History of Congressional Legislation for FDA

Several significant congressional legislative actions have directly affected the establishment, oversight authority, and processes of the US Food and Drug Administration (FDA).

As a component of professional regulatory competencies, it is important for a regulatory professional to be aware of the laws that affect FDA and what each Act accomplishes. Following is major legislation dating from the establishment of the Food, Drug, and Cosmetic Act in 1938. 

1938 to 2000 

Food, Drug, and Cosmetic Act (FDCA) of 1938 

The FDCA was a significant piece of legislation that gave the FDA authority to oversee the safety of food, drugs, cosmetics, and medical devices. 

It required drug manufacturers to demonstrate safety before marketing a product and prohibited false therapeutic claims. The FDCA also established the New Drug Application (NDA) process for drug approval and introduced requirements for labeling and advertising. 

Durham-Humphrey Amendment of 1951 

This amendment to the FDCA established a distinction between prescription and over-the-counter drugs. It authorized the FDA to regulate prescription drug labeling and required drugs to bear the legend: “Caution: Federal law prohibits dispensing without a prescription.” 

Kefauver-Harris Amendment of 1962 

The Kefauver-Harris Amendment strengthened drug regulation by requiring drug manufacturers to prove the efficacy of their products, in addition to safety, before marketing. 

It mandated informed consent for clinical trials, established Good Manufacturing Practices (GMPs), and increased FDA oversight of drug advertising. 

Medical Device Amendments of 1976 

These amendments to the FDCA expanded the FDA’s regulatory authority over medical devices. 

They introduced a classification system for medical devices based on risk, with different regulatory requirements for each class, established the requirement for premarket approval (PMA) for high-risk devices, and established performance standards for certain devices. 

Orphan Drug Act of 1983 

The Orphan Drug Act incentivized the development of drugs for rare diseases by providing tax credits, grants, and exclusive marketing rights to manufacturers. 

It defined “orphan drugs” as those intended to treat diseases affecting fewer than 200,000 people in the United States. 

Safe Medical Devices Act (SMDA) of 1990 

This act amended the FDCA to improve the safety and effectiveness of medical devices. 

It required device manufacturers to report adverse events and device malfunctions to the FDA, established unique device identifiers (UDIs) for tracking devices, and expanded the FDA’s authority to regulate device recalls. 

Prescription Drug User Fee Act (PDUFA) of 1992 

PDUFA was first enacted in 1992 and has been reauthorized multiple times since then. It imposes fees on drug manufacturers to fund the FDA’s drug review process, aiming to expedite the approval of new drugs. 

Food and Drug Administration Modernization Act (FDAMA) of 1997 

Though enacted in 1997, FDAMA’s effects were substantial in the early 2000s. It aimed to streamline FDA regulatory processes, promote innovation, and enhance patient access to new therapies. 

In addition, FDAMA introduced provisions such as the Accelerated Approval pathway for drugs addressing serious conditions, and the Prescription Drug User Fee Act (PDUFA) III. 

From 2000 to Present 

PDUFA Reauthorizations 

Reauthorizations occurred in 2002 (PDUFA II), 2007 (PDUFA III), 2012 (PDUFA IV), and 2017 (PDUFA V). Each reauthorization introduced enhancements to the drug review process, including improved communication between the FDA and drug sponsors, and the establishment of performance goals to expedite review times. 

Medical Device User Fee and Modernization Act (MDUFMA) of 2002 

MDUFMA was the first legislation to establish user fees for medical device applications to support the FDA’s review process. It aimed to expedite device approvals and enhance post-market surveillance. MDUFMA also mandated improvements in FDA processes and performance goals for device reviews. 

Medical Device User Fee Amendments (MDUFA) I to V: 

• MDUFA I (2002) marked the introduction of user fees for medical device applications, aiming to improve review efficiency. It aimed to expedite device approvals and enhance post-market surveillance and mandated improvements in FDA processes and performance goals for device reviews. 
• MDUFA II (2007) built upon MDUFA I, emphasizing performance goals and increasing FDA resources for device review. 
• MDUFA III (2012) focused on enhancing the predictability, consistency, and transparency of the device review process. 
• MDUFA IV (2017) further refined performance goals and metrics for device review, aiming to expedite access to safe and effective medical devices. 
• MDUFA V (2022) continued the trajectory of enhancing device review efficiency and strengthening post-market surveillance activities. 

Food and Drug Administration Amendments Act (FDAAA) of 2007 

FDAAA expanded the FDA’s authority in various areas, including drug safety. It required clinical trial registration and results reporting on ClinicalTrials.gov, established the Risk Evaluation and Mitigation Strategies (REMS) program, and authorized user fees for the FDA. 

Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 

FDASIA reauthorized user fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products. It also introduced breakthrough therapy designation, enhanced regulatory oversight of drug compounding, and promoted innovation in drug and device development. 

Drug Quality and Security Act (DQSA) of 2013 

DQSA addressed drug compounding and established a new category of compounders called “outsourcing facilities” that are subject to FDA oversight.  

It also created a track-and-trace system to enhance the security of the pharmaceutical supply chain, requiring the electronic tracing of prescription drugs from manufacturers to dispensers. 

21st Century Cures Act of 2016 

The 21st Century Cures Act aimed to accelerate medical product development and innovation, providing additional funding for medical research and FDA initiatives. It introduced the Regenerative Medicine Advanced Therapy (RMAT) designation to expedite the development and approval of regenerative medicine products, such as cell therapies and gene therapies. It also included provisions to streamline the FDA’s review of medical devices and promote the use of real-world evidence in regulatory decision-making. 

Conclusion

These Laws have played pivotal roles in shaping the FDA’s regulatory landscape, fostering innovation, and ensuring the safety and efficacy of drugs and medical devices for public health.