Live Q&A: The FDA's accelerated approval pathway. Good for patients? Or a pharma end-around?
When drugs are FDA approved, doctors and patients have reason to believe that those decisions came as the result of intense scrutiny on both safety and efficacy. But is the FDA’s “accelerated pathway” being misused, possibly harming patients and enriching for-profit industry?
Join me tomorrow for a live Q&A with two experts on the FDA’s accelerated drug approval pathway.
When: Monday, October 23rd, 12:30pm ET.
Where: Instagram Live (follow @MedPage on Instagram).
Background: The FDA's accelerated approval pathway is a hot topic in health policy. Recent controversies include the approval of Aduhelm for Alzheimer's disease and the overdue market withdrawal of Makena (meant for preterm birth protection). Meanwhile, approvals for a number of indications for cancer drugs have been withdrawn in recent years after confirmatory trials failed to show benefit for patients.
While many criticize the process and have called on Congress to reform it, others (including patient advocates) see the pathway as an essential tool to bring much-needed therapies to market, especially for rare diseases where high-quality research is extremely challenging.
In this Instagram Live session, I’ll be joined by two experts to dive into the world of accelerated drug approval to share their perspectives and answer audience questions.
To join us, follow @MedPage on Instagram to tune in tomorrow, Monday October 23rd at 12:30 p.m. ET.
Do you have questions for our panel or experiences to share about this process? Share them in the comment section below!
A very important topic to address. Most of us with rare and serious chronic disabling diseases have a love/hate relationship with Big Pharma. As someone with the Progressive form of MS since 1985 (15% of the MS population) I went almost 15 years without being able to get ANY disease modifying drugs as damage accumulated. It was an internist who also had MS (RR form) who lied for me so I could try Copaxone. It wasn't very powerful and made no difference. Then about 6 years ago FDA approved the first DMD that could be used for folks like me with the Progressive form. I had MS for 32 damaging years with no help. For us Ocrevus has a 50% chance of elongating our lives. Which it has done for me as I was in end stages with impact on my diaphragm and autonomic system involving my heart, etc. On the dark side however, the first charge at a 6 month pop was $345,000. For most of my life car commercials dominated the commercials we all saw on network TV. In the last 5 years it is now pharmaceutical commercials. What does that tell you? Now that Big Pharma realized they can still make big $$$$ on us what does that do to the pressure on FDA?? What are the true serious side effects of these drugs that lower your immune system so drastically? How do we determine what diseases and level of disease should be using these drugs, and how does the potential for such exorbitant profit in the for-profit-industry corrupt the process of research and approval?
I will be with my students so hopefully we can see/read later. There is also lots of “noise”on a new variant in France, UK and US. Would appreciate anything you know.