Nordic Life Science 1
A University of Texas graduate, her no-nonsense a
nd straight-shooting way of speaking results in generous guidance on getting past the FDA gates. She says she wishes to assist other forward-thinking organizations, agency boards, and committees with the goal of influencing and optimizing health care product development – and improving public health for everyone. SO, HOW DO WE APPROACH THE FDA? Dr. Rose laughs as she says: “Do it cautiously. Very cautiously.” And she emphasizes that the key is in the science. ”You need data-driven evidence in scientifically-based research published in reputable journals.” As a medical epidemiologist, Rose has hands-on experience from both sides: the congressional branch as well as the executive one. She explains there is a joint interaction between the executive branch and the role of policy. “So, what did I learn in five years at Health and Human Services?” she asks rhetorically. “I truly got the culture of the FDA. The FDA has a certain number of days per year to work on applications. For devices, it is 180 days. Know your deadlines. Follow the rules. If you’re late… you’re too late.” She also advises people to use their time wisely: to ensure all the details on a given application are current and complete. “Whatever you do” she says, “don’t get blacklisted.” Rose speaks of the early AIDS epidemic. She was instrumental in licensing the first AIDS invention at the NIH to the private sector. Rose paints a complete picture of a time that is so palpable one can almost imagine being there. “In 1983 when young men in San Francisco were coming down with a type of sarcoma that was usually found in an older population, I wanted to help. The challenge was to come up with a diagnostic method to test for HIV.” She credits the academics behind the research and warns people not to be intimidated by the strict regulations of the FDA. “There is no doubt the FDA is hardworking and knowledgeable. But they are not the cutting-edge scientists out there. You guys are! Your task is to educate them.” IT IS NOT ALWAYS FAIR Go to a consultant to help with the process, Dr. Rose advises; however, never to an ex-FDA FDA Q&A’S 1. When to contact the FDA? “As soon as you think the invention is ready to go to the people.” 2. Whom should you contact? “A seasoned regulatory professional who is not a scientist, not the investor, nor the CEO. These people don’t have the skillset base that a seasoned regulatory professional would.” 3. How to contact the FDA? “Depending on the stage and division, there are three things you must consider: you must be very clear in the description of the device or product, the intended use and the indication for use, and the rationale behind why this drug is appropriate for the condition or diagnosis.” member. “A regulatory professional has only a specific set of skills. But you know your product more than they do.” She explains: “As a sponsor, you can request who you want to review your application. But, how would you know whom to request?” Dr. Rose says it’s all dependent upon the consultants you hire and the companies with which you are working. There are a number of things one must consider: How can you ensure a successful meeting? How can you prepare? What questions should be asked? What is the background information that is needed? Dr. Rose says everything boils down to situational issues: “For example,” she says, “if the FDA is under a mandate – and they’ve been followed.” She says those at the FDA are not big gamblers: “If it’s a high-profile case or a high-risk drug, the FDA is going to want to weigh on the safer side. The safer horse to bet on is the first one out of the gate.” She also says the FDA will be quicker to consider a larger company that can legally cover itself as well as the FDA. Again, she states: “It is not always fair, but it is the reality. “A smaller company doesn’t have the large distribution that a bigger company would. “Is the process fair?” she asks. “Not necessarily. But, is it real? Yes.” PEOPLE WHO ADVISE THE FDA COULD ALSO ADVISE YOU Dr. Rose also encourages companies to seek thought leaders in the field “who are not FDAers”. “An ex-FDA’er is still an FDA’er.” But a member or former member of the FDA advisory board may have crucial information to which you would not otherwise be privy. People who advise the FDA could also advise you. What does that mean? That it’s a good idea to find someone who may be or who has recently been a member of the FDA advisory board: perhaps even someone who has just stepped down. “Bringing in a thought leader with you carries a lot of weight with the FDA. Always try to put them on your sponsor team. If you don’t know of any, know this: the FDA has advisory committees and the people on those advisory committees will know the concerns of the FDA and how those problems have been resolved. They possess the insight that you would otherwise not have access to.” NLS