Earlier this month, I wrote a short post about the Food and Drug Administration (FDA). Let’s take another look:
FDA Still Quicker To Approve New Cancer Drugs Than Europeans…
This is good news! But I can’t help wondering if recent congressional budget cuts won’t slow us down, allowing the Europeans to catch-up…
FDA Approves Cancer Drugs Faster Than European Agency
Hope that isn’t the case. Are we really going to help our budget deficit by cutting cancer research and limiting the FDA’s ability to approve new cancer drugs quickly?
A week or so earlier, I responded to an email from Christine Murphy, Government Relations Director with the International Myeloma Foundation, asking her to highlight the risks cutting FDA funding might pose. Here was her response:
Thanks for your e-mail and I apologize for it taking so long to get back to you. As you know, FDA serves as the nexus between new scientific discoveries and routine cancer care as all new cancer treatments must be reviewed and approved by the FDA before being available to cancer patients.
New oncology drug applications are the most active area of FDA medical product regulation. In 1993 the overall approval times for new drugs was an average of 13.2 months to less than a year today. This drop in approval time means earlier access for patients to new cancer therapies. During this time, 1,010 new drugs and about 100 biologics were been approved including 62 new cancer drugs. It is estimated that there are over 800 new, potentially life-saving, cancer therapies (including for myeloma) currently in development.
It is imperative that the FDA have enough resources to see these new treatments through the approval process so they will be available to patients as soon as possible. While I don’t have specifics, it is safe to assume that a cut in funding could result a reduction in staff as well as the possibility that the approval times for new drugs including those for myeloma will increase. This would be detrimental to myeloma patients.
FDA is a critically important agency that has suffered a chronic lack of resources. To put the FDA’s budget in perspective, the entire budget for the Montgomery County school system in Maryland was $2.104 billion in FY 2011 while the FY 2011 allocation for the FDA was $2.457 billion. The Montgomery County school system serves 144,064 students in a Washington, DC suburb while the FDA is responsible for protecting the health of the entire nation by ensuring that our food supply is safe and that drugs and medical devices are safe and effective.
I’m working on getting more specifics on what the cut means for the FDA and I’m happy to answer any other questions you may have about FDA’s budget.
It would be unfortunate if newly developed anti-cancer drugs cannot be brought to market quickly. I will keep you updated. Feel good and keep smiling! Pat