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January 11, 2007



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FDA Proposes New Measures to Strengthen Drug Safety Under PDUFA Reauthorized User Fee Program
Proposed Recommendations Would Also Enhance Drug Development, Boost Reviews of TV Drug Commercials

The Food and Drug Administration (FDA) today proposed recommendations to Congress for the next reauthorization of the Prescription Drug User Fee program which, if adopted, would significantly broaden and upgrade the agency's drug safety program, increase resources for review of television drug advertising, and facilitate more efficient development of safe and effective new medications for the American public. To achieve these public health benefits, the agency proposes to recommend, as part of the reauthorization of the program, that annual user fee collections be increased to $392.8 million, an $87.4 million increase over the current base line.

The user fee program, which was first authorized by the Prescription Drug Use Fee Act (PDUFA) in November 1992, adds industry's funds to the agency's appropriations to help FDA's human drug review program achieve demanding performance goals. Over the years, the PDUFA programs, which have to be reauthorized by Congress every five years, have enabled the agency to dramatically reduce its review times for drugs and biological medications while increasing scientific consultations, clarifying issues involving drug development, and increasing oversight of postmarket safety.

"The proposed recommendations would support significant improvements in FDA's ability to monitor and respond to emerging drug safety issues, as well as continuing FDA's commitment to scientific improvements and streamlining the drug approval process," said HHS Secretary Mike Leavitt. "I commend FDA for the important progress they have made and look forward to working with Congress to ensure action on these proposals."

"In the last 14 years, three consecutive user fee programs — PDUFA I, II and III — have brought enormous public health gains to our and, indeed, the world's consumers, by helping FDA make increasingly complex medications available to patients faster than was ever possible before without sacrificing quality," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "Our proposed recommendations for PDUFA IV aim to top these accomplishments by achieving, above all, an impressive expansion and modernization of our drug safety system, and adding resources to enhance information technology initiatives."

To develop the proposal, FDA held a public meeting and other consultations with stakeholders, including organizations representing health care professionals, consumers, patient advocates, and regulated industry. These stakeholders urged the FDA to seek additional appropriated funds to strengthen its ongoing drug safety program. In addition, consumer groups favored the adoption of user fees to increase FDA's capacity for review of direct-to-consumer TV ads.

Based on these consultations and an analysis of its commitments and anticipated means, FDA proposes to recommend using the $87.4 million user fee increase for significant program enhancements. PDUFA IV is the mechanism for placing the drug review process on a sound financial footing. The following are the key components of the proposal:

Program enhancements: $37.9 million

The biggest recommended increase, of $29.3 million, would provide a major boost for FDA activities to ensure the safety of medications after they are on the market. The increased funds would be available for FDA drug safety activities for marketed medications throughout as long as they remain on the market and would increase FDA's drug safety capacity for surveillance including hiring an additional 82 employees to perform postmarket safety work. To that end, FDA also recommends elimination of a statutory provision under which PDUFA fees may be used to assess safety issues only during the first three years after the product's approval. The agency would also use the added resources to adopt new scientific approaches and improve the utility of existing tools for the detection and prevention of adverse events, for example obtaining access to the best available databases to better analyze drug safety signals.

Other enhancement proposals call for:

  • $4.6 million in new user fees and 20 employees to help expand FDA's implementation of guidance for FDA's reviewers (Good Review Management Principles) and develop guidelines for industry on clinical trial designs and other topics; and
  • additional $4 million to improve the information technology activities for human drug review by moving the agency and industry towards an all-electronic environment.

In addition, the FDA proposes to recommend creating a separate new user fee program to collect new fees from companies that seek FDA advisory reviews of their direct-to-consumer television advertisements. FDA anticipates that these fees will be $6.2 million in the first year and support 27 additional staff to carry out this review function.

Financial baseline: $49.4 million

Since the user fees collected have not kept up with the increasing costs of the program, FDA proposes to request several increases in user fees to stabilize PDUFA IV's financial base line, to be divided as follows:

  • $17.7 million to adjust the base amount for inflation and support increases in salaries and benefits;
  • $11.7 to ensure that the fees cover a share of increased rents and the costs of the agency's move to the new White Oak facility in Silver Spring, Md.;
  • $20 million in additional fees to cover significant increases in FDA's drug review workload that were incurred but not compensated for under PDUFA III, and are expected to continue.

FDA's PDUFA proposals will be presented to the public at a public meeting on February 16, 2007. After all public comments are evaluated and any appropriate changes made, final proposals will be submitted to Congress. PDUFA reauthorization would go into effect only after enacted by Congress and signed by the President.

For more information, The Federal Register Notice is available at http://www.accessdata.fda.gov/scripts/oc/ohrms/dailylist.cfm?yr=2007&mn=1&dy=16".

FDA's PDUFA proposals will be presented to the public at a public meeting on February 16, 2007. After all public comments are evaluated and any appropriate changes made, final proposals will be submitted to Congress.

To submit electronic comments on the documents, visit the FDA Dockets page. Written comments may be sent to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852. Comments must be received by Feb. 23, 2007 and should include the docket number 2007N-0005.


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