''FDA user fee bill gives agency new powers to inspect overseas prescription drug plants''
"A Food and Drug Administration bill designed to increase inspections of foreign drug factories, while also speeding approvals of new drugs at home, is headed to the president’s desk after an overwhelming approval in the U.S. Senate.
The core of the bill is critical to the FDA: It bolsters the agency’s budget with billions of dollars in drug industry fees for scientists who review new medicines. For the first time, generic drugmakers will pay review fees to speed the approval of their products. Branded drugmakers have paid those fees for 20 years.
Lawmakers seized on the legislation to address recent concerns about the safety and quality of prescription medicines, especially those that are imported. The bill also gives the FDA new tools to fight counterfeiting and drug shortages, which have made headlines in the past year.
"This legislation will, for the first time, enable the FDA to regularly inspect foreign drug manufacturing facilities, which supply 80 percent of the ingredients in our medications,” said Allan Coukell, director of the Pew Charitable Trusts’ medical programs.
The risks of unchecked foreign drug manufacturing hit home in 2008, when hundreds of U.S. patients suffered allergic reactions — some fatal — to a blood thinner imported from China. An FDA investigation concluded the drug had been contaminated, to reduce costs, with an ingredient that mimics the blood thinner heparin.
- Date added:
- Jun 26, 2012
In response to final Senate passage of the Drug Quality and Security Act—legislation that establishes a national standard for tracing pharmaceuticals through the drug supply system and clarifies federal authority over pharmaceutical compounding—Allan Coukell, senior director of drugs and medical devices at The Pew Charitable Trusts, issued the following statement.More info
A year after a meningitis outbreak from contaminated pain injections killed at least 64 people and sickened hundreds, Congress is ready to increase federal oversight over compounding pharmacies that custom-mix medications.More info
It's been more than a year since a deadly fungal meningitis outbreak traced to a filthy New England compounding pharmacy put a shocking spotlight on the risks of medications mass-produced by underregulated firms.More info
Letter from Pew and The Pharmaceutical Distribution Security Alliance to Senate Leadership Calling for Passage of Track and Trace Legislation
Pew and the Pharmaceutical Distribution Security Alliance, or PDSA, PDSA have co-signed a letter asking Majority Leader Harry Reid (D-NV) and Republican Leader Mitch McConnell (R-KY) to pass The Drug Quality and Security Act (HR 3204), which would implement a “track and trace” system for the U.S. pharmaceutical distribution supply chain and enhanced federal oversight of compounding pharmacies to safeguard the nation’s drug supply against counterfeit and contaminated medicines.More info
A year after a deadly fungal meningitis outbreak tied to tainted pain shots, victims like Margaret Snopkowski say they remain devastated by the ordeal — but determined to rebuild their lives.More info
The Pew Charitable Trusts continues to call for passage of the Drug Quality and Security Act (HR 3204) in the Senate. The legislation would implement a "track and trace" system for the U.S. pharmaceutical distribution supply chain and establish enhanced federal oversight of compounding pharmacies to keep the nation’s supply of drugs and other pharmaceutical products as safe as possible and increase patient safety.More info
The following Q&A—prepared by the food and medical products programs at The Pew Charitable Trusts–helps explain how the federal government shutdown is affecting the U.S. Food and Drug Administration and other agencies and departments with responsibility to protect the public’s health.More info
The U.S. Food and Drug Administration (FDA) has issued a proposed rule that would require manufacturers of medical devices, with certain exceptions, to place a unique identifier on the label of medical devices. Some medical devices would also need to be directly marked with the unique identifier.More info
The Pew Charitable Trusts thanks congressional leadership for advancing patient safety by moving forward with legislation to implement a “track and trace” system to authenticate medicines through the U.S. pharmaceutical supply chain and enhanced federal oversight of pharmaceutical compounding. The Drug Quality and Security Act (H.R. 3204) is a tremendous victory in the bipartisan effort to improve oversight and strengthen the quality and safety of drugs in the United States. The legislation passed the U.S. House September 28 and now moves to the Senate, where supporters anticipate approval.More info
"A bipartisan committee of lawmakers from the Senate and the House reached a compromise on Wednesday on legislation that would give the Food and Drug Administration greater control over compounding pharmacies. But analysts said it was still unclear whether the law would actually make drugs safer."More info
Pew and the Pharmaceutical Distribution Security Alliance, or PDSA, are advocating for legislation to establish a single, rigorous and uniform supply chain standard for all participants, and to set up a system governing all elements of the chain: product manufacturers, primary and secondary wholesale distributors, logistics providers and pharmacies.More info