"The Food and Drug Administration’s mandate is too important to be compromised by a clunky personnel system.
The FDA is charged with protecting the nation’s public health by ensuring the safety of food, drugs and medical devices, among other things. But in 2007, an agency panel found that the FDA’s “scientific workforce does not have sufficient capacity and capability” and the agency is “not positioned to meet current or emerging regulatory responsibilities.”
The Pew Charitable Trusts wanted to know if that’s still the case, because “FDA is critically important to protecting the public health,” said Kathleen Stratton, Pew’s director of the Innovate FDA Project. It asked the Partnership for Public Service to find out.
“FDA has made progress,” says the Partnership’s report, but the agency “continues to have significant workforce and management challenges in the scientific and medical arenas that need to be addressed.”
The Partnership released its study, “The State of the FDA Workforce,” (PDF) Tuesday. It cites several improvements the agency has made since 2007, including the use of visiting scientists, a fellowship program, new training for medical device reviewers, a peer review program and the return this year to the FDA of its human relations office, which had been centralized in the Department of Health and Human Services.
But the FDA’s HR system still isn’t the “well-oiled machine” Stratton says it needs to be."
- Date added:
- Nov 21, 2012
- Project:
- Innovate FDA
- Related Expert:
- Kathleen Stratton
Related Resources
''Let The Sunshine In: CMS Releases Transparency Rule''
"After 15 months of delay, the Centers for Medicare & Medicaid Services has finally released the long-awaited Sunshine Act rule, which establishes procedures for gathering and publishing data containing financial ties between physicians, teaching hospitals and drug and device makers, as well as group purchasing organizations."
More info''FDA Stakeholders Worry About Sequestration''
"Representatives from the FDA and industry expressed serious concerns about the potential impact of sequestration Monday, saying it's not a good time to shortchange the agency when it's under so much pressure to help bring innovative new drugs to market."
More infoA Healthy Dose of Bipartisanship
Passed by Congress on June 26 and signed by President Obama on July 9, the FDA Safety and Innovation Act will increase inspections of foreign manufacturers that supply 80 percent of the ingredients in our pharmaceuticals, putting American companies on the same footing as their foreign competitors. In addition, it requires drug makers to hold their suppliers to high standards.
More info''Drug, device reform gets bipartisan push''
"The U.S. Supreme Court's eagerly awaited Affordable Care Act ruling unfortunately overshadowed the unusually bipartisan work underway at the U.S. Capitol last week, where Congress finalized sweeping legislation crammed with smaller-scale but still vital health reforms."
More info''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."
More info''Study: FDA reviews new drugs faster than Europe, Canada''
"Researchers say the U.S. approved more new medicines in less time than Europe and Canada in the last decade, challenging long-standing criticisms that the Food and Drug Administration lags behind its peers in clearing important new drugs."
More infoFDA Reviews New Drug Applications Faster than European, Canadian Regulators
WASHINGTON—The U.S. Food and Drug Administration (FDA) approves new drugs more quickly than its counterparts in Europe and Canada, according to a new paper, “Regulatory Review of Novel Therapeutics Comparing FDA, EMA and Health Canada,” published online on May 16
More info''User Fees Clear E&C, But Waxman, Consumer Advocates Still Seek GAIN Changes''
"As FDA user fee legislation heads to the House floor, a key Democratic lawmaker called for antibiotic incentive to be focused on serious and life-threatening infections and an HHS directive to work on stewardship programs while the lead sponsor of antibiotic incentives pushed back against attempts to change the incentive structure outlined in the Generating Antibiotic Incentives Now section of the bill."
More info''Lawmakers to Tweak Antibiotic Incentives, Online Pharmacy Measures Prior to Full E&C Markup''
"House lawmakers said they will continue efforts to narrowly tailor antibiotic incentives and clarify an online pharmacy measure before the full Energy and Commerce Committee takes up FDA user fee legislation that gained bipartisan subcommittee backing Tuesday morning."
More infoTestimony before the Senate Committee on Health, Education, Labor and Pensions
Allan Coukell, Director of Medical Programs, Pew Health Group: Chairman Harkin, Ranking Member Enzi, and members of this committee, thank you for the opportunity to testify about the importance of the user fee agreement legislation to patients.
More info''FDA unveils user fee program for generic drugs''
"The Food and Drug Administration would collect hundreds of millions of dollars in new fees from pharmaceutical companies to help speed up the review of generic drugs ... "
More info
