Legislation to reauthorize the Prescription Drug User Fee Act (PDUFA IV) will provide more tools and legal authority for the US Food and Drug Administration to monitor and mitigate drug risks, while also boosting user fees and extending several FDA programs. The bill, which the Congress is expected to finalize by the end of this month, implements an FDA–industry user fee agreement issued in January, and a similar plan for medical devices. Additional provisions renew incentives for manufacturers to study pediatric uses of drugs and establishes such incentives for medical devices.

The US Food and Drug Administration plans to shut down its regional offices and some additional field facilities, a move that reflects an ever-tightening squeeze on agency funding and staff. FDA also seeks to make more efficient use of its limited resources by establishing risk-based approaches for selecting those drug-manufacturing sites most in need of frequent oversight, while reducing inspections for less risky facilities. More highly trained inspectors will be able to assess modern manufacturing systems with greater efficiency, and field staff will collaborate better with reviewers in FDA Centers to understand company quality-control systems better.

View Full Article

Regulating and monitoring clinical trials has become an increasingly complex and challenging business for the Food and Drug Administration and other government agencies that fund and oversee biomedical research. There are more clinical studies in the United States and abroad, many involving multiple sites, complex study designs, and more research participants. Many studies deal with complex biotech therapies, medical devices, and combination products and call for greater participation of vulnerable subjects, including children.

Efforts to better manage the flood of data from these research programs is generating a number of electronic record keeping and processing methods and systems that, in turn, require new rules. These developments impose new challenges for IRBs and research institutions, which continue to evolve to meet new requirements.

The development of more complex therapies to treat chronic illnesses and complex diseases warrants a whole new approach to testing and regulating prescription drugs, according to a much anticipated report from the Institute of Medicine (IOM). Several high-profile drug withdrawals and safety alerts in recent years have undermined public confidence in the Food and Drug Administration and the pharmaceutical industry and raised concerns about the agency's ability to assure the safety of critical medicines, according to a panel of health experts assessing "The Future of Drug Safety." The study says that FDA needs more funding, stronger regulatory authority, and many internal reforms to enhance its ability to monitor and implement changes in drug use after a product comes to market.

View Full Article

As the Food and Drug Administration celebrated its 100th birthday in June, it unveiled a major initiative for overhauling how it regulates clinical trials and protects participants in research studies. In outlining the plan for the Human Subject Protection and Bioresearch Monitoring (HSP/BIMO) initiative at the annual meeting of the Drug Information Association (DIA), Deputy Commissioner for Operations Janet Woodcock noted that it reflects the emergence of an "increasingly large, decentralized, and global" research enterprise. She cited the need to respond to dramatic changes in the nature and conduct of clinical research characterized by:

a steady increase in the number of clinical trial studies and sites in the United States and abroad
larger trials involving many small, individual sites
proliferation of different electronic record-keeping methods and systems for data collection and processing

Yes, the US Food and Drug Administration has issued its long-awaited task force report and has stated: "We continue to believe that RFID is the most promising technology for implementing electronic track and trace in the drug supply chain and that the stakeholders should move quickly to implement this technology." No, it's not a mandate, but it's clearly an "almost." The June 8, 2006 Drug Taskforce Report has the makings of becoming a high-level doctrine toward building a more secure and dependable system for safeguarding the drug supply chain.

Baby steps. With more than 24 months of in-depth research, the taskforce has been examining RFID technology and the search for the Holy Grail: an e-pedigree solution that will stem the tide of drug counterfeiting, black marketing, gray market diversion, and tampering.

April 1 is usually a day to expect the unexpected. However, on April 1, 2005, the U.S. Food and Drug Administration (FDA) released the "Guidance for Industry, Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics."1 The document describes the agency's "current thinking" while providing "recommendations to sponsors on endpoints for cancer clinical trials submitted to the FDA."

The following article explores the impact this guidance is having on the clinical research industry and the increasingly important role that imaging has in the assessment of cancer tumors.

View Full Article

After months of turmoil over drug safety, vaccine shortages, and pressure to import low-cost drugs from abroad, the Food and Drug Administration faces further internal upheaval. Commissioner Lester Crawford resigned abruptly in September after only two months in the top spot, generating considerable uncertainty about the future leadership of the agency. The White House quickly named Andrew von Eschenbach, director of the National Cancer Institute (NCI) at the National Institutes of Health (NIH), as acting FDA commissioner. Von Eschenbach agreed to drop day-to-day management of NCI after being blasted for proposing to lead both NCI and FDA. He faced clear conflicts of interest in advocating for speedy access to new cancer treatments while overseeing the assessment of safety and effectiveness in those therapies. Leading legislators have urged the White House to nominate a permanent, full-time FDA commissioner.

After months of delay, the Senate confirmed Lester Crawford in July as the official head of the Food and Drug Administration. Crawford's nomination had been put on hold as various legislators sought to pressure FDA to take action on pet issues, such as drug importing and approval of an over-the-counter version of the "morning-after" pill Plan B. Senate Finance Committee chairman Charles Grassley (R-Iowa) reflected general concerns about the agency in criticizing Crawford for not tackling drug safety failures and FDA's "structural, personnel, cultural and scientific problems."

In the end, Grassley and most Senators agreed with the leadership on both sides of the aisle that FDA would be better off with a permanent chief than without. Now it's up to the new commissioner to demonstrate that FDA decisions will be based on scientific and medical evidence —and not on pressure from industry or political leaders.