How to Make Drugs A Little Less Expensive
More government isn't generally a better thing, but ...
FDA Commissioner Scott Gottlieb is making it his agency's business to ensure that generic drugs get to market sooner. This is not outside FDA's purview, but it is a seeming expansion of FDA's motivation, which has traditionally been on safety and effectiveness, but which now includes the high cost of drugs as a barrier to access.
If consumers are priced out of the drugs they need, that’s a public health concern that FDA should address. ... Our plan has a number of different domains. Among them is a compilation of efforts to improve the efficiency of the generic drug approval process; and another is a group of policies aimed at closing loopholes that allow branded drug companies to game our rules in ways that forestall the generic competition that Congress intended.
Why would federal policy allow branded drug developers to keep a patent on a product that would cost magnitudes less were it able to be created by generic producers? That's like saying Alexander Graham Bell is the only one who can own a telephone company because he was the first to come up with the device. That sounds like a story that's already been told.
Gottlieb explains the biggest barriers to getting generics to market.
Some drugs lack generic competition because they cannot be measured through traditional in vivo bioequivalence (ed: testing that generics act the same as established drugs in live animals/humans) methods and there’s no efficient and convincing bioequivalence test method available.
In these instances, an applicant needs to conduct more extensive clinical endpoint testing to show bioequivalence of a generic drug to a brand-name drug. This can be burdensome and discourage generic product development. A further barrier to generic competition for certain complex drug products is the lack of established methods for showing the sameness of the active ingredient of a proposed generic drug to a brand-name drug for certain complex drugs.
Over the next year, FDA’s generic drug regulatory science program will work to identify gaps in the science and develop more tools, methods, and efficient alternatives to clinical endpoint testing, where feasible.
Sounds like government trying to tear down barriers to access. We'll wait and see how it plays out, but it'd be nice to be able to afford food AND medicine.
What are your monthly prescription drug expenses? Do you or can you use generics?