|
|
|
We look back on the BIO Patient Advocacy Changemaker Event (PACE) in Washington, D.C.—here’s what we learned. (700 words, 3 minutes, 30 seconds) |
|
|
|
What we learned at this week’s BIO Patient Advocacy Changemaker Event (PACE) |
|
|
Patient advocates fighting to improve access to innovative medicines by amplifying the patient voice met at BIO’s PACE in Washington, D.C., this week and shared challenges and opportunities. A few of the topics discussed include:
PDABs: There is still a growing threat to patient access from state boards to control prices, but officials are beginning to listen when patients explain the problems caused by PDABs. Read more.
IRA: The Inflation Reduction Act (IRA) is increasingly impacting patient access through tighter utilization management by insurers, advocates said. Meanwhile, there are concerns that delayed reimbursements will hurt small community pharmacies—and by extension patient access.
340B: Though Congress created this program to help safety-net hospitals care for underinsured patients, it became a profit generator for wealthy hospitals. Patient advocates want reform.
Medicaid cuts: The pain of reduced federal funding will play out in state legislatures as Medicaid budgets are cut, but advocates urged push-back through patients’ stories. Read more.
Vaccine hesitancy: Several things this year have mobilized advocates to try to protect vaccine access at the state and federal level, said Phyllis Arthur, BIO EVP & Head of Healthcare Policy and Programs, who moderated a panel on vaccines. Read more.
Small but mighty miracles: While Genetically Targeted Technologies work wonders, the Inflation Reduction Act (IRA) restrictions on small molecule drugs make it hard to support the development of these innovations. The MINI Act is one proposed solution.
BIO’s view: “When we think about 21st-century access for patients, it's a constellation of policy challenges that need to come together to be truly addressed: the pediatric priority review voucher program, the PDUFA process, 340B reforms, the Safe Step Act, and more,” said Michele Oshman, BIO’s Chief Patient Advocate and Head, Patient Advocacy Center of Excellence. “We need to ensure that the policy that shapes the 21st-century innovation environment is also creating a 21st-century access environment for patients.” |
|
|
|
New CDER director’s fireside chat with BIO President and CEO John F. Crowley |
|
|
Dr. George Tidmarsh, the new Director of the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), joined a fireside chat with BIO President & CEO John F. Crowley. A few highlights are below.
Ways to speed approval: - Reforming Investigational New Drug applications: “There's a law about when you need an IND and when you don't need an IND.” Dr. Tidmarsh said. His team reviewed “applications for INDs that were actually already open, and we found about 20% were qualified to be exempt.”
- Streamlining paperwork: By rethinking the length of INDs and improving communication around new drug applications.
- Improving accelerated approval (AA): Using data from past AAs to determine which surrogate endpoints are meaningful. “The whole use of surrogate endpoints is mature enough that we can begin to do that analysis,” Dr. Tidmarsh said.
- Commissioner's National Priority Voucher pilot program, accelerating review for companies supporting national interests.
About those layoffs...Asking how to improve morale, “the message was clear that we need to reassure people, number one, that there weren't going to be any more reductions in force,” said Dr. Tidmarsh. “It was easy to communicate. It's always easy to communicate if you stick to the truth.”
Now they’re hiring: FDA is one of the few agencies allowed to add staff after the DOGE cuts—1,000 new drug reviewers, which benefits companies and patients, Dr. Tidmarsh said. Read more on Bio.News. |
|
|
|
ICYMI: What they’re saying at PACE |
|
|
|
|
|
|
|
|
|
|
|
|
|
