Washington Editor

WASHINGTON - Recently proposed legislation could prove troublesome to drug companies that fail to comply with post-approval study commitments.

The measure, introduced here last week, would give the FDA authority to pull products from the market if drug makers shirk their Phase IV responsibilities. It follows a recent Government Accountability Office report that criticized the agency's ability to police products after they're approved. Notably, the GAO recommended that Congress give the FDA power to mandate post-approval safety studies. (See BioWorld Today, May 2, 2006.)

In response, Rep. Rosa DeLauro (D-Conn.) is seeking to empower the agency to require such studies when needed. Her proposed measure was offered as an amendment to the Fiscal Year 2007 Agriculture Appropriations bill during a House Appropriations Committee hearing, and the language now is part of that bill.

The amendment from DeLauro, who said "problems plaguing this agency far exceed anything that can be fine tuned in the system," would allow the FDA to begin proceedings to remove a drug from the market should its maker refuse to carry out its agreed-upon post-approval study. She said the fact that nearly two-thirds of such studies still are pending underscores the need for a fix.

"Many in Congress are willing to give this agency the legal authority it needs to increase oversight of drug safety and uphold public health," DeLauro said.

She serves as the ranking member of the Agriculture Subcommittee of the House Appropriations Committee, which has FDA jurisdiction and oversight responsibilities. The House is expected to vote on the bill this week.

Presently, only accelerated approvals come with mandated Phase IV requirements.

NIH Begins Rare Study Initiative

The National Institutes of Health launched the first clinical studies of its Rare Diseases Clinical Research Network (RDCRN), which has received five-year funding awards totaling $71 million to investigate a variety of diseases that by definition affect fewer than 200,000 Americans.

The initiative includes interventional trials to test new therapies or drugs, as well as natural history studies that will provide information about the characteristics of rare diseases and their progression over time.

A central data and technology coordinating center and 10 research consortia will investigate diseases such as Angelman, Rett, Prader-Willi syndromes; myelodysplastic syndrome and other bone marrow failure conditions; lymphangioleiomyomatosis (LAM), rare genetic disorders of the airways and other rare lung diseases; episodic ataxia, Andersen-Tawil syndrome and nondystrophic myotonias; several vasculitides; urea cycle disorders; antiphospholipid syndrome and other rare thrombotic diseases; rare pediatric liver diseases; and rare genetic steroid defects.

More than 20 studies are expected to open in the next few months at about 50 sites across the U.S. and in several other countries, including the UK, Japan and Brazil. The RDCRN is coordinated primarily by two NIH components: the Office of Rare Diseases and the National Center for Research Resources.

FDA Examining Advisory Committees

The agency's Center for Drug Evaluation and Research (CDER) has begun an introspective look into its advisory committee meeting system to improve the process. Described as part of the FDA's broader effort to modernize the new drug review process, CDER's review will include the current practices for nominating members, choosing consultants appropriate for meeting topics, developing lists of competing products, screening for conflicts of interest and employing special government employees outside of an advisory committee meeting. At present, 16 advisory committees operate within CDER, which expects these efforts to take a year.

Agency Makes New Appointments

The FDA named Steven Kozlowski director of the Office Biotechnology Products within the Office of Pharmaceutical Science, after a year of serving in that post on an acting basis.

In addition, the FDA appointed Susan Walker director of its Division of Dermatology and Dental Products, which is housed within the Office of Drug Evaluation III in the Office of New Drugs at CDER.

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