Summary
The FDA budget has important implications for the food, drug, and drug device industries.
Analysis
There is a pretty widespread consensus that FDA needs more money for food safety legislation- this will be be funded mostly
by some sort of user fee, similar to PDUFA, the Prescription Drug User Fee Act.
Similarly, that FDA has control over tobacco -and funding comes from users in the FDA tobacco bill.
So a significant source of new funding comes from user fees. These fees will be passed along to consumers. From a policy perspective, this is not a bad thing regarding tobacco, not so good, for food since it would be a regressive tax.
The budget also seeks (a relatively small amount of) funding for the FDA to develop policies to allow Americans to import drugs from other countries.
This sounds good, since it would (in the short term) allow consumers to get less expensive drugs. But in essence, we'd
be importing not only drugs, but price controls. This would have a terrible affect on innovation, and thus bad for public health
in the long run. (not many new drugs are developed for markets with price controls).
The budget would also fund an approach to approve follow on biologics, the equivalent of generics for biotech medicine. There's widespread
support for the need to do this- representing a balance between protection intellectual property rights and innovation, vs the goal of allowing
for lower cost medication -- that is safe-- taking into account how biologics are different in nature than traditional medicines- and can't simply be
copied the same way- as they are made by a biological process.
