A great white shark swimming with a slight smile on its face just below the surface. The environment is the deep blue ocean. The shark looks to be in hunting mode.

Just When You Thought It Was Safe to Go Back into the Ocean!

With the User Fee negotiations complete, agreed upon by both FDA and industry and proposed bills ready for mark-up, it appears that now the Secretary of the Department of Health and Human Services (DHHS), Tom Price, is requesting that Congress consider raising the negotiated and agreed upon fees to be in line with the Trump budget.  Such a move could derail the timely passage of the User Fee reauthorizations.

The effort to make industry pay for all review and approval activities “to ensure 100% funding” of the FDA is, in my opinion, not only misplaced, but dangerous.  The FDA provides a service to the American people and that service is something that our taxes have paid for throughout history.  It is the extra stuff, the expedited reviews, the unanticipated workload, the new requirements that the current User Fee system is designed to cover, not the whole enchilada.  Having the FDA fully funded through fees may have an adverse impact on the number of players that can compete in the game.  As fees rise, new smaller entrants into the market may be priced out of the process with the chilling effect of increased prices as the field of competitors narrows.  Remember User Fees were to supplement appropriations, not replace them.  On one hand, the administration complains that the prices of drugs are too high, and then makes a move to propose and increase fees by 100%, Who does Mr. Price and President Trump think are ultimately going to pay for these increased fees?  Well, if they can’t figure it out, I’ll tell you – the American public.

I ranted about the money for the wall in previous posts.  We know that generic drugs save consumers $4 billion a week according to the Association of Affordable Medicines.  The more generics that get approved, the more that not only the paying public benefit, but also the Federal Government saves, since the government purchases a huge share of drugs for its Medicare, Medicaid, military, and VA programs.  Let’s take $1 billion off the wall and fund the entire FDA drug approval programs and adequately staff the Agency, so that additional savings can be realized.  Let’s not play “hide the salami”, folks- if you can get savings that far exceed your investment in a program, that seems to make more sense than creating inflated prices by passing through the costs to consumers.  It seems pretty simple to me, but then again, I don’t work in Washington.