Passed in July 2012, the Food and Drug Administration Safety and Innovation Act has notably changed the Food and Drug Administration’s authority regarding the collection of fees, the manner in which reviews of drug applications are conducted, access of patients to medications, and the participation of stakeholders in the process.
The legislation is expected to affect domestic and foreign manufacturers of pharmaceuticals, devices, and biologics considerably in the coming years. As such, pharmaceutical executives should understand the impact of this legislation.
The Food and Drug Administration Safety and Innovation Act gives the Food and Drug Administration the authority to collect the following:
• User fees from manufacturers of prescription drugs
• Generic drugs
• Devices
• Biologics
• Biosimilars to fund reviews of innovator pharmaceuticals
• Devices which expedite patients' access to innovator pharmaceuticals that they determine to be safe and effective, increase the participation of stakeholders in the review process and make the supply pipeline for pharmaceuticals safer.
The legislation has changed the manner in which the Food and Drug Administration approves pharmaceuticals and the clinical trials that ascertain their safety and efficacy.
As a result of the act, pharmaceuticals designed to treat serious or life-threatening conditions could be designated as "breakthrough therapies," which enables their review and development to be expedited.
The act provides a new mechanism for devices to be approved, increases the FDA's ability to monitor pharmaceuticals after they have been marketed, decreases the length of time for scheduling appeals and providing decisions, and changed the process by which devices are reclassified.
The law also changes the reporting requirements regarding drug shortages and the guidelines regarding review of products that would avert a shortage. The legislation also requires the Food and Drug Administration to develop a risk-benefit assessment approach for when they evaluate pharmaceuticals and biologics.
As a result of the legislation, several existing laws, such as the Prescription Drug User Fee Act and the Medical Device User Fee Act, were updated and additional laws, such as Generic Drug User Fee Amendments of 2012 and the Biosimilar User Fee Act, were enacted.
These laws have provided funding that enables the Food and Drug Administration to focus more on the development of patient-centered drugs and devices. As part of the recertification of Prescription Drug User Fee Act, a review program for New Molecular Entities, New Drug Applications, and Biologic License Applications was also created.
The goal of this program is to make the first review cycle of these products more efficient and effective by shortening the review times and increasing the access of patients to these products.
Although not all of the of the objectives have been met at present, implementation of the Food and Drug Administration Safety and Innovation Act has increased approvals, decreased costs, and increased access to medications.
The legislation has also changed the Food and Drug Administration’s understanding of patients’ issues and the amount of time they spend collaborating with outside entities.
Food and Drug Administration Safety and Innovation Act has notably affected the approval, cost, and access to medications and devices. According to the Food and Drug Administration, review times for devices have decreased.
The agency has instated legal professionals and reviewers within the Office of Generic Drugs to decrease delays. Under the new review process for new molecular entities, pharmaceuticals, and biologics, Food and Drug Administration has approved new therapies ahead of the drug user fee dates. As such, the Food and Drug Administration Safety and Innovation Act has enabled the agency to approve applications faster.
The funding provided by the Prescription Drug User Fee Program has enabled the Food and Drug Administration to review more than fifty percent of the applications for generic pharmaceuticals, which has increased patients' access to inexpensive medications.
The funding has also enabled the Food and Drug Administration to provide input on more than ninety of the applications for biosimilars, which results in faster approvals and lower costs for patients.
The patient-focused drug development program has enabled the Food and Drug Administration to better understand perspectives from patients regarding diseases and their effect on patients' lives.
They have met with patients regarding at least eight diseases and plan to conduct meetings on more conditions. In September 2014, the Food and Drug Administration also published the Report on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies. In this report they identified four projects that should take precedence.
These included improving tools for:
• Counseling between patients and prescribers
• Assessing the feasibility regarding the accreditation of continuing education for the Report on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies
• Using structured product labeling to standardize information in the Report on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies so that it can be included into pharmacy systems, providing a central source for the Report on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies in practice settings.
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