Food and Drug Administration Safety and Innovation Act (S. 3187 / H.R. 5651)

June 20, 2012

The United States has been the global leader in the device and biopharmaceutical industries for decades. U.S. medical device-related employment totals over 2 million jobs and the biopharmaceutical industry is responsible for over 4 million U.S. jobs. But that leadership position is at risk. Patients, innovators, and job creators have testified that the lack of predictability, consistency, transparency, and efficiency at the Food and Drug Administration is driving innovation overseas and threatening America’s leadership.

The FDA Safety and Innovation Act reauthorized FDA user fees to ensure the 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. The bill also took action to curb drug shortages and speed the approval of groundbreaking treatments that will save and improve lives.

Dozens of groups representing patients, hospitals, medical device and pharmaceutical companies have voiced their support for these reforms. The Alzheimer’s Association wrote, “reauthorization of the FDA user fee programs are vital to ensuring patient access to safe and effective new therapies and devices.” AdvaMed explained, "this legislation is good for FDA; it is good for industry; and most of all, it is good for American patients.”

The House unanimously approved the reforms on June 20, 2012, and President Obama signed the bill into law on July 9, 2012.

Legislative Summary

Title I: The Prescription Drug User Fee Act (PDUFA) Reauthorization

FDA will commit to attaining performance goals regarding the review of priority and standard drug applications. It also fosters greater interaction between drug sponsors and FDA and more engagement with patients, including those with rare diseases. To support these efforts, industry will pay over $700 million in FY 2013 and a higher amount in the remaining four years. 

Title II: The Medical Device User Fee Act (MDUFA) Reauthorization

FDA will make the following improvements to speed the review of medical devices, which have slowed in recent years, while maintaining patient safety: FDA will have to report its total time for reviewing devices; the review process will include greater interaction between sponsors and the agency; an independent entity will review the device approval and clearance process; and FDA will have to implement a corrective action plan to address deficiencies. To support these efforts, industry will pay $595 million in user fees for FY 2013-2017.

Title III: Generic Drug User Fee Act (GDUFA) Authorization

The 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) Authorization

This new user fee applies 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 will be set equal to the PDUFA rate for each type of fee, and the product development fee is 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 are permanently authorized, incentivizing testing to allow for the safe use of prescription drugs by children.

Title VI: Medical Device Regulatory Reforms

Title VI reforms 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 VII: Drug Supply Chain

Title VII implements reforms that allow FDA to deal with the increased globalization of drug manufacturing.

Title VIII: GAIN Act

The Generating Antibiotic Incentives Now (GAIN) Act includes incentives for the development of antibiotics to address the public health threat of antibiotic resistance.

Title IX: Drug Approval and Patient Access

Title IX protects American patients by expediting the availability of drugs for serious or life-threatening diseases or conditions.

Title X: Drug Shortages

Title X helps patients, hospitals, doctors, and nurses handle the current drug shortages crisis. The legislation includes reforms that 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. The title also establishes a task force to enhance HHS’ efforts to address shortages.

Title XI: Other Provisions

Title XI contains miscellaneous provisions to improve the administration of the FDA, ensure the FDA has access to the best scientific and medical expertise, and protect the public from dangerous synthetic drugs.