget squabbles, the Democrats and Republicans cooperated to pass the House bill, which is similar to the one that sailed through the US Senate the week before the House vote. Chairman Tom Harkin, a Democrat, and Ranking Member Mike Enzi, a Republican, of the Senate Health, Education, Labor and Pensions Committee, issued a joint statement lauding how the Senate bill overcame “election year politics and partisanship”. Now the two bills are headed to conference to align them, which is expected to be an easy process. According to House leaders, agreement could come together in a final bill before the July 4 congressional recess. The bill modifies the FDA’s regulation of drugs and devices in a broad range of areas. It renews mandated user fees for companies to accelerate evaluation of drugs and devices through the FDA and also adds new fees; requires companies to inform the FDA of looming drug shortages; changes the market entry timing for lower-priced generic drugs and biosimilars; sharpens punishment for drug counterfeiting; and gives the FDA authority to inspect manufacturing facilities outside the USA. Both bills, the House and Senate versions, are slated to bring US$6·4 billion from user fees into FDA coffers over 5 years, beginning in 2013. Around $4·1 billion will come from brand-name drug makers, which is 6% more than they have
FDA commissioner Margaret Hamburg welcomed the latest vote on the Reform Act
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FDA reform plan edges closer to realisation A bill that gives the US Food and Drug Administration much new heft in addressing drug shortages and drug and device approvals has cleared House vote. Vivien Marx reports.
www.thelancet.com Vol 379 June 9, 2012
paid in the past 5-year stretch of user fees. Around $1·6 billion would stem from new fees from generic drug manufacturers. While requiring fees from traditional pharmaceutical companies, drug manufacturers, and device makers is not new, the reform legislation institutes fees for generic drug makers for the first time.
“The bill passed by the House requires drug companies to quickly report drug shortages...” According to a Congressional Budget Office estimate, the user-fee programmes will reduce the federal deficit over a 10-year period by $247 million in the 2013–22 period and $72 million in the 2013–17 timeframe. User fees were first put in place at the FDA in 1992 and are provisions that must be renewed every 5 years. The current term is set to expire at the end of September. The funds will allow the FDA to hire additional scientists to help with the drug and device safety review process. The bill passed by the House requires drug companies to quickly report drug shortages to the government. In the past, manufacturers have had problems producing cancer drugs and anaesthetics, leading to shortages across the USA. Federal officials must act in the case of shortages to assure ample supply from other sources. Much behind the scenes wrangling, which extended from policy makers to industry, accompanied the evolution of these bills, which changes the process of drug and device approval at the FDA. Industry has been lobbying extensively for a more transparent evaluation and approval process for drugs and medical devices. The two bill versions are not identical but
have many elements in common. For example, both bills mandate that drug companies inform the FDA if drug shortages loom but differ in approaches to tracking drugs to curtail counterfeiting. The House legislation addresses tainted drugs by giving the FDA more power to inspect not only US factories but also manufacturing and packaging plants anywhere in the world. Drug companies are also supposed to police their suppliers more intently. According to one estimate, around 80% of the ingredients in drugs sold in the USA are made in India and China. The House bill also increases the penalty for drug counterfeiting from a 3-year to a 20-year prison sentence, which could be brought to bear in a case under investigation about a fake version of the cancer drug Avastin that reached the USA in February from Turkey with middlemen in Egypt Switzerland, Denmark, and the UK. In April, another fake Avastin batch reached the USA also from Turkey through the UK wholesaler Richard’s Pharma—a case which the UK’s Medicines and Healthcare products Regulatory Agency is investigating.
For more on the Senate bill http://www.help.senate.gov/ newsroom/press/ release/?id=e1bfeed3-75b84945-81bdFor the Congressional Budget Office report see http://www. cbo.gov/publication/43268
Vivien Marx
Manuel Balce Ceneta/AP/Press Association Images
In a 387–5 vote, the US House of Representatives in Washington, DC, passed its version of the Food and Drug Administration (FDA) Reform Act last week. “This vote signals support for innovation and access to safe and effective medical products”, FDA Commissioner Margaret Hamburg said in a statement after the House vote. Unlike the country’s previous budget squabbles, the Democrats and Republicans cooperated to pass the House bill, which is similar to the one that sailed through the US Senate the week before the House vote. Chairman Tom Harkin, a Democrat, and Ranking Member Mike Enzi, a Republican, of the Senate Health, Education, Labor and Pensions Committee, issued a joint statement lauding how the Senate bill overcame “election year politics and partisanship”. Now the two bills are headed to conference to align them, which is expected to be an easy process. According to House leaders, agreement could come together in a final bill before the July 4 congressional recess. The bill modifies the FDA’s regulation of drugs and devices in a broad range of areas. It renews mandated user fees for companies to accelerate evaluation of drugs and devices through the FDA and also adds new fees; requires companies to inform the FDA of looming drug shortages; changes the market entry timing for lower-priced generic drugs and biosimilars; sharpens punishment for drug counterfeiting; and gives the FDA authority to inspect manufacturing facilities outside the USA. Both bills, the House and Senate versions, are slated to bring US$6·4 billion from user fees into FDA coffers over 5 years, beginning in 2013. Around $4·1 billion will come from brand-name drug makers, which is 6% more than they have
FDA commissioner Margaret Hamburg welcomed the latest vote on the Reform Act
2135