The United States has led the global medical device and biopharmaceutical industries for decades. This leadership has made the U.S. the medical innovation capital of the world, bringing hundreds of thousands of high-paying jobs to our country and life-saving devices and drugs to our nation’s patients.
U.S. medical device-related employment totals over 2 million jobs, and these are good, rewarding jobs as employees in the device industry earn an average of $60,000 per year. The U.S. biopharmaceutical industry is responsible for over 4 million U.S. jobs.
Unfortunately, our nation’s device and biopharmaceutical leadership is under threat. Because of the lack of predictability, consistency, transparency and efficiency at the Food and Drug Administration, U.S. device and drugs jobs have gone overseas and foreign patients, not U.S. patients, have been the first to benefit from U.S. innovation
Legislation to reauthorize FDA user fees will ensure continuation of various FDA programs and the creation of new ones to facilitate the review and approval of life-saving and life-improving drugs and medical devices. As part of the agreement, FDA will commit to certain performance goals, fostering more interaction, predictability, and certainty between industry and FDA. The legislation also includes reforms to ensure patients receive quality care and timely access to new therapies while promoting innovation and job creation.
Title I: The Prescription Drug User Fee Act (PDUFA) ReauthorizationFDA would commit to attaining performance goals regarding the review of priority and standard drug applications. It also would foster greater interaction between drug sponsors and FDA and more engagement with patients, including those with rare diseases. To support these efforts, industry would pay approximately $713 million in FY 2013 and a higher amount in the remaining four years. Title II: The Medical Device User Fee Act (MDUFA) ReauthorizationFDA would make the following improvements to speed the review of medical devices, which have slowed in recent years, while maintaining patient safety: FDA would have to report its total time for reviewing devices; the review process would include greater interaction between sponsors and the agency; an independent entity would review the device approval and clearance process; and FDA would have to implement a corrective action plan to address deficiencies. To support these efforts, industry would pay $595 million in user fees for FY 2013-2017. Title III: Generic Drug User Fee Act (GDUFA) AuthorizationThe FDA will provide faster and more predictable review of generic drug applications and increased inspections of drug facilities, facilitated by approximately $1.5 billion over five years from the generic drug industry. Title IV: Biosimilars User Fee Act (BSUFA) AuthorizationThis new user fee would apply to products approved under the abbreviated approval pathway for biological products shown to be biosimilar to an FDA-licensed biologic. It authorizes four types of fees: application, product, establishment, and biosimilar product development. The first three would be set equal to the PDUFA rate for each type of fee, and the product development fee would be set at 10 percent of the PDUFA application fee. Title V: Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA) BPCA and PREA would be permanently authorized, incentivizing testing to allow for the safe use of prescription drugs by children. Title VI: FDA Administrative Reforms Title VI would change FDA’s guidance process to encourage public participation and congressional oversight and improve FDA’s conflict of interest rules to ensure the agency has access to the most knowledgeable scientific experts. Title VII: Medical Device Regulatory Reforms Title VII would reform FDA’s medical device review process to build additional certainty, predictability and transparency into the process. Many of these reforms were based on suggestions from patients and innovators who shared first-hand experiences of how the current system hinders patients’ access to American innovation. Title VIII: Drug Regulatory ReformsThe legislation includes numerous provisions to improve the drug approval process including for drugs that treat rare diseases, and streamlining and modernizing the regulation of medical gas.
The legislation also includes incentives for the development of antibiotics to address the public health threat of antibiotic resistance.
Title VIII would protect American patients by implementing reforms that would allow FDA to deal with the increased globalization of drug manufacturing.
Title IX: Drug ShortagesTitle IX would help patients, hospitals, doctors, and nurses handle the current drug shortages crisis. The legislation includes reforms that would require the FDA inform the public through a drug shortages list, alleviate shortages by modifying current reporting requirements and expediting the approval of drugs in need, and work to prevent a future crisis by authorizing GAO to conduct a study to examine the causes and make recommendations to prevent a shortage.
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