Last week, FDA posted a slew of testimony that was submitted before Congress. In reverse order, Steven Galson testified before the Senate Special Committee on Aging on "Bio-Identical Hormones: Sound Science or Bad Medicine" on April 19. The day before, Dr. Jesse Goodman testified before the Committee on Homeland Security, Subcommittee on Emerging Threats, Cybersecurity, and Science and Technology on "FDA’s Role in the Regulation of Vaccines".
On the 17th of April, Theresa M. Mullin, Ph.D., Assistant Commissioner for Planning offered testimony before the House Subcommittee on Health, Committee on Energy and Commerce on the Prescription Drug User Fee Act. Time and space do not permit an in-depth look at all three, though it is commendable that the agency posted these in a timely fashion. Given the expediency of the issue, perhaps it is best to look at the last one involving PDUFA.
The testimony included the usual litany of past PDUFA achievements and then looked at four specific areas for PDUFA IV funding:
- Ensuring Sound Financial Footing – No surprises here – resources have not kept up with costs. The current system does not allow for payroll cost increases, only pay increases – so things like healthcare coverage, retirement benefits, etc, aren’t covered. The new system would cover total payroll costs.
- Enhancing Process for Pre-Market Review – This looks at two areas and in particular seeks to add additional initiatives to help expedite drug development by adding staff.
- Modernizing and Transforming Post-Market Drug Safety System – This is something it seems everyone wants, it is just a matter of how. They say they are going to evaluate risk management interventions here, but not which ones. Are they going to finally see if Black Box Warnings actually have any impact? The details are a little vague here – with references to hiring additional outside research and adding staff and to identify best practices and to improve IT systems. Nothing too radical here.
- Reviewing DTC Advertising – This one interested me most because of the situation I’ve raised many times here regarding DDMAC – they are getting more money and doing less with it – at least as expressed in the issuance of Warning Letters. The interesting twist here is that rather than use regular PDUFA fees for this, they would be charging only those companies who want DDMAC to review their DTC ads prior to airing. So a company that asks for a review, pays for it. I suppose that would be insurance against a Warning Letter, but the agency hasn’t been issuing many Warning Letters, so what is the incentive for companies to pay this fee?
Have a good day all.