WASHINGTON - The FDA wants to better assist patients who have serious or life-threatening diseases access investigational treatments by improving its database of clinical trials.
Patients who cannot be treated with existing therapies or who do not meet eligibility requirements for certain drugs can gain information about ongoing clinical trials via the FDA's Clinical Trials Data Bank. The agency is looking for ways to increase and improve the information available and is asking interested parties to comment on proposals related to providing the information in a more straightforward and efficient way.
For example, the agency has established a web-based system in which firms can submit clinical trial information electronically. Companies are asked to submit a description of the location of the trial sites and a point of contact.
Once the information is entered, studies will be available to the public on ClinicalTrials.gov within two to five days. Information contained in the data bank is considered part of a long-term registry, which will remain available through accrual, analysis and even after the product is approved.
With the exception of the investigational new drug application number, the serial number and the FDA center designation, all information submitted to the system will be available to the public.
Beyond basic information about a trial, the agency encourages firms to submit more detailed notes including projected enrollment, as well as information about other trials under the IND, such as trials for a disease or condition that is not serious or not designed to test effectiveness.
The entire proposal is available on the Federal Register's website. Comments and suggestions will be accepted through March 27 via U.S. mail at the Division of Dockets Management, 5630 Fishers Lane, Room 1061, Rockville, Md. 20852.
Bush Requests Additional FDA Funds
Under the Bush administration, issues at the FDA are being taken into consideration as the agency's proposed budget is poised to increase by $25.6 million to total $216.7 for fiscal year 2005. (See BioWorld Today, Feb. 3, 2004.)
As part of the increase, FDA Commissioner Mark McClellan had requested an additional $5 million to help fund the agency's medical countermeasures program, which will require the FDA to devote more personnel to assist companies developing countermeasures and to implement regulations necessary for emergency use authorization of countermeasures.
According to McClellan's request, funds under the countermeasures heading are needed to:
Expedite the review of medical countermeasure NDAs, generic and over-the-counter drug applications
Conduct or continue studies for the plague
Increase drug review personnel with additional staff who have specific scientific expertise, such as in infectious diseases and radiation
Fund studies on animal models to determine the lowest effective antibiotic dose to treat pneumonic plague and to review available data that may lead to product labeling for plague indications
Determine better dosing requirements for humans through animal model studies for radiation-related countermeasures
Increase staff levels with reviewers and scientists who can focus time on application review of potential countermeasure products, product inspections and emergency preparedness
Drugs and biologics are not the only areas in need of attention or additional funding during times of terrorist threats. One of the big winners within the agency is the food division. In fact, food security initiatives at the FDA call for $181 million, a 56 percent increase over fiscal year 2004, to increase the number of inspections to 97,000 per year. Also, on a security note, the National Institutes of Health in Bethesda, Md. is expected to receive an increase from $121 million to $1.7 billion to help fund basic research on bioterror-related agents.
The FDA is expecting an increase next year in user fees of about $34.6 million for prescription drug review. Under the Prescription Drug User Fee Act (PDUFA), companies filing drug applications must pay fees. When the act was reauthorized (to become PDUFA III) in 2002, the government agreed to increase fees every year over the next five years. Fees are generally about $300,000 for an application, and are expected to reach $400,000 in the near-term.
In other business, the FDA says it needs upward of $20 million in fiscal 2005 to move the Center for Drug Evaluation and Research to the new White Oak, Md., facility in April 2005. The move would impact some 1,700 employees.
At the NIH, officials are looking at a budget request of $28.8 billion for fiscal 2005. That represents an increase of $764 million, or 2.7 percent over last year. The funds will support a record total of nearly 40,000 research project grants in fiscal year 2005, including an estimated 10,393 new and competing awards, an increase of 258 over fiscal year 2004, according to documents released by the department of Health and Human Services.
NIH's budget also includes $2.9 billion for HIV/AIDS-related research.
On The Move In Washington
When Carl Feldbaum, president of the Biotechnology Industry Organization, announced his plan to retire this year at age 60, he told BioWorld Today 2004 will be a good year to recruit new talent because high-caliber, high-profile political people often change jobs in an election year. (See BioWorld Today, Feb. 3, 2003.)
Indeed, while Feldbaum's replacement likely won't be named for several months, there's gossip around Washington that Alan Holmer's replacement has been picked.
Like Feldbaum, Holmer, president of the Washington-based Pharmaceutical Research and Manufacturers America (PhRMA), announced his retirement earlier this year. Recently it has been reported that U.S. Rep. Billy Tauzin (R-La.) is considering taking the position as PhRMA's president. This week Tauzin resigned as the chairman of the House Energy and Commerce Committee.
Meanwhile, it also has been reported that Tommy Thompson, HHS secretary, has put FDA Commissioner Mark McClellan's name in the hat to head the Centers for Medicare and Medicaid Services. Thomas Scully, the last CMS commissioner, resigned in December to take a position in the private sector with a Washington-based law firm.