The FDA (Food and Drug Administration) is the regulatory arm of the United States Federal Government that promotes public health through the supervision of food and drug safety, cosmetics, dietary supplements, veterinary medicine, and many more facets of the health care industry. Their oversight helps ensure consumers are confident that the drugs and pharmaceuticals they use are both safe and effective. This is done by a four-stage review process that can be long, costly, and hard to navigate before a therapy or product or is allowed on the market. However, changes in the law have allowed some approvals of drug therapies to be streamlined and fast-tracked. Between 2015 and 2017, 64% of approved drugs have taken advantage of one or more faster review processes. The FDA has now attempted to streamline its approval process for new therapies. These processes are extremely complex and legally complicated. If you have a new drug therapy or product, you may qualify to take advantage of this streamlined FDA approval process. Contact an experienced attorney at The Law Office of Philip P. Crowley, LLC at (908) 663-8253 today to if you qualify for the new streamlined FDA approval process.
Understanding the FDA Approval Process
The timely and costly FDA approval process is broken into four stages of development:
- Pre-Clinical: The discovery and screening stage where the drug sponsor initially develops the new therapy, runs animal testing trials for safety, and begins the Investigational New Drug Therapy (IND) application to the FDA.
- Clinical: A three-phase process where clinical trial studies are held on patients to discern the safety, side effects, and effectiveness of new drug therapies. Phase 1 usually has 20-80 participants, and focuses on safety and side effects. Phase 2 has focuses on how well the drug treats the disease or condition it is being tested for against a placebo with hundreds of participants. Phase 3 of clinical trials is the largest, usually with thousands of participants, and continues to test a drug’s safety, efficacy, and reactions with other drugs.
- NDA Review: Once the clinical trials are concluded, an FDA review meeting will be held to prepare the drug’s sponsor for the submission of the New Drug Application (NDA). The application will be reviewed, along with the drug’s labeling, and a facility inspection. The NDA review concludes with the FDA either approving the drug therapy for use or issuing a rejection letter.
- Post-Marketing: After the FDA approves the use of a drug, the sponsor is required to continue to update the FDA on safety issues as part of a follow-up process. Some safety issues only become evident post-marketing. The FDA utilizes the manufacturer’s monitoring, as well as the FDA’s MedWatch that allows physicians and consumers to report safety issues. This may result in label changes, restriction of use, or in rare cases, withdrawal from the market.
How Can the FDA Approval Process be Completed Faster?
There are several pathways using special programs and designations that can expedite the FDA approval process. The experienced attorneys at The Law Office of Philip P. Crowley, LLC can help advise and complete the applications to begin one or more of the following accelerated review programs:
- Accelerated Approval: Originally launched in 1992, this program is primarily used to streamline the approval of drug therapies that treat a serious disease, or fill an unmet medical need. In 2012, the Food and Drug Administration Safety Innovations Act (FDASIA) expanded the program to allow the approval to be based on a “surrogate or intermediate clinical endpoint”. These are markers where the effectiveness of a therapy can be measured, such as the reduction of tumor size or the reduction of cholesterol, though they are not always true indicators of how well the treatment works. HIV and cancer drugs are two examples that have benefited from Accelerated Approval in the past.
- Fast Track: Drugs designated for the Fast Track program will facilitate a faster review and approval process for drugs that treat a serious condition or fill an unmet medical need. Several Covid-19 vaccines were developed using the Fast Track program.
- Breakthrough Therapy: A drug whose early clinical evidence demonstrates a substantial improvement over existing therapies of a serious condition, may apply for the Breakthrough Therapy designation. Once designated as a Breakthrough Therapy, the drug also has the benefit of being part of the Fast Track designation, and an organizational commitment with senior FDA managers.
- Priority Review: In 1992, the Prescription Drug User Act (PDUFA) was passed and created a two tiered review system. While the Standard Review has an expected action time of 10 months, applications designated as Priority Review can expect to be acted on within 6 months.
How an Experienced Attorney Can Help You Through the FDA Process
Navigating the FDA approval process for new drug therapies and pharmaceuticals, as well as food products, cosmetics, dietary supplements, medical devices, and veterinary products can be difficult and time-consuming. A skilled and experienced attorney who has an understanding of the FDA and how to navigate the application and review processes can streamline the entire experience. Getting your product approved for a Priority Review or designated for the Fast Track program can greatly reduce your time to market and save more lives sooner.
The Prescription Drug User Act and other laws have created several pathways to accelerate the FDA approval process. With more than three decades in the life sciences sector, The Law Office of Philip P. Crowley, LLC will help guide you through the entire process. From the Investigational New Drug Therapy application to the New Drug Application, to the exploration of the Accelerated Approval, Fast Track, or Priority Review programs, we can help guide you for reduced approval times. Every new therapy will have a different set of facts and circumstances, consulting with an experienced attorney can help ensure you understand all of your legal rights and those rights remain protected.
