BioMed Industry Requirements
Reading:
Requirements Unique to the Industry
- U.S. Food and Drug Administration (FDA) Regulation
- The FDA regulates medical devices, radiological health, over-the-counter and prescription drugs including biological therapeutics, and biological products including certain human cells and tissue products, medical test kits, and drug products. Specific products requiring FDA approval include color additives and new food additives.
- For new drugs, you must complete 3 phases of clinical trials. If the data shows the therapy is effective and safe, you submit a New Drug Application to the FDA
- If you need FDA approval for your product, start learning about it early in your business planning. You can begin with their website, fda.gov.
- The FDA sponsors workshops, conferences, and trainings.
- Health Insurance Reimbursement
- If your product is a biomedical treatment or device, make sure the health insurance companies will provide reimbursement for use of your product.
- If a medical procedure is involved, you may need to secure a new procedural code so health care providers can bill for the procedure, as well as FDA approval.
Scenario:
Name: Sarah Johnson, PhD
Sarah has applied for a patent for a novel method produced by Dr. Johnson (patent pending) to produce antiviral peptibodies and wishes to start a business to develop them. She hopes that they will be used to respond to new viral variants some day. She knows that it would involve a long process to get FDA approval and is just getting started looking into what is involved. A friend in pharmaceutical industry connects her with an expert in FDA approval process, David Wong, who agrees to take a short phone meeting with her and answer some basic questions.
Sarah: Thank you for agreeing to talk with me about FDA approval process, Dr. Wong..
Dr. Wong: Certainly, I am excited to hear about innovative ideas and want to support their development. What questions do you have?
Sarah: How long does it take for a new drug to get FDA approval?
Dr. Wong: It depends upon many factors, such as how novel a drug is and your approach is novel. It could take 10 years.
Sarah: The expense must be enormous, like millions of dollars!
Dr. Wong: Even billions.
Sarah: So how could a great idea thought of by one scientist like me ever reach and help patients?
Dr. Wong: Most biotech companies with ideas that look like they are going to succeed get acquired by pharmaceutical companies that have the resources and experience required to take a new drug to market.
Sarah: So are you saying I might as well sell my idea now?
Dr. Wong: That depends upon how much data you have to support the effectiveness and marketability of your novel method for producing the product.
Sarah: It sounds like what I need to to is start the business, obtain research and development funding, gather evidence that my method works, and then try to sell the idea to pharma.
Dr. Wong: I want to add that you don’t have to wait until you have collected all the evidence to start talking to pharma. Contact me again when you have completed more preclinical research, and I might be able to help make some connections.
Sara: Thank you Dr. Wong! You have been very helpful.
Dr. Wong: My pleasure.
Challenge:
FDA Approval
Tips:
- If you need FDA approval, seek help from attorneys and other expert consultants familiar with the process.
- Be sure to collect all of the data you will need for FDA approval or to support the adoption of a new insurance procedural code when you have the chance to collect it.
- For medical devices or treatments, determine whether your product fits within existing clinic protocols or whether a protocol change would be needed for your product to be adopted.
Read More:
- Industry-Specific Requirements, Licenses and Permits– Start here to find resources on FDA approval and health insurance reimbursement.
